Adverse Events (adverse + event)

Distribution by Scientific Domains
Distribution within Medical Sciences

Kinds of Adverse Events

  • cardiac adverse event
  • cardiovascular adverse event
  • clinical adverse event
  • common adverse event
  • drug-related adverse event
  • experience adverse event
  • fewer adverse event
  • frequent adverse event
  • major adverse event
  • mild adverse event
  • minor adverse event
  • monitoring adverse event
  • one adverse event
  • other adverse event
  • potential adverse event
  • relate adverse event
  • reported adverse event
  • respiratory adverse event
  • serious adverse event
  • severe adverse event
  • significant adverse event
  • systemic adverse event
  • treatment-emergent adverse event
  • treatment-related adverse event

  • Terms modified by Adverse Events

  • adverse event profile
  • adverse event rate
  • adverse event report
  • adverse event reporting
  • adverse event reporting system

  • Selected Abstracts


    Francesc Formiga MD
    No abstract is available for this article. [source]


    D. A. Watters
    An adverse event is defined as unintentional harm (to a patient) arising from an episode of healthcare and not due to the disease process itself. Surgical adverse events include death, unplanned reoperation, unplanned readmission, unplanned ICU readmission, medication errors and side-effects, falls, pressure ulcers, hospital acquired infection, and inadvertent injury during surgery. Adverse events occur in around 10% of general surgical cases. The rates also vary between specialties. Reporting: , Adverse events need to be reported through both a hospital incident reporting system (eg Riskman) and through surgical audit. Each adverse event should be graded using a Severity Assessment Code (1,4) on the basis of its effect on the patient or hospital service, and the likelihood of it recurring. Some of the more severe events will trigger an entry on the risk register, making service managers responsible for action. Reviewing: , The opportunity must be seized to improve system issues. An investigation (eg root cause analysis) should be conducted in an atmosphere of ,no-blame' with engagement of and consultation with the major stakeholders who are responsible for delivering solutions. Training in system-wide approaches and teamwork can be invaluable. Responding: , The response needs to recognise the needs of the patient who has been harmed. There should be an honest and frank discussion with the patient and/or their family, acknowledging their suffering with empathy and an apology should be offered without necessarily admitting any liability. Open disclosure has the potential to reduce risk of litigation. Surgeons need to engage in reporting, reviewing and responding if the rate of adverse events is to be reduced. [source]


    J. Collins
    The sustained production of competent surgeons in sufficient numbers to meet the increasing needs of society commences with recruitment and selection of the most able medical graduates. As the process begins through self-selection, accurate information must be readily available to enable these graduates make an informed judgement on their career choice. Each surgical discipline aspires to use best practice selection in order to identify those who have the potential to acquire the necessary standard of technical and non technical skills and attributes required to practice as a surgeon. A selection system must rank applicants effectively and be reliable, valid, fair, defensible, cost effective and feasible. Best practice selection commences with an analysis of the relevant knowledge, skills, abilities and attitudes associated with successful performance in the particular target job. This information is used to construct a person specification in order to identify selection criteria at a level appropriate for entry to training. Selection methods are then chosen which will best elicit measurable applicant behaviour related to these selection criteria. A number of selection methods are used which include structured references, curriculum vitae and interviews. Other methods available although rarely used include tests of mental ability, aptitude tests and personality inventories. More recently selection or assessment centres (a selection method, not a place) involving a combination of selection techniques such as written exercises, interviews and work simulations have been shown to be highly effective. Eligibility criteria for application (long listing), shortlising for interview, scoring of items within each selection method and overall % weighting for each method are important variables in the selection process. [source]

    Detecting Adverse Events in Dermatologic Surgery

    BACKGROUND Despite increasing awareness of and public attention to patient safety, little is documented about how adverse events (AEs) can or should be monitored in dermatologic surgery. Data to address this shortcoming are needed, although well-defined methodologies have yet to be implemented. OBJECTIVE To summarize current strategies in detecting adverse outcomes of dermatologic surgical procedures. MATERIALS AND METHODS A Medline literature search was conducted using the terms "adverse event,""detection,""reporting,""monitoring," and "surgery." Articles selected addressed the efficacy of one or more AE reporting techniques in surgical patients. RESULTS Prospective and retrospective reporting methods were identified, with morbidity and mortality conference being the most commonly used method of AE reporting. Retrospective medical record review, the retrospective trigger tool approach, and an anonymous electronic reporting system were more sensitive approaches. The Surgical Quality Improvement Program, a program that has successfully translated AE data into lower postoperative morbidity and mortality, was analyzed. CONCLUSIONS Although generally considered safe, dermatologic surgery has no current standard for AE reporting. Standard definitions and high-quality data regarding AEs" currently limit this analysis. Pilot studies are needed to develop feasible measures, with the goal of increasing the sensitivity of AE detection and ultimately improving patient outcomes. The Center for Dermatology Research is supported by an unrestricted educational grant from Galderma Laboratories. [source]

    Time Course of Adverse Events in Patients with Localization-related Epilepsy Receiving Topiramate Added to Carbamazepine

    EPILEPSIA, Issue 5 2005
    Jerzy Majkowski
    Summary:,Purpose: To explore the time course of treatment-emergent adverse events (AEs) during topiramate (TPM) adjunctive therapy. Methods: Post hoc analyses were performed by using data from a large (264 subjects) multicenter, double-blind, placebo-controlled trial in which 200 mg/day TPM was added to carbamazepine (CBZ) with or without another antiepileptic drug (AED) in adults with treatment-resistant partial-onset seizures. The daily incidence and mean duration of the most common (,5% incidence) AEs were calculated for patients completing the 12-week study. Results: The daily incidence of somnolence, headache, loss of appetite, nervousness, fatigue, dizziness, upper respiratory tract infection, and vertigo peaked during titration and declined to rates similar to that of placebo after the target TPM dose had been reached. In contrast, the daily incidence of paresthesia increased during titration and was maintained for the study duration. Relatively few patients had cognitive symptoms (9% with TPM, 5% with placebo), but these were the most common AEs associated with treatment discontinuation. Patient/investigator reports of weight loss increased gradually over the course of the trial, corresponding with the pattern of change in weight measured at study visits. Conclusions: This study demonstrates that most of the more common AEs with TPM adjunctive therapy are transient. Patients can be counseled that most AEs emerging when TPM is initially added to CBZ can be expected to diminish with continued therapy. [source]

