September 1, 2014Journal of the American College of Cardiology
A Polypill Strategy to Improve Adherence
José M. CastellanoGinés SanzJosé L. PeñalvoSameer BansilalAntonio Fernández‐OrtízLuz María de Guadalupe González ÁlvarezLuís GuzmánJuan Carlos LinaresFernando Flores GarcíaFabiana D’AnielloJoan Albert ArnáizSara VareaFelipe A. MartínezAlberto LorenzattiIñaki Imaz-IglesiaLuis María Sánchez-GómezMaria Carla RoncaglioniMarta BavieraSidney C. SmithKathryn A. TaubertStuart PocockCarlos BrotonsMichael E. FarkouhValentı́n Fuster
Key result
Polypill strategy improves adherence ~24% vs three separate drugs in post-MI patients.
- P=0.019
- n=695
Why the study?
Adherence to evidence-based CV medications post-MI drops after 6 months, and no previous randomized trial had analyzed the impact of a polypill strategy on adherence in post-MI patients.
Key Points
- To assess whether a fixed-dose combination polypill strategy improves medication adherence compared to standard multi-pill regimens.
- Evaluation of patient adherence using fixed-dose polypill strategies combining baseline cardiovascular medications.
- Comparison of adherence rates and therapeutic persistence between polypill regimens and standard multiple-pill care.
- Fixed-dose polypill formulations significantly increase overall treatment adherence compared with multi-pill standard care.
- Simplified drug delivery through a polypill regimen improves long-term persistence with essential baseline therapies.
Study Design
Type
RCT (n=695)
Randomization
randomized
Multicenter
Yes
PICO
P
Population
695 post-myocardial infarction patients randomized to a polypill or separate medications and followed for 9 months.
I
Intervention / Comparator
Polypill vs 3 drugs given separately (aspirin 100 mg, simvastatin 40 mg, and ramipril 2.5, 5, or 10 mg)
O
Primary Outcome
Adherence to the treatment measured at the final visit by the self-reported Morisky-Green questionnaire (MAQ) and pill count, p=0.019
Main Result
Absolute Event Rate: 50.8% vs 41%
p-value: p=0.019
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Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“Adherence to treatment after an acute myocardial infarction is essential for effective secondary prevention. The polypill, being a very simple strategy that combines three essential treatments for this type of patient, has proved its worth because the improved adherence means that these patients are receiving better treatment and therefore have a lower risk of recurrent cardiovascular events.”
VFValentín FusterCNIC General Director, Mount Sinai Heart Director
“The study demonstrates how improvements in adherence made possible by using the polypill strategy can achieve significant improvements in treatment outcomes and cost savings to healthcare systems by reducing recurrent CV events.”
VFValentín FusterCNIC General Director, Mount Sinai Heart Director
“the SECURE study findings suggest that the polypill could become an integral element of strategies to prevent recurrent cardiovascular events in patients who have had a heart attack. By simplifying treatment and improving adherence, this approach has the potential to reduce the risk of recurrent cardiovascular disease and death on a global scale.”
Implication
Polypill may aid adherence in practice; leaves open outcome benefits without randomized confirmation.
Abstract
BACKGROUND: Adherence to evidence-based cardiovascular (CV) medications after an acute myocardial infarction (MI) is low after the first 6 months. The use of fixed-dose combinations (FDC) has been shown to improve treatment adherence and risk factor control. However, no previous randomized trial has analyzed the impact of a polypill strategy on adherence in post-MI patients. OBJECTIVES: The cross-sectional FOCUS (Fixed-Dose Combination Drug for Secondary Cardiovascular Prevention) study (Phase 1) aimed to elucidate factors that interfere with appropriate adherence to CV medications for secondary prevention after an acute MI. Additionally, 695 patients from Phase 1 were randomized into a controlled trial (Phase 2) to test the effect of a polypill (containing aspirin 100 mg, simvastatin 40 mg, and ramipril 2.5, 5, or 10 mg) compared with the 3 drugs given separately on adherence, blood pressure, and low-density lipoprotein cholesterol, as well as safety and tolerability over a period of 9 months of follow-up. METHODS: In Phase 1, a 5-country cohort of 2,118 patients was analyzed. Patients were randomized to either the polypill or 3 drugs separately for Phase 2. Primary endpoint was adherence to the treatment measured at the final visit by the self-reported Morisky-Green questionnaire (MAQ) and pill count (patients had to meet both criteria for adherence at the in-person visit to be considered adherent). RESULTS: In Phase 1, overall CV medication adherence, defined as an MAQ score of 20, was 45.5%. In a multivariable regression model, the risk of being nonadherent (MAQ <20) was associated with younger age, depression, being on a complex medication regimen, poorer health insurance coverage, and a lower level of social support, with consistent findings across countries. In Phase 2, the polypill group showed improved adherence compared with the group receiving separate medications after 9 months of follow-up: 50.8% versus 41% (p = 0.019; intention-to-treat population) and 65.7% versus 55.7% (p = 0.012; per protocol population) when using the primary endpoint, attending the final visit with MAQ = 20 and high pill count (80% to 110%) combined, to assess adherence. Adherence also was higher in the FDC group when measured by MAQ alone (68% vs. 59%, p = 0.049). No treatment difference was found at follow-up in mean systolic blood pressure (129.6 mm Hg vs. 128.6 mm Hg), mean low-density lipoprotein cholesterol levels (89.9 mg/dl vs. 91.7 mg/dl), serious adverse events (23 vs. 21), or death (1, 0.3% in each group). CONCLUSIONS: For secondary prevention following acute MI, younger age, depression, and a complex drug treatment plan are associated with lower medication adherence. Meanwhile, adherence is increased in patients with higher insurance coverage levels and social support. Compared with the 3 drugs given separately, the use of a polypill strategy met the primary endpoint for adherence for secondary prevention following an acute MI. (Fixed Dose Combination Drug [Polypill] for Secondary Cardiovascular Prevention [FOCUS]; NCT01321255).
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Cite This Study
Castellano et al. (2014) conducted an RCT in Secondary cardiovascular prevention after an acute myocardial infarction (n=695). Polypill vs. 3 drugs given separately was evaluated on Adherence to the treatment measured at the final visit by the self-reported Morisky-Green questionnaire (MAQ) and pill count (p=0.019).