A new American Heart Association and National Institutes of Health-sponsored study found that use of a polypill reduced cardiovascular risk in a low-income population in Mobile, Alabama.
With curiosity and information supporting its efficacy at an all-time high, the idea of implementing a polypill for cardiovascular disease has never seemed more feasible.
Coming on the heels of the PolyIran study and a study from Beth Israel Deaconess Medical Center examining the cost-effectiveness of the approach, a new study that found use decreased the risk of cardiovascular disease by 25% is providing support for the use of a cardiovascular polypill in underserved communities in the United States.
"We think there are advantages to combining population-based strategies like the polypill with all of the virtues of precision medicine,” said study investigator Daniel Muñoz, MD, a cardiologist at Vanderbilt University Medical Center. “It is a running start for people who need access to some medical care, but precision medicine should still be used to add therapy and adjust therapy."
In order to assess the ability of a polypill for the prevention of cardiovascular disease, investigators conducted a randomized, controlled trial in a cohort of patients without cardiovascular disease from a single community health center in Mobile, Alabama. The 2-group, open-label clinical trial, which was sponsored by the American Heart Association and National Institutes of Health, compared a polypill, composed of 10 mg atorvastatin, 2.5 mg amlodipine, 25 mg losartan, and 12.5 mg hydrochlorothiazide, with usual-care.
For inclusion, patients needed to be between 40 and 75 years of age and no history of coronary heart disease, stroke, cancer, liver disease, or insulin-dependent diabetes. Further inclusion criteria included having a systolic blood pressure between 120 and 160 mm Hg, an LDL cholesterol level of less than 190 mg per deciliter (4.90 mmol per liter), an estimated glomerular filtration rate (eGFR) of at least 60 ml per minute per 1.73 m2 of body-surface area, normal potassium levels, hepatic aminotransferase levels of less than 3 times the upper limit of the normal range, no contraindications to any polypill component, status of not being pregnant, and current use of no more than two antihypertensive medications.
Eligible participants were randomized to receive 90-day refillable supplies of daily polypill medication or usual-care. Investigators noted the trial pills were produced a cost to investigators of $26 per participant.
Follow-up visits occurred at 2 months and 12 months after randomization. During visits, a clinical exam was conducted, blood pressure was measured, and fasting blood sample was obtained. Investigators assessed adherence by means of pill counts performed by the trial coordinator at each trial visit. Investigators noted that patients received $50 for each clinic visit completed.
A total of 1201 patients were screened for eligibility, of which 303 underwent randomization. Of the 303, 148 were assigned to the polypill group and 155 were assigned to receive usual-care. Investigators noted that 126 were included in the final analysis for the polypill group and 147 were included form the usual-care group.
Mean age of study participants was 56 years, mean BMI exceeded 30, 43% of participants had hypertension at stage 2 or higher, and 96% were black. The baseline blood pressure was 140/83 mmHg, the baseline LDL cholesterol level was 113 mg per deciliter, and the mean estimated 10-year risk of the study population was 12.7%. Investigators noted the mean estimated 10-year cardiovascular risk was 12.4% in the polypill group and 13.0% in the usual-care group.
At the final visit, adherence to the polypill regimen was 86%. Clinicians reduced doses or discontinued use of other antihypertensive or lipid-lowering medications in 44% of patients in the polypill group while 0 patients in the usual-care group had a de-escalation of therapy.
Analyses revealed mean systolic blood pressure deceased by 9 mmHg in the polypill group compared to 2 mmHg in the usual-care group (difference, −7 mmHg; 95% CI, −12 to −2; P=0.003). Additionally, the polypill group saw a mean LDL cholesterol level reduction of 15 mg per deciliter compared to 4 mg per deciliter in the usual-care group (difference, −11 mg per deciliter; 95% CI, −18 to −5; P<0.001).
Study investigator Thomas Wang, MD, chief of the Division of Cardiovascular Medicine at Vanderbilt University Medical Center, stated the results of the study support the idea