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One Adverse Event (one + adverse_event)
Selected AbstractsA randomized, placebo-controlled study of the efficacy and safety of sertraline in the treatment of the behavioral manifestations of Alzheimer's disease in outpatients treated with donepezilINTERNATIONAL JOURNAL OF GERIATRIC PSYCHIATRY, Issue 1 2004Sanford I. Finkel Abstract Objective To examine the safety and efficacy of sertraline augmentation therapy in the treatment of behavioral manifestations of Alzheimer's disease (AD) in outpatients treated with donepezil. Methods and materials Patients with probable or possible AD, and a Neuropsychiatric Inventory (NPI) total score >5 (with a severity score ,2 in at least one domain), were treated with donepezil (5,10,mg) for 8 weeks, then randomly assigned to 12 weeks of double-blind augmentation therapy with either sertraline (50,200,mg) or placebo. Primary efficacy measures were the 12-item Neuropsychiatric Inventory (NPI) and the Clinical Global Impression Improvement (CGI-I) and Severity (CGI-S) scales. Results 24 patients were treated with donepezil+sertraline and 120 patients with donepezil+placebo. There were no statistically significant differences at endpoint on any of the three primary efficacy measures. However, a linear mixed model analysis found modest but statistically significantly greater improvements in the CGI-I score on donepezil+sertraline. Moreover, in a sub-group of patients with moderate-to-severe behavioral and psychological symptoms of dementia, 60% of patients on sertraline vs 40% on placebo (p,=,0.006) achieved a response (defined as ,;50% reduction in a four-item NPI-behavioral subscale). One adverse event (diarrhea) was significantly (p,<,0.05) more common in the donepezil+sertraline group compared to the donepezil+placebo group. Conclusion Sertraline augmentation was well-tolerated in this sample of AD outpatients. In addition, post hoc analyses demonstrated a modest but statistically significant advantage of sertraline over placebo augmentation in mixed model analyses and a clinically and statistically significant advantage in a subgroup of patients with moderate-to-severe behavioral and psychological symptoms of dementia. Copyright © 2004 John Wiley & Sons, Ltd. [source] Safety of Magnetic Resonance Imaging of Stapes Prostheses,THE LARYNGOSCOPE, Issue 3 2005Mark James Syms MD Abstract Objective: Assess the safety of performing magnetic resonance imaging (MRI) on patients with stapes prostheses. Study Design: Survey and animal model. Methods: A survey regarding implant usage, MRI procedures, and adverse outcomes after MRI in patients previously undergoing stapes procedures. Guinea pigs implanted with ferromagnetic 17 to 4 stainless steel, 316L nonferromagnetic stainless steel, titanium, and fluoroplastic stapes prostheses underwent a MRI in a 4.7 Tesla MR system. Results: Three adverse outcomes were reported on the clinical survey. One adverse event occurred during an MRI performed on a recalled ferromagnetic prosthesis. The other two adverse events were probably not secondary to MRI exposure. No damage or inflammation was observed in the region of the oval window or vestibule of implanted guinea pigs exposed to a 4.7 Tesla MR system. Conclusions: The combination of prior studies, the clinical survey, and the absence of histopathologic evidence of damage in the guinea pigs is compelling evidence that MRI for patients with stapes prostheses is safe. Implanting physicians should feel comfortable clearing a patient for a MRI in a 1.5 Tesla or 3.0 Tesla MRI. It is imperative for the physician to qualify the field strength when clearing a patient to undergo a MRI. [source] Assessment of Adverse Events Associated With Triptans,Methods of Assessment Influence the ResultsHEADACHE, Issue 10 2004Fred D. Sheftell MD Background.,A recent study conducted in triptan-naïve 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 prospective Italian survey on the safety of subcutaneous immunotherapy for respiratory allergyCLINICAL & EXPERIMENTAL ALLERGY, Issue 10 2009M. Schiappoli Summary Background Subcutaneous immunotherapy is effective for the treatment of respiratory allergy, and it is largely used in Italy, but no systematic safety assessment has been carried out so far. Objective To assess prospectively the safety of injection immunotherapy in a multicentre, real-life survey. Methods Eleven Italian allergy departments recorded the clinical characteristics of systemic reactions (SRs) due to immunotherapy. Vaccines were prescribed according to guidelines; only standardized depot extracts were used. SRs were graded according to the EAACI recommendations, and were classified as immediate or delayed. Results One thousand seven hundred and thirty-eight patients (847 males, age range 5,71) received immunotherapy from eight different manufacturers, for a total of 2038 courses (300 patients received two extracts). A total of 60 785 injections were given over a mean immunotherapy duration of 3 years. Overall, 95 reactions were observed in 57 patients (3.28%), corresponding to 4.7% of the courses and 1.56/1000 injections. Twenty-five patients experienced more than one adverse event. There were 34 grade 2, 60 grade 3 and one grade 4 reactions and no fatality. SRs occurred more frequently in patients with asthma than in patients with rhinitis alone (4.1% vs. 1.1%), and were equally distributed between the build-up and the maintenance phase. Ragweed and grass extracts caused significantly more side effects than other allergens. Conclusion In this large prospective study, the rate of SRs was low, thus confirming that injection immunotherapy has an acceptable risk/benefit ratio when prescribed and carried out according to recommendations. [source] | ||||||||||