The Polypill - a remedy for almost everything?

In 2003, the principle of the Polypill was first presented to the public by British researchers. This pill contains not only blood pressure-lowering agents but also other active ingredients such as lipid-lowering agents (statins) and aspirin. According to the researchers, the Polypill should be taken preventively by all people aged 55 and older. Regardless of existing or non-existing personal cardiovascular risk factors, it is intended to minimize the risk of cardiovascular diseases.

Both American researchers and researchers in Iran studied this. The Iranian study, in particular, showed impressive results at first glance. It also included a high number of participants, over 6,800 people, aged between 50 and 75 years. The study lasted for five years. Only about one-tenth of the participants had a diagnosed cardiovascular disease. 75 percent of these individuals were already in treatment. Thus, the majority of the participants had no (at least no diagnosed) cardiovascular disease.

The participants were divided into two groups. One group received the Polypill, while the other group did not. During the observation period, 301 out of 3,417 in the control group experienced a serious cardiovascular event, while only 202 out of 3,421 participants in the Polypill group did. Such events included hospitalization for acute coronary syndrome, a fatal myocardial infarction, sudden death, heart failure, a coronary artery revascularization procedure, as well as a non-fatal and a fatal stroke. Therefore, 99 more people in the group taking the Polypill were spared compared to the control group.

The smaller American study also yielded similar results. The 303 participants here were low-income individuals, mostly unable to afford health insurance. These people must cover their own medication costs, as there is no statutory health insurance in the USA. No participant had a cardiovascular disease at the start of the study. Again, the participants were divided into two groups. One part received a Polypill, while the other part did not. The observation period of the study lasted twelve months. Adherence to therapy was - similar to the Iranian study - over 80 percent.

The results were impressive. In the experimental group, the mean systolic blood pressure was reduced by 9 mmHg, while in the control group without the Polypill, it only decreased by 2 mmHg. The LDL cholesterol also decreased significantly more in the Polypill group. Here, a reduction of 15 mg/dl with the Polypill compared to only 4 mg/dl in the control group was observed. Thus, the mean LDL cholesterol level decreased by 11 mg/dl more in the experimental group.

Is the Polypill the miraculous medication for everyone?

As the two studies mentioned above show, a preventively administered pill with multiple active ingredients can indeed provide benefits in certain population groups. In both studies, the participants came from populations that, for various reasons, have little access to medical care. Achieving an effect here is therefore much more likely than in groups with good access to medical care. In the participant groups, the likelihood of encountering individuals with undiagnosed hypertension or elevated blood lipid levels was relatively high. For the healthy individuals in the group, taking a blood pressure-lowering medication is not so problematic, as it only slightly lowers blood pressure. This "shotgun therapy" is seen as more critical for the statins and aspirin also contained in the Polypill, as these can increase the risk of bleeding. This is viewed as an unpredictable risk, just like the unnecessary administration of statins.

An earlier overview study by English and American physicians showed that the Polypill is not more effective than the corresponding individual preparations. Moreover, it contains a fixed dosage of the individual active ingredients and cannot be adjusted as flexibly as when administering the individual active ingredients. This refers to the targeted prescription for patients with cardiovascular risk factors. Healthy individuals over 55 benefit more from a healthy lifestyle than from the initial idea of distributing the Polypill preventively to everyone from this age onward.

Polypill rethought

In 2022, the concept of the previously little-noticed Polypill was rethought. A study examined the effects of a Polypill consisting of three active ingredients that almost every patient receives as long-term medication after a heart attack. These are: aspirin as a platelet aggregation inhibitor, an ACE inhibitor, here ramipril, and the statin atorvastatin in several strengths, resulting in six different combinations in the respective Polypill.

The reduced pill burden, meaning the lower number of pills that need to be taken, resulted in significantly improved adherence among the patients in the observation group. After six months, 70.6% took their medications regularly, while in the control group, which received the three components as individual medications instead of a Polypill, only 62.7% did. After two years, pill intake improved slightly in both groups: in the Polypill group, 74.1%, and in the control group, 63.2% of patients regularly took the prescribed medications.

After about three years of follow-up, it was shown that the improved adherence also had an impact on the occurrence of heart attacks, strokes, urgently needed procedures to eliminate narrowing in blood vessels, and deaths due to cardiovascular diseases. In the observation group, 9.5% of participants experienced such an event, while in the control group, 12.7% were affected. A particularly noticeable difference was seen in the number of deaths: in the control group, 5.8% of participants died during this time, while in the group receiving the Polypill, only 3.9% did not survive the end of the follow-up period.

Since the Polypill showed no increase in side effects and no safety risks, it could be a suitable means for secondary prevention after a heart attack.

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By Sabine Croci. This article is medically reviewed. Last updated (04/2024).
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The Polypill - a remedy for almost everything?

Is the Polypill the miraculous medication for everyone?

Polypill rethought

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