Home About us Contact
|
Home About us Contact | ||
|
|
||
Study Duration (study + duration)
Selected AbstractsThe effects of Panax ginseng on quality of lifeJOURNAL OF CLINICAL PHARMACY & THERAPEUTICS, Issue 1 2003C. I. Coleman Pharm D SummaryPanax ginseng is marketed and used to maintain natural energy, increase mental and physical abilities, improve mood and promote general health and well-being. Panax ginseng has been studied in a number of randomized clinical trials investigating its effect on physical and psychomotor performance, cognitive function, immunomodulation, diabetes mellitus and herpes simples type-II infections. Equivocal results have been demonstrated for many of these indications. P. ginseng is also commonly used to promote quality of life (QoL). As a result, ginseng's effect on QoL has become an increasingly important endpoint in clinical trials. We reviewed all studies (n = 9) that determined the effect of P. ginseng on QoL. P. ginseng's has been evaluated at dosages of 80,400 mg. Study duration has spanned from 2 to 9 months. Several QoL measures have been used, ranging from widely accepted core instruments to unpublished investigator-derived questionnaires. In addition, many of the investigators utilized ginseng extracts that were supplemented with vitamins and minerals while others used only standardized ginseng extract. Populations evaluated also differed in terms of underlying morbidity. Nearly every study evaluated (n = 8) demonstrated some degree of QoL improvement. Beneficial effects were evident within instrument summary component scores but improvement in overall composite scores of QoL was rarely seen. However, findings were equivocal. While populations evaluated varied in terms of underlying morbidity, there did not appear to be a substantial difference in their response to ginseng with respect to QoL. Despite some positive results, improvement in overall health-related quality of life cannot, given the current research, be attributed to P. ginseng. However, the possibility that various facets of QoL may have improved and the potential of early transient effects cannot be discounted. [source] Effects of alcoholism severity and smoking on executive neurocognitive functionADDICTION, Issue 1 2009Jennifer M. Glass ABSTRACT Aims Neurocognitive deficits in chronic alcoholic men are well documented. Impairments include memory, visual,spatial processing, problem solving and executive function. The cause of impairment could include direct effects of alcohol toxicity, pre-existing cognitive deficits that predispose towards substance abuse, comorbid psychiatric disorders and abuse of substances other than alcohol. Cigarette smoking occurs at higher rates in alcoholism and has been linked to poor cognitive performance, yet the effects of smoking on cognitive function in alcoholism are often ignored. We examined whether chronic alcoholism and chronic smoking have effects on executive function. Methods Alcoholism and smoking were examined in a community-recruited sample of alcoholic and non-alcoholic men (n = 240) using standard neuropsychological and reaction-time measures of executive function. Alcoholism was measured as the average level of alcoholism diagnoses across the study duration (12 years). Smoking was measured in pack-years. Results Both alcoholism and smoking were correlated negatively with a composite executive function score. For component measures, alcoholism was correlated negatively with a broad range of measures, whereas smoking was correlated negatively with measures that emphasize response speed. In regression analyses, both smoking and alcoholism were significant predictors of executive function composite. However, when IQ is included in the regression analyses, alcoholism severity is no longer significant. Conclusions Both smoking and alcoholism were related to executive function. However, the effect of alcoholism was not independent of IQ, suggesting a generalized effect, perhaps affecting a wide range of cognitive abilities of which executive function is a component. On the other hand, the effect of smoking on measures relying on response speed were independent of IQ, suggesting a more specific processing speed deficit associated with chronic smoking. [source] Dose-related effects following oral exposure of 2,4-dinitrotoluene on the western fence lizard, Sceloporus occidentalisENVIRONMENTAL TOXICOLOGY & CHEMISTRY, Issue 2 2008Jamie G. Suski Abstract 2,4-dintitrotoluene (2,4-DNT) is an explosive frequently found in the soil of military installations. Because reptiles can be common on these sites, ecological risk assessments