Warnings without guidance: patient responses to an FDA warning about ezetimibe.

BACKGROUND: In January 2008, the Food and Drug Administration (FDA) communicated concerns about the efficacy of ezetimibe, but did not provide clear clinical guidance, and substantial media attention ensued. We investigated the proportion of patients who discontinued therapy and switched to a clinically appropriate alternative after the FDA communication. METHODS: Using claims data from a national pharmacy benefits manager, we created a rolling cohort of new users of ezetimibe between January 2006 and August 2008 and created a supply diary for each patient in the year after cohort entry. A patient was identified as nonpersistent if a gap of 90 days was seen in the diary. Using segmented linear regression, we compared rates of nonpersistence before and after the FDA communication and assessed patient-level characteristics associated with discontinuation. Among nonpersistent patients, we determined whether a patient made a clinically appropriate switch in the subsequent 90 days by adding a new cholesterol-lowering medication or by increasing the dose of an existing one. We used a weighted t test to compare the rates of appropriate switching before and after the communication. RESULTS: Among 867,027 new ezetimibe users, 407,006 (46.9%) were nonpersistent in the first year. After the FDA communication, the monthly level of ezetimibe nonpersistence increased by 5.7 percentage points (P<0.0001). Younger patients, those who lived in low-income zip codes, and female patients were less likely to discontinue therapy (P<0.0001 for all). Among nonpersistent patients, rates of clinically appropriate switching increased from 10.8% before to 16.5% after the FDA warning (P = 0.004). CONCLUSIONS: A substantial increase in ezetimibe nonpersistence rates was seen after an FDA communication regarding its efficacy and following associated media attention, and a small proportion of patients made a clinically appropriate switch after discontinuation. Further consideration is needed to deliver messages that promote appropriate use of chronic therapy rather than simply reduce use.

The impact of medication adherence on coronary artery disease costs and outcomes: a systematic review.

BACKGROUND: Given the huge burden of coronary artery disease and the effectiveness of medication therapy, understanding and quantifying known impacts of poor medication adherence for primary and secondary prevention is crucial. We sought to systematically review the literature on this topic area with a focus on quantified cost and clinical outcomes related to adherence. METHODS: We conducted a systematic review of the literature between 1966 and November 2011 using a fixed search strategy, multiple reviewers, and a quality rating scale. We found 2636 articles using this strategy, eventually weaning them down to 25 studies that met our inclusion criteria. Three reviewers independently reviewed the studies and scored them for quality using the Newcastle Ottawa Scoring Scale. RESULTS: We found 5 studies (4 of which focused on statins) that measured the impact of medication adherence on primary prevention of coronary artery disease and 20 articles that focused on the relationship between medication adherence to costs and outcomes related to secondary prevention of coronary artery disease. Most of these latter studies focused on antihypertensive medications and aspirin. All controlled for confounding comorbidities and sociodemographic characteristics, but few controlled for likelihood of adherent patients to have healthier behaviors ("healthy adherer effect"). Three studies found that high adherence significantly improves health outcomes and reduces annual costs for secondary prevention of coronary artery disease (between $294 and $868 per patient, equating to 10.1%-17.8% cost reductions between high- and low-adherence groups). The studies were all of generally of high quality on the Newcastle Ottawa Scale (median score 8 of 9). CONCLUSIONS: Increased medication adherence is associated with improved outcomes and reduced costs, but most studies do not control for a "healthy adherer" effect.

Association between different types of social support and medication adherence.

OBJECTIVES: To evaluate the association between social support and medication adherence. STUDY DESIGN: A search of articles published before November 2010 in peer-reviewed, healthcare-related journals was conducted using PubMed, EMBASE, and Web of Science, and search terms related to social support (social support OR friend OR family OR agency) and adherence (patient compliance OR medication adherence), yielding 5331 articles. METHODS: Articles were included if they directly measured the relationship between medication adherence and some form of social support. Excluded were case studies, studies with participants < 18 years of age, and non-English language studies. Four social support categories were reported: structural, practical, emotional, and combination. Medication adherence was reported in the manner in which it was described in each study. RESULTS: Fifty studies were included in the final analysis. A greater degree of practical support was most consistently associated with greater adherence to medication; evidence for structural or emotional support was less compelling. However, most studies were limited in size and design, and substantial variability in designs and outcome measurement prohibited pooling of results, necessitating qualitative evaluation of the studies. CONCLUSIONS: This qualitative analysis found that practical social support was most consistently associated with greater medication adherence. Interventions that use existing contacts (friends or family) to engage patients in the mundane and practical aspects of medication purchasing and administration may be an effective approach to promoting better medication adherence.