Pharmacoepidemiology and drug safety
-
Pharmacoepidemiol Drug Saf · Mar 2014
Randomized Controlled TrialUtilization patterns of antihyperuricemic agents following safety announcement on allopurinol and benzbromarone by Taiwan Food and Drug Administration.
The purpose of this study is to evaluate the utilization of four approved antihyperuricemic agents in Taiwan before and after two safety announcements rescinded an indication for allopurinol and added a warning on benzbromarone-induced hepatotoxicity in the year 2005. ⋯ Further research is required to evaluate the direct impacts of the safety announcements on clinical outcomes, treatment costs, and patient's quality of life.
-
Pharmacoepidemiol Drug Saf · Sep 2013
Randomized Controlled TrialThe effect of obesity on antibiotic treatment failure: a historical cohort study.
Obesity, a major health issue, is also an important risk factor for infections. Evidence demonstrates that excess weight affects the disposition of antibiotics but little work has been done to explore if this results in antibiotic treatment failure (ATF). ATF has serious adverse health outcomes and may increase treatment resistance. Given that obese patients often have other health issues, it is important to determine if excess weight independently increases the likelihood of ATF. ⋯ Obesity is a significant risk factor for ATF, and this association may be due to the current "one size fits all" dosing strategy, which warrants further investigation.
-
Pharmacoepidemiol Drug Saf · Jun 2012
Randomized Controlled TrialAccuracy of pneumonia hospital admissions in a primary care electronic medical record database.
When using electronic medical record data to study drug use, hospitalizations are markers of severe outcomes. To identify events within a specified time window, it is important to validate hospitalization diagnoses and dates. Our objective was to validate pneumonia hospitalizations and their dates identified using hospitalization codes in The Health Improvement Network (THIN), a UK primary care electronic medical record. ⋯ THIN hospitalization codes performed well in identifying acute pneumonia hospitalizations and their timing. Admission date validity might be better for conditions associated with shorter versus longer hospitalizations.
-
Pharmacoepidemiol Drug Saf · Apr 2005
Randomized Controlled Trial Multicenter Study Clinical TrialA large simple clinical trial prototype for assessment of OTC drug effects using patient-reported data.
Innovative methods are needed to assess risks related to treatment for common medical conditions, where therapy is usually patient-directed or over-the-counter (OTC), and where tolerability, i.e. patient experienced events, may affect patterns of use. A large-scale, blinded, randomised trial was conducted to compare the tolerability of paracetamol (acetaminophen), aspirin and ibuprofen at OTC doses, with patient-reported adverse event (AE) data as the primary outcome. ⋯ A large, simple, randomised trial with patient-generated data can provide a sensitive source of information on AE, particularly in comparative safety assessments of OTC medications and other short-term therapies. This suggests reconsideration of the view that investigators are the most valid source for identifying and reporting AE.
-
Pharmacoepidemiol Drug Saf · Jul 2003
Randomized Controlled Trial Clinical TrialIndinavir did not further increase mean triglyceride levels in HIV-infected patients treated with nucleoside reverse transcriptase inhibitors: an analysis of three randomized clinical trials.
Metabolic abnormalities including hyperlipidemia have developed in patients infected with the human immunodeficiency virus (HIV) after treatment with protease inhibitor drugs. It is unclear whether the deleterious effects on plasma triglyceride concentrations observed in patients receiving highly active antiretroviral therapy are a class effect of protease inhibitors. Hypertriglyceridemia may constitute a risk factor for cardiovascular disease. The purpose of this retrospective analysis of HIV-infected patients enrolled in three randomized, double-blind trials of indinavir therapy was to determine whether indinavir use was associated with a larger increase in triglyceride levels than treatment without a protease inhibitor. ⋯ On average, the combination of indinavir and NRTI therapy was not associated with a greater elevation of non-fasting triglyceride levels in HIV-infected men with at least moderately advanced immunosuppression than treatment with NRTI drugs alone.