for compounds such as 2,4-DNT could be improved with toxicity data specific to reptiles. Western fence lizards, Sceloporus occidentalis, were used to develop a laboratory toxicity model for reptiles. A hierarchical approach was used; acute to subchronic studies were conducted to provide toxicity data relevant to short- and long-term exposures. First, a modified median lethal dose (LD50) study was conducted on male and female lizards using a stage-wise probit model. The LD50 was 577 mg/kg for female and 380 mg/kg for male lizards. Subsequently, a subacute experiment was conducted to further assess 2,4-DNT toxicity to male lizards and to define exposure levels for a longer term, subchronic study. The subchronic study was conducted for 60 consecutive days; male lizards were exposed to 0, 9, 15, 25, 42, 70 mg/kg/d. Dose-dependent mortality was observed in the three highest dose groups (25, 42, and 70 mg/kg/d); all other animals survived the study duration. Benchmark dose model calculations based on mortality indicated a 5% effect level of 15.8 mg/kg/d. At study termination, a gross necropsy was performed, organ weights were taken, and blood was collected for clinical and hematological analysis. Body weight, kidney weight, food consumption, postdose observations, and blood chemistries all were found to be significantly different from controls at doses above 9 mg/kg/d. Also, preliminary results suggest behavioral observations, and reduced food consumption may be a sensitive indicator of toxicity. The present study indicates Sceloporus occidentalis is suitable for evaluating toxicity of compounds to reptilian species. [source] Time Course of Adverse Events in Patients with Localization-related Epilepsy Receiving Topiramate Added to CarbamazepineEPILEPSIA, Issue 5 2005Jerzy 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] Creatine has no beneficial effect on skeletal muscle energy metabolism in patients with single mitochondrial DNA deletions: a placebo-controlled, double-blind 31P-MRS crossover studyEUROPEAN JOURNAL OF NEUROLOGY, Issue 4 2005C. Kornblum The purpose of our randomized, double-blind, placebo-controlled crossover study in 15 patients with chronic progressive external ophthalmoplegia (CPEO) or Kearns,Sayre syndrome (KSS) because of single large-scale mitochondrial (mt) DNA deletions was to determine whether oral creatine (Cr) monohydrate can improve skeletal muscle energy metabolism in vivo. Each treatment phase with Cr in a dosage of 150 mg/kg body weight/day or placebo lasted 6 weeks. The effect of Cr was estimated by phosphorus-31 magnetic resonance spectroscopy (31P-MRS), clinical and laboratory tests. 31P-MRS analysis prior to treatment showed clear evidence of severe mitochondrial dysfunction. However, there were no relevant changes in 31P-MRS parameters under Cr. In particular, phosphocreatine (PCr)/ATP at rest did not increase, and there was no facilitation of post-exercise PCr recovery. Clinical scores and laboratory tests did not alter significantly under Cr, which was tolerated without major side-effects in all patients. Cr supplementation did not improve skeletal muscle oxidative phosphorylation in our series of patients. However, one explanation for our negative findings may be the short study duration or the limited number of patients included. [source] Semiparametric variance-component models for linkage and association analyses of censored trait dataGENETIC EPIDEMIOLOGY, Issue 7 2006G. Diao Abstract Variance-component (VC) models are widely used for linkage and association mapping of quantitative trait loci in general human pedigrees. Traditional VC methods assume that the trait values within a family follow a multivariate normal distribution and are fully observed. These assumptions are violated if the trait data contain censored observations. When the trait pertains to age at onset of disease, censoring is inevitable because of loss to follow-up and limited study duration. Censoring also arises when the trait assay cannot detect values below (or above) certain thresholds. The latent trait values tend to have a complex distribution. Applying traditional VC methods to censored trait data would inflate type I error and reduce power. We present valid and powerful methods for the linkage and association analyses of censored trait data. Our methods are based on a novel class of semiparametric VC models, which allows an arbitrary distribution for the latent trait values. We construct appropriate likelihood for the observed data, which may contain left or right censored observations. The maximum likelihood estimators are approximately unbiased, normally distributed, and statistically efficient. We develop stable and efficient numerical algorithms to implement the corresponding inference procedures. Extensive simulation studies demonstrate that the proposed methods outperform the existing ones in practical situations. We provide an application to the age at onset of alcohol dependence data from the Collaborative Study on the Genetics of Alcoholism. A computer program is freely available. Genet. Epidemiol. 