    Assessment of Adverse Events Associated With Triptans,Methods of Assessment Influence the Results

    HEADACHE, Issue 10 2004
    Fred D. Sheftell MD
    Background.,A recent study conducted in triptan-naļve migraine patients showed that tolerability was the second most important attribute of an acute treatment. However, the proportion of patients reporting side effects after any acute treatment may vary with regard to the method of assessment. Objectives.,To contrast two methods of assessing adverse events (prompted and unprompted) in those with headache using triptans. Methods.,This study was conducted in two sites, a headache center in the United States, and a neurology office focusing on headache in Italy. We prospectively surveyed 415 adults with headache, who had been using the same triptan for at least 3 months. Participants were asked about their headache and treatment history. Subjects then completed a standardized questionnaire, assessing adverse events in two different ways. First, subjects were asked if they had any adverse events when using the triptan. After returning the first part of the questionnaire, subjects received a second form, where 49 possible adverse events were listed. We contrasted and correlated both sets of answers. Results.,Most patients (U.S. = 74.9%, Italy = 65.5%) reported no side effects in the unprompted questionnaire. However, most of them (U.S. = 62.9%, Italy = 54.1%) reported at least one side effect in the prompted questionnaire. Most patients that reported side effects in the unprompted questionnaire said they had just one adverse event, while most reported two or more side effects in the prompted questionnaire. Both in the unprompted and in the prompted questionnaires, most side effects were rated as mild or moderate. Interestingly, 31 (7.5%) subjects (pooling data from both sites together) graded their adverse events as severe in the prompted questionnaire, but had not self-reported them. Conclusions.,(1) When assessing adverse events, the method of data collection may dramatically influence the results. (2) From those subjects who did not self-report adverse events after using a triptan, most of them will report positively if presented with a list of side effects. [source]

    A study of dietary advice and care provided to HIV positive patients referred for lipid lowering: as part of a service improvement initiative

    N.A. Billing
    Background:, Combination antiretroviral therapy (ART) has dramatically reduced mortality in HIV-infected patients. As life expectancy of HIV infected patients has increased, concerns about the long-term effects of treatment grow (Sax, 2006). HIV positive patients have a greater risk of myocardial infarction (MI) and ART has been associated with a 26% increase in the rate of MI per year of exposure (DAD Study Group, 2003). The aim of this study was to evaluate provision of dietetic care to patients referred for lipid lowering advice and identify potential areas for service improvement. Methods:, Departmental activity statistics identified 117 new clients referred for lipid lowering advice in the previous 11 months. The biochemical data and dietetic record cards were screened, of the initial sample 30 were excluded as they did not have follow up biochemistry after their dietetic consultation and a further seven were excluded as they were seen primarily for other conditions. The remaining cards (n = 80) had their dietetic record cards audited to check dietary topics discussed, risk factors identified length before follow up and clinical outcomes. Results:, There were 68 men and 12 women in this sample with a mean age of 46 years and mean body mass index (BMI) of 25.4 kg m,2 (3.7 kg m,2). Of the clients referred, only 48.8% of the sample had high density lipoprotein (HDL): cholesterol ratios taken to calculate cardiovascular risk and most patients were seen an average of 30.7 days (35.3 days) after high was identified. Following their dietetic consultation, 77% of clients had a reduction in their cholesterol levels and 61% had a reduction in triglyceride levels. This sample's average percentage change in cholesterol was ,10% (16%) and triglyceride was ,6% (32%). The most popular dietary advice was reducing saturated fat intake (90%), increasing fibre intake (76%), benefits of plant stanols (40%), importance of regular meals (29%), exercise (26%) and benefits of omega three (11%). Additional risk factors identified 11% of clients seen were smokers, however most records (66%) did not have documentation on whether smoking behaviour was discussed. Only 20% of clients had a follow up appointments and not all were seen within 3 months with average time between follow up being 14.9 weeks (13.2 weeks). Discussion:, Improvement in biochemical results were comparable to a study by Henry et al., (1998) which showed that in HIV infected clients receiving ART, diet modification and increased exercise were successful in reducing cholesterol levels by 11% and triglyceride levels by 21%. The level of smoking was considerably lower than other studies (DAD Study Group, 2003) which reported 56% of HIV positive clients to be smokers. A large number of clients were lost to follow up and were not seen within 3 months. Lazzaretti et al., (2007) showed in a randomized trial that seeing patients at regular 3 month intervals for dietary intervention prevented an increase in lipid blood levels in individuals who start ART. Conclusions:, Not all clients are having their cardiovascular risk calculated before referral for dietary advice. Clients are not being seen at regular intervals by dietitians, some are lost to follow up and smoking status is not regularly documented during dietetic consultation. References, Data Collection on Adverse Events of Anti-HIV Drugs (DAD) Study Group. (2003) Combination antiretroviral therapy and the risk of myocardial infarction. N. Engl. J. Med.349, 1993,2003. Friis-Moller, N., Weber, R., Reiss, P., Thiebaut, R., Kirk, O., d'Arminio, M.A. et al. (2003) Cardiovascular disease risk factors in HIV patients' association with antiretroviral therapy. Results from the DAD study. AIDS17, 1179,1193. Henry, K., Melroe, H., Huebesch, J., Hermundson, J. & Simpson, J. (1998) Atorvastatin and gemfibrozil for protease inhibitor-related lipid abnormalities. Lancet352, 1031,1032. Sax, P.E. (2006)Strategies for management and treatment of dyslipidemia in HIV/AIDS. AIDS Care 18, 149,157. Lazzaretti, R., Pinto-Ribeiro, J., Kummer, R., Polanczyk, C. & Sprinz, E. (2007) Dietary intervention when starting HAART prevents the increase in lipids independently of drug regimen: a randomized trial. Oral abstract session: 4th IAS Conference on HIV Pathogenesis, Treatment and Prevention: Abstract no.WEAB303. [source]

