What do you get when you combine three BP-lowering drugs, a cholesterol-lowering statin, and aspirin into a single pill? The polypill!! The Indian Polycap Study (TIPS) recently published a report on a double-blind, clinical trial conducted in 50 medical centers in India; 2,053 individuals age 45 to 80 without cardiovascular disease (CVD) and with one risk factor for CVD consented to participate.1
The risk factors identified for inclusion criteria should be familiar to advanced practice nurses (APNs): type 2 diabetes mellitus; BP over 140 mm Hg systolic or 90 mm Hg diastolic, but under 160/100 mm Hg; smoker within the past 5 years; increased waist-to-hip ratio; or abnormal lipids (high low-density lipoprotein [LDL] or low HDL).
Participants were randomly assigned to one of nine treatment groups using various combinations of the five medications; only one group received the Polycap pill over the 12-week study period. The Polycap pill contained very low doses of hydrochlorthiazide, atenolol, ramipril, simvastatin, and aspirin. Adverse reactions and tolerability were similar to those experienced by patients taking one agent or a combination of individual agents. Study results were mixed, with the Polycap pill demonstrating lower or higher efficacy in reducing systolic and diastolic BP and LDL cholesterol when compared with each of the other eight treatment groups.
One pill fits all
The TIPS study stirred discussion among attendees at the American College of Cardiology's 58th scientific session held in Orlando this past March. Even though many questioned the practicality and safety of a treatment option that would be difficult to tailor to a large number of patients, the polypill could potentially reduce the burden of adherence for patients with complicated medication regimens.
In the TIPS Phase II trial, study participants were relatively healthy and without known CVD, so "the thought that people might be able to take a single pill to reduce multiple cardiovascular risk factors has generated a lot of excitement."2
Back to reality
The idea of a polypill was first introduced in 2003 as a strategy to reduce CVD. After the article appeared in the British Medical Journal, letters to the editor voiced multiple concerns. How would a healthcare provider know which component was the culprit in the case of an adverse reaction? How would dosage titration be handled? One writer stated, "How nice it would be to live in a polypill world. In reality, however, we must deal with each problem in turn, often accepting a less-than-perfect result. There are no quick fixes, in life or in medicine."3
Pharmaceutical companies continually seek to improve pharmacologic treatment options, and the TIPS study did receive industry support. Until large, multicenter Phase III clinical trials are conducted, APNs must continue to assess risk and counsel all patients accordingly about healthy lifestyle behaviors to reduce their risk of CVD. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure and Adult Treatment Panel III stresses the importance of therapeutic lifestyle changes. We cannot rely on a miracle polypill just yet!!
Jamesetta Newland, RN, PhD, FNP-BC, FAANP, FNAP
Editor-in-Chief
[email protected]
REFERENCES