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Vital Signs (vital + sign)

Distribution by Scientific Domains

Medical Sciences	91%
Psychology	2%
Life Sciences	2%
Humanities and Social Sciences	2%

Distribution within Medical Sciences

Anesthesia & Pain Management	8%
Dermatology	6%
Obstetrics & Gynecology	2%
24 Other Subdomains	70%

Selected Abstracts

Evaluation of the disposable Vital ViewÔ laryngoscope

ANAESTHESIA, Issue 4 2001
apparatus
The Vital ViewÔ laryngoscope (Vital Signs, NJ, USA) consists of a plastic disposable blade containing a fibrelight and a non-disposable handle; there is therefore no need to sterilise the blade and no concern about disintegration of the fibrelight. In a random cross-over design, we compared the Vital View laryngoscope with a conventional metal fibrelight laryngoscope (Welch Allyn, NY, USA) in 100 patients. The Vital View laryngoscope produced a brighter field than the metal laryngoscope (p < 0.001), whereas there was no significant difference in the view of the glottis or the success rate of tracheal intubation. In no patient did any problem occur, such as damage to the laryngoscope blade or loss of light during laryngoscopy. In another 10 patients, prevention of light emission from the side of the laryngoscope blade reduced the brightness (p < 0. 01). This indicated that the brightness of the Vital View laryngoscope is produced by light emission not only from the tip of the blade but also from the side of the blade. Therefore, the disposable Vital View laryngoscope can be used as effectively as a conventional non-disposable laryngoscope. [source]

Early intervention with second-generation antipsychotics in first-episode psychosis: results of an 8-week naturalistic study

EARLY INTERVENTION IN PSYCHIATRY, Issue 1 2010
Richard C. Josiassen
Abstract Objective: The objective was to compare short-term effectiveness of aripiprazole with three other second-generation antipsychotics (SGAs) in the treatment of first-episode psychosis. Method: In a naturalistic, ,single-blind' design, 60 subjects experiencing their first psychotic episode were treated for 8 weeks with aripiprazole (n = 19), risperidone (n = 16), olanzapine (n = 14) or quetiapine (n = 11). Medication and dosing decisions were made by treating psychiatrists, constrained to once-a-day dosing, low initial doses and no clozapine. Weekly ratings were obtained using the Positive and Negative Syndrome Scale (PANSS), Simpson-Angus Rating Scale and Barnes Akathasia Rating Scale. Weight and vital signs were also collected weekly. Results: The group presented with severe psychotic symptoms (mean baseline PANSS total score of 105.2), which were reduced rapidly (P < 0.0005). The between-group and group by time interaction terms were non-significant. Similar reductions were seen across all PANSS sub-scales. At Week 1 the mean PANSS Activation Scale score was reduced more with olanzapine than in the other groups (P < 0.002). Few instances of extrapyramidal symptoms occurred; all were sporadic and did not require treatment. Group body weight increased by 7.3% over the study. Vital signs remained unchanged. Conclusions: Early intervention with low doses of four SGAs led to rapid symptom reduction in first-episode psychotic patients with severe psychopathology. Although no clear medication advantages were observed in the short term, longer duration studies with larger samples will be required for determining efficacy, rates of compliance, relapse prevention and diminished incidence of extrapyramidal signs and symptoms. [source]

A Combination of Midazolam and Ketamine for Procedural Sedation and Analgesia in Adult Emergency Department Patients

ACADEMIC EMERGENCY MEDICINE, Issue 3 2000
Carl R. Chudnofsky MD
Abstract Objective: To describe the clinical characteristics of a combination of midazolam and ketamine for procedural sedation and analgesia in adult emergency department (ED) patients. Methods: This was a prospective, observational trial, conducted in the ED of an urban level II trauma center. Patients , 18 years of age requiring procedural sedation and analgesia were eligible, and enrolled patients received 0.07 mg/kg of intravenous midazolam followed by 2 mg/kg of intravenous ketamine. Vital signs were recorded at regular intervals. The adequacy of sedation, adverse effects, patient satisfaction, and time to reach discharge alertness were determined. Descriptive statistics were calculated using statistical analysis software. Results: Seventy-seven patients were enrolled. Three were excluded due to protocol violations, three due to lack of documentation, and one due to subcutaneous infiltration of ketamine, leaving 70 patients for analysis. The average age was 31 years, and 41 (59%) were female. Indications for procedural sedation and analgesia included abscess incision and drainage (66%), fracture/joint reduction (26%), and other (8%). The mean dose of midazolam was 5.6 ± 1.4 mg and the mean dose of ketamine was 159 ± 42 mg. The mean time to achieve discharge criteria was 64 ± 24 minutes. Fivepatients experienced mild emergence reactions, but there were no episodes of hallucinations, delirium, or other serious emergence reactions. Eighteen (25%) patients recalled dreaming while sedated; twelve (17%) were described as pleasant, two (3%) unpleasant, three (4%) both pleasant and unpleasant, and one (1%) neither pleasant nor unpleasant. There were four (6%) cases of respiratory compromise, two (3%) episodes of emesis, and one (1%) case of myoclonia. All of these were transient and did not result in a change in the patient's disposition. Only one (1%) patient indicated that she was not satisfied with the sedation regimen. Conclusions: The combination of midazolam and ketamine provides effective procedural sedation and analgesia in adult ED patients, and appears to be safe. [source]

HELICOBACTER INFECTION IN CHILDREN WITH APPENDICITIS AND LACTOSE INTOLERANCE

JOURNAL OF GASTROENTEROLOGY AND HEPATOLOGY, Issue 12 2000
Eva J. Soelaeman
Helicobacter pylori eradication has been debated. Most investigators do not recommended treating the infection except in severe case. We report a unique case: H. pylori infection with appendicitis and lactose intolerance. Case report: A 6 year old girl was brought to children and maternity Hospital Harapan Kita due to abdominal pain and vomiting. She had 6- month history of epigastric pain. In the past 2 days, she suffered from abdominal pain arround Mc. Burney area. On physical examination, she was in pain. Her weight was 19 Kg. Vital signs were normal. Findings in heart, lung and extremities were also normal. Abdomen: severe pain in the epigastric and Mc. burney area.Laboratory investigations showed hemoglobin 12 g/dl, leukocyte 12800/ul. Platelets 289000/ul. Bleeding and clotting time were normal. Abdominal ultrasonography revealed inflammation of appendix with 9-mm diameter. Stool examination was normal.Appendectomy was done at the same time with esofagogastroduodenoscopy (EGD). On EGD, we found moderete anthral gastritis. On histopathological examination, we found H. pylori at antral of the stomach. Breath hydrogen test was positive. After H. pylori eradication and milk avoidance, abdominal pain has never occurred. Conclusion: Abdominal: pain is not specific for H. pylori infection. The pain caused by many diseases including H. pylori infection. In our case, we can control abdominal pain by H. pylori eradication. [source]

Vital signs for vital people: an exploratory study into the role of the Healthcare Assistant in recognising, recording and responding to the acutely ill patient in the general ward setting

