Process evaluation of the impact and acceptability of a polypill for prevention of cardiovascular disease

Abstract

ImportanceThe Use of a Multidrug Pill In Reducing cardiovascular Events (UMPIRE) trial has shown improved adherence with the use of a polypill strategy when compared with usual medications for cardiovascular disease (CVD) prevention. To advance from efficacy to impact, we need a better understanding of why and how such a strategy might be deployed in complex health systems.ObjectiveTo understand, from the perspective of UMPIRE trial participants and professionals, how and why a polypill strategy improves adherence compared with usual care, why improvement is greater in some subgroups, and to explore the acceptability of a polypill strategy among trial participants and healthcare professionals.Design, setting and participantsA preplanned process evaluation, based on qualitative interviews, was conducted with a subsample of 102 trial participants and 41 healthcare professionals at the end of the UMPIRE trial in India and Europe.ResultsMost patients contrasted the simplicity of the polypill with usual medications that they found complex and, for many in India, expensive. Patients with low baseline adherence struggled most with complex medication lists, and those without established disease described less motivation to adhere when compared with people who had already been diagnosed with CVD; people in the latter group had already undertaken self-directed measures to adhere to CVD preventive medicines prior to entering the trial. Taking medication was one of many adaptations described by patients; these included dietary changes, stopping smoking and maintaining exercise. Most patients liked the polypill strategy, although some participants and health professionals were concerned that it would provide less tailored therapy for individual needs.ConclusionsAdherence to treatment lists with multiple medications is complex and influenced by several factors. Simplifying medication by using a once-daily polypill is one approach to CVD prevention that may enhance adherence. Prescribers should also consider the wide variety of adjustments that individuals need to make to cope with daily medication.

Stroke survivors', caregivers' and GPs' attitudes towards a polypill for the secondary prevention of stroke: a qualitative interview study

“…While a polypill was acceptable to most patients of the UMPIRE trial, some felt that FDC therapy was less tailored to individual patient needs. 49 A recent investigation of the views of cardiovascular patients and providers who participated in polypill trials reported similar advantages and concerns to those identified in our study, 50 suggesting that polypill perspectives translate to other regions and healthcare settings.…”

Implications of prescribing a fixed-dose combination in clinical cardiology practice: a retrospective observational study using a single medical centre database in Korea

“…Those results would suggest the importance of FDC in high-risk patients in terms of preventing CVD 1–3. Those were in accordance with our results and could be explained by the simplicity of a single polypill and the strong motivation in established or high risk patients to stay healthy 22. Therefore, in patients with established CV diseases or at high risk, a clear benefit of FDC was observed as indicated in cases of clustering risk factors such as dyslipidaemia, hypertension, and diabetes 3 23.…”

Treatment of Modifiable Risk Factors Is Associated With Decrease in Coronary Heart Disease Incidence: Time to Use the Polypill

“…Regarding the costs of treatment with the polypill for primary and secondary CVD prevention, several studies have shown that the cost benefits of polypill use were significantly lower than the use of component drugs given separately. In addition, the patient and doctor acceptance of the polypill were significantly higher compared with the component drugs given separately . .…”

“…In addition, no problems have been found between the component drugs of the polypill regarding bioavailability and pharmacokinetic interactions . With respect to the effectiveness and costs of the polypill, these have been shown to be highly acceptable by patients and doctors alike . In fact, the polypill has been called “a best bargain” for the primary and secondary prevention of CVD and strokes.…”

“…17 With respect to the effectiveness and costs of the polypill, these have been shown to be highly acceptable by patients and doctors alike. [10][11][12][13][14][15][16] In fact, the polypill has been called "a best bargain" for the primary and secondary prevention of CVD and strokes. Despite these positive results, acceptance and approval of the polypill by the FDA and WHO have been resisted so far for lack of outcomes data.…”