Do combination therapies given in fixed-doses polypills with aspirin reduce the risk of cardiovascular disease events?

This study investigated whether a combination pill given in fixed doses with or without aspirin can reduce the risk of cardiovascular disease events in patients without a previous history of cardiovascular disease. The data showed that a fixed-dose combination treatment strategy with aspirin significantly reduced the risks of cardiovascular disease, heart attacks, stroke, and cardiovascular death in these patients.

Hypertension or high blood pressure (BP) is a common condition. It increases the risk of cardiovascular disease. It also increases the risk of major cardiovascular events such as heart attack or stroke. Managing BP can sometimes require multiple medications. There are many ways to target BP. Combining treatment can be very effective. Aspirin is often given to patients with heart disease to reduce the risk of heart attack and stroke. It reduces the ability of the blood to form clots.

The combination of two or more BP-lowering drugs and a cholesterol-lowering drug such as statins (with or without aspirin) at fixed doses (a polypill) has been proposed to reduce cardiovascular disease. It is thought that giving multiple medications in a single pill improves adherence to treatment compared to giving multiple pills per day. However, whether aspirin should be included in fixed-doses combination pills to reduce the risk of cardiovascular disease events is still unknown.

This study analyzed 3 other studies that involved 18,162 patients without a previous history of cardiovascular disease. Patients were assigned into 2 groups. Group 1 included 9074 patients who received a fixed-dose combination treatment of at least 2 BP-lowering drugs plus a statin (with or without aspirin). Group 2 included 9088 patients who received a control treatment (either placebo or usual care). The average follow-up time was 5 years.

The estimated 10-year risk of cardiovascular disease for the population was 17.7%. Fixed-dose combination treatment reduced the risk of cardiovascular disease events by 38% compared to control treatment. Fixed-dose combination treatment was associated with a 48% lower risk of heart attacks, a 41% lower risk of stroke, and a 35% lower risk of cardiovascular death compared to control treatment.

Fixed-dose combination treatment benefits were similar in patients with different cholesterol levels, BP levels, and with or without diabetes. The reduction in the risk of cardiovascular disease events was greater when aspirin was included along with the fixed-dose combination treatment.

Gastrointestinal bleeding occurred in 19 (0.4%) patients who received fixed-dose combination treatment with aspirin compared to 11 (0.2%) patients who received the control treatment. This difference was not significant.

Side effects like hemorrhagic stroke, fatal bleeding, and peptic ulcer disease were low and were not significantly different between the 2 groups. Dizziness was more common with fixed-dose combination treatment (11.7%) compared to the control treatment (9.2%)

This study concluded that a fixed-dose combination treatment strategy with aspirin significantly reduced the risks of cardiovascular disease, heart attacks, stroke, and cardiovascular death in patients without a previous history of cardiovascular disease.