JOURNAL OF NURSING MANAGEMENT, Issue 5 2010
JAYNE JAMES RN., Ortho.
james j., butler-williams c., hunt j. & cox h. (2010) Journal of Nursing Management18, 548,555 Vital signs for vital people: an exploratory study into the role of the Healthcare Assistant in recognising, recording and responding to the acutely ill patient in the general ward setting Aim, To examine the contribution of the Healthcare Assistant (HCA) as the recogniser, responder and recorder of acutely ill patients within the general ward setting. Background, Concerns have been highlighted regarding the recognition and management of the acutely ill patient within the general ward setting. The contribution of the HCA role to this process has been given limited attention. Methods, A postal survey of HCAs was piloted and conducted within two district general hospitals. Open and closed questions were used. Results, Results suggest that on a regular basis HCAs are caring for acutely ill patients. Contextual issues and inaccuracies in some aspects of patient assessment were highlighted. It would appear normal communication channels and hierarchies were bypassed when patients' safety was of concern. Educational needs were identified including scenario-based learning and the importance of ensuring mandatory training is current. Conclusions and implications for nursing management, HCAs play a significant role in the detection and monitoring of acutely ill patients. Acknowledgement is needed of the contextual factors in the general ward setting which may influence the quality of this process. The educational needs identified by this study can assist managers to improve clinical supervision and educational input in order to improve the quality of care for acutely ill patients. [source]

Open-Label Exploration of an Intravenous Nalbuphine and Naloxone Mixture as an Analgesic Agent Following Gynecologic Surgery

PAIN MEDICINE, Issue 6 2007
Assaf T. Gordon MD
ABSTRACT Objective., The purpose of this series was to explore a 12.5:1 fixed-dose ratio of an intravenous nalbuphine and naloxone mixture (NNM) for use in patients following gynecologic surgery. Design and Patients., Open-label, nonrandomized case series. The first series was a dose-ranging investigation for 12 patients following elective total abdominal hysterectomy or myomectomy. In this series, fentanyl was used for intraoperative analgesia, and patients were assigned to a lower NNM (2.5 mg/0.2 mg) or to a higher NNM (5 mg/0.4 mg) dose group. The second series evaluated the fixed dose of 5 mg nalbuphine/0.4 mg naloxone for four patients undergoing ambulatory gynecologic procedures. In the second series, no opioid agents were administered intraoperatively to eliminate the possibility of mu-opioid reversal by naloxone postoperatively. Outcome Measures., Pain control was assessed using a Verbal Pain Scale (0,10). Vital signs, side effects, and adverse events were recorded to determine drug safety. Results., In the first series, there were no adverse events; however, each patient required rescue medication (either morphine or fentanyl). In the second series, two of the four patients reported a reduction in pain following drug administration and did not require any further analgesic agents in the 3-hour postoperative period. One patient had an asymptomatic lowering of heart rate after receiving the drug. Conclusion., Additional research of the unique combination therapy of nalbuphine and naloxone is warranted to further determine its potential clinical efficacy and safety. [source]

Low Central Venous Pressure with Milrinone During Living Donor Hepatectomy

AMERICAN JOURNAL OF TRANSPLANTATION, Issue 4 2010
H.-G. Ryu
Maintaining a low central venous pressure (CVP) has been frequently used in liver resections to reduce blood loss. However, decreased preload carries potential risks such as hemodynamic instability. We hypothesized that a low CVP with milrinone would provide a better surgical environment and hemodynamic stability during living donor hepatectomy. Thirty-eight healthy adult liver donors were randomized to receive either milrinone (milrinone group, n = 19) or normal saline (control group, n = 19) infusion during liver resection. The surgical field was assessed using a four-point scale. Intraoperative vital signs, blood loss, the use of vasopressors and diuretics and postoperative laboratory data were compared between groups. The milrinone group showed a superior surgical field (p < 0.001) and less blood loss (142 ± 129 mL vs. 378 ± 167 mL, p < 0.001). Vital signs were well maintained in both groups but the milrinone group required smaller amounts of vasopressors and less-frequent diuretics to maintain a low CVP. The milrinone group also showed a more rapid recovery pattern after surgery. Milrinone-induced low CVP improves the surgical field with less blood loss during living donor hepatectomy and also has favorable effects on intraoperative hemodynamics and postoperative recovery. [source]

ORIGINAL ARTICLE: Optimal timing for the administration of intranasal dexmedetomidine for premedication in children

ANAESTHESIA, Issue 9 2010
V. M. Yuen
Summary Previous studies have shown that 1 ,g.kg,1 intranasal dexmedetomidine produces significant sedation in children aged between 2 and 12 years. This investigation was designed to evaluate the onset time. One hundred children aged 1,12 years of ASA physical status 1,2 undergoing elective surgery were randomly allocated to five groups. Patients in groups A to D received intranasal dexmedetomidine 1 ,g.kg,1. Patients in Group E received intranasal placebo (0.9% saline). Children from groups A, B, C, D and E had intravenous cannulation attempted at 30, 45, 60, 75 and 45 min respectively after intranasal drug or placebo administration. Vital signs, behaviour and sedation status of the children were assessed regularly until induction of anaesthesia. More children from groups A to D achieved satisfactory sedation at the time of cannulation when compared to group E (p < 0.001). The proportion of children who achieved satisfactory sedation was not significantly different among groups A to D. Overall 62% of the children who received intranasal dexmedetomidine had satisfactory sedation at the time of cannulation. The median (95% CI) time for onset of sedation was 25 (25,30) min. The median (95% CI) duration of sedation was 85 (55,100) min. [source]

Acidosis and Catecholamine Evaluation Following Simulated Law Enforcement "Use of Force" Encounters

ACADEMIC EMERGENCY MEDICINE, Issue 7 2010
Jeffrey D. Ho MD
ACADEMIC EMERGENCY MEDICINE 2010; 17:E60,E68 © 2010 by the Society for Academic Emergency Medicine Abstract Objectives:, Law enforcement authorities are often charged with controlling resisting suspects. These encounters sometimes result in the sudden and unexpected death of the suspect. Drug intoxication, excited delirium syndrome, or excessive uses of force are factors that are often blamed, but sometimes the mechanism of these deaths is not fully understood. It is possible that worsening acidosis or excessive catecholamine release play a part. The objective of this study was to determine the effect on markers of acidosis and catecholamines of various tasks intended to simulate common arrest-related situations. Methods:, Subjects were assigned to one of five task groups: 1) a 150-meter sprint and wall hurdle (simulated flight from arrest); 2) 45 seconds of striking a heavy bag (simulated physical resistance); 3) a 10-second TASER X26 electronic control device exposure; 4) a fleeing and resistance exercise involving a law enforcement dog (K-9); or 5) an oleoresin capsicum (OC) exposure to the face and neck. Baseline serum pH, lactate, potassium, troponin I, catecholamines, and creatine kinase (CK) were evaluated. Serum catecholamines, pH, lactate, and potassium were sampled immediately after the task and every 2 minutes for 10 minutes posttask. Vital signs were repeated immediately after the task. Serum CK and troponin I were evaluated again at 24 hours posttask. Results:, Sixty-six subjects were enrolled; four did not complete their assigned task. One subject lost the intravenous (IV) access after completing the task and did not have data collected, and one subject only received a 5-second TASER device exposure and was excluded from the study, leaving 12 subjects in each task group. The greatest changes in acidosis markers occurred in the sprint and heavy bag groups. Catecholamines increased the most in the heavy bag group and the sprint group and increased to a lesser degree in the TASER, OC, and K-9 groups. Only the sprint group showed an increase in CK at 24 hours. There were no elevations in troponin I in any group, nor any clinically important changes in potassium. Conclusions:, The simulations of physical resistance and fleeing on foot led to the greatest changes in markers of acidosis and catecholamines. These changes may be contributing or causal mechanisms in sudden custodial arrest-related deaths (ARDs). This initial work may have implications in guiding applications of force for law enforcement authorities (LEAs) when apprehending resisting subjects. [source]

