Does a polypill slow cognitive decline in at-risk older adults?
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.
Plan de l'etude:
Randomized controlled trial (double-blinded)
Industry + govt
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.
Henry C. Barry, MD, MS
Michigan State University
East Lansing, MI