Several years ago, The Lancet suggested the potential benefits of the marketing of a so-called “polypill”, a medication based on the combination of aspirin (100mg), ramipril (2.5, 5 or 10 mg) and atorvastatin (20 or 40 mg), indicated for the secondary prevention of myocardial infarction. The aim was to increase patients’ compliance, but no company was interested in investing in this combination product based on 3 ingredients whose patent had expired. The Lancet and New England Journal of Medicine published two new clinical trials, wherein the results once again support the clinical benefits of a polypill. Below are some of the key findings of the trials.

The Lancet study, published in 2019, was performed in Iran and enrolled 6838 individuals. Median adherence to polypill tablets was 80.5%. The reduction in the risk of major cardiovascular events was significant. The use of the polypill was effective in preventing major cardiovascular events, medication adherence was high and adverse event numbers were low. The polypill strategy could be considered as an additional effective component in controlling cardiovascular diseases, especially in LMICs.1

The New England study, published in August 2022, enrolled 2499 patients. A primary-outcome event occurred in 118 of 1237 patients (9.5%) in the polypill group and in 156 of 1229 (12.7%) in the usual-care group (P=0.02). A key secondary-outcome event occurred in 101 patients (8.2%) in the polypill group and in 144 (11.7%) in the usual-care group (P=0.005). Medication adherence as reported by the patients was higher in the polypill group than in the usual-care group. Adverse events were similar between groups. The conclusion is that treatment with a polypill containing aspirin, ramipril, and atorvastatin within 6 months after myocardial infarction resulted in a significantly lower risk of major adverse cardiovascular events than usual care.2

You can read more about the clinical trials at the Lancet here and the New England Journal of Medicine here.

References

  1. Roshandel, G., Khoshnia, M., Poustchi, H., Hemming, K., Kamangar, F., Gharavi, A., Ostovaneh, M. R., Nateghi, A., Majed, M., Navabakhsh, B., Merat, S., Pourshams, A., Nalini, M., Malekzadeh, F., Sadeghi, M., Mohammadifard, N., Sarrafzadegan, N., Naemi-Tabiei, M., Fazel, A., . . . Malekzadeh, R. (2019, August). Effectiveness of polypill for primary and secondary prevention of cardiovascular diseases (PolyIran): a pragmatic, cluster-randomised trial. The Lancet, 394(10199), 672–683. https://doi.org/10.1016/s0140-6736(19)31791-x
  2. Castellano, J. M., Pocock, S. J., Bhatt, D. L., Quesada, A. J., Owen, R., Fernandez-Ortiz, A., Sanchez, P. L., Marin Ortuño, F., Vazquez Rodriguez, J. M., Domingo-Fernández, A., Lozano, I., Roncaglioni, M. C., Baviera, M., Foresta, A., Ojeda-Fernandez, L., Colivicchi, F., Di Fusco, S. A., Doehner, W., Meyer, A., . . . Fuster, V. (2022, September 15). Polypill Strategy in Secondary Cardiovascular Prevention. New England Journal of Medicine, 387(11), 967–977. https://doi.org/10.1056/nejmoa2208275

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