Polypill, a single capsule that combines four to five drugs to reduce cardiovascular diseases and death risks, has been adopted in WHO’s Model List of Essential Medicines (EML) based on studies by Bengaluru’s St John’s Medical College and Research Institute (SJRI) and Canada’s Population Health Research Institute.
Many Indians have hypertension and high cholesterol levels which require taking multiple tablets lifelong, resulting in high costs and low treatment adherence. A single polypill can substitute these medicines.
With its inclusion in WHO’s EML, polypill is expected to be included in India’s essential medicines list as well, and possibly in the country’s public health programmes later.
Polypill is not a new drug, but is a combination of pre-existing drugs, says Dr Denis Xavier, head of pharmacology and clinical research at the SJRI. The combination includes three common blood pressure-lowering drugs and one cholestrol-lowering drug, with or without aspirin.
The capsule was developed in India around 2005, in collaboration with Dr Salim Yusuf in Canada.
The Indian Polycap Study (TIPS-I), conducted among 2,053 Indians with a risk factor for cardiovascular disease, was published in 2009. It showed that the pill significantly reduced hypertension and cholesterol levels. TIPS-2 established the tablet’s safety and efficacy at higher doses.
The International Polycap Study (TIPS-3) was conducted between 2012 and 2019 among 5,713 people across the world, of whom nearly half were from India.
This study found that, among people with an intermediate risk for heart disease, polypill reduced the risk of heart attack, stroke and death by 31%. But getting the drug into the EML was a long process, with the WHO rejecting the researchers’ application twice, says Dr Xavier.
The approval came the third time after the team conducted a meta-analysis of TIPS and two other polypill studies, which showed over 40% reduction in heart attacks, strokes and deaths.
Dr Xavier says that currently polypill is not popular globally as it is not a profit-making proposition for pharma companies, and since many doctors prefer to titrate multiple medicines frequently as per blood test results. “But such titration is needed for only about 20% of patients.” He adds that polypills can be developed at different doses too, and even for other conditions like diabetes plus hypertension.
Dr Prem Pais, principal investigator of the TIPS study at SJRI, says, “In people who have not yet had a heart problem but have risk factors like hypertension, polypill can significantly reduce heart attacks and deaths. It can be used in public health programmes because it can be given in a fixed dose without necessarily measuring the patient’s cholesterol levels, etc., regularly.”