Intracervical application of the nitric oxide donor isosorbide dinitrate for induction of cervical ripening: a randomised controlled trial to determine clinical efficacy and safety prior to first trimester surgical evacuation of retained products of conception

BJOG : AN INTERNATIONAL JOURNAL OF OBSTETRICS & GYNAECOLOGY, Issue 12 2005
Gabriel Arteaga-Troncoso
Objective To determine the therapeutic efficacy and safety of a nitric oxide (NO) isosorbide dinitrate donor to induce cervical ripening of women with missed abortions before surgical evacuation of the uterus. Design A prospective, randomised, double-blind controlled trial. Setting Tertiary referral maternity teaching hospital. Population Sixty women with missed abortions and no cervical dilation. Methods Women requesting surgical evacuation of the uterus were randomly selected to receive endocervical 80 mg/1.5 mL isosorbide dinitrate gel solution (n= 30) or 400 ,g/1.5 mL misoprostol gel solution (n= 30) every 3 hours to a maximum of four doses or until reaching cervical ripening. Vital signs and symptoms were recorded at baseline and then every 3 hours until finishing therapy. Adverse events, such as headache, abdominal pain, pelvic pain, backache, nausea and vomiting, were evaluated. Main outcome measures Probability of reaching cervical ripening >8 mm Hegar dilator; evaluated at 3, 6, 9 and 12 hours after application of isosorbide dinitrate or misoprostol. Results The probabilities of induction of cervical ripening by isosorbide dinitrate and misoprostol after four repeated doses at 3-hour intervals were significantly different (P < 0.001). Efficacy of therapy after 12 hours was 97% for the isosorbide dinitrate group and 70% for the misoprostol group. Systolic and diastolic blood pressures were lower after administration of isosorbide dinitrate than prostaglandin analogues. The difference in the mean systolic and diastolic blood pressure between treatment groups was greatest at 3 hours, with a difference of 7.7 mmHg (P < 0.001) and 5.9 mmHg (P < 0.003), respectively. The most frequent side effect associated with isosorbide dinitrate administration was headache, which occurred in 18 out of 30 patients, compared with only 5 out of 30 women in the misoprostol group [relative risk (RR) 2.41, 95% confidence interval (CI) 1.45,4.03, P < 0.001). Women treated with misoprostol reported mainly pelvic pain (RR 3.24, 95% CI 1.99,5.27, P < 0.001). Conclusions Intracervical administration of 80 mg isosorbide dinitrate in women with missed abortions appears to be effective for cervical ripening prior to surgical evacuation of the uterus. Differences in the incidence of non-serious adverse events are not likely to be clinically significant. [source]

TASER X26 Discharges in Swine Produce Potentially Fatal Ventricular Arrhythmias

ACADEMIC EMERGENCY MEDICINE, Issue 1 2008
Robert J. Walter PhD
Abstract Objectives:, Data from the authors and others suggest that TASER X26 stun devices can acutely alter cardiac function in swine. The authors hypothesized that TASER discharges degrade cardiac performance through a mechanism not involving concurrent acidosis. Methods:, Using an Institutional Animal Care and Use Committee (IACUC)-approved protocol, Yorkshire pigs (25,71 kg) were anesthetized, paralyzed with succinylcholine (SCh; 2 mg/kg), and then exposed to two 40-second discharges from a TASER X26 with a transcardiac vector. Vital signs, blood chemistry, and electrolyte levels were obtained before exposure and periodically for 48 hours postdischarge. Electrocardiograms and echocardiography (echo) were performed before, during, and after the discharges. p-Values < 0.05 were considered significant. Results:, Electrocardiograms were unreadable during the discharges due to electrical interference, but echo images showed unmistakably that cardiac rhythm was captured immediately at a rate of 301 ± 18 beats/min (n = 8) in all animals tested. Capture continued for the duration of the discharge and in one animal degenerated into fatal ventricular fibrillation (VF). In the remaining animals, ventricular tachycardia (VT) occurred postdischarge for 1,17 seconds, whereupon sinus rhythm was regained spontaneously. Blood chemistry values and vital signs were minimally altered postdischarge and no significant acidosis was seen. Conclusions:, Extreme acid,base disturbances usually seen after lengthy TASER discharges were absent with SCh, but TASER X26 discharges immediately and invariably produced myocardial capture. This usually reverted spontaneously to sinus rhythm postdischarge, but fatal VF was seen in one animal. Thus, in the absence of systemic acidosis, lengthy transcardiac TASER X26 discharges (2 × 40 seconds) captured myocardial rhythm, potentially resulting in VT or VF in swine. [source]

Olanzapine versus placebo in the treatment of psychosis with or without associated behavioral disturbances in patients with Alzheimer's disease

INTERNATIONAL JOURNAL OF GERIATRIC PSYCHIATRY, Issue 2 2004
Peter Paul De Deyn
Abstract Objectives Psychotic symptoms and behavioral disturbances are a concern in the care of elderly patients with Alzheimer's dementia (AD). This study was conducted to compare the efficacy of olanzapine versus placebo in patients with psychotic symptoms associated with AD in long-term or continuing-care settings. Methods Patients (n,=,652) with AD and delusions or hallucinations were randomly assigned to 10 weeks of double-blind treatment with placebo or fixed-dose olanzapine (1.0, 2.5, 5.0, 7.5,mg/day). Results Mean age was 76.6±10.4 years. Repeated-measures analysis showed significant improvement from baseline in NPI/NH Psychosis Total scores (sum of Delusions, Hallucinations items,primary efficacy measure) in all five treatment groups (p<0.001), but no pairwise treatment differences were seen at the 10-week endpoint. However, under LOCF analysis, improvement in the 7.5,mg olanzapine group (,6.2,±,4.9) was significantly greater than with placebo (,5.0,±,6.1, p,=,0.008), while endpoint CGI-C scores showed the greatest improvement in the Olz,2.5 olanzapine group (2.8,±,1.4, p,=,0.030) relative to placebo (3.2,±,1.4). There were significant overall treatment-group differences in increased weight, anorexia, and urinary incontinence, with olanzapine showing numerically higher incidences. However, neither the incidence of any other individual events, including extrapyramidal symptoms, nor of total adverse events occurred with significantly higher frequency in any olanzapine group relative to placebo. No clinically relevant significant changes were seen across groups in cognition or any other vital sign or laboratory measure, including glucose, triglyceride, and cholesterol. Conclusions While 1.0,mg olanzapine did not show significant differences from placebo, the 2.5,mg dose was a reasonable starting dose. Olanzapine at 7.5,mg/day significantly decreased psychosis and overall behavioral disturbances (NPI/NH, BPRS) and was well tolerated. Copyright © 2004 John Wiley & Sons, Ltd. [source]

