Abstract WP525: Adherence and Adherence Recovery in a Stroke Trial

Objective: Standards for reporting and analyzing adherence to medical therapy have recently improved due to international consensus efforts. We report adherence in a stroke trial using the EMERGE guidelines and demonstrate how support of patients can lead to adherence recovery during therapy implementation. Methods: We analyzed 3 phases of adherence according to current taxonomy in the Insulin Resistance Intervention after Stroke (IRIS) trial: initiation (did patient start drug), implementation (did patient take a drug holiday, defined as temporary cessation lasting ≥14 days), and persistence (did patient permanently and prematurely discontinue drug). IRIS was a randomized, placebo controlled trial testing pioglitazone to prevent stroke or MI in patients with ischemic stroke/TIA and insulin resistance. Adherence was classified by self-report. Researchers used coaching algorithms to seek adherence recovery if participants went off drug. Results: During 2005-2013, 3876 participants were enrolled from 179 sites in 7 countries. Mean age was 63.5 years; 65% were male, 11% Black race, and 4% Hispanic ethnicity. A total of 26 patients (<1%) did not start study drug. During implementation, 706 (18%) patients took a drug holiday: 587 took 1 holiday, 97 took 2, and 22 took ≥3. Study drug was discontinued early in 1275 (33%). Major reasons for holidays and discontinuations are shown below by treatment. Conclusion: For the first time in a stroke trial, we report adherence according to internationally recommended guidelines. Results show that holidays are common, but participants will resume drug with coaching. Among reasons for drug cessation, only those secondary to study protocol were unavoidable and misattributions of AEs to study drug were common as seen in the placebo group. Our findings have implications for trials that require high drug adherence to successfully answer scientific hypotheses.