Need for longer trials may delay preventive polypill
THE first polypill demonstrated to lower cardiovascular risk may struggle to get regulatory approval in Australia without long-term outcomes data, an expert says.
A study in 378 people without an indication for any component of the pill but who had a five-year cardiovascular risk over 7.5% suggested it could halve cardiovascular events.
The polypill – containing aspirin 75 mg, lisinopril 10 mg, hydrochlorothiazide 12.5 mg and simvastatin 20 mg – reduced systolic blood pressure by 9.9 mmHg and LDL cholesterol by 0.8 mmol/L over 12 weeks. Side-effects occurred in 58% of the polypill group versus 42% receiving placebo.
Professor Anthony Rodgers, from the George Institute for Global Health and the study steering committee, hoped the polypill, manufactured by Indian pharmaceutical company Dr Reddy’s Ltd, would be available in Australia “within a year or two”.
However, Professor Phil Harris, clinical director