Polypill Tested for Cognitive and Functional Benefits

lower blood pressure and cholesterol TIPS-3 A secondary analysis showed that trials using polypills with or without aspirin showed no protective effect on cognition in older adults with cardiovascular disease risk factors.

According to Jacqueline Bosch, Ph.D., of McMaster University, Hamilton, Ontario, and colleagues, during the five-year follow-up period, approximately equal numbers of trial participants in TIPS-3 experienced substantial cognition in both the treatment and placebo groups. experienced a decline in function.

The primary outcome – a composite of cognitive impairment score and functional impairment score – occurred in 6.52 per 100 patient-years in the polypill group and 6.34 per 100 patient-years in the placebo group (HR 1.05, 95% CI 0.90-1.21, P.=0.55), they are Department of Neurology, JAMA.

However, the polypill showed efficacy against functional decline. Adjusted Standardized Assessment of Global Daily Activities (SAGEA) scores were 0.06 vs. 0.15 for polypill vs. placebo follow-up and 0.01 vs. 0.14 for polypill vs. aspirin vs. placebo. (Pboth = 0.01).

“Large studies with longer follow-up may be warranted to detect small changes in cognition that may still be relevant at the population level,” write Bosch and colleagues. “The use of functional assessment may be a more sensitive outcome measure in international studies.”

A meta-analysis suggests that antihypertensive treatment may have a modest effect (7% to 9%) on cognitive decline, the researchers say. “While the assessment we used is sensitive to change, changes may be slow, at least initially, in populations without overt vascular disease,” they observed.

TIPS-3 reported that aspirin was added to the polypill Reduce the incidence of cardiovascular events in the intermediate-risk population. The polypill contained 100 mg atenolol, 10 mg ramipril, 25 mg hydrochlorothiazide, and 40 mg simvastatin.

Bosch and colleagues used the primary composite outcome of cognitive and functional assessment scores to assess cognitive impairment in TIPS-3. The composite included the Montreal Cognitive Assessment. Numeric symbol substitution test of speed, attention and executive function. Trailmaking test part B to assess attention.and the sage, Patient-reported results that measure ability to perform usual activities. A change of 1.5 standard deviations was considered a substantial decline in cognitive or functional ability.

Results were based on standardized scores by country. “These scores were used to account for country-level differences in scores, possibly due to undocumented cultural or regional differences,” the researchers wrote.

Overall, 2,098 TIPS-3 participants (60% female) with a mean age of 70 years completed baseline and follow-up assessments. Participants were from her eight countries, mainly the Philippines and India, and from July 2012 he was followed until September 2020.

Most participants (86%) had hypertension and 32% had low fasting blood glucose levels. Baseline mean systolic blood pressure was 146.1 mm Hg, decreased by 5.7 mm Hg in the polypill group. Mean LDL cholesterol level was 124.3 mg/dL, a decrease of 24 mg/dL.

A total of 1,076 people were randomly assigned to the polypill and 1,022 received placebo. Within each group, participants were divided into a group receiving aspirin (75 mg/day) and a group receiving no aspirin.

At 5-year follow-up, there was no significant difference in the number of participants with substantial cognitive decline (polypill group 356, placebo 328) or dementia (polypill group 2, placebo 4). Similar results were obtained with aspirin and polypills taken daily.

Bosch and colleagues say there are several possible reasons for this. “First, the effects of vascular modification on cognitive decline may be modest,” they wrote. It may be associated with increased random errors in international studies involving cultures and different educational backgrounds.”

The study may not have adequately assessed cognitive decline, and it is also possible that changes in function are at least partially attributable to physical decline, the researchers noted. We used measures developed in our study, but it is unclear whether these measures respond to changes in other populations,” they admitted.