2006. © 2006 Wiley-Liss, Inc. [source] A Double-Blind Comparison of OnabotulinumtoxinA (BOTOX®) and Topiramate (TOPAMAX®) for the Prophylactic Treatment of Chronic Migraine: A Pilot StudyHEADACHE, Issue 10 2009Ninan T. Mathew MD Background., There is a need for effective prophylactic therapy for chronic migraine (CM) that has minimal side effects. Objective., To compare the efficacy and safety of onabotulinumtoxinA (BOTOX®, Allergan, Inc., Irvine, CA) and topiramate (TOPAMAX®, Ortho-McNeil, Titusville, NJ) prophylactic treatment in patients with CM. Methods., In this single-center, double-blind trial, patients with CM received either onabotulinumtoxinA, maximum 200 units (U) at baseline and month 3 (100 U fixed-site and 100 U follow-the-pain), plus an oral placebo, or topiramate, 4-week titration to 100 mg/day with option for additional 4-week titration to 200 mg/day, plus placebo saline injections. OnabotulinumtoxinA or placebo saline injection was administered at baseline and month 3 only, while topiramate oral treatment or oral placebo was continued through the end of the study. The primary endpoint was treatment responder rate assessed using Physician Global Assessment 9-point scale (+4 = clearance of signs and symptoms and ,4 = very marked worsening [about 100% worse]). Secondary endpoints included the change from baseline in the number of headache (HA)/migraine days per month (HA diary), and HA disability measured using Headache Impact Test (HIT-6), HA diary, Migraine Disability Assessment (MIDAS) questionnaire, and Migraine Impact Questionnaire (MIQ). The overall study duration was approximately 10.5 months, which included a 4-week screening period and a 2-week optional final safety visit. Follow-up visits for assessments occurred at months 1, 3, 6, and 9. Adverse events (AEs) were documented. Results., Of 60 patients randomized to treatment (mean age, 36.8 ± 10.3 years; 90% female), 36 completed the study at the end of the 9 months of active treatment (onabotulinumtoxinA, 19/30 [63.3%]; topiramate, 17/30 [56.7%]). In the topiramate group, 7/29 (24.1%) discontinued study because of treatment-related AEs vs 2/26 (7.7%) in the onabotulinumtoxinA group. Between 68% and 83% of patients for both onabotulinumtoxinA and topiramate groups reported at least a slight (25%) improvement in migraine; response to treatment was assessed using Physician Global Assessment at months 1, 3, 6, and 9. Most patients in both groups reported moderate to marked improvements at all time points. No significant between-group differences were observed, except for marked improvement at month 9 (onabotulinumtoxinA, 27.3% vs topiramate, 60.9%, P = .0234, chi-square). In both groups, HA/migraine days decreased and MIDAS and HIT-6 scores improved. Patient-reported quality of life measures assessed using MIQ after treatment with onabotulinumtoxinA paralleled those seen after treatment with topiramate in most respects. At month 9, 40.9% and 42.9% of patients in the onabotulinumtoxinA and topiramate groups, respectively, reported ,50% reduction in HA/migraine days. Forty-one treatment-related AEs were reported in 18 onabotulinumtoxinA-treated patients vs 87 in 25 topiramate-treated patients, and 2.7% of patients in the onabotulinumtoxinA group and 24.1% of patients in the topiramate group reported AEs that required permanent discontinuation of study treatment. Conclusions., OnabotulinumtoxinA and topiramate demonstrated similar efficacy in the prophylactic treatment of CM. Patients receiving onabotulinumtoxinA had fewer AEs and discontinuations. [source] Pregabalin for peripheral neuropathic pain: results of a multicenter, non-comparative, open-label study in Indian patientsINTERNATIONAL JOURNAL OF CLINICAL PRACTICE, Issue 9 2006LYRICA STUDY GROUP Summary The aim of this study was to evaluate the tolerability, safety and efficacy of pregabalin in Indian patients with peripheral neuropathic pain. In this prospective, multicenter, non-comparative, open-label study, patients with peripheral neuropathic pain (n = 111) received pregabalin in doses ranging from 75 to 300 mg twice daily for 3 weeks. Primary efficacy measures included