FDA Approves Triple Therapy Polypill for High Blood Pressure

The US Food and Drug Administration approved a triple therapy polypill for the treatment of patients with hypertension, manufacturer George Medicines announced yesterday.

The single pill (Widaplik), which contains the ARB telmisartan, calcium-channel blocker amlodipine, and diuretic indapamide, is the first triple combination medication approved by the FDA as an initial treatment for patients likely to need multiple medications to lower blood pressure. It will be available at standard doses for the three drugs, as well as at two lower doses. The product label includes a warning from the FDA that the polypill should be immediately stopped in pregnant patients, as the ARB may cause birth defects.

The approval is based on two studies, including one comparing the polypill against placebo as an initial treatment in patients with hypertension and another comparing the polypill against dual combinations of the component drugs. In both studies, the polypill resulted in significant and clinically meaningful improvements in blood pressure.

A 2023 meta-analysis, as reported by TCTMD, found that use of polypills with three or four antihypertensive medications were significantly better at lowering blood pressure than monotherapy, usual care, or placebo.

Current treatment guidelines typically recommend starting with one or two antihypertensives, but the approach can be challenging because it requires patients to make frequent visits over several months to their healthcare provider as the medications are titrated. The fixed-dose combination pills containing low doses of three or four blood pressure-lowering medications have been developed in recent years to improve adherence to therapy and to simplify treatment regimens.

In the US, the American Heart Association estimates that more than 122 million adults have high blood pressure, and that nearly 40% of adults aren’t aware they have it. Globally, more than 1.2 billion adults have hypertension, with roughly two-thirds of these people living in low- and middle-income countries. The World Health Organization (WHO) has previously stated one of their global targets was to reduce the prevalence of hypertension by 33% between 2010 and 2030. 

The WHO also recently added several polypills to its list of essential medications, although the three polypills that made the list include other drugs (statin and aspirin) in addition to antihypertensive agents to reduce the risk of atherosclerotic cardiovascular disease. Polypills have been tested widely in both primary- and secondary-prevention patients and been successful in reducing the risk of major cardiovascular events.

The manufacturer plans to commercially launch Widaplik, formerly known as GMRx2, later this year.