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Polypill improves BP, LDL, adherence in high-risk patients
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In patients with CVD or at high risk for it, a fixed-dose polypill consisting of aspirin, a statin and two BP-lowering medications was associated with improved outcomes compared with usual care, according to a new meta-analysis.
Researchers conducted the meta-analysis of individual participant data from three trials covering 3,140 patients from six countries (mean age, 62 years; 75% men).
Two versions of polypill
In all three trials, participants with CVD or Framingham-based calculated 5-year CVD risk of at least 15% were randomly assigned to the usual care or to a polypill (Red Heart Pill, Dr. Reddy’s Laboratories). Attending physicians for those in the polypill groups had the choice of two versions of the polypill: aspirin 75 mg, simvastatin 40 mg, lisinopril 10 mg and atenolol 50 mg; or aspirin 75 mg, simvastatin 40 mg, lisinopril 10 mg and hydrochlorothiazide 12.5 mg.
The primary outcomes were self-reported adherence to combination therapy at 12 months, defined as taking all therapy at least 4 days in the final week; change in systolic BP from baseline to 12 months; and change on LDL from baseline to 12 months. Median follow-up was 15 months.
Ruth Webster
At baseline, 84% of participants were taking a statin, 87% were taking aspirin or another antiplatelet agent and 61% were taking at least two BP-lowering drugs, Ruth Webster, MBBS, MIPH, and colleagues reported.
Compared with those assigned the usual care, those assigned the polypill had greater adherence to combination therapy (80% vs. 50%; RR = 1.58; 95% CI, 1.32-1.9), lower systolic BP (–2.5 mm Hg; 95% CI, –4.5 to –0.4) and lower LDL (–0.1 mmol/L; 95% CI, –0.2 to 0) at 12 months, the researchers wrote.
Effect greatest in undertreated
Improvement in adherence associated with the polypill was greatest for those with low or no adherence at baseline (17% at baseline; 74% at 12 months; RR = 4.46; 95% CI, 3.72-5.36), and the effect size was smaller in those with high adherence at baseline (86% at baseline; 90% at 12 months; RR = 1.04; 95% CI, 1.01-1.07), Webster, from The George Institute for Global Health, University of Sydney, and colleagues wrote.
Baseline adherence also was an effect modifier for improvement in systolic BP (P for interaction = .02), whereas effect size for LDL changed greatly due to age, country and established CVD, they wrote.
The proportion of participants with at least one serious adverse event was similar in both arms (polypill arm, 22.9%; usual-care arm, 20.1%; RR = 1.12; 95% CI, 0.99-1.27), they wrote.
The polypill was not associated with a reduction in CV events, which “is not unexpected given the relatively small number of events overall, the small absolute improvements in risk factors ... due to the active comparator in usual care, and the relatively short follow-up of 15 months (previous trials have shown a lag time of 1 to 2 years before the onset of benefits from BP and cholesterol lowering),” Webster and colleagues wrote.
“There was little evidence of net benefit for those already well treated, but there is likely to be a significant net benefit for those undertreated,” they concluded. “Since most CVD patients globally do not take these medications at present, this strategy could contribute significantly to the WHO goal of reducing CVD by 25% by 2025.” – by Erik Swain
Disclosure: The research was funded in part by Dr. Reddy’s Laboratories. All researchers report receiving support from Dr. Reddy’s Laboratories related to the submitted work.
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