weekly pain score and the Visual Analogue Scale (VAS) score of the Short-Form McGill Pain Questionnaire (SF-MPQ). Despite a short study duration, a significant reduction was seen in weekly pain score (p < 0.0001), as well as VAS score of SF-MPQ (p < 0.0001). Significant improvements were also seen in other pain-related endpoints, weekly sleep interference score, quality of life measures, and patient and clinician ratings of global improvement. Pregabalin was well tolerated, and the most common adverse events were dizziness and somnolence. The short study duration precluded the assessment of longer term safety issues such as weight gain. This study has demonstrated the safety, tolerability and efficacy of pregabalin for peripheral neuropathic pain in Indian patients. [source] In-vitro and in-vivo characterization of a buprenorphine delivery systemJOURNAL OF PHARMACY AND PHARMACOLOGY: AN INTERNATI ONAL JOURNAL OF PHARMACEUTICAL SCIENCE, Issue 3 2006Sofie R. Kleppner Buprenorphine is a mu-opioid receptor partial agonist with enhanced safety and comparable efficacy to methadone for treatment of opioid dependence. The sublingual formulation of buprenorphine, approved for treatment of opioid dependence, produces variable buprenorphine blood levels and requires frequent dosing that limits patient compliance. To achieve stable buprenorphine levels that may improve patient outcome, an implantable sustained buprenorphine delivery system was developed. Each implant consists of ethylene vinyl acetate copolymer and 90 mg buprenorphine HCl, and measures 26 mm in length and 2.4 mm in diameter. Steady-state release in-vitro was 0.5 mg/implant/day. In-vivo pharmacokinetics and safety were examined for up to 52 weeks in beagle dogs receiving 8, 16 or 24 subcutaneous implants. Plasma buprenorphine concentrations correlated with the number of implants administered. Peak buprenorphine concentrations were generally reached within 24 h after implantation. Steady-state plasma levels were attained between 3 and 8 weeks, and were maintained for study duration, with a calculated mean release rate of 0.14 ± 0.04 mg/implant/day. There were no test-article-related adverse effects. This delivery system can provide long-term stable systemic buprenorphine levels, and may increase patient compliance, thereby improving outcome for opioid-dependent patients. [source] Correcting poor vitamin D status: Do older adults need higher repletion doses of vitamin D3 than younger adults?MOLECULAR NUTRITION & FOOD RESEARCH (FORMERLY NAHRUNG/FOOD), Issue 8 2010Susan J. Whiting Abstract We conducted an examination of recent studies to determine whether older adults (,65 years) need higher levels of supplementary vitamin D than young adults when attempting to replete vitamin D status in deficient subjects, i.e. those with levels of 25-hydroxyvitamin D less than 75,nmol/L. As data on repletion with vitamin D2 have recently been published, we restricted our discussion to the use of vitamin D3 from dietary supplements, prescriptions for large oral doses, and bolus dosing or injections. Most published dosing regimens failed to achieve 75,nmol/L in most all subjects, whether young adults (<65 years) or older adults (,65 years). Whether as daily or bolus oral supplementation, elderly subjects appeared to need more vitamin D3 compared with younger adults, however, baseline levels, endpoints, study duration, compliance, and other factors were different among studies. To ensure most subjects are replete in vitamin D, a daily dose of more than 50,,g (2000,IU) in younger and 125,,g (5000,IU) is required. Other strategies including bolus and loading doses are described. No study reported adverse effects of using oral intakes about the current upper level of 50,,g (2000,IU). [source] Sample size estimation for non-inferiority trials of time-to-event dataPHARMACEUTICAL STATISTICS: THE JOURNAL OF APPLIED STATISTICS IN THE PHARMACEUTICAL INDUSTRY, Issue 4 2008Adam Crisp Abstract We consider the problem of sample size calculation for non-inferiority based on the hazard ratio in time-to-event trials where overall study duration is fixed and subject enrolment is staggered with variable follow-up. An adaptation of previously developed formulae for the superiority framework is presented that specifically allows for effect reversal under the non-inferiority setting, and its consequent effect on variance. Empirical performance is assessed through a small simulation study, and an example based on an ongoing trial is presented. The formulae are straightforward to program and may prove a useful tool in planning trials of this type. Copyright © 2007 John Wiley & Sons, Ltd. [source] Effect of non-steroidal anti-inflammatory drugs on non-melanoma skin cancer incidence in the SKICAP-AK trial,PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 4 2009Mary C. Clouser MPH, PhDc Abstract Recent studies link the prostaglandin metabolic pathway to skin carcinogenesis expanding possibilities that cyclooxygenase (COX) inhibitors may be utilized in non-melanoma skin cancer (NMSC) chemoprevention. Using data from a study of the efficacy of retinol supplementation on incidence of NMSC, we sought to determine the role of non-steroidal anti-inflammatory drugs (NSAIDs) in NMSC development. Cox proportional hazards models describe the relationship between NSAID use and time to first squamous cell carcinoma (SCC) or basal cell carcinoma (BCC) among participants categorized by use pattern: continuous users (use for length of study duration), new users (use for less than study duration), and non-users. For SCC and BCC, there was a statistically significant protective effect for participants who reported use for less than the study duration (HR,=,0.49, 95%CI 0.28,0.87 and HR,=,0.43, 95%CI 0.25,0.73, respectively). Categorical examination of NSAIDs (aspirin (ASA) vs. non-ASA NSAIDs) showed significant effects for BCC among those using non-ASA NSAIDs for less than the study duration (HR,=,0.33, 95%CI 0.13,0.80). For SCC and BCC, NSAID use of shorter duration and potentially more recent, was more protective than longer duration of use. These results are counter to the idea that longer duration of NSAID use is more protective. Additional investigations are needed into the role NSAIDs play in the chemoprevention of NMSC. Copyright © 2009 John Wiley & Sons, Ltd. [source] Glucose Depletion Enhances Sensitivity to Shear Stress-induced Mechanical Damage in Red Blood Cells by Rotary Blood PumpsARTIFICIAL ORGANS, Issue 9 2009Daisuke Sakota Abstract The metabolic process in red blood cells (RBCs) is anaerobic. The life-dependent adenosine triphosphate (ATP) for survival of cells is produced through glycolytic process. The aim of the study was to evaluate the effects of the glucose level on the mean corpuscular volume, mean corpuscular hemoglobin concentration, and hemolysis rate during hemolysis study by rotary blood pumps. The shear stress generated by rotary blood pumps may enhance glucose utilization by RBCs with depletion of glucose affecting ATP production and, consequently, cell size, shape, and morphology. The shear stress increases metabolism of RBCs consuming more energy ATP which is produced anaerobically from glycolytic process. Hence, in the closed circuit testing of rotary blood pumps, depletion of glucose might occur after prolonged pumping, which in turn affects metabolic process of RBCs by changing their size, shape, and morphology. It is thus suggested to monitor and control the glucose level of the fluid that suspends RBCs depending on the study duration. [source] Functional and Biocompatibility Performances of an Integrated Maglev Pump-OxygenatorARTIFICIAL ORGANS, Issue 1 2009Tao Zhang Abstract To provide respiratory support for patients with lung failure, a novel compact integrated pump-oxygenator is being developed. The functional and biocompatibility performances of this device are presented. The pump-oxygenator is designed by combining a magnetically levitated pump/rotor with a uniquely configured hollow fiber membrane bundle to create an assembly free, ultracompact, all-in-one system. The hemodynamics, gas transfer and biocompatibility performances of this novel device were investigated both in vitro in a circulatory flow loop and in vivo in an ovine animal model. The in vitro results showed that the device was able to pump blood flow from 2 to 8 L/min against a wide range of pressures and to deliver an oxygen transfer rate more than 300 mL/min at a blood flow of 6 L/min. Blood damage tests demonstrated low hemolysis (normalized index of hemolysis [NIH],0.04) at a flow rate of 5 L/min against a 100-mm Hg afterload. The data from five animal experiments (4 h to 7 days) demonstrated that the device could bring the venous blood to near fully oxygen-saturated condition (98.6% ± 1.3%). The highest oxygen transfer rate reached 386 mL/min. The gas transfer performance was stable over the study duration for three 7-day animals. There was no indication of blood damage. The plasma free hemoglobin and platelet count were within the normal ranges. No gross thrombus is found on the explanted pump components and fiber surfaces. Both in vitro and in vivo results demonstrated that the newly developed pump-oxygenator