Efficacy and safety of the dipeptidyl peptidase-4 inhibitor alogliptin in patients with type 2 diabetes inadequately controlled by glyburide monotherapy

DIABETES OBESITY & METABOLISM, Issue 2 2009
R. E. Pratley
Aim:, To evaluate the efficacy and safety of alogliptin, a potent and highly selective dipeptidyl peptidase-4 (DPP-4) inhibitor, in combination with glyburide in patients with type 2 diabetes inadequately controlled by sulphonylurea monotherapy. Methods:, After a 2-week screening period, adult patients 18,80 years of age entered a 4-week run-in/stabilization period in which they were switched from their own sulphonylurea medication to an equivalent dose of glyburide (open label) plus placebo (single blind). After the run-in period, patients were randomly assigned to double-blind treatment with alogliptin 12.5 mg (n = 203), alogliptin 25 mg (n = 198), or placebo (n = 99) for 26 weeks. The primary end-point was change from baseline to week 26 in glycosylated haemoglobin (HbA1c). Secondary end-points included clinical response rates and changes in fasting plasma glucose, ,-cell function (fasting proinsulin, insulin, proinsulin/insulin ratio, and C-peptide, and homeostasis model assessment ,-cell function), body weight, and safety end-points [adverse events (AEs), clinical laboratory tests, vital signs and electrocardiographic readings]. Results:, The study population had a mean age of 57 years and a mean disease duration of 8 years; it was well balanced for gender (52% women) and was mainly white (71%). The mean baseline HbA1c was approximately 8.1% in each group. Significantly greater least squares (LS) mean reductions in HbA1c were seen at week 26 with alogliptin 12.5 mg (,0.38%) and 25 mg (,0.52%) vs. placebo (+0.01%; p < 0.001), and more patients in the alogliptin 25-mg group had HbA1c levels ,7.0% at week 26 (34.8%, p = 0.002) vs. placebo (18.2%). Proportionately more patients in the alogliptin 12.5 mg (47.3%) and 25 mg (50.5%) groups had an HbA1c reduction ,0.5% from baseline compared with patients in the placebo group (26.3%; p < 0.001). Minor improvements in individual markers of ,-cell function were seen with alogliptin, but no significant treatment group differences were noted relative to placebo. Minor LS mean changes in body weight were noted across groups (placebo, ,0.20 kg; alogliptin 12.5 mg, +0.60 kg; alogliptin 25 mg, +0.68 kg). AEs were reported for 63,64% of patients receiving alogliptin and 54% of patients receiving placebo. Few AEs were treatment limiting (2.0,2.5% across groups), and serious AEs (2.0,5.6%) were infrequent, similar across groups, and generally considered not related to treatment. The incidences of hypoglycaemia for placebo, alogliptin 12.5 mg and alogliptin 25 mg groups were 11.1, 15.8 and 9.6% respectively. Conclusions:, In patients with type 2 diabetes inadequately controlled by glyburide monotherapy, the addition of alogliptin resulted in clinically significant reductions in HbA1c without increased incidence of hypoglycaemia. [source]

Early intervention with second-generation antipsychotics in first-episode psychosis: results of an 8-week naturalistic study

Enhanced Left Ventricular Endocardial Border Delineation with an Intravenous Injection of SonoVue, a New Echocardiography Contrast Agent:

ECHOCARDIOGRAPHY, Issue 8 2000
A European Multicenter Study
The safety and efficacy of SonoVue (also referred to as BR1), a new contrast agent for delineating endocardial border of the left ventricle after intravenous administration, was assessed. Two hundred and eighteen patients with suspected coronary artery disease undergoing fundamental echocardiography for the assessment of left ventricle were enrolled in a prospective multicenter, single blind, cross-over study with random sequence allocation of four different doses of SonoVue. Endocardial border definition in the apical and parasternal views was scored as O = not visible, 1 = barely visible, and 2 = well visualized before and after contrast enhancement. Analysis was performed by two pairs of off-site observers. Safety of SonoVue was also assessed. Results of our study indicated that the mean improvements in the endocardial border visualization score were as follows: 3.1 ± 7.8 (95% CI, 2.5 and 3.7) for 0.5 ml, 3.4 ± 8.0 (95% CI, 2.8 and 4.0) for 1 ml, 3.4 ± 7.9 (95% CI, 2.8 and 4.0) for 2 ml, and 3.7 ± 8.0 (95% CI, 3.1 and 4.3) for 4 ml (P < 0.05 for all doses from baseline). Changes from baseline in endocardial visualization scores were also seen in the apical views (P < 0.05) and they were dose-dependent (P < 0.001). Similar enhancements of endocardial visualization scores were observed in the apical views in patients with suboptimal baseline echocardiographic images. Diagnostic confidence for assigning a score and image quality also were significantly better following contrast enhancement. No significant changes in the laboratory parameters and vital signs were noted following contrast enhancement, and the side effects were minimal. It was concluded that SonoVue is safe and effective in delineating endocardial border, including in patients with suboptimal baseline images. [source]

Pain Scores Improve Analgesic Administration Patterns for Trauma Patients in the Emergency Department

ACADEMIC EMERGENCY MEDICINE, Issue 3 2004
Paul A. Silka MD
Abstract Objective: To determine the efficacy of pain scores in improving pain management practices for trauma patients in the emergency department (ED). Methods: A prospective, observational study of analgesic administration to trauma patients was conducted over a nine-week period following educational intervention and introduction of verbal pain scores (VPSs). All ED nursing and physician staff in an urban Level I trauma center were trained to use the 0,10 VPS. Patients younger than 12 years old, having a Glasgow Coma Scale score (GCS) <8, or requiring intubation were excluded from analysis. Demographics, mechanism of injury, vital signs, pain scores, and analgesic data were extracted from a computerized ED database and patients' records. The staff was blinded to the ongoing study. Results: There were 150 patients studied (183 consecutive trauma patients seen; 33 patients excluded per criteria). Pain scores were documented for 73% of the patients. Overall, 53% (95% confidence interval [CI] = 45% to 61%) of the patients received analgesics in the ED. Of the patients who had pain scores documented, 60% (95% CI = 51% to 69%) received analgesics, whereas 33% (95% CI = 18% to 47%) of the patients without pain scores received analgesics. No patient with a VPS < 4 received analgesics, whereas 72% of patients with a VPS > 4 and 82% with a VPS > 7 received analgesics. Mean time to analgesic administration was 68 minutes (95% CI = 49 to 87). Conclusions: Pain assessment using VPS increased the likelihood of analgesic administration to trauma patients with higher pain scores in the ED. [source]