    Challenges in Establishing the Epidemiology of Adverse Events Associated with Interventional Therapies for Chronic Pain

    PAIN MEDICINE, Issue S1 2008
    Timothy R. Deer MD
    ABSTRACT Objectives., This paper aims to examine the current state of knowledge about adverse events associated with interventional pain techniques. Methods., This paper reviews the available databases on risk from sources such as closed claim analysis, peer review, and published literature; and also examines risk stratification for pain practitioners, the current state of malpractice insurance, and the procedures that are considered to have elevated risk. Conclusions., Substantial neurological sequelae can occur from interventional pain techniques. Considering the growing number of physicians who perform these procedures the actual occurrence of these problems appears to be low. The incidences of complications are difficult to correctly identify based on limitations of reporting and data analysis. The author recommends a national data bank be created to allow better monitoring and self assessment of the specialty of pain medicine. This information could be used to improve outcomes, reduce risk, and change clinical practice. [source]

    Severity of health conditions identified in a pediatric cancer survivor program,

    PEDIATRIC BLOOD & CANCER, Issue 7 2010
    Karen Wasilewski-Masker MD
    Abstract Background The Common Terminology Criteria for Adverse Events v3.0 (CTCAE) was designed for reporting acute and late effects of cancer treatment. To date, no study of pediatric-aged cancer survivors has graded health conditions using CTCAE, for patients in active follow-up in a cancer survivor program. Procedure Medical records were reviewed on 519 survivors of non-central nervous system childhood malignancies seen in the Cancer Survivor Program between January 1, 2001 and December 15, 2005. Health problems identified through histories, physicals, and recommended evaluation using the Children's Oncology Group (COG) Long-Term Follow-Up Guidelines for Survivors of Childhood, Adolescent and Young Adult Cancer were graded using the CTCAE. Results Overall, 1,625 adverse health conditions were reported or detected in 519 pediatric-age cancer survivors (mean age at diagnosis 4.8 years; mean age at first survivor visit 12.1 years). The majority of conditions were mild (47.4% Grade 1) or moderate (35.2% Grade 2); however, 17.4% of conditions were severe (Grade 3) or life-threatening/disabling (Grade 4). Only 12.1% of survivors had no adverse condition, and 36.2% of survivors had a Grade 3 or 4 condition. In a Cox multivariate analysis risk factors for a Grade 3 or 4 condition included minority race, diagnosis of other malignancy, older age, and a history of a hematopoietic stem cell transplant. Conclusions The majority of adverse health conditions in pediatric-aged cancer survivors are mild; however, a significant percentage will have a serious condition. Long-term follow-up with a multidisciplinary approach is essential to detect and intervene in health problems early. Pediatr Blood Cancer 2010;54:976,982 © 2010 Wiley-Liss, Inc. [source]

    Ensuring Patient Safety: What Lessons Can Be Learned from Device-Related Adverse Events in Hemodialysis?

    ARTIFICIAL ORGANS, Issue 4 2002
    Richard A. WardArticle first published online: 22 MAY 200
    No abstract is available for this article. [source]

    Intraperitoneal chemotherapy for advanced epithelial ovarian malignancy: Lessons learned

    Michael BUNTING
    Background:, The administration of intraperitoneal (IP) chemotherapy as first-line adjuvant treatment for women with optimally debulked advanced ovarian malignancy results in improved median and overall survival when compared with intravenous (IV) chemotherapy. However, the number of adverse events and toxicities are increased in patients treated with IP chemotherapy. In addition, the administration of IP chemotherapy is technically more challenging and the schedule is more demanding in terms of time and resources. Aims:, We report on our initial experience with the administration of IP chemotherapy at two gynaecological oncology units in Australia. Methods:, We collected retrospective data from a series of 23 women undergoing IP chemotherapy as adjuvant treatment for advanced ovarian cancer. In addition to standard (Common Terminology Criteria for Adverse Events v3.0, CTCAE) toxicity data, we collected technical data specific to the administration of IP chemotherapy. Results:, The average number of IP chemotherapy cycles received was 4.3. Forty-three per cent of patients received all six planned IP chemotherapy cycles. Thirty-nine per cent of patients discontinued their IP treatment. Of those, 22% were discontinued because of drug-related toxicities and the remaining 17% experienced a port complication or toxicity directly related to the route of administration. Conclusions:, This study demonstrates the feasibility and practicality of and lessons learned from initial experiences with IP chemotherapy for ovarian cancer in Australia. [source]

    Qualitative Approaches to the Study of Adverse Events and Near Misses

    Mark Hauswald MD
    First page of article [source]

    Epidemiology of Adverse Events in Air Medical Transport

    Russell D. MacDonald MD
    Abstract Objectives:, This observational study determined frequency and describes all-cause adverse event epidemiology in a large air medical transport system. Methods:, Records of a mandatory reporting system were reviewed and a data set containing all of the patient care records was searched to identify aviation- and non,aviation-related adverse events. Two reviewers independently identified adverse events and categorized them using an established taxonomy. Descriptive statistics were used to report adverse events, with frequency calculated per 1,000 flights and 1,000 hours flown. Results:, Between January 1, 2002, and June 30, 2005, there were 1,447 reports, of which 598 included an adverse event. Case-finding identified an additional 125. A complete report was available in 680 of 723 (94.1%) events. There were 58,956 flights and 103,632 hours flown during the study period, for a rate of 11.53 adverse events per 1,000 flights (95% CI = 10.7 to 12.4 adverse events) or 6.56 per 1,000 hours flown (95% CI = 6.1 to 7.1 adverse events). The frequencies of events by category were as follows: communication (229; 33.7%), transport vehicle (143; 21.0%), medical equipment (88; 12.9%), patient management (77; 11.4%), clinical performance (68; 10.0%), weather (30; 4.4%), unclassified (24; 3.5%), and patient factors causing death (21; 3.1%). There was possible patient harm in 117 events. Conclusions:, Air medical transport is associated with a low incidence of adverse events and possible patient harm. Communication problems were the most common cause of an event. Determining event epidemiology is necessary to identify modifiable factors, propose solutions to decrease the adverse events, and direct future efforts to improve safety. [source]

    Comparison of Adverse Events during Procedural Sedation between Specially Trained Pediatric Residents and Pediatric Emergency Physicians in Israel

