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Polypill does not slow cognitive decline in older adults at intermediate cardiovascular risk (TIPS-3)
Clinical Question
Does a polypill slow cognitive decline in at-risk older adults?
Bottom line
In this multinational study of adults older than 65 years with intermediate cardiovascular risk, a polypill (40 mg simvastatin, 100 mg atenolol, 25 mg hydrochlorothiazide, and 10 mg ramipril) was no more effective than placebo in slowing the rate of cognitive decline. 1b-
Reference
Study design: Randomized controlled trial (double-blinded)
Funding: Industry + govt
Setting: Outpatient (any)
Synopsis
The International Polycap Study 3 (TIPS-3) was a multinational study that recruited adults at intermediate cardiovascular risk (10 or more on the INTERHEART Risk Score) and randomized them into 4 groups: a polypill plus aspirin; a polypill plus placebo; placebo plus 75 mg aspirin; placebo plus placebo). This report addresses cognitive and functional outcomes in adults who were at least 65 years of age at baseline. There was another wing of this trial that evaluated vitamin D, but those results were not included in this report. Of the 2389 participants, the researchers only had baseline assessments on 2361 and baseline plus at least one subsequent assessment during the subsequent follow-up on 2098 (87.9%). The polypill contained 40 mg simvastatin, 100 mg atenolol, 25 mg hydrochlorothiazide, and10mg ramipril. Study participants engaged in a 4-week run-in period in which they all took a half-dose version of the polypill and only those who were adherent and willing to continue were randomized. In other words, they were an adherent and tolerant group, so maybe not like all the patients we see. After 5 years of follow-up, blood pressure and lipid levels all declined, but there was no significant difference in the rate of cognitive decline between patients taking the polypill and those taking double placebo. The authors report the polypill recipients, with or without aspirin, experienced slower functional decline than with double placebo; however, it is unclear if the differences in scores are clinically meaningful. The authors report polypill recipients experienced more hypotension, dizziness, and cough, but rather than reporting the frequency of adverse events or drug discontinuations, they simply say the incidence of adverse events was "low." I don’t know how the European Commission defines low, but we reviewed a study that illustrated the widely divergent interpretations of semiquantitative language.
Reviewer
Henry C. Barry, MD, MS
Professor
Michigan State University
East Lansing, MI
Comments
Impact assessment
Excellent
May I know Who sponsored this study?
Industry influence has been devastating about which medications we are using in which specialty.
I have learnt from lifestyle medicine that most of the chronic diseases can be reversed in early stages and can be put into remission with an extra effort from physician and patient both. Food is the main source of these diseases. Food industry and pharmaceutical industry ownership have thin lines and mostly owned by same companies. One is feeding the disease and one is treating it and no one is talking about curing it. I feel physicians have become gatekeepers of pharmaceutical industry. Let food be thy medicine… we are forgetting this important fact.
Polypill
That is depressing news. One would think that combination would at least benefit vascular dementia.