September 24, 2019

This pill combines 4 drugs to lower heart disease risk. But does it have a place in US medicine?

Daily Briefing

    A single pill that contains four drugs that treat cardiovascular risk factors was tied to a reduced risk of heart disease among at-risk low-income U.S. patients, according to a study published Thursday in the New England Journal of Medicine.

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    Researchers test combo pill in US

    According to the Associated Press, researchers abroad already have found evidence that the combo pill can be used to treat conditions that lead to heart attack and stroke. The goal of the latest study was to see if the pill would work as well among low-income Americans as it has in other countries, according to the AP.

    "The use of combination pills (also called 'polypills') containing low doses of medications with proven benefits for the prevention of cardiovascular disease may be beneficial in [individuals with low socioeconomic status and nonwhite individuals]," the study authors wrote. "However, few data are available regarding the use of polypill therapy in underserved communities in the United States, in which adherence to guideline-based care is generally low."

    To determine whether the pill would work well among low-income Americans, the American Heart Association and NIH funded a randomized, controlled trial that enrolled 303 participants, ages 45 to 75, from a community health center in Mobile, Alabama. Half of the participants were assigned to take the combo pill and the rest continued their usual care.

    The majority of the patients had annual incomes under $15,000, and 96% of participants were black. All of the participants had at least borderline high blood pressure. People with very high cholesterol were excluded from the study because their condition would require more aggressive treatment. Overall, the mean estimated 10-year cardiovascular disease risk among all the participants was 12.7%.

    Key findings

    After one year, participants who received the combo pill saw their blood pressure drop by seven points and their cholesterol drop by 11 points compared to participants who received regular care, the researchers found. The researchers estimated that the improvements translate to a 25% reduction in the 10-year risk for heart attack, stroke, and other cardiovascular conditions in a population that is prone to cardiovascular disease.

    However, the study duration was not long enough to measure whether the pill helped prevent heart attacks or strokes.

    The researchers noted that 91% of participants came to the final trial visit. This is significant because about 50% of U.S. residents who should be taking heart medication stop taking it within one year, according to Reuters.   

    Will it work in the United States?

    The researchers said the results indicate the combo pill could help prevent cardiovascular disease in low-income, U.S. patients and make it easier for patients to adhere to their medication. "The simplicity of taking a single daily pill may be an important contributor to adherence," the researchers said. The fact that several medications are contained in one pill would mean patients don't have to make return visits to the doctor, which is usually difficult for low-income patients, the researchers explained.

    However, Salim Yusuf of McMaster University in Canada and leader of a different combination pill study, noted that combo pills are not available in the United States. According to Yusuf, it's unclear if U.S. doctors would adopt the treatment because they often prefer to customize patients' medications individually—a practice he argues that is hard to maintain.

    Sidney Smith, a former heart association president from the University of North Carolina at Chapel Hill who was not involved in the study, said the evidence from this study could be what the health care community needs to "help move this strategy forward" (Johnson, Associated Press, 9/18; Emery, Reuters, 9/18; Muñoz et al., New England Journal of Medicine, 9/19).

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