Bispectral Electroencephalographic Analysis of Patients Undergoing Procedural Sedation in the Emergency Department

ACADEMIC EMERGENCY MEDICINE, Issue 6 2003
James R. Miner MD
Abstract Objective: To determine whether there is a correlation between the level of sedation achieved during procedural sedation (PS) in the emergency department as determined by bispectral electroencephalographic (EEG) analysis (BIS) and the rate of respiratory depression (RD), the patient's perception of pain, recall of the procedure, and satisfaction. Methods: This was a prospective observational study conducted in an urban county hospital of adult patients undergoing PS using propofol, methohexital, etomidate, and the combination of fentanyl and midazolam. Consenting patients were monitored by vital signs, pulse oximetry, nasal-sample end-tidal carbon dioxide (ETCO2), and BIS monitors during PS. Respiratory depression (RD) was defined as an oxygen saturation <90%, a change from baseline ETCO2 of >10 mm Hg, or an absent ETCO2 waveform at any time during the procedure. After the procedure, patients were asked to complete three 100-mm visual analog scales (VASs) concerning their perception of pain, recall of the procedure, and satisfaction with the procedure. Patients were divided into four groups based on the lowest BIS score recorded during the procedure, group 1, >85; group 2, 70,85; group 3, 60,69; group 4, <60. Rates of RD and VAS outcomes were compared between groups using chi-square statistics. Results: One hundred eight patients were enrolled in the study. No serious adverse events were noted. RD was seen in three of 14 (21.4%) of the patients in group 1, seven of 34 (20.6%) in group 2, 16 of 26 (61.5%) in group 3, and 18 of 34 (52.9%) in group 4. The rate of RD in patients in group 2 was not significantly different from that in group 1 (p = 0.46). The rate of RD in group 2 was significantly lower than that in groups 3 (p = 0.0003) and 4 (p = 0.006). For the VAS data, when group 1 was compared with the combined groups 2, 3, and 4, it had significantly higher rates of pain (p = 0.003) and recall (p = 0.001), and a dissatisfaction rate (p = 0.085) that approached significance. When groups 2, 3, and 4 were compared with chi-square test, there was not a significant difference in pain (p = 0.151), recall (p = 0.27), or satisfaction (p = 0.25). Conclusions: Patients with a lowest recorded BIS score between 70 and 85 had the same VAS outcomes as more deeply sedated patients and the same rate of RD as less deeply sedated patients. This range of scores represented the optimally sedated patients in this study. [source]

Bench to Bedside: Electrophysiologic and Clinical Principles of Noninvasive Hemodynamic Monitoring Using Impedance Cardiography

ACADEMIC EMERGENCY MEDICINE, Issue 6 2003
Richard L. Summers MD
Abstract The evaluation of the hemodynamic state of the severely ill patient is a common problem in emergency medicine. While conventional vital signs offer some insight into delineating the circulatory pathophysiology, it is often impossible to determine the true clinical state from an analysis of blood pressure and heart rate alone. Cardiac output measurements by thermodilution have been the criterion standard for the evaluation of hemodynamics. However, this technology is invasive, expensive, time-consuming, and impractical for most emergency department environments. Impedance cardiography (ICG) is a noninvasive method of obtaining continuous measurements of hemodynamic data such as cardiac output that requires little technical expertise. ICG technology was first developed by NASA in the 1960s and is based on the idea that the human thorax is electrically a nonhomogeneous, bulk conductor. Variation in the impedance to flow of a high-frequency, low-magnitude alternating current across the thorax results in the generation of a measured waveform from which stroke volume can be calculated by a modification of the pulse contour method. To adequately judge the possible role of this technology in the practice of emergency medicine, it is important to have a sufficient understanding of the basic scientific principles involved as well as the clinical validity and limitations of the technique. [source]

CLINICAL STUDY: Effect of saquinavir/ritonavir (1000/100 mg bid) on the pharmacokinetics of methadone in opiate-dependent HIV-negative patients on stable methadone maintenance therapy

ADDICTION BIOLOGY, Issue 3 2009
Candice Jamois
ABSTRACT This study was performed to determine the effect of two protease inhibitors, saquinavir (SQV, oral 1000 mg bid) boosted by ritonavir (RTV, oral 100 mg bid), on pharmacokinetics (PK) of methadone in opiate-dependent HIV-negative patients on stable methadone maintenance therapy. This was a two-center, open-label, one-sequence cross-over, multiple-dose study in 13 HIV-negative patients who were on stable methadone therapy (oral, 60,120 mg qd). All patients continued methadone treatment on days 2,15. All patients received SQV/RTV in combination with methadone from days 2,15. PK of methadone was assessed on day 1 (alone) and on day 15 when methadone treatment was combined with SQV/RTV at steady state. Twelve patients completed the study. Median age, body weight and height were 50 years (range: 24,54 years), 80 kg (range: 57,97 kg) and 174 cm (range: 163,189 cm), respectively. All patients were Caucasian, and 11 were smokers. Median methadone dose was 85 mg qd. Geometric mean area under curve of the plasma concentration-time curve over 24 hour dosing interval (AUC0,24 hour) ratio of methadone with and without SQV/RTV was 0.81% (90% confidence interval: 71,91%). There was no significant plasma protein-binding displacement of methadone by SQV/RTV. The combination of SQV/RTV and methadone was well tolerated. There were no clinically significant adverse events or significant changes in laboratory parameters, electrocardiograms or vital signs. The 19% decrease in R-methadone AUC0,24 hour in the presence of SQV/RTV was not clinically relevant. There appears to be no need for methadone dose adjustment when methadone (60,120 mg qd) and SQV/RTV (1000/100 mg bid) are coadministered. [source]

Long-Term, Open-Label Safety Study of Oral Almotriptan 12.5 mg for the Acute Treatment of Migraine in Adolescents

