Impact of switching from different treatment regimens to a fixed-dose combination pill (polypill) in patients with cardiovascular disease or similarly high risk

Abstract

Aims Cardiovascular fixed-dose combination pills, or polypills, may help address the widespread lack of access and adherence to proven medicines. Initiation of polypill-based care typically entails switching from current separately taken medications. Given the heterogeneity in usual care, there is interest in the impact of polypill treatment across different patterns of prior medication regimen. Methods A total of 2004 participants with established cardiovascular disease or estimated 5-year cardiovascular risk of over 15% were randomised to polypill-based treatment (aspirin 75 mg, simvastatin 40 mg, lisinopril 10 mg and either atenolol 50 mg or hydrochlorothiazide 12.5 mg) or usual care. Baseline medications were classified by potency relative to polypill components. Estimated cardiovascular risk reduction was calculated by combining risk factor changes with results seen in meta-analyses of previous randomised trials. Results For cholesterol reduction conferred by polypills, there was a dose response across baseline statin groups, with mean low-density lipoprotein (LDL)-cholesterol differences of 0.37, 0.22, 0.14 and 0.07 mmol/L among patients taking no statin, less potent, equipotent and more potent statin at baseline, respectively. Similarly there were differences in mean systolic BP of 5.4, 6.2, 3.3 and 1.8 mmHg among patients taking 0, 1, 2 or 3 BP-lowering agents. Among patients taking more potent statins at baseline, there was no significant difference in LDL-cholesterol but there were benefits for BP and aspirin adherence. Similar results were seen among patients taking 3 BP-lowering agents at baseline. Switching to a polypill-based strategy resulted in estimated cardiovascular relative risk reductions across a wide range of usual care patterns of antiplatelet, statin and BP-lowering therapy prescribing. Conclusion Adherence benefits from switching to a polypill resulted in risk factor changes that were at least as good as usual care across a wide variety of treatment patterns, including equally potent or more potent regimens. The benefits of switching to polypill-based care were greatest among those stepped up from partial treatment or less potent treatment.

Reaching cardiovascular prevention guideline targets with a polypill-based approach: a meta-analysis of randomised clinical trials

“…This study provides evidence directly relevant to clinical implementation, contrasting with trial designs in which participants are prescribed the same medications as separate pills in the usual care group. In addition, participants were recruited regardless of baseline level or type of therapy, which again aids in assessment of treatment impact in real-life situations29 and is of particular importance when assessing the potential role of a polypill in reducing treatment gaps.…”

Fixed‐dose combination therapy to reduce the growing burden of cardiovascular disease in low‐ and middle‐income countries: feasibility and challenges

“…The current literature is clear about the fact that polypills increase adherence to medication . Nonadherence to medication has been shown to be more prevalent in LMICs.…”

“…The current literature is clear about the fact that polypills increase adherence to medication. [10][11][12][13][14][15][16][17][18][21][22][23] Nonadherence to medication has been shown to be more prevalent in LMICs. For instance, the PURE (Prospective Urban Rural Epidemiology) study demonstrated that in LMICs, only 3% of participants with a history of coronary heart disease or stroke were still taking drugs for secondary prevention of CVD 5 years post-event.…”

“…Polypills are generally made of a fixed combination of one or two antihypertensive agents, a lipid‐lowering medicine and sometimes an antiplatelet drug. Several studies have demonstrated that cardiovascular polypills may simplify treatment algorithms, improve patients’ adherence, increase accessibility, and reduce cardiovascular events and associated costs as compared with usual care . However, cardiovascular polypills have not gained much popularity when compared with fixed‐dose combinations for other diseases such as HIV, tuberculosis, and malaria.…”

“…Several studies have demonstrated that cardiovascular polypills may simplify treatment algorithms, improve patients' adherence, increase accessibility, and reduce cardiovascular events and associated costs as compared with usual care. [10][11][12][13][14][15][16][17][18][19][20] However, cardiovascular polypills have not gained much popularity when compared with fixed-dose combinations for other diseases such as HIV, tuberculosis, and malaria. They are still facing a huge challenge to their implementation, especially in LMICs.…”