Global health has paid a heavy price in deaths due to the lack of widespread use of antihypertensive drugs, statins, and aspirin—simple, inexpensive medications in single-pill form, also known as a "polycapsule." The widespread availability of polycapsules, at a price affordable to most of the world's population, would substantially reduce the risk of cardiovascular disease (CVD), according to an appeal published today in The Lancet by two leading cardiologists.
"Despite considerable scientific evidence of high efficacy, safety and affordability of the polycapsule, there are few combination products of this type and their use is low in the few countries where they are available," explains Cat. Fausto Pinto, president of the World Heart Federation.
“This systemic failure is a global tragedy, as many premature deaths from CVD could be avoided,” adds Cat. Salim Yusuf, executive director of the PHRI (Population Health Research Institute) and professor emeritus of medicine at McMaster University.
The number of people suffering from cardiovascular disease is around 54 million a year - of which a third die as a result of CVD - and 80% of them live in low- and middle-income countries.
The majority of heart attacks and strokes affect people without a previous CVD, which means that (primary) prevention of the first heart attack or stroke is essential. Secondary prevention, in those who already have CVD, is also important, but does not have the same impact.
“The current primary and secondary CVD prevention strategy has had only modest success in most countries, including high-income countries. Even in these countries, less than half of patients with a previous CVD and less than 20% of those without a history of CVD receive effective preventive treatments,” explains Cat. Yusuf.
Polycapsule, also known as fixed-dose combination therapy (FDC), which combines antihypertensive drugs, a statin to lower LDL cholesterol, and a low dose of acetylsalicylic acid, was proposed in the early 2000s as a way to reduce substantially CVD with a low cost.
“We now have a clear and resounding answer, as data from three large independent long-term trials on primary prevention show its importance in saving lives,” explains Yusuf, whose TIPS-3 trial (NEJM, 2020) showed how heart attacks and strokes were reduced by between 20 and 40% when using a polycapsule.
"It is time to use the polycapsule widely to save millions of lives a year," concludes Cat. Pinto. Both he and Cat. Yusuf recommend the following new strategies:
- Encourage large pharmaceutical laboratories to invest in the development and study of polycapsules—in particular, new polycapsules with greater antihypertensive effects (for example, combining low doses of 3 or 4 classes of drugs with statins and low doses of acetylsalicylic acid). Manufacturing with generic active ingredients and putting the polycapsules on the market at prices in line with local reality would ensure their affordability and at the same time maintain their profitability for companies, thereby promoting their use by the majority of the population in everyone.
- Including polycapsules in the WHO List of Essential Medicines and clinical guidelines for both primary and secondary prevention of CVD would be an important step forward. "This would encourage governments and insurers, especially in low- and middle-income countries, to include them in their lists of covered medications and doctors to recommend their use," write Pinto and Yusuf.
- Combining polycapsule with lifestyle advice to prevent CVD offered by appropriately trained senior healthcare professionals (SHPs) – not as a substitute for doctors, who can then focus on caring for patients with more complex diseases, but as a strategy combined to be able to reach many more people.