HEADACHE, Issue 5 2010
Frank Berenson MD
(Headache 2010;50:795-807) Objectives., This study evaluated the long-term safety of oral almotriptan 12.5 mg for the treatment of multiple migraine episodes in adolescents over a 12-month period. Efficacy outcomes were assessed as a secondary objective. Methods., Adolescent migraineurs aged 12-17 years were enrolled in this 12-month, open-label study (Study ID CR002827). Patients were instructed to record their assessments on paper headache records whenever they experienced a migraine headache that they treated with study medication. Safety was assessed descriptively and assessments included adverse event (AE) recording, change in laboratory values, vital signs, and electrocardiogram parameters. Efficacy outcomes were assessed descriptively and outcomes included rates for 2- and 24-hour pain relief and sustained pain relief, 2- and 24-hour pain-free and sustained pain-free, and presence of migraine-associated symptoms of photophobia, phonophobia, nausea and vomiting. Results., Overall, 67.1% of patients reported ,1 AE over the course of the trial, 7.6% had an AE judged by the study investigator to be related to treatment with almotriptan, 2.4% discontinued because of an AE, and 1.9% reported serious AEs. The most commonly reported treatment-related AEs (occurring in ,1% of patients) were nausea (1.4%) and somnolence (1.4%). Pain relief responses for treated migraines of moderate or severe intensity at baseline were 61.7% and 68.6%, at 2 and 24 hours, respectively; the sustained pain relief rate was 55.5%. Pain-free responses were reported for 40.5% of all treated migraines at 2 hours and 65.9% of treated migraines at 24 hours; the sustained pain-free rate was 38.4%. The proportion of migraines that achieved the pain relief, sustained pain relief, pain-free and sustained pain-free endpoints were similar in the 12- to 14-year and 15- to 17-year age groups. Treating with almotriptan 12.5 mg when headache pain was mild was associated with higher rates of pain relief and pain-free at 2 and 24 hours, and sustained pain relief and sustained pain-free, compared with treatment initiated when pain was severe. Conclusions., Almotriptan 12.5 mg was well tolerated in this adolescent population over a 12-month period. No unexpected safety or tolerability concerns were revealed over the course of this study. The results are consistent with almotriptan 12.5 mg being effective for the acute treatment of pain and symptoms associated with migraine in both younger and older adolescents. [source]

Divalproex Sodium Extended-Release for the Prophylaxis of Migraine Headache in Adolescents: Results of a Stand-Alone, Long-Term Open-Label Safety Study

HEADACHE, Issue 1 2009
George Apostol MD
Objective., The objective of this long-term open-label study in adolescents was to assess the safety and tolerability of divalproex sodium extended-release in the prophylaxis of migraine headaches. Background., Two formulations of divalproex sodium have demonstrated efficacy in the prevention of migraine headaches in adults. However, no medications are currently approved for this indication in adolescents, and long-term safety data on agents for migraine prevention are lacking for this younger population. Therefore, the current study was conducted to assess the long-term safety and tolerability of divalproex extended-release in adolescents with migraine headaches. Methods., This was a 12-month, phase 3, open-label, multicenter study of adolescents aged 12 to 17 years with migraine headaches diagnosed by International Headache Society criteria. Divalproex sodium extended-release was initiated at 500 mg/day for 15 days then increased to 1000 mg daily, with subsequent adjustments permitted within a dosing range of 250-1000 mg daily. Study visits were conducted at days 1 and 15 and months 1, 2, 3, 6, 9, and 12. Safety was evaluated by adverse event collection, laboratory assessments, physical and neurological examinations, vital signs, electrocardiograms, the Udvalg for Kliniske Undersøgelser Side Effect Rating Scale, the Wechsler Abbreviated Scale of Intelligence, and the Behavioral Assessment Scale for Children. Efficacy was evaluated by following the number of migraine headache days reported in subjects' headache diaries over sequential 4-week intervals for the duration of the trial. Results., A total of 241 subjects were enrolled and treated. The most frequently reported adverse events were nausea (19%), vomiting (18%), weight gain (12%), nasopharyngitis (11%), migraine (10%), and upper respiratory tract infection (10%). Ten (4%) subjects experienced serious adverse events, and 40 (17%) subjects discontinued because of an adverse event. Increases in ammonia levels were observed. No other clinically significant changes were observed in laboratory values, vital signs, rating scales, or electrocardiograms. Median 4-week migraine headache days decreased 75% between the first and the fourth months of the study (from 4.0 to 1.0) and remained at or below this level for the remainder of the study. Conclusions., In this long-term open-label study of adolescents with migraine, the safety and tolerability profile of divalproex sodium extended-release was consistent with findings from previous trials in adults, as well as 2 studies recently completed in adolescents. In general, divalproex sodium extended-release was well-tolerated in adolescents with migraine. [source]

Sumatriptan Nasal Spray in Adolescent Migraineurs: A Randomized, Double-Blind, Placebo-Controlled, Acute Study

HEADACHE, Issue 2 2006
Paul Winner DO
Objective.,To compare the efficacy and tolerability of sumatriptan nasal spray (NS) (5, 20 mg) versus placebo in the acute treatment of migraine in adolescent subjects. Background.,Currently, no triptan is approved in the United States for the treatment of migraine in adolescent subjects (12 to 17 years). In a previous randomized, placebo-controlled study of 510 adolescent subjects, sumatriptan NS at 5, 10, and 20 mg doses was well tolerated. However, the primary efficacy analysis for headache relief with 20 mg at 2 hours did not demonstrate statistical significance (P= .059). A second study was initiated to evaluate the efficacy of sumatriptan NS in this population. Methods.,This was a randomized (1:1:1), placebo-controlled, double-blind, parallel-group study. Overall, 738 adolescent subjects (mean age: 14 years) with ,6-month history of migraine (with or without aura) self-treated a single attack of moderate or severe migraine. The primary endpoints were headache relief at 1 hour and sustained relief from 1 to 24 hours. Pain-free rates, presence/absence of associated symptoms, headache recurrence, and use of rescue medications were also assessed. Tolerability was based on adverse events (AEs) and vital signs. Results.,Sumatriptan NS 20 mg provided greater headache relief than placebo at 30 minutes (42% vs. 33%, respectively; P= .046) and 2 hours (68% vs. 58%; P= .025) postdose, but did not reach statistical significance at 1 hour (61% vs. 52%; P= .087) or for sustained headache relief from 1 to 24 hours (P= .061). Significant differences (P < .05) in favor of sumatriptan NS 20 mg over placebo were observed for several secondary efficacy endpoints including sustained relief from 2 to 24 hours. In general, sumatriptan NS 5 mg percentages were slightly higher than placebo but the differences did not reach statistical significance. Both doses of sumatriptan NS were well tolerated. No AEs were serious or led to study withdrawal. The most common event was taste disturbance (2%, placebo; 19%, sumatriptan NS 5 mg; 25%, sumatriptan NS 20 mg). Conclusions.,This study suggests that sumatriptan may be beneficial to some adolescents and is generally well tolerated in the acute treatment of migraine in this population. [source]

Long-Term Tolerability of Sumatriptan Nasal Spray in Adolescent Patients With Migraine