    Itai Shavit MD
    Abstract Objectives:, The aim was to compare the rate of procedural sedation,related adverse events of pediatric residents with specific training in "patient safety during sedation" and pediatric emergency physicians (PEPs) who completed the same course or were teaching faculty for it. Methods:, This prospective single-blinded, nonrandomized study was conducted in two university-affiliated pediatric emergency departments (PEDs) in Israel. Pediatric residents who were authorized to perform unsupervised sedations had previously completed a course in patient safety during sedation. Unsupervised sedations by residents were defined as sedations where the entire procedure was performed independently. Study subjects had autonomy in choosing medications for sedation. Adverse events were defined as transient hypoxia (oxygen saturation , 90%) or apnea. Adverse outcomes were situations where intubation or hospitalization directly related to sedation complications would occur. Sedations over 12 consecutive months were recorded, and rates of adverse events in each group were compared. Results:, A total of 984 eligible sedations were recorded, 635 by unsupervised residents and 349 by PEPs. A total of 512 (80.6%) sedations were performed by residents when attending physicians were not in the ED. The total adverse event rate was 24/984 (2.44%). When the two groups used a similar type drugs, residents had 8/635 (1.26%) events, compared to 11/328 (3.35%) by PEPs. There was no statistically significant difference in the rates of hypoxia or apnea between the two groups (p = 0.29 and p = 0.18, respectively). Adverse outcomes did not occur. Conclusions:, Unsupervised pediatric residents with training in patient safety during sedation performed procedural sedations with a rate of adverse events similar to that of PEPs. [source]

    Emergency Medical Services Provider Perceptions of the Nature of Adverse Events and Near-misses in Out-of-hospital Care: An Ethnographic View

    EMT-P, Rollin J. Fairbanks MD
    Abstract Objectives:, The objectives were to examine the perceptions of emergency medical services (EMS) providers regarding near-misses and adverse events in out-of-hospital care. Methods:, This study uses qualitative methods (focus groups, interviews, event reporting) to examine the perceptions of EMS providers regarding near-misses and adverse events in out-of-hospital care. Results were reviewed by five researchers; analytic domains were assigned and emerging themes were identified. Descriptive statistics were calculated. Results:, Fifteen in-depth interviews (73% advanced life support [ALS], 40% volunteer, and 87% male) resulted in 50 event descriptions. Eleven additional event reports were obtained from the anonymous reporting system. Of the 61 total events, 27 (44%) were near-misses and 34 (56%) were adverse events. Fourteen (23%) involved a child (<19 years). Types of error included 33 clinical judgment (54%), 13 skill performance (21%), 9 medication event (15%), 3 destination choice (5%), and 3 others (5%). For the 21 cases where the provider discussed the event, 10 (48%) were reported to a physician, and 9 (43%) to a supervisor; 4 (19%) were not reported, and none were reported to the patient. Focus groups supported interview and event report data. Emerging themes included a focus on the errors of others and a "blame-and-shame" culture. Conclusions:, Adverse events and near-misses were common among the EMS providers who participated in this study, but the culture discourages sharing of this information. Participants attributed many events to systems issues and to inadequacies of other provider groups. Further study is necessary to investigate whether these hypothesis-generating themes are generalizable to the EMS community as a whole. [source]

    Effects of epidermal growth factor receptor inhibitor-induced dermatologic toxicities on quality of life,

    CANCER, Issue 16 2010
    Smita S. Joshi MD
    Abstract BACKGROUND: Epidermal growth factor receptor (EGFR) inhibitors frequently result in dermatologic toxicities, including rash, xerosis, pruritus, and paronychia. Although the frequency and severity of these events have been described, their effect on health-related quality of life (QoL) remains poorly understood. By using a dermatology-specific questionnaire, the authors examined the effect of these toxicities on QoL. METHODS: Patients completed the Skindex-16, a questionnaire that measures the effects on 3 domains of QoL: symptoms, emotions, and functioning. The severity of dermatologic toxicities was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0 (NCI-CTCAE). Correlations of dermatology QoL scores with NCI-CTCAE grade, skin phototype (SPT), sex, age, type of EGFR inhibitor, and cancer type were investigated. RESULTS: Concordant with greater severity of rash grade, there was an increase in median scores for symptoms (P = .0006), emotions (P < .0001), function (P = .001), and overall score (P < .0001). There was an inverse correlation between age and emotions (r = ,0.26; P = .03) and overall score (r = ,0.25; P = .04). There was a significant difference between patients aged ,50 years and patients aged >50 years with regard to symptoms (P = .02), emotions (P = .03), functioning (P = .04), and overall score (P = .02). There were no significant differences between QoL and SPT, sex, treatment type, or cancer type (P > .05). CONCLUSIONS: Toxicities, including rash, xerosis, paronychia, and pruritus, adversely affected QoL, and rash was associated with a QoL greater decrease. Younger patients reported lower overall QoL than older patients who had the same toxicities. The current results support using the NCI-CTCAE as a correlative tool for measuring the effects of rash on dermatology-specific QoL. Cancer 2010. © 2010 American Cancer Society. [source]

    Tetracycline to prevent epidermal growth factor receptor inhibitor-induced skin rashes,

