Findings of the TIPS-2 study, announced at the recent 2012 World Congress of Cardiology, 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. Here, Dr Christopher Cannon puts the TIPS-2 results in perspective.
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
• 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.