Polycap

Polycap is a five-in-one polypill created by Cadila Pharmaceuticals Limited of Ahmedabad, India that combines moderate levels of five different medications in a single, one-a-day pill aimed at reducing heart attacks and strokes. A 2009 study found that the combination of three blood pressure medications, a cholesterol reducer and aspirin cut the risks of heart attack and stroke in half, with no increase in adverse effects compared to taking the components separately.

While researchers have sought to create many different "polypills", combinations of active ingredients to treat various diseases, a pill targeted at heart attack and stroke risk was long-sought. While the benefits of reducing the number of pills patients would have to take seemed clear, concerns were raised that the shotgun approach would fit few patients, offering many too little of the medication they needed or components that they didn't need at all, while exposing them to side effects of all the medications included.

A hypothesis proposed by Wald and Law published in 2003 recommended a six-drug combination to be taken by patients over age 55 with cardiovascular disease events, that would include three half-dose antihypertensives drugs, aspirin, a statin and folic acid. After further research showed no improvement in clinical outcomes for patients taking folic acid, it was omitted from Cadila Pharmaceuticals' formulation. As tested, Polycap combines 100 milligrams of aspirin, with simvastatin (a generic version of Zocor, the cholesterol-lowering statin; 20 mg) and low doses of three blood pressure medications, atenolol (50 mg), ramipril (5 mg) and thiazide (12.5 mg). The small size of the pill can help make swallowing easier.

The Indian Polycap Study (TIPS)

A study called The Indian Polycap Study (TIPS) was sponsored by Cadila Pharmaceuticals Limited, (where the drug development program was coordinated by JP Parswani, President, and Dr. Arun Maseeh, Vice-President Medical Affairs), and led by Dr. Salim Yusuf of McMaster University in Hamilton, Ontario, and Dr. Prem Pais of St. John's Medical College in Bangalore, India. The results of the randomized, controlled, double-blind study, reported in March 2009 at an American College of Cardiology conference and published online by The Lancet, documented the outcome of 2,000 individuals with an average age of 54 given the medication, all of whom had at least one heart disease risk factor: diabetes, hypercholesterolemia, hypertension, obesity or smoking. The study was registered with ClinicalTrials.gov, number NCT00443794.

During a 12-week treatment period, 400 of the study participants were given Polycap. The remainder were divided into eight groups of 200 who were given either individual components or groups of them. Three of the groups of 200 received only aspirin, simvastatin or thiazide respectively; Three groups received two of the three blood pressure medications; Another received all three blood pressure medications, while the last received all three combined with aspirin.

The individuals who were given Polycap saw their blood pressure drop from six to seven points for both their systolic and diastolic levels. These reductions in blood pressure could cut the risk of heart disease by 62% and of stroke by 48% based on the results of other studies that showed risk reductions from cutting blood pressure levels. The combined pill was almost as effective as the individual pills with no increase in side effects.

Generic versions of the five components cost $17 per month in the United States as of 2009. Estimates are that the combined dose would sell for far less while offering the psychological benefit of reducing the "pill burden" on patients taking multiple medications. Distribution would require approval by the U.S. Food and Drug Administration and other regulatory bodies worldwide. Details of the polycap data were widely reported in the popular media, including USA Today, The Guardian (UK), BBC, CBS Healthwatch, ABC News, India Today.

Sources

• "Effects of a polypill (Polycap) on risk factors in middle-aged individuals without cardiovascular disease (TIPS): a phase II, double-blind, randomised trial", S Yusuf (cochair and principal investigator), P Pais (cochair and principal investigator), D Xavier, A Sigamani, R Gupta, K K Haridas, S S Iyengar, T M Jaison, P Joshi, P Kerkar, V Mohan, S Naik, D Prabhakaran, S Thanikachalam, N Thomas, J Parwani, A Maseeh. http://www.thelancet.com Published online March 30, 2009 DOI:10.1016/S0140-6736(09)60611-5
• Christopher P Cannon. Editorial Comment. Can the polypill save the world from heart disease? Published Online March 30, 2009 DOI:10.1016/S0140- 6736(09)60652-8. http://www.thelancet.com Published online March 30, 2009 DOI:10.1016/S0140-6736(09)60652-8

External links

• The Indian POLYCAP Study (TIPS)
• Cadila Pharmaceuticals Limited
• The actual size "zero" capsule used in The Indian Polycap Study

Marchione, Marilynn via Associated Press. "Study says one combo pill does work of five", The Record (Bergen County), March 31, 2009. Accessed March 31, 2009.

Xavier, Denis, et. al. "The Need to Test the Theories Behind the Polypill: Rationale Behind the Indian Polycap Study", Nature Clinical Practice Cardiovascular Medicine, 2009; 6(2): 96-97, posted February 12, 2009. Accessed March 31, 2009.

The Indian POLYCAP Study (TIPS), ClinicalTrials.gov. Accessed April 6, 2009.