    CANCER, Issue 4 2008
    Results of a placebo-controlled trial from the North Central Cancer Treatment Group (N03CB)
    Abstract BACKGROUND. Epidermal growth factor receptor (EGFR) inhibitors are effective cancer therapies, but they are reported to cause a rash in >50% of patients. In the current study, the authors examined the use of tetracycline for rash prevention. METHODS. This placebo-controlled, double-blinded trial enrolled patients who were starting cancer treatment with an EGFR inhibitor. Patients could not have had a rash at the time of enrollment. All patients were randomly assigned to receive either tetracycline at a dose of 500 mg orally twice a day for 28 days versus a placebo. Patients were monitored for rash (through monthly physician assessment and weekly patient-reported questionnaires), quality of life (using the SKINDEX-16, a skin-specific quality of life index), and adverse events. Monitoring occurred during the 4-week intervention and then for an additional 4 weeks. The primary objective of the current study was to compare the incidence of rash between the study arms, and the enrollment of 30 patients per arm provided a 90% probability of detecting a 40% difference in incidence with a P value of .05 (2-sided). RESULTS. A total of 61 evaluable patients were enrolled. The 2 treatment arms were well balanced with regard to baseline characteristics, dropout rates, and rates of discontinuation of the EGFR inhibitor. The incidence of rash was found to be comparable across treatment arms. Physicians reported that 16 patients treated with tetracycline (70%) and 22 patients treated with placebo (76%) developed a rash (P = .61). Tetracycline appears to have lessened the rash severity, although the high dropout rates invite caution when interpreting these findings. By Week 4, physician-reported grade 2 rash (using the National Cancer Institute's Common Terminology Criteria for Adverse Events [version 3.0]) occurred in 17% of tetracycline-treated patients (n = 4 patients) and in 55% of placebo-exposed patients (n = 16 patients) (P = .04). Patients treated with tetracycline reported better scores, as per the SKINDEX-16, on certain quality-of-life parameters such as skin burning or stinging, skin irritation, and being bothered by the persistence/recurrence of a skin condition. Adverse events were found to be comparable across treatment arms. CONCLUSIONS. In the current study, tetracycline was not found to prevent EGFR inhibitor-induced rashes and therefore cannot be clinically recommended for this purpose. However, preliminary observations of diminished rash severity and improved quality of life suggest this antibiotic merits further study. Cancer 2008. © 2008 American Cancer Society. [source]

    Anticipating Demand for Emergency Health Services due to Medication-related Adverse Events after Rapid Mass Prophylaxis Campaigns

    Nathaniel Hupert MD
    Objectives: Mass prophylaxis against infectious disease outbreaks carries the risk of medication-related adverse events (MRAEs). The authors sought to define the relationship between the rapidity of mass prophylaxis dispensing and the subsequent demand for emergency health services due to predictable MRAEs. Methods: The authors created a spreadsheet-based computer model that calculates scenario-specific predicted daily MRAE rates from user inputs by applying a probability distribution to the reported timing of MRAEs. A hypothetical two- to ten-day prophylaxis campaign for one million people using recent data from both smallpox vaccination and anthrax chemoprophylaxis campaigns was modeled. Results: The length of a mass prophylaxis campaign plays an important role in determining the subsequent intensity in emergency services utilization due to real or suspected adverse events. A two-day smallpox vaccination scenario would produce an estimated 32,000 medical encounters and 1,960 hospitalizations, peaking at 5,246 health care encounters six days after the start of the campaign; in contrast, a ten-day campaign would lead to 41% lower peak surge, with a maximum of 3,106 encounters on the busiest day, ten days after initiation of the campaign. MRAEs with longer lead times, such as those associated with anthrax chemoprophylaxis, exhibit less variability based on campaign length (e.g., 124 out of an estimated 1,400 hospitalizations on day 20 after a two-day campaign versus 103 on day 24 after a ten-day campaign). Conclusions: The duration of a mass prophylaxis campaign may have a substantial impact on the timing and peak number of clinically significant MRAEs, with very short campaigns overwhelming existing emergency department (ED) capacity to treat real or suspected medication-related injuries. While better reporting of both incidence and timing of MRAEs in future prophylaxis campaigns should improve the application of this model to community-based emergency preparedness planning, these results highlight the need for coordination between public health and emergency medicine planning for infectious disease outbreaks to avoid preventable surges in ED utilization. [source]

    Safety and efficacy of ezetimibe monotherapy in 1624 primary hypercholesterolaemic patients for up to 2 years

    C. A. Dujovne
    Summary Aims:, This report examined the safety and efficacy of treatment for up to 2 years with the cholesterol absorption inhibitor, ezetimibe (EZE). Methods:, Two identical, randomised, double-blind trials (starting with 827 and 892 patients), evaluated the efficacy and safety of EZE 10 mg/day vs. placebo for 12 weeks in patients with primary hypercholesterolaemia [low-density lipoprotein cholesterol (LDL-C) 3.3,5.1 mmol/l]. Upon completion of these base studies, patients were offered a 2-year, open-label extension study. Adverse event (AE) reports for EZE monotherapy-treated patients were summarised for 3-month intervals to allow for comparison with the placebo group of the 3-month base studies. The primary end-point for this analysis was the evaluation of the long-term safety and tolerability of EZE 10 mg monotherapy dosed daily for up to 24 months. Results:, The incidences of new AEs, treatment-related (TR) AEs, serious AEs (SAEs), TRSAEs and discontinuations as a result of AEs during any 3-month interval were comparable with the respective observations in the placebo group of the base studies. The incidences of AEs, TRAEs, SAEs, TRSAEs and discontinuations as a result of AEs decreased in almost every interval compared with earlier intervals throughout the 2-year study. In addition, the incidences of , 3-fold consecutive elevations of liver transaminases (0.7%) or , 10-fold increases in creatine phosphokinase (0.4%) for the entire 2-year treatment period were comparable with those of the placebo group (0.7% and 0.2% respectively). LDL-C reductions of ,18% were maintained throughout the study. Conclusions:, Compared with placebo, treatment with EZE for up to 2 years in 1624 patients showed no evidence of increased incidence of AEs with increased treatment duration, while showing sustained effects on LDL-C reduction. [source]

    Case series of liver failure associated with rosiglitazone and pioglitazone,

    James S. Floyd MD
    Abstract Purpose The thiazolidinedione drugs rosiglitazone and pioglitazone are not widely known to be hepatotoxic. We evaluated the FDA Adverse Event Reporting System (AERS) to determine the number of reported cases of liver failure associated with rosiglitazone and pioglitazone between 1997 and 2006, and described their clinical characteristics. Methods Adverse event reports spontaneously submitted to the FDA AERS from 1997 to 2006 were examined. Liver failure associated with rosiglitazone or pioglitazone was defined as liver injury accompanied by hepatic encephalopathy, liver transplantation, placement on a liver transplant list, or death in which all other likely etiologies were excluded. Using prescribing data, the number of reported cases of liver failure per million patient-years of exposure was calculated for each drug. Results Twenty-one cases met our case definition. Clinical characteristics, outcomes, and pathologic data were similar between cases of liver failure associated with rosiglitazone and with pioglitazone. The median duration of therapy was 9 weeks and 85% of cases were acute, defined as symptom onset to liver failure in less than 26 weeks. The case-fatality rate was 81% (17/21), and only 14% (3/21) spontaneously recovered. Accounting for underreporting, the number needed to harm (NNH) for each case of liver failure was 44,000 patient-years of exposure for rosiglitazone and 52,000 patient-years of exposure for pioglitazone. Conclusions This is the largest case series of liver failure associated with rosiglitazone or pioglitazone reported to date, strengthening the evidence that these drugs can cause severe hepatotoxicity. Copyright © 2009 John Wiley & Sons, Ltd. [source]

