Exclusion of Elderly People from Randomized Clinical Trials of Drugs for Ischemic Heart Disease

Abstract

Background/Objectives Evidence-based and patient-centered care of elderly adults with ischemic heart disease requires clinical trials that study the patient population seen by clinicians in practice. We aimed to measure the exclusion of elderly persons from randomized trials studying drug interventions for ischemic heart disease and describe the characteristics of these trials. Design and setting Interventional clinical trials studying a drug intervention for ischemic heart disease and started 2006 and after were identified in ClinicalTrials.gov. Data were extracted on study features, including age-based inclusion criteria. Data on participants and their age distribution were collected from trial publications, investigator inquiry, and result data in ClinicalTrials.gov. Measurements Proportion of trials excluding patients based on age, mean age of trial participants, and proportion of enrolled participants who were ≥65 years and ≥75 years. Results Of 839 identified trials, 446 (53%) explicitly excluded elderly persons. The most frequent upper age limits were 80 (n=164) and 75 (n=114) with a median upper age limit of 80 (IQR 75, 80). Trials with upper age limit exclusions tended to be smaller (median number of participants 100 vs 201, p<0.001) and were more likely to be funded primarily by non-industry sources (78.3% vs 70.0%, p=0.006). The overall mean age of trial participants was 62.7 years with a mean maximum age of 74 years. The estimated proportion of participants that was ≥65 years was 42.5% and the estimated proportion that was ≥75 years was 12.3%. Conclusion Despite the high burden of ischemic heart disease among elderly patients, the majority of drug trials do not enroll participants reflective of age-related prevalence of the disease.

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