New Delhi, Sept. 3: Patients with a history or at high risk of cardiovascular disease are more likely to take preventive medicines when they are combined into a single cocktail-like polypill that combines four drugs into a single capsule.
A clinical trial among patients from India, England, Ireland, and the Netherlands has shown that the polypill dramatically improved patients’ adherence to preventive treatment and led to parallel improvements in blood pressure and cholesterol levels.
Doctors who conducted the trial found that 86 per cent of 960 patients who had opted for the polypill were continuing treatment at the end of the study in contrast to 64 per cent of 961 patients who took the same medications as multiple pills.
“For such high-risk patients, the most important step to reduce the risk of a repeat heart attack or premature death is compliance with medications, and we find that polypills achieve this,” said Dorairaj Prabhakaran, a cardiologist with the Centre for Chronic Disease Control, New Delhi, who was the trial’s principal investigator in India. The results of the trial will be published tomorrow in the Journal of American Medical Association.
The polypills contained aspirin, blood pressure lowering drugs, and a stain prescribed to patients who have survived heart attacks or strokes or to people with a combination of risk factors such as diabetes, high cholesterol levels, blood pressure, and smoking.
But medical studies as well as anecdotal evidence amassed by doctors over the years suggests that many patients stop taking one or more medications when they have to take four, five, or six pills every day with separate sips of water.
“We find the polypill strategy improves the use of these life-saving drugs,” Anushka Patel, lead investigator at The George Institute for Global Health, India, told The Telegraph.
“We believe the results have important and immediate implications for clinical practice.”
While several polypills have been approved by regulators in India, Patel said, their uptake has not been high because of the absence of supportive clinical trial data.
“These trial results change that — they give reassurance to doctors that switching to polypills can improve outcomes, particularly in patients who’re not taking their recommended medications.”
The Indian-European clinical trial conducted over a 15-month period during 2010 and 2011 used polypills produced by the Hyderabad-based Dr Reddy's Laboratories. The company decided to invest in polypills about a decade ago after a casual over-coffee conversation between its late founder Kallam Anji Reddy and cardiologist K Srinath Reddy, now president of the Public Health Foundation of India, New Delhi.
“For clinical practice, the polypill strategy could have considerably bigger impact than the arrival of a new blockbuster drug for either cholesterol or blood pressure,” said Simon Thom, a senior cardiologist at Imperial College, London, and lead author of the study.
Doctors caution that the polypills are exclusively intended for patients who've survived cardiovascular events or high risk people with combinations of risk factors. Srinath Reddy said there is no evidence yet to claim that polypills may also be used in primary prevention -- in all people above age 55 years.
The reductions in blood pressure and cholesterol among patients who took the polypills were “numerically small but highly significant”, Thom told this newspaper. “The reductions provide powerful internal validation of the importance of adherence to treatment,” he said.
The study did not detect any significant differences in the rate of serious adverse effects or heart attacks or strokes between the patients who took the polypills and those who opted for standard medications.