    Once-Daily Prolonged-Release Tacrolimus (ADVAGRAF) Versus Twice-Daily Tacrolimus (PROGRAF) in Liver Transplantation

    P. Trune
    The efficacy and safety of dual-therapy regimens of twice-daily tacrolimus (BID; Prograf) and once-daily tacrolimus (QD; Advagraf) administered with steroids, without antibody induction, were compared in a multicenter, 1:1-randomized, two-arm, parallel-group study in 475 primary liver transplant recipients. A double-blind, double-dummy 24-week period was followed by an open extension to 12 months posttransplant. The primary endpoint, event rate of biopsy-proven acute rejection (BPAR) at 24 weeks, was 33.7% for tacrolimus BID versus 36.3% for tacrolimus QD (Per-protocol set; p = 0.512; treatment difference 2.6%, 95% confidence interval ,7.3%, 12.4%), falling within the predefined 15% noninferiority margin. At 12 months, BPAR episodes requiring treatment were similar for tacrolimus BID and QD (28.1% and 24.7%). Twelve-month patient and graft survival was 90.8% and 85.6% for tacrolimus BID and 89.2% and 85.3% for tacrolimus QD. Adverse event (AE) profiles were similar for both tacrolimus BID and QD with comparable incidences of AEs and serious AEs. Tacrolimus QD was well tolerated with similar efficacy and safety profiles to tacrolimus BID. [source]

    A double-blind study of the efficacy of venlafaxine extended-release, paroxetine, and placebo in the treatment of panic disorder

    Mark H. Pollack M.D.
    Abstract To date, no large-scale, controlled trial comparing a serotonin,norepinephrine reuptake inhibitor and selective serotonin reuptake inhibitor with placebo for the treatment of panic disorder has been reported. This double-blind study compares the efficacy of venlafaxine extended-release (ER) and paroxetine with placebo. A total of 664 nondepressed adult outpatients who met DSM-IV criteria for panic disorder (with or without agoraphobia) were randomly assigned to 12 weeks of treatment with placebo or fixed-dose venlafaxine ER (75,mg/day or 150,mg/day), or paroxetine 40,mg/day. The primary measure was the percentage of patients free from full-symptom panic attacks, assessed with the Panic and Anticipatory Anxiety Scale (PAAS). Secondary measures included the Panic Disorder Severity Scale, Clinical Global Impressions,Severity (CGI-S) and ,Improvement (CGI-I) scales; response (CGI-I rating of very much improved or much improved), remission (CGI-S rating of not at all ill or borderline ill and no PAAS full-symptom panic attacks); and measures of depression, anxiety, phobic fear and avoidance, anticipatory anxiety, functioning, and quality of life. Intent-to-treat, last observation carried forward analysis showed that mean improvement on most measures was greater with venlafaxine ER or paroxetine than with placebo. No significant differences were observed between active treatment groups. Panic-free rates at end point with active treatment ranged from 54% to 61%, compared with 35% for placebo. Approximately 75% of patients given active treatment were responders, and nearly 45% achieved remission. The placebo response rate was slightly above 55%, with remission near 25%. Adverse events were mild or moderate and similar between active treatment groups. Venlafaxine ER and paroxetine were effective and well tolerated in the treatment of panic disorder. Depression and Anxiety 24:1,14, 2007. © 2006 Wiley-Liss, Inc. [source]

    Safety of Lidocaine 15% and Prilocaine 5% Topical Ointment Used as Local Anesthesia for Intense Pulsed Light Treatment

    BACKGROUND Literature cautions against applying lidocaine 15%/prilocaine 5% over an area larger than 300 cm2. The area of the face, neck, and chest is 400 cm2 or greater. OBJECTIVE To investigate the safety of lidocaine 15%/prilocaine 5% topical anesthetic ointment used as anesthesia for intense pulsed light (IPL) treatment. METHODS AND MATERIALS Lidocaine 15%/prilocaine 5% ointment was applied to the face only (n=10) for 30 ± 15 minutes or to the face, neck, and chest (n=10) for a total of 60 ± 15 minutes before IPL. Blood lidocaine and prilocaine levels were measured. Adverse events were recorded. RESULTS For the entire cohort, blood was drawn 25.6 ± 6.6 minutes after IPL was completed. In the face only group, the mean lidocaine level was 0.122 ± 0.125 ,g/mL, and the mean prilocaine level was 0.048 ± 0.029 ,g/mL. In the face, neck, and chest group, the mean lidocaine level was 0.272 ± 0.208 ,g/mL, and the mean prilocaine level was 0.087 ± 0.060 ,g/mL. No adverse events related to systemic toxicity were observed or reported to the nurse. At the 24-hour follow-up, no subject reported symptoms of systemic toxicity after leaving the clinic. CONCLUSION Under the conditions of this study, topical lidocaine 15%/prilocaine 5% produces low levels of systemic absorption. The authors have indicated no significant interest with commercial supporters. [source]

    Persistence and Improvement of Nasolabial Fold Correction with Nonanimal-Stabilized Hyaluronic Acid 100,000 Gel Particles/mL Filler on Two Retreatment Schedules: Results up to 18 Months on Two Retreatment Schedules

    BACKGROUND Nonanimal-stabilized hyaluronic acid (NASHA) fillers are frequently used for facial soft tissue augmentation. Their long-term efficacy and the effects of different retreatment schedules are not well established. OBJECTIVE This is an 18-month interim analysis of a 30-month study to evaluate the efficacy and persistence of NASHA 100,000 gel particles/mL filler with two different retreatment schedules. METHODS This multicenter, randomized, evaluator-blinded study enrolled 75 patients with moderate to severe nasolabial folds. Patients were randomized to retreatment of one nasolabial fold at 4.5 months and the contralateral fold at 9 months after correction of both folds at the initial visit. RESULTS Wrinkle Severity Rating Scale scores improved significantly (p<.001) from baseline, with mean improvements ranging from 1.1 to 1.7 grades. Almost all patients (97%) responded satisfactorily, and the efficacy of the retreatment schedules did not differ significantly. Adverse events, primarily swelling and bruising, occurred in 33% of patients; none were serious. CONCLUSION The improvements seen after initial treatment with NASHA 100,000 gel particles/mL filler persisted for up to 18 months with one retreatment. The response was equivalent for retreatment at 4.5 and 9 months. [source]

    Exenatide: a review from pharmacology to clinical practice

    R. Gentilella
    Background:, Exenatide is an incretin mimetic that activates glucagon-like-peptide-1 receptors. It blunts the postprandial rise of plasma glucose by increasing glucose-dependent insulin secretion, suppressing inappropriately high glucagon secretion and delaying gastric emptying. Methods:, In seven clinical trials performed in 2845 adult patients with type 2 diabetes mellitus who were inadequately controlled by a sulphonylurea and/or metformin (glycosylated haemoglobin, HbA1c ,11%), or by thiazolidinediones (with or without metformin) and treated for periods from 16 weeks to 3 years, exenatide (5 ,g b.i.d. s.c. for the first 4 weeks of treatment and 10 ,g b.i.d. s.c. thereafter) reduced HbA1c, fasting and postprandial glucose, and body weight dose dependently, and was similar to insulin glargine and biphasic insulin aspart in reducing HbA1c. Body weight diminished with exenatide, whereas it increased with both insulin preparations. Positive effects on the lipid profile and a reduction in C-reactive protein were also recorded with exenatide. Treatment extensions up to 3 years showed that benefits were maintained in the long term. Adverse events were usually mild to moderate in intensity, and generally the frequency decreased with continued therapy. The most common was nausea (whose incidence may be reduced by gradual dose escalation from 5 ,g b.i.d. to 10 ,g b.i.d.), vomiting, diarrhoea, headache and hypoglycaemia (almost exclusively in patients treated with a sulphonylurea). Results and conclusions:, Exenatide is a new, promising therapeutic option for type 2 diabetic patients inadequately controlled by oral agents, before insulin therapy, offering the added benefits of body weight reduction and tight postprandial glucose control. [source]

    Telemetry Monitoring during Transport of Low-risk Chest Pain Patients from the Emergency Department: Is It Necessary?

    Adam J. Singer MD
    Abstract Background: Low-risk emergency department (ED) patients with chest pain (CP) are often transported by nurses to monitored beds on telemetry monitoring, diverting valuable resources from the ED and delaying transport. Objectives: To test the hypothesis that transporting low-risk CP patients off telemetry monitoring is safe. Methods: This was a secondary analysis of a prospective, observational cohort of ED patients with low-risk chest pain (no active chest pain, normal or nondiagnostic electrocardiogram, normal initial troponin I) admitted to a non,intensive care unit monitored bed who were transported off telemetry monitor by nonclinical personnel. A protocol allowing transportation of low-risk CP patients off telemetry monitoring to a monitored bed was developed, and an ongoing daily log of patients transported off telemetry was maintained for the occurrence of any adverse events en route to the floor. Adverse events requiring treatment included dysrhythmias, hypotension, syncope, and cardiac arrest. The study population included patients who presented during September,October 2004, whose data were abstracted from the medical records using standardized methodology. A subset of 10% of the medical records were reviewed by a second investigator for interrater reliability. Death, syncope, resuscitation, and dysrhythmias during transport or immediately on arrival to the floor were the outcomes measured. Descriptive statistics and confidence intervals (CIs) were used in data analysis. Results: During the study period, 425 patients had CP of potentially ischemic origin, of whom 322 (75.8%) were low risk and met the inclusion criteria and were transported off monitors. Their mean (±standard deviation) age was 58.3 (±16.0) years; 48.1% were female. During transport from the ED, there was no patient with any adverse events requiring treatment and there was no death (95% CI = 0% to 0.93%). Conclusions: Transportation of low-risk ED chest pain patients off telemetry monitoring by nonclinical personnel to the floor appears safe. This may reduce diversion of ED nurses from the ED, helping to alleviate nursing shortages. [source]

    A double-blind, placebo-controlled trial of modafinil (200 mg/day) for methamphetamine dependence

    ADDICTION, Issue 2 2009
    James Shearer
    ABSTRACT Aim To examine the safety and efficacy of modafinil (200 mg/day) compared to placebo in the treatment of methamphetamine dependence and to examine predictors of post-treatment outcome. Participants and design Eighty methamphetamine-dependent subjects in Sydney, Australia were allocated randomly to modafinil (200 mg/day) (n = 38) or placebo (n = 42) under double-blind conditions for 10 weeks with a further 12 weeks post- treatment follow-up. Measures Comprehensive drug use data (urine specimens and self-report) and other health and psychosocial data were collected weekly during treatment and research interviews at baseline, week 10 and week 22. Results Treatment retention and medication adherence were equivalent between groups. There were no differences in methamphetamine abstinence, craving or severity of dependence. Medication-compliant subjects tended to provide more methamphetamine-negative urine samples over the 10-week treatment period (P = 0.07). Outcomes were better for methamphetamine-dependent subjects with no other substance dependence and those who accessed counselling. There were statistically significant reductions in systolic blood pressure (P = 0.03) and weight gain (P = 0.05) in modafinil-compliant subjects compared to placebo. There were no medication-related serious adverse events. Adverse events were generally mild and consistent with known pharmacological effects. Conclusions Modafinil demonstrated promise in reducing methamphetamine use in selected methamphetamine-dependent patients. The study findings support definitive trials of modafinil in larger multi-site trials. [source]

    Efficacy and Safety of Oral Lacosamide as Adjunctive Therapy in Adults with Partial-Onset Seizures

