Polypill Would Be Cost-Effective in Latin America

January 16, 2013

MADISON, Wisconsin — The polypill, a combination drug that includes aspirin, a statin, and three antihypertensive medications, would be a cost-effective treatment strategy to reduce the risk of cardiovascular disease in Latin America, according to a new study [1].

Treating all men and women at high risk of cardiovascular disease would reduce its lifetime risk by 15% in women and 21% in men, report investigators. To accomplish this goal, 26% of the population would need to be treated with the polypill at a cost of $34 to $36 per quality-adjusted life-year (QALY).

"The main cause of morbidity and mortality in Latin America is cardiovascular disease," lead investigator Dr Leonelo Bautista (University of Wisconsin, Madison) told heartwire . "Even though we know how we can prevent cardiovascular disease in developing countries, the main issue remains--how do we do it? In this sense, how do we make the interventions we have, the interventions we know that work, available for large [portions] of the population?"

Published in the January 2013 issue of Health Affairs, the analysis is based on data from the Latin American Consortium of Studies in Obesity and results from The Indian Polycap Study (TIPS). The estimates of cost-effectiveness are based on a model that assessed the risks of not prescribing the polypill vs the costs and benefits of prescribing the combination therapy to men and women of various ages in different high-risk groups. The polypill in the TIPS trial combined simvastatin 20 mg, aspirin 100 mg, thiazide 12.5 mg, atenolol 50 mg, and ramipril 5 mg.

Without the polypill, the 10-year risk of coronary heart disease and stroke would be 7.3% and 2.9% in women and 9.0% and 2.0% in men, respectively. The lifetime risk of cardiovascular events in women would be 29.1%, but this could be reduced by 15% if the polypill were prescribed to women at high risk for cardiovascular disease, that being women with a 10-year risk of cardiovascular disease >15%. For men, the lifetime risk of cardiovascular disease would be 36.5% if untreated, but this could be reduced by 21% if all high-risk patients were treated with the polypill.

The researchers report that giving the polypill to high-risk women would be the best intervention, as it would result in the lowest increase in cost per additional QALY gained. In women at high risk for cardiovascular disease treated with the polypill, the incremental cost-effectiveness ratio would be $268/QALY. Giving the polypill to all men aged 55 years and older would be best approach, say the researchers, resulting in an incremental cost-effectiveness ratio of $449/QALY.

"If you compare the polypill with other interventions that we already use, this would be a highly cost-effective intervention," said Bautista. "For the average country in Latin America, the best scenario would be giving the polypill to women at high risk for cardiovascular disease and to men over the age of 55 years. If you go to countries that have a lower incidence of cardiovascular disease, then maybe the best option is to give the polypill to everybody older than 55. On the other extreme, in countries like Argentina, then the best option might be patients with a high risk of cardiovascular disease."

To heartwire , Bautista said that Latin America represents a particularly attractive population for using the polypill, given that cardiovascular disease accounts for 35% of all deaths. In addition, there are high rates of hypertension and hypercholesterolemia. When the distribution of cardiovascular risk factors is compared with those of individuals in the US, the main difference between the two populations is the rate of obesity, which is higher in the US.

One major caveat that remains with regard to the polypill in Latin America is testing. The polypill still needs to be evaluated in a population of Latin American subjects, said Bautista, and such trials should include hard clinical outcomes and not just surrogate end points such as LDL cholesterol or blood-pressure levels. Although such trials would be complex and lengthy, only such trials will be able to move the polypill forward in the field of public health and in clinical practice.