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A polypill containing an aspirin, a statin, and two antihypertensive agents greatly improved medication adherence compared with usual care, but the polypill patients achieved only modest -- though significant -- lowering of systolic blood pressure and LDL cholesterol, researchers found.

Moreover, those adherent patients were no less likely to experience a serious adverse event such as myocardial infarction or stroke, according to results from the UMPIRE trial, which were published in the Sept. 4 issue of the Journal of the American Medical Association.

Patients randomized to the polypill were 33% more likely to be adherent than controls -- 86% versus 65% -- (P<0.001), with an average 2.6 mmHg decrease in systolic blood pressure (95% CI minus 4.0-minus 1.1 mmHg, P<0.001) and an average drop of 4.2 mg/dL in LDL cholesterol (95% CI minus 6.6-minus 1.9 mg/dL, P<0.001), wrote , MBBS, MD, of the International Center for Circulatory Health at the National Heart and Lung Institute, Imperial College London, and colleagues.

The study, Use of a Multidrug Pill in Reducing Cardiovascular Events (UMPIRE), recruited 2004 adults with established cardiovascular disease (CVD) or at increased risk of CVD at centers in India and Europe. Patients were recruited from July 2010 through July 2011 and followed through July 2012.

Participants were evenly randomized to a high- or low-fixed-dose combination pill (75 mg aspirin, 40 mg simvastatin, 10 mg lisinopril, and 50 mg atenolol; or 75 mg aspirin, 40 mg simvastatin, 10 mg lisinopril and 12.5 mg hydrochlorothiazide) or to usual care.

After a median follow-up of 15 months, 50 patients in the polypill group and 35 patients in the control group reached a cardiovascular endpoint (P=0.09).

The UMPIRE investigators noted that the study was limited by regulations concerning the way in which medications are distributed requiring that the polypill be distributed for free by the participating study centers, while patients in the control group received their medications via their individual physicians, and they were required to pay for the drugs.

Taken as a whole, the results of the UMPIRE randomized trial did not prove a "precise advantage" for the polypill strategy, wrote JAMA associate editor , MD, MPH, in an editorial in the same issue.

"Until additional rigorous data are available that demonstrate that the polypill improves clinical CVD outcome, it may be more important to carefully assess the multiple medications many patients are currently prescribed, often by several physicians," wrote Gaziano. "Another way to reduce the number of pills patients are taking is to eliminate those medications for which the benefits are marginal."

The way in which the UMPIRE results were interpreted was heavily dependent upon the eye of the beholder.

, chief of cardiology at Northwestern University Feinberg School of Medicine in Chicago, did not behold a big win.

UMPIRE moved the polypill "a step closer to something, but it is not yet clear if we can change outcomes," Yancy said. "I think it's wonderful that this polypill allows us to improve adherence, but I find it concerning that the delta in blood pressure is so small and the delta in LDL cholesterol levels is reasonably small.

"Exactly what are we going to accomplish? That's the key consideration," he said.

, MD, DPhil., of the Population Health Research Institute at McMaster University and Hamilton Health Sciences in Hamilton, Ontario, by contrast, saw the polypill glass as more than half full.

"I think the UMPIRE study results in JAMA indicate that giving medicine at a fixed dose ... makes prescribing easier, " Yusuf told MedPage Today. "That means that more people will be getting it [the medications] because it is easier to get and easier to continue."

Yusuf has been one of the leading proponents of the polypill and has been the lead investigator for several previous studies.

He noted that "only a minority of people receive all the drugs they ought to receive. Less than 25% of the hypertensives in Canada and the U.S. are controlled."

The single fixed-dose pill "makes prevention much easier," Yusuf said.

But Yancy questioned the wisdom of putting every drug "in one combination and hoping by scatter-shooting that we can get everyone to a better place."

A preferable option, he said, would be to "take a personalized approach and do the right thing for the right patient at the right time."

Yusuf said that individual approach is admirable but not practical, and he characterized such criticism as an "intellectual handicap ... they say they cannot tailor to individual patients using the polypill, but in reality they don't [tailor to individual patients]."

Nonetheless, Yancy said he and others are weary of polypill enthusiasm with few measurable results.

"We need to see outcomes get better soon. Remember, we've been studying this for a while now -- it's no longer news. We need to see some good outcomes from the polypill approach," Yancy concluded.

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