HEADACHE, Issue 10 2004
Shankar Natarajan MD
Objective.,This 1-year, open-label, multicenter study was designed to assess the long-term tolerability and efficacy of sumatriptan nasal spray 20 mg in adolescent patients with migraine. Methods.,A prospective, multicenter, open-label study was conducted in patients aged 12 to 17 years who were allowed to treat an unlimited number of migraines at severe, moderate, or mild pain intensity with sumatriptan nasal spray for up to 1 year. All patients started the study at the 20-mg dose of sumatriptan nasal spray. Dose could be adjusted downward to 5 mg at the discretion of the investigator to optimize therapy. Results.,A total of 484 adolescent migraineurs treated 4676 migraines with sumatriptan nasal spray 20 mg (3593 during the first 6 months and 1083 during the second 6 months). A total of 3940 migraines and 699 migraines were treated with one and two 20-mg doses of sumatriptan nasal spray, respectively. Only 10 patients (treating 42 migraines) took the 5-mg dose of sumatriptan nasal spray. The overall percentage of migraines treated with either one 20-mg dose or one, two, or three 20-mg doses with at least 1 drug-related adverse event was 19%. The most common specific drug-related adverse event was unpleasant taste, reported in 17% of migraines. No other single drug-related adverse event was reported in more than 1% of migraines over the 1-year treatment period. When unpleasant taste was excluded from the adverse-event tabulations, the percentages of migraines with at least 1 drug-related adverse event after one or one, two, or three 20-mg doses declined to 4% and 3%, respectively. No patient experienced any drug-related changes in 12-lead ECGs, vital signs, or nasal assessments; and no clinically meaningful changes in clinical laboratory values were observed. Across all migraines with evaluable efficacy data (n = 4334), headache relief was reported in 43% of migraines at 1 hour and in 59% at 2 hours after dosing with sumatriptan nasal spray 20 mg. Of the 2561 migraines with headache relief 2 hours postdose, headache recurrence was reported within 24 hours of initial dosing in 7% of migraines. None of the efficacy or tolerability results varied as a function of time in the study (ie, first 6 months vs. second 6 months). Conclusion.,Sumatriptan nasal spray 20 mg is generally well tolerated and may be beneficial during long-term use by adolescent migraineurs ages 12 to 17 years. [source]

Thirty-day Outcomes of Emergency Department Patients Undergoing Electrical Cardioversion for Atrial Fibrillation or Flutter

ACADEMIC EMERGENCY MEDICINE, Issue 4 2010
Frank Xavier Scheuermeyer MD
Abstract Objectives:, While the short-term (<7-day) safety and efficiency of electrical cardioversion for emergency department (ED) patients with atrial fibrillation or flutter have been established, the 30-day outcomes with respect to stroke, thromboembolic events, or death have not been investigated. Methods:, A two-center cohort of consecutive ED patients undergoing cardioversion for atrial fibrillation or flutter between January 1, 2000, and September 30, 2007, was retrospectively investigated. This cohort was probabilistically linked with both a regional ED database and the provincial health registry to determine which patients had a subsequent ED visit or hospital admission, stroke, or thromboembolic event or died within 30 days. In addition, trained reviewers performed a detailed chart abstraction on 150 randomly selected patients, with emphasis on demographics, vital signs, medical treatment, and predefined adverse events. Hemodynamically unstable patients or those whose condition was the result of an underlying acute medical diagnosis were excluded. Data were analyzed by descriptive methods. Results:, During the study period, 1,233 patients made 1,820 visits for atrial fibrillation or flutter to the ED. Of the 400 eligible patients undergoing direct-current cardioversion (DCCV), no patients died, had a stroke, or had a thromboembolic event in the following 30 days (95% confidence interval [CI] = 0.0 to 0.8% for all outcomes). A total of 141 patients were included in the formal chart review, with five patients (3.5%, 95% CI = 0.5% to 6.6%) failing cardioversion, six patients (4.3%, 95% CI = 0.9% to 7.6%) having a minor adverse event that did not change disposition, and five patients (3.5%, 95% CI = 0.5% to 6.6%) admitted to hospital at the index visit. Conclusions:, Cardioversion of patients with atrial fibrillation or flutter in the ED appears to have a very low rate of long-term complications. ACADEMIC EMERGENCY MEDICINE 2010; 17:408,415 © 2010 by the Society for Academic Emergency Medicine [source]

Mirtazapine naturalistic depression study (in Sweden),MINDS(S): clinical efficacy and safety

HUMAN PSYCHOPHARMACOLOGY: CLINICAL AND EXPERIMENTAL, Issue 3 2006
Jan Wålinder
Abstract Objective To study how implementation of a naturalistic trial design for mirtazapine treatment in major depressive disorder for six (up to 12) months could be used and evaluated by means of clinical efficacy and safety. Method An open-labelled, prospective, multicenter, non-comparative trial was conducted during a 2-year period in patients with major depression according to DSM-IV treated in psychiatric departments and primary care in Sweden. Minimal inclusion and exclusion criteria were used in order to diminish the potential patient selection bias. Maximum flexibility of the dosage of mirtazapine was allowed, and clinical assessments included MADRS, CGI, vital signs and spontaneous reporting of adverse events. Results 192 patients were found eligible and enrolled in the study. A significant improvement in depressive symptoms according to MADRS and CGI was observed including particularly marked sleep improvement early in the treatment. Slight increases in body weight and BMI were observed. The investigational drug was well tolerated overall. Conclusion The clinical efficacy and safety of mirtazapine found in this naturalistic setting is in line with previously reported data on mirtazapine in traditional controlled clinical trials. The results confirm that the naturalistic study design facilitated conduct of the trial. The authors suggest that this type of study design should also be applied to other antidepressant drugs that are frequently prescribed in the general population. Copyright © 2006 John Wiley & Sons, Ltd. [source]

Safety and tolerability of duloxetine in the treatment of major depressive disorder: analysis of pooled data from eight placebo-controlled clinical trials

HUMAN PSYCHOPHARMACOLOGY: CLINICAL AND EXPERIMENTAL, Issue 5 2005
James I. Hudson
Abstract Objective To examine the safety and tolerability of the antidepressant duloxetine across multiple studies for major depressive disorder (MDD). Method Safety data were integrated from the acute phases of eight double-blind, placebo-controlled trials in which patients were randomized to duloxetine (40,120,mg/d; n,=,1139) or placebo (n,=,777) for up to 9 weeks. This data set included all acute-phase clinical trials that formed the basis of the New Drug Application (United States) or European Union submission package for duloxetine in the treatment of MDD. Two studies included continuation phases in which acute treatment responders received duloxetine or placebo for an additional 26 weeks. Safety assessments included serious adverse event reports, rates of discontinuation, spontaneously reported treatment-emergent adverse events, changes in vital signs and laboratory values, and electrocardiograms. Results The rates of serious adverse events for duloxetine- and placebo-treated patients were 0.3% and 0.6%, respectively (p,=,0.282). Adverse events led to discontinuation in 9.7% of duloxetine-treated patients, compared with 4.2% of patients receiving placebo (p,<,0.001). Treatment-emergent adverse events with an incidence for duloxetine ,,5.0% and significantly greater than placebo were nausea, dry mouth, constipation, insomnia, dizziness, fatigue, somnolence, increased sweating and decreased appetite. Mean changes in blood pressure and heart rate were small, and the incidence of increases above normal ranges was low. Duloxetine-treated patients had a mean decrease in weight of 0.5,kg compared with an increase of 0.2,kg for patients receiving placebo (p,<,0.001). No significant differences were found between duloxetine and placebo in the incidence of potentially clinically significant laboratory values at anytime while on treatment. Conclusion These results are consistent with those obtained previously from smaller pooled data sets, and suggest that duloxetine is safe and well tolerated in patients with MDD. Copyright © 2005 John Wiley & Sons, Ltd. [source]

Online pattern recognition based on a generalized hidden Markov model for intraoperative vital sign monitoring

