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Improved adherence adjustment in the Coronary Drug Project.

ABSTRACT: BACKGROUND:The survival difference between adherers and non-adherers to placebo in the Coronary Drug Project has been used to support the thesis that adherence adjustment in randomized trials is not generally possible and, therefore, that only intention-to-treat analyses should be trusted. We previously demonstrated that adherence adjustment can be validly conducted in the Coronary Drug Project using a simplistic approach. Here, we re-analyze the data using an approach that takes full advantage of recent methodological developments. METHODS:We used inverse-probability weighted hazards models to estimate the 5-year survival and mortality risk when individuals in the placebo arm of the Coronary Drug Project adhere to at least 80% of the drug continuously or never during the 5-year follow-up period. RESULTS:Adjustment for post-randomization covariates resulted in 5-year mortality risk difference estimates ranging from -?0.7 (95% confidence intervals (CI), -?12.2, 10.7) to 4.5 (95% CI, -?6.3, 15.3) percentage points. CONCLUSIONS:Our analysis confirms that appropriate adjustment for post-randomization predictors of adherence largely removes the association between adherence to placebo and mortality originally described in this trial. TRIAL REGISTRATION:ClinicalTrials.gov, Identifier: NCT00000482 . Registered retrospectively on 27 October 1999.

SUBMITTER: Murray EJ

PROVIDER: S-EPMC5836455 | biostudies-literature | 2018 Mar

REPOSITORIES: biostudies-literature

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Improved adherence adjustment in the Coronary Drug Project.

Murray Eleanor J EJ Hernán Miguel A MA

Trials 20180305 1

<h4>Background</h4>The survival difference between adherers and non-adherers to placebo in the Coronary Drug Project has been used to support the thesis that adherence adjustment in randomized trials is not generally possible and, therefore, that only intention-to-treat analyses should be trusted. We previously demonstrated that adherence adjustment can be validly conducted in the Coronary Drug Project using a simplistic approach. Here, we re-analyze the data using an approach that takes full ad ...[more]

PMID: 29506561

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Project description:Hypertension is highly prevalent after the age of 65 years affecting more than 60% of individuals in developed countries. Today, there is sufficient evidence from clinical trials that treating elderly subjects with hypertension with antihypertensive medications has a positive benefit/risk ratio even in very elderly patients (>80 years). In recent years, partial or total non-adherence has been recognized as major issues in the long-term management of hypertension in all age categories. However, whether non-adherence is more frequent in hypertensive patients older than 65 years or not is still a matter of debate and the common belief is that adherence is lower in older than in younger patients. Are clinical data supporting this belief? In this brief review, we discuss the topic of drug adherence in elderly in the context of the medical treatment of hypertension. Studies show that drug adherence is actually better in patients aged 65 to 80 years when compared to younger hypertensive patients (<50 years). However, in very old patients (>80 years) the prevalence of non-adherence does increase. In this patients' group, there are specific risk factors for non-adherence such as cognitive ability, depression, and health believes, in addition to classical risk factors for non-adherence. One important aspect in the elderly is the prescription of potentially inappropriate medications that will interfere with the adherence to necessary treatments. In this context, an interesting new concept was developed few years ago, i.e., the process of deprescribing. Thus, today, in addition to conventional guidelines recommendations (use of single pill combinations, individualization of treatments), the evaluation of cognitive abilities, the regular assessment of potentially inappropriate medications, and the process of deprescribing appear to be three new additional steps to improve drug adherence in the elderly and thereby ameliorate the global management of hypertension.

Dataset Information

Improved adherence adjustment in the Coronary Drug Project.

Publications

Improved adherence adjustment in the Coronary Drug Project.

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