can achieve sufficient blood flow and oxygen transfer with excellent biocompatibility. [source] Doxazosin for treating lower urinary tract symptoms compatible with benign prostatic obstruction: a systematic review of efficacy and adverse effectsBJU INTERNATIONAL, Issue 9 2004Roderick MacDonald The first paper in this section is a systematic review of the efficacy and adverse effects of doxazosin for treating LUTS compatible with benign prostatic obstruction. The criteria for inclusion were met by 13 studies involving 6033 men. The authors found evidence that doxazosin was effective and well tolerated in patients with LUTS. Combined therapy was superior to doxazosin alone in reducing the risk of clinical progression and other long-term complications of this condition. Authors from the UK reviewed the long-term results they achieved with an endourethral stent for treating BPH; quite a large proportion of patients had either died from unrelated causes or had had the stent removed. They stressed the necessity for careful case selection, but showed that it was a safe treatment for BPH in poor-risk patients. OBJECTIVE To evaluate the efficacy and adverse effects of doxazosin for treating lower urinary tract symptoms (LUTS) compatible with benign prostatic obstruction (BPO). METHODS Randomized controlled trials were included in the meta-analysis if: the study duration was ,,1 month; the study involved men with symptomatic BPO; and doxazosin was compared with placebo or active controls. Study and patient characteristics and outcome data were extracted in duplicate onto standardized forms using a prospectively developed protocol. RESULTS Thirteen studies involving 6033 men with (mean age 64 years) met the inclusion criteria; 10 were placebo-controlled, including two with combined doxazosin/finasteride therapy and finasteride monotherapy arms. Three trials were a comparison with other ,-blockers. The study duration was 1,54 months. The mean baseline symptom scores and peak urinary flow (PUF) rates were indicative of moderate BPO. Doxazosin gave significant improvements in LUTS, assessed by symptom scores, vs placebo and finasteride in the short- to long-term. Two long-term studies (1 and 4 years) reported mean changes from baseline for the International Prostate Symptom Score of ,,8.3 and ,,6.6 points (,49% and ,,39%) for doxazosin and ,,5.7 and ,,4.9 points (,33% and ,,29%) for placebo, respectively. Doxazosin significantly increased PUF rates vs placebo. In pooled results from three studies, the weighted mean difference in the mean change from baseline vs placebo was 1.6 mL/s (95% confidence interval 1.2,2.1). Efficacy was comparable with other ,1,blockers. In the long-term (>4 years) doxazosin was no better then finasteride in improving PUF. Combined doxazosin and finasteride significantly reduced the risk of overall clinical progression of BPO vs each drug separately in men followed for >4 years. Absolute risk reductions vs placebo were 11.3%, 6.9% and 6.4% for combined therapy, doxazosin and finasteride, respectively (P < 0.001). Improvements in symptom scores and PUF were also significantly greater with combined than monotherapy, and the former reduced the need for invasive treatment for BPO and the risk of long-term urinary retention, although the absolute reductions in risk vs placebo were small (<4%). Dizziness and fatigue were significantly more common with doxazosin than placebo (11% vs 7%, and 6% vs 3%, respectively). Adverse events reported for combined therapy were similar to those with each monotherapy. CONCLUSION The evidence indicates that doxazosin is effective and generally well tolerated for improving LUTS and PUF in men with symptomatic BPO. Combined therapy was better than doxazosin alone in reducing the risk of clinical progression of BPO and other long-term complications related to BPO. [source] Transthoracic echocardiography for precardioversion screening during atrial flutter/fibrillation in young patientsCLINICAL CARDIOLOGY, Issue 7 2004M. Silvana Horenstein M.D. Abstract Background: Transthoracic echocardiography (TTE) is reliable for detection of thrombi in the left ventricle and right atrium, but not in the left atrial appendage. Therefore, transesophageal echocardiography (TEE) is routinely performed in adults prior to electric cardioversion for atrial flutter/fibrillation (AFF). Whetheryoung survivors of congenital heart disease repair with AFF need routine TEE prior to electric cardioversion is unknown. Hypothesis: Electric cardioversion for AFF is safe in survivors of congenital heart disease repair/palliation if an intracardiac thrombus is