Results of The Indian Polycap Study-2 (TIPS-2) were announced at the 2012 World Congress of Cardiology, held in Dubai in mid-April. TIPS-2 found that the full-dose Indian Polycap—a combination of aspirin, 3 antihypertensives, and a statin—led to greater drops in blood pressure and LDL cholesterol than reductions seen with the original half-dose combination pill, and without an increase in side effects or in the rate of drug discontinuation. The findings put the promise of the polypill—a simplified, one-size-fits-all approach to prevention of cardiovascular morbidity—back on the table for international discussion.
Where does research on the safety and efficacy of the polypill now stand? Do the data point to a significant role for the pill in primary or secondary prevention, or both? Does a single-pill strategy hold promise in combating patient noncompliance?
Here to put the polypill and the study findings into perspective is Dr Christopher Cannon. Dr Cannon is a senior investigator with the TIMI Study Group, editor-in-chief of Cardiosource Science and Quality, and a professor of medicine at Harvard Medical School. He is also an associate physician in the Cardiovascular Division of Brigham and Women’s Hospital in Boston.
|Podcast: Role of the Polypill and CV Disease: Results of the TIPS-2 Trial|
Podcast: Role of the Polypill and CV Disease: Results of the TIPS-2 Trial
• The full-dose polypill was more effective in lowering blood pressure and LDL cholesterol than the half-dose version; there was no increase in adverse events or in drug discontinuation over that seen with the half-dose.
• After 3 months, the double-dose pill reduced systolic BP by an approximate additional 3 mm Hg and diastolic BP by an added 2 mm Hg compared with the half-dose. Heart rate did not differ between groups but LDL was approximately 8 mg/dL lower in the double-dose group.
• TIPS trial series coinvestigator Salim Yusuf, MD (McMaster University, Hamilton, Ontario) has met twice with the United States Food and Drug Administration and believes that a polypill could be available in the US within 6 months to 1 year.