Before the widespread adoption of vaccination, adenovirus type 4 and type 7 were long associated with respiratory illnesses among military recruits. When supplies were depleted and vaccination was suspended in 1999 for approximately a decade, respiratory illnesses due to adenovirus infections resurged. In March 2011, a new live, oral adenovirus vaccine was licensed by the US Food and Drug Administration and was first universally administered to military recruits in October 2011, leading to rapid, dramatic elimination of the disease within a few months. As part of licensure, a postmarketing study (Sentinel Surveillance Plan) was performed to detect potential safety signals within 42days after immunization of military recruits. This study retrospectively evaluated possible adverse events related to vaccination using data from the Armed Forces Health Surveillance Branch Defense Medical Surveillance System (DMSS) database. Among 100,000 recruits who received the adenovirus vaccine, no statistically significant greater risk of prespecified medical events was observed within 42days after vaccination when compared with a historical cohort of 100,000 unvaccinated recruits. In an initial statistical analysis of International Classification of Disease, 9th Revision, Clinical Modification codes, a statistically significant higher risk for 19 other (not prespecified) medical events occurring in 5 or more recruits was observed among vaccinated compared with unvaccinated groups. After case record data abstraction for attribution and validation, two events (psoriasis [21 vs 7 cases] and serum reactions [12 vs 4 cases]) occurred more frequently in the vaccinated cohort. A causal relation of these rare events with adenovirus vaccination could not be established given confounding factors in the DMSS, such as coadministration of other vaccines and incomplete or inaccurate medical information, for some recruits. Prospective surveillance assessing these uncommon, but potentially relevant, immune-related symptoms may be beneficial in defining potential causal association with adenovirus vaccination.
In this large multicenter retrospective cohort study, concurrent administration of R+ATD was not associated with STS. The findings of this phase IV study expand the drug interaction and pharmacovigilance safety awareness for the use of antidepressants in patients with PD.
Daily glatiramer acetate (GA) 20 mg/1.0 mL is a first-line treatment for relapsing-remitting multiple sclerosis (RRMS). To reduce the occurrence of injection pain and local injection site reactions (LISRs), a reduced volume formulation of GA was developed. This study compared pain and LISRs after injecting the marketed and the novel formulations. RRMS patients currently injecting GA participated in this multicenter, randomized, crossover comparative study. All patients administered once-daily subcutaneous injections of GA 20 mg/1.0 mL (marketed formulation) or GA 20 mg/0.5 mL (reduced volume formulation) for 14 days. Patients were crossed-over to the alternate treatment for an additional 14 days. Using a Visual Analog Scale (VAS), patients recorded in daily diaries the severity of injection pain immediately and 5 min post-injection, and the presence and severity of LISRs (swelling, redness, itching, lump) within 5 min and 24 h post-injection. VAS pain scores were ranked significantly lower immediately and 5 min after GA 20 mg/0.5 mL injections (p < 0.0001). Although LISRs were rare for both preparations, the severity of reactions ranked significantly lower and fewer symptoms occurred within 5 min and 24 h of using the reduced volume formulation (p < 0.0001). GA injected subcutaneously in a reduced volume formulation is a more tolerable option.Electronic supplementary materialThe online version of this article (doi:10.1007/s00415-010-5779-x) contains supplementary material, which is available to authorized users.
Health and Wellness Survey (NHWS) in Brazil.. QOL was measured by the physical component score (PCS) and mental component score (MCS) of the Short Form-12 . Loss of work/productivity was measured by the validated Work Productivity and Activity Impairment instrument. Medical resource utilization was measured by health care provider, emergency room visits and hospitalization in the past 6 months. RESULTS: Of the 12,000 respondents, 215 (1.6%) were identified as AD patient's caregivers where 63.7% were women. The age group with the highest proportion of caregivers was 45-54yrs old (36.2%), and they are significantly older than non-caregivers (44.7 vs. 40.8, pϽ0.05). AD caregivers group reported more specific co-morbidities (insomnia 33.8%, cardiac arrhythmia 20.7%), similar mean scores of PCS (49.8 vs. 49.7) and MCS (47.3 vs. 46.9), similar percentage of emergency room visits (21.5% vs. 21.8%), and similar percentage of hospitalization visits (9.9 vs. 9.8) over the past 6 months compared to the group of not caregivers of AD patients. Furthermore, caregivers of AD patients' group reported 22.3% impairment in daily activity compared to 22.1% in the group of not caregivers of AD patients. CONCLUSIONS: From the Brazil NHWS results, AD caregivers suffer from impairment in QOL, work/productivity loss and more specific co-morbidities. Findings indicate there is still an unmet medical need in AD caregivers in Brazil. OBJECTIVES:The majority of currently approved disease-modifying therapies for Multiple Sclerosis (MS) are injectables; however, there is no validated injection satisfaction questionnaire for patients with MS. The Satisfaction with Injection Experience (SIE) questionnaire was developed as a reliable and valid scale to evaluate this critical aspect of MS treatment satisfaction. METHODS: The medical literature was reviewed to determine the domains that were relevant to MS injection satisfaction. Five domains were identified, along with the most commonly used response options and recall period. A draft SIE questionnaire was evaluated in cognitive debriefing interviews with MS patients. The final 5-item SIE questionnaire utilized a 2-week recall period, a 5-point Likert scale, and was scored as an unweighted mean composite with higher scores representing greater satisfaction. Preliminary psychometric analyses were conducted using baseline data from EN-CORE, a multicenter clinical trial designed to investigate 2 formulations of glatiramer acetate (GA) for subcutaneous injection. Data were analyzed using itemtotal Spearman correlations, Cronbach's alpha, and principal components analysis. RESULTS: Complete data were available for 142 MS patients who had been on the currently marketed 20mg formulation of GA utilizing the autoject 2 for glass syringe for at least 90 days (mean ϭ 4.8 years; SD ϭ 3.6). The mean score on the SIE questionnaire was 4.1 (SD ϭ 0.8; range 1.0 to 5.0). All item-total Spearman correlations were greater than 0.30 (range 0.34 to 0.79) and the SIE questionnaire demonstrated excellent overall interna...
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