Polypills: Should You Be Taking Them As The Treatment For Heart Attack?

A considerable population all around the world is dealing with hypertension, dyslipidemia, diabetes, and Cardiovascular diseases that remain a significant healthcare delivery challenge.

The cost and complexity of multi-drug regimens impact adversely on adherence to such treatment and therefore, on its effectiveness. Therefore, most patients are not able to sustain a variety of medications for the long term.

With this idea, Wald and Law in 2003 published a study in the British Medical Journal introducing the concept of the combination of multiple pills in a single pill for CVD prevention termed “polypill”.This intervention was estimated with following outputs:

• Large scale reduction of “heart attacks and stroke if taken by everyone aged 55 years and older” irrespective of risk factors.
• Reduce ischemic heart diseases by 88% and strokes by 80%.
• To provide an average of 11 disease-free years of life to 1/3 rd population taking polypill.

Since then, several researchers out there have been trying to figure out the effectiveness of polypills in the treatment of heart patients. Today, multiple fixed-dose combination polypills are available in different countries for clinical trials and research.Few of them are even available in stores also but with a poor selling rate.

In India, Polycap by Cadila, Polypill and start pill by Cipla and red heart pill by Dr Reddy’s lab are primarily available for clinical use and research.^1,2

However, heart patients need to familiarize themselves with the ongoing trials of these polypills before opting them.

What are polypills?

The polypill is a pill containing a combination of 4-6 medications used for the treatment of heart disease and high blood pressure. These medications include:

1.Aspirin

2. Cholesterol-lowering medications (statins)

3. beta-blocker

4. angiotensin-converting enzyme (ACE) inhibitor

5. Diuretics

6. Folic acid

The clinical trials of Polypills on humans have shown, to improve adherence to these pills, with corresponding improvements in high blood pressure and LDL- Cholesterol.

A recent phase 3 trial on 2499 heart attack survivors treated with a polypill consisting of aspirin, ramipril, and atorvastatin for 3 consecutive years resulted in a 33% lower risk of major cardiovascular events than usual care. ³

In another clinical trial on "polyiran" polypill manufactured by Alborz Darou Pharmaceutical, Iran. A four-component polypill including aspirin, atorvastatin, hydrochlorothiazide, and either enalapril or valsartan was tested on 50,045 participants aged 40–75 years to prevent heart attack. This polypill was found as an effective treatment in preventing major cardiovascular events.⁴

1. Improve Adherence

The major health challenge in managing heart conditions is adherence to medications over a long duration and even lifelong in some patients who may be asymptomatic.

For that reason, the immediate benefits of treatment may not be perceived by them.

However, the use of polypills for heart conditions is conceptualized to reduce pill burden and thus improve adherence. ⁸

2. Improve the quality of life

The self-rated health score on a graduated scale of (0–100) also called EQ-5D visual analog scale, is reported to be significantly higher for the trial patients taking polypills than the trial patients without polypills.

Hence, the quality of life in heart patients taking polypills is generally improved.⁸

3. Better Cardiovascular risk factor control

The treatment with polypills can better lower both systolic and diastolic blood pressure and cholesterol level as compared to the individual medication for the treatment.

4. Cost-saving Treatment

The polypill strategy is cost-saving compared to usual care among patients with a high risk of heart conditions.⁶

Pollypills have been considered to reduce the average cost, summing the cost of medications, healthcare visits, and hospitalizations, as compared to usual care. This strategy for secondary prevention of heart conditions is cost-effective according to World Health Organization standards.

A low-cost polypill would improve the access, availability, and affordability of cardiovascular disease prevention and treatment for a huge population living with cardiovascular disease globally. ⁷

1. Dose Adjustments

The inconvenience of dose adjustments with a polypill had been a concern for most practitioners, for which they do not recommend taking polypills.

2. Impact of Drug intolerance

Another drawback of using polypill is that the side-effect of any one of the components in polypill can lead to the discontinuation of all medications for the treatment of health conditions associated with the heart with a discontinuation rate of 26%.

However, this discontinuation can be counterbalanced by other benefits of polypill including better adherence.⁸

Takeaway

Even after prolonged years of research on the health benefit of polypills on cardiovascular conditions and their availability in stores, its use is still controversial globally.

The lack of clarity in regulatory paths and market failure in funding affordable medicines have hampered efforts to make polypills a success in clinical practice.

However, this medical intervention will not go in vain. The next decade is expected to see a turnaround in the fortunes with the use of polypills, as a pragmatic solution to cardiovascular health conditions.⁵