INTERNATIONAL JOURNAL OF ADAPTIVE CONTROL AND SIGNAL PROCESSING, Issue 5 2010
Ping Yang
Abstract The trend patterns of vital signs provide significant insight into the interpretation of intraoperative physiological measurements. We have modeled the trend signal of a vital sign parameter as a generalized hidden Markov model (also known as a hidden semi-Markov model). This model treats a time series as a sequence of predefined patterns and describes the transition between these patterns as a first-order Markov process and the intra-segmental variations as different dynamic linear systems. Based on this model, a switching Kalman smoother combines a Bayesian inference process with a fixed-point Kalman smoother in order to estimate the unconditional true signal values and generates the probability of occurrence for each pattern online. The probabilities of pattern transitions are tested against a threshold to detect change points. A second-order generalized pseudo-Bayesian algorithm is used to summarize the state propagation over time and reduces the computational overhead. The memory complexity is reduced using linked tables. The algorithm was tested on 30 simulated signals and 10 non-invasive-mean-blood-pressure trend signals collected at a local hospital. In the simulated test, the algorithm achieved a high accuracy of signal estimation and pattern recognition. In the test on clinical data, the change directions of 45 trend segments, out of the 54 segments annotated by an expert, were correctly detected with the best performing threshold, and with the introduction of only 8 false-positive detections. The proposed method can detect the changes of trend patterns in a time series online, while generating quantitative evaluation of the significance of detection. This method is promising for physiological monitoring as the method not only generates early alerts, but also summarizes the temporal contextual information for a high-level decision support system. Copyright © 2009 John Wiley & Sons, Ltd. [source]

Improvement in duration of erection following phosphodiesterase type 5 inhibitor therapy with vardenafil in men with erectile dysfunction: the ENDURANCE study

INTERNATIONAL JOURNAL OF CLINICAL PRACTICE, Issue 1 2009
M. T. Rosenberg
Summary Objective:, The ENDURANCE study evaluated the efficacy of vardenafil, a phosphodiesterase type 5 (PDE5) inhibitor, in men with erectile dysfunction (ED), by measuring the duration of erection leading to successful intercourse using a stopwatch as the assessment instrument. Methods:, This was a randomised, multicentre, double-blind, placebo-controlled, crossover study consisting of a 4-week treatment-free run-in phase after which patients were randomised to either fixed-dose vardenafil 10 mg or placebo (to be administered 60 min prior to intercourse) and entered the first of the two 4-week double-blind treatment periods, separated by a 1-week washout. The primary efficacy end-point was the stopwatch-assessed duration of erection, which was defined as the time from erection perceived hard enough for penetration until withdrawal from the partner's vagina leading to successful intercourse as measured by Sexual Encounter Profile Question 3 (SEP-3). Secondary efficacy end-points included SEP-2 and SEP-3 success rates, the erectile function domain of the International Index of Erectile Function, global assessment questionnaire, change from baseline in duration of erection and duration of erection not leading to successful intercourse. Safety was assessed by adverse events (AEs), laboratory samples, vital signs and ECGs. Results:, Of the 191 men included in the safety population, 40% had moderate ED and 33% had severe ED at baseline. The duration of erection (least squares mean ± SE) leading to successful intercourse was longer with vardenafil than with placebo (12.81 ± 1.00 min vs. 5.45 ± 1.00 min; p < 0.001). The differences recorded for all secondary end-points were statistically significant in favour of vardenafil compared with placebo (p < 0.001), with the exception of duration of erection not leading to successful intercourse. Vardenafil was well tolerated in this study; the majority of AEs being mild-to-moderate in intensity. Conclusion:, Vardenafil 10-mg therapy provided a statistically superior duration of erection leading to successful intercourse in men with ED compared with placebo. [source]

Safety of efalizumab in adults with chronic moderate to severe plaque psoriasis: A phase IIIb, randomized, controlled trial

INTERNATIONAL JOURNAL OF DERMATOLOGY, Issue 5 2006
Kim A. Papp MD
Background, To provide safety data for efalizumab, a recombinant humanized monoclonal IgG1 antibody, in adults with chronic plaque psoriasis. Methods, A 12-week, Phase IIIb, randomized, double-blind, parallel-group, placebo-controlled trial. At 58 study sites in the USA and Canada, 686 patients with moderate to severe chronic plaque psoriasis received an initial conditioning dose of efalizumab 0.7 mg/kg subcutaneously (SC) followed by either 11 weekly doses of efalizumab 1 mg/kg SC or matching placebo. Main outcome measures were safety and tolerability outcomes (primary) and efficacy outcomes (secondary). Results, During 12 weeks of therapy with efalizumab or placebo, the incidence of clinical adverse events was 82.2% and 72.9%, respectively; the incidence of serious adverse events was 1.8% and 3.4%, respectively; and the incidence of nonserious adverse events leading to withdrawal was 1.8% and 1.7%, respectively. In the efalizumab group, there were no clinically significant changes in vital signs or laboratory parameters and no evidence of end-organ toxicities. A significantly higher proportion of patients receiving efalizumab than those receiving placebo achieved , 75% improvement in the Psoriasis Area and Severity Index (PASI) (P < 0.001), , 50% improvement in PASI (P < 0.001), and a static Physician's Global Assessment rating of Minimal or Clear (P < 0.001). The mean improvement in the Psoriasis Symptom Assessment was significantly greater in the efalizumab group (P < 0.001). Conclusions, Efalizumab treatment SC for 12 weeks was safe, well tolerated, and effective in patients with moderate to severe chronic plaque psoriasis. [source]

Clinical efficacy and safety of oral terbinafine in fungal mycetoma

INTERNATIONAL JOURNAL OF DERMATOLOGY, Issue 2 2006
Bassirou N'Diaye MD
Objectives, An open-label study was performed to assess the efficacy and safety of terbinafine in the treatment of eumycetoma. Methods, Single-center, open-label study, including 27 patients with signs and symptoms of eumycetoma which had developed within 5 years and was confirmed by mycological examination. The intention-to-treat population (n = 23) received 500 mg of terbinafine bid for 24,48 weeks. Efficacy evaluations included clinical signs and symptoms (e.g. sinuses open or closed, degree of tumefaction, and emission of grains either present or absent); mycological examinations from Week 24 onwards; and investigators' overall assessment of efficacy (cure, improved since baseline, unchanged since baseline, or deterioration since baseline). Safety evaluations included monitoring of adverse events, laboratory assessments, vital signs and physical examinations. Results, Good clinical improvement was seen in patients who completed the study (n = 20). Tumefaction was absent or improved in 80% of patients; sinuses were closed in 50% of patients, and grain emissions were absent in 65% of patients. Of the 16 patients who had repeat mycological assessment, four (25%) were mycologically cured. In the investigators' overall opinion at the end of the study, five (25%) were cured and 11 (55%) were clinically improved. The majority of adverse events reported were mild to moderate, and consistent with the known tolerability profile of terbinafine. Conclusion, High-dose terbinafine (1000 mg/day) is well tolerated and clinically effective in patients with eumycetoma, a difficult-to-treat subcutaneous mycoses. [source]