The outcomes of the 12 large randomized, controlled trials that we studied were not predicted accurately 35 percent of the time by the meta-analyses published previously on the same topics.
Context.-Although clinical trials have demonstrated the benefits of lipidlowering therapy, little is known about how these drugs are prescribed or used in the general population. Objective.-To estimate predictors of persistence with therapy for lipid-lowering drug regimens in typical populations of patients in the United States and Canada. Design.-A cohort study defining all prescriptions filled for lipid-lowering drugs during 1 year, as well as patients' demographic and clinical characteristics. Setting.-New Jersey's Medicaid and Pharmacy Assistance for the Aged and Disabled programs and Quebec's provincial medical care program. Patients.-All continuously enrolled patients older than 65 years who filled 1 or more prescriptions for lipid-lowering drugs (N = 5611 in the US programs, and N = 1676 drawn from a 10% sample in Quebec). Main Outcome Measures.-Proportion of days during the study year for which patients had filled prescriptions for lipid-lowering drugs; predictors of good vs poor persistence with therapy. Results.-In both populations, patients failed to fill prescriptions for lipid-lowering drugs for about 40% of the study year. Persistence rates with 3-hydroxy-3methylglutaryl coenzyme A reductase inhibitors were significantly higher than those seen with cholestyramine (64.3% vs 36.6% of days with drug available, respectively). Patients with hypertension, diabetes, or coronary artery disease had significantly higher rates of persistence with lipid-lowering regimens. In New Jersey, multivariable analysis indicated that the poorest patients (those enrolled in Medicaid) had lower rates of drug use than less indigent patients (those enrolled in Pharmacy Assistance for the Aged and Disabled) after adjusting for possible confounders, despite virtually complete drug coverage in both programs. When rates of use were measured in the US population for the 5 years following the study year, only 52% of surviving patients who were initially prescribed lipid-lowering drugs were still filling prescriptions for this drug class. Conclusion.-In all populations studied, patients who were prescribed lipidlowering drug regimens remained without filled prescriptions for over a third of the study year on average. Rates of persistence varied substantially with choice of agent prescribed, comorbidity, and socioeconomic status, despite universal coverage of prescription drug costs. After 5 years, about half of the surviving original cohort in the United States had stopped using lipid-lowering therapy altogether.
HIV+ individuals were at higher risk of AMI than the general population, and several antiretrovirals were associated with an increased risk of AMI. Results should be interpreted with caution in absence of data on smoking and HIV clinical status.
For the purpose of controlling for protopathic bias in pharmacoepidemiological studies, we have provided a method to assess the most appropriate lag-time that should be applied for the assessment of drug exposure.
In pharmacoeconomics, the comparison of the costs of 2 different drugs used for the same treatment is of great interest. The problem is especially challenging when the drugs are likely to produce costly adverse effects in a small number of patients, which is often the case. The data are then skewed and traditional statistical methods to analyse the difference in the mean costs produced by 2 treatments may be inappropriate. The bootstrap method is presented as an alternative approach. A pharmacoeconomic cost-analysis example is presented and used throughout this article.
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