Background Women living with HIV/AIDS who drink alcohol are at increased risk for adverse health outcomes, but there is little evidence on best methods for reducing alcohol consumption in this population. We conducted a pilot study to determine the acceptability and feasibility of conducting a larger randomized clinical trial of naltrexone vs. placebo to reduce alcohol consumption in women living with HIV/AIDS. Methods We designed the trial with input from community and scientific review. Women with HIV who reported current hazardous drinking (>7 drinks/week or ≥4 drinks per occasion) were randomly assigned to daily oral naltrexone (50mg) or placebo for 4 months. We evaluated willingness to enroll, adherence to study medication, treatment side effects, and drinking and HIV-related outcomes. Results From 2010 to 2012, 17 women enrolled (mean age 49 years, 94% African American). Study participation was higher among women recruited from an existing HIV cohort study compared to women recruited from an outpatient HIV clinic. Participants took 73% of their study medication; 82% completed the final assessment (7-months). Among all participants, mean alcohol consumption declined substantially from baseline to month 4 (39.2 vs. 12.8 drinks/week, p<0.01) with continued reduction maintained at 7-months. Drinking reductions were similar in both naltrexone and placebo groups. Conclusions A pharmacologic alcohol intervention was acceptable and feasible in women with HIV, with reduced alcohol consumption noted in women assigned to both treatment and placebo groups. However, several recruitment challenges were identified that should be addressed to enhance recruitment in future alcohol treatment trials.
obtained from 1225 patients [709 male, 516 female]. The average age of the patients was found to be 56.8±0.5 years. The average number of medications prescribed was 10.6±0.2. 585 patients were found to be aged 60 years or more and 613 patients were in the age group 18-60 years. Out of the 1225 patients, 848 did not have any medication error. An error was noted on only in 377 patient profiles. The total number of medication errors was found to be 638. Of these, 597 were errors 'with no harm' and only 41 were errors 'with harm'. Of these medication errors, drug interactions (DIs) were found to be leading the list with 50% of the medication errors. Cardiovascular agents contributed maximum to the DIs followed by anticoagulants and antimicrobial agents. Only 172 DIs had a moderate severity. DIs was followed by duplication of therapy (20%), incorrect interval (10%), monitoring error, incompleteness of prescription, omission error and overdosing, respectively. CONCLUSIONS: These results confirm that drug interaction continue to lead the list of medication errors in Indian tertiary health care settings. The study is ongoing to determine the interventions to reduce the errors.
BackgroundDrug retention is considered an indicator of the overall effectiveness, safety and tolerability of a treatment. It is a useful guide to decide the best anti-TNF therapy in patients with R.A.ObjectivesTo determine which of the TNF inhibitors has the highest retention rate in patients with R.A and to analyze the different reasons for drug discontinuation.MethodsA search of MEDLINE, CENTRAL and EMBASE identified 201 randomized controlled trials (RCTs). We included those comparing a TNF inhibitor (standard dose) with a placebo group, plus concomitant use of conventional DMARDs. We excluded those allowing rescue therapy or not reporting the outcomes of interest. These outcomes were: drug discontinuation and reasons, adverse events, serious adverse events, infections, serious infections and acute infusion events or injection site reactions. A mixed-treatment comparisons analysis was constructed to indirectly compare each study group to one another. Calculation of the probability that each treatment is best was implemented using the Bayesian Markov chain Monte Carlo method.Results18 RCTs, including 6948 patients, were extracted. The mean length of study was 6.6 months. On average, patients were 52 years old with active R.A of 5.5 years duration, with 24 TJC, 15 SJC and CRP of 2.3 mg/dl at baseline.All TNF inhibitors were associated with relatively high rates of drug survival and no statistically significant differences were noted. By rank probability, Infliximab had the highest probability (52%) of retaining patients, and Golimumab (26%) and Certolizumab (29%) had the highest probabilities of being least likely to retain patients (see graphic). Regarding discontinuation due to lack/loss of efficacy, Certolizumab was the most likely and Infliximab the least likely drug to be discontinued. With respect to discontinuation due to adverse events, Infliximab had a 77% probability of being the most likely drug to be discontinued and Certolizumab (30%) was the least likely drug to be discontinued. Additionally, regarding adverse event-related outcomes, several observations were notable. Both Adalimumab and Golimumab were statistically significantly less likely than Infliximab to cause infections and, by rank probability, Infliximab had a 96% chance of being the drug most likely to cause infections. Regarding infusion/injection reactions, both Certolizumab and Infliximab were associated with very high probabilities (51% and 47%, respectively) relative to the other agents of being most likely to cause infusion reactions.ConclusionsInfliximab had the highest retention rate and was the least likely drug to be discontinued due to lack or loss of efficacy, but had the highest discontinuation rate due to adverse events. More data is needed with longer study periods to further reinforce these findings.ReferencesNeovius M, Arkema E V, Olsson H, et al. Drug survival on TNF inhibitors in patients with rheumatoid arthritis comparison of adalimumab, etanercept and infliximab. Ann Rheum Dis 2013; 0: 1–7AcknowledgementTo Helene Walco...
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