Polypills may be safe, effective for BP lowering vs. monotherapy, usual care or placebo
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Key takeaways:
- Polypill therapy may lower blood pressure more compared with monotherapy, usual care or placebo.
- The combination pill may also confer more sustained blood pressure lowering.
Compared with monotherapy, usual care or placebo, polypills containing three or four low-dose antihypertensive drugs were associated with greater achievement of target BP and more sustained BP lowering, according to a meta-analysis.
Polypills were not associated with adverse treatment effects except for dizziness compared with monotherapy, usual care or placebo, according to the meta-analysis published in JAMA Cardiology.
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“Hypertension treatment guidelines traditionally recommended initiation of treatment with a single BP-lowering agent and more recently have recommended starting with dual combinations for an increasing proportion of people. These guidelines only recommend triple combination therapy in those whose BP remains uncontrolled with dual therapy. However, trial data have recently emerged relating to a new paradigm of hypertension treatment, indicating that low-dose combinations of three or more BP-lowering agents (also referred to as hypertension polypills), are a potentially useful initial or early treatment strategy,” Nelson Wang, MD, research fellow at the George Institute for Global Health, University of New South Wales, clinical associate lecturer at the Royal Prince Alfred Hospital in Sydney, and colleagues wrote. “To our knowledge, there has been no review comparing the evidence generated for these hypertension polypills.”
Wang and colleagues, therefore, conducted a meta-analysis of seven randomized clinical trials of polypills composed of three or four BP-lowering drugs compared with monotherapy, usual care or placebo, which included 1,918 patients (mean age, 59 years; 38% women).
Of the seven trials included in the analysis, four tested a triple-therapy polypill and three tested a quadruple-therapy polypill.
The primary outcome was average reduction in systolic BP in the polypill cohorts compared with monotherapy, usual care or placebo. Other outcomes of interest included the proportion of patients achieving BP less than 140/90 mm Hg, adverse effect rates and treatment withdrawal.
Polypills and BP reduction
The researchers reported no significant heterogeneity between trials of patients taking or not taking BP-lowering therapy at baseline or between double-blinded trials compared with open-label ones.
At 4 to 12 weeks, Wang and colleagues observed that polypill therapy was associated with greater reduction in average systolic BP compared with initial monotherapy or usual care (mean reduction, 7.4 mm Hg; 95% CI, 4.3-10.5) and placebo (mean reduction, 18 mm Hg; 95% CI, 15.1-20.8).
At 4 to 12 weeks, polypill therapy was also associated with a greater proportion of patients achieving BP less than 140/90 mm Hg compared with both monotherapy or usual care (66% vs. 46%; RR = 1.4; 95% CI, 1.27-1.52) and placebo (54% vs. 18%; RR = 3.03; 95% CI, 1.93-4.77), according to the meta-analysis.
In addition, finding from two trials — the QUARTET trial of quad therapy and the TRIUMPH trial of triple therapy — indicated polypill achieved superiority compared with monotherapy or usual care at 6 to 12 months.
Polypill therapy was associated with more patients experiencing dizziness compared with monotherapy, usual care or placebo (14% vs. 11%; RR = 1.28; 95% CI, 1-1.63) but was not significantly associated with other adverse effects, including peripheral edema, headache, musculoskeletal pain or serious adverse effects, according to the study.
Moreover, treatment withdrawal due to adverse effects was not significantly different between polypill therapy compared with monotherapy, usual care or placebo; however, CIs were wide (polypills, 5%; comparators, 4%; RR = 1.14; 95% CI, 0.71-1.82).
‘A single-step solution’
“In this study, [a polypill] with three or four antihypertensives provided an effective and well-tolerated BP-lowering treatment option for the initial management of hypertension,” the researchers wrote. “[Polypill] antihypertensives provide a single-step solution that has been shown to achieve 70% sustained BP control rates — an important therapeutic advance. However, to achieve long-term control rates even higher than this, further research on the best strategy to tolerably intensify therapy for people taking [polypills] is required.”
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