not suspected on TTE imaging. Methods: This study reports the outcome of patients in a pediatric tertiary care cardiac unit where electric cardioversion was performed if no intracardiac thrombus was suspected on TTE. We performed a retrospective chart review of all patients treated with electric cardioversion for AFF at Children's Hospital of Michigan during 1997-2002. Results: Of 35 patients who presented with 110 episodes of AFF requiring electric cardioversion during the study duration, 32 (age 3 months-49 years, median age 20.5 years, 104 AFF episodes) had previously undergone palliative surgery or repair of their congenital heart disease. Of these 32 patients, 18 were survivors of a Fontan palliation (for a single-ventricle variant) and the remaining 14 were survivors of other defects and repairs (septal defects, valve replacements, and tetralogy of Fallot). During 81% of the episodes, patients were receiving aspirin, warfarin, or heparin for anticoagulation at presentation. Transthoracic echocardiography was performed in 74 AFF episodes; of these, 10 TTE studies were suspicious for atrial thrombi. Transesophageal echocardiography confirmed the presence of athrombus in 3 of these 10 patients. These patients received warfarin for 2 weeks and then underwent electric cardioversion. No thromboembolic events occurred immediately after or on follow-up in any patient. Conclusions: These findings suggest that TTE may be an effective imaging tool for precardioversion screening in young patients with AFF. [source] One-year follow-up of patients with acromegaly treated with fixed or titrated doses of lanreotide Autogel®CLINICAL ENDOCRINOLOGY, Issue 6 2004Ph. Caron Summary objective, Somatostatin analogue treatment is first-line medical therapy for acromegaly. This study compared the efficacy and tolerability of titrated doses of the long-acting somatostatin analogue preparation lanreotide Autogel® with fixed doses and with lanreotide prolonged release (PR) 30 mg microparticles. patients, Patients entering the initial study had received a diagnosis of active acromegaly within the previous 5 years. design, This open, comparative, multicentre study was a 1-year extension of a previous trial during which patients with acromegaly had switched from lanreotide PR 30 mg microparticles injected intramuscularly every 7, 10 or 14 days, for at least 3 months, to one of three fixed doses of lanreotide Autogel® (120, 90, or 60 mg every 28 days, respectively). In this extension study, patients continued to receive 60, 90, or 120 mg of lanreotide Autogel® by deep subcutaneous injection every 28 days for 1 year. Doses could be titrated at entry or after four or eight injections, according to the GH/IGF-I response (dose increased if GH > 2·5 µg/l, or decreased if GH < 1 µg/l with normal IGF-I). measurements, Mean ± SEM GH and IGF-I concentrations were analysed and gallbladder echography performed at weeks 0, 16, 32, and 48. Acromegaly symptoms were recorded monthly and tolerance and side-effects were monitored throughout the study. results, In total, 130 patients entered this extension phase. After 1 year of treatment with titrated doses of lanreotide Autogel®, mean GH (2·4 ± 0·2 µg/l) and IGF-I (287 ± 12 µg/l) concentrations were significantly lower than with lanreotide microparticles (GH, 2·8 ± 0·2 µg/l, P < 0·001; IGF-I, 332 ± 15 µg/l, P < 0·01) or with fixed-dose lanreotide Autogel® (GH, 3·0 ± 0·2 µg/l, P < 0·001; IGF-I, 310 ± 14 µg/l, P = 0·02). GH hypersecretion was reduced to , 2·5 µg/l in 68% of patients with titrated-dose lanreotide Autogel® compared with 49% with microparticles (P < 0·001) and 56% with fixed-dose lanreotide Autogel® (P , 0·005). In the 65 patients who did not require any dose titration, there was no substantial change in serum lanreotide concentration, GH or IGF-I levels over the 12-month study duration. Acromegaly was effectively controlled (GH , 2·5 µg/l and normalized IGF-I) in significantly more patients (43%) compared with microparticles (32%; P < 0·05). There was a trend for improved control of acromegalic symptoms with dose titration, whereas the incidence of gastrointestinal symptoms and local tolerance was similar with lanreotide Autogel® and lanreotide microparticles. Gallbladder echographies showed new lithiasis in 8% of lanreotide Autogel® patients. conclusion, Dose titration of lanreotide Autogel® improved GH and IGF-I control in patients with acromegaly beyond that achieved using fixed doses of lanreotide Autogel® or lanreotide microparticles. Titrated long-term lanreotide Autogel® treatment is well tolerated. [source] | |||||||||||||||||||||||||