    EPILEPSIA, Issue 7 2007
    Elinor Ben-Menachem
    Summary:,Purpose: To evaluate the efficacy and safety of lacosamide when added to 1 or 2 antiepileptic drugs (AEDs) in adults with uncontrolled partial-onset seizures, and assess plasma concentrations of concomitant AEDs to determine any potential for drug interactions. Methods: During this multicenter, double-blind, placebo-controlled trial, patients were randomized to placebo or lacosamide 200, 400, or 600 mg/day after an 8-week baseline period. Lacosamide was titrated in weekly increments of 100 mg/day over 6 weeks and maintained for 12 weeks. Results were analyzed on an intention-to-treat basis. Results: Four hundred eighteen patients were randomized and received trial medication; 312 completed the trial. The median percent reduction in seizure frequency per 28 days was 10%, 26%, 39%, and 40% in the placebo, lacosamide 200, 400, and 600 mg/day treatment groups, respectively. The median percent reduction in seizure frequency over placebo was significant for lacosamide 400 mg/day (p = 0.0023) and 600 mg/day (p = 0.0084). The 50% responder rates were 22%, 33%, 41%, and 38% for placebo, lacosamide 200, 400, and 600 mg/day, respectively. The 50% responder rate over placebo was significant for lacosamide 400 mg/day (p = 0.0038) and 600 mg/day (p = 0.0141). Adverse events that appeared dose-related included dizziness, nausea, fatigue, ataxia, vision abnormal, diplopia, and nystagmus. Lacosamide did not affect mean plasma concentrations of concomitantly administered AEDs. Conclusions: In this trial, adjunctive lacosamide significantly reduced seizure frequency in patients with uncontrolled partial-onset seizures. Along with favorable pharmacokinetic and tolerability profiles, these results support further development of lacosamide as an AED. [source]

    Comparative Cognitive Effects of Carbamazepine and Gabapentin in Healthy Senior Adults

    EPILEPSIA, Issue 6 2001
    Roy Martin
    Summary: ,Purpose: This study compared the cognitive effects of carbamazepine (CBZ) and gabapentin (GBP) in healthy senior adults by using a randomized, double-blind crossover design. Methods: Thirty-four senior adults were randomized to receive one of the two drugs followed by a 5-week treatment period. A 4-week washout phase preceded initiation of the second drug. Antiepileptic drugs (AEDs) were titrated to target doses of either CBZ (800 mg/day) or GBP (2,400 mg/day). Primary outcome measures were standardized neuropsychological tests of attention/vigilance, psychomotor speed, motor speed, verbal and visual memory, and the Profile of Mood State (POMS), yielding a total of 17 variables. Each subject received cognitive testing at predrug baseline, end of first drug phase, end of second drug phase, and 4 weeks after completion of the second drug phase. Results: Fifteen senior adults (mean age, 66.5 years; range, 59,76 years) completed the study. Seniors completing the study did not differ significantly from noncompleting seniors in terms of demographic features or baseline cognitive performances. Fifteen of the 19 seniors not completing the study dropped out while receiving CBZ. Adverse events were frequently reported for both AEDs, although they were more common for CBZ. Mean serum levels for the completers were within midrange clinical doses (CBZ, 6.8 ,g/ml; GBP, 7.1 ,g/ml). Significant differences between CBZ and GBP were found for only one of 11 cognitive variables, with better attention/vigilance for GBP, although the effect was modest. Performances on the nondrug average were significantly better on 45% of cognitive variables compared with CBZ and 36% compared with GBP. The overall pattern of means favored GBP over CBZ on 15 of 17 (p < 0.001), nondrug over CBZ on 17 of 17 (p < 0.0000), and nondrug over GBP on eight of 17 (NS). Conclusions: Mild cognitive effects were found for both AEDs compared with the nondrug average condition. The magnitude of difference between the two AEDs across the cognitive variables was modest. Self-reported mood was not significantly affected by either AED. However, overall tolerability and side-effect profile of CBZ were poorer than those of GBP in senior adults at doses and titration rates reported in this study. [source]

    Efficacy screening trials of paroxetine, pentoxifylline, riluzole, pramipexole and venlafaxine in cocaine dependence

    ADDICTION, Issue 2005
    Domenic A. Ciraulo
    ABSTRACT Aims The two studies presented here were conducted to assess the efficacy of paroxetine, pentoxifylline, riluzole, venlafaxine and pramipexole as medications for the treatment of cocaine dependence. Design A multi-arm, modified blinded, placebo-controlled design was used. Setting The studies were conducted at the Boston VA Healthcare System and the Boston University School of Medicine Medication Development Research Unit (MDRU). Participants Participants met criteria for cocaine dependence during a 2-week screening period. Intervention Following random assignment to one of the treatment groups, subjects received active medication or placebo for 8 weeks in combination with cognitive behavioral counseling. In the first study the efficacy of the antidepressant paroxetine (20 mg daily), the phosphodiesterase inhibitor pentoxifylline (1200 mg daily) and the glutamate release inhibitor riluzole (100 mg daily) was assessed. The antidepressant venlafaxine (150 mg daily) and the dopamine agonist pramipexole (1.5 mg daily) were evaluated in the second study. Measurements Urine benzoylecgonine (BE) concentrations, self-report of cocaine use and global impression scores served as primary outcome measures. Secondary measures included assessments of cocaine craving and psychiatric functioning. Adverse events were monitored during the treatment period. Findings None of the active medications produced greater reductions in urine BE concentrations over the treatment period than did placebo. There were trends for BE levels to become reduced in the pentoxifylline group during the first 4 weeks of treatment and for Addiction Severity Index (ASI) drug composite scores to be lower in the pentoxyfylline group at end-point compared to the placebo group. Significant within-group reductions in reported cocaine use and craving were found for all treatment groups, but none of the active medications were superior to placebo on these measures. The accuracy of self-reported cocaine use declined over the study period. Overall, the active medications were well tolerated. Conclusions This study does not support the use of paroxetine, pentoxifylline, riluzole, venlafaxine or pramipexole for the treatment of cocaine dependence. However, these results need to be interpreted with caution because of the small size and lack of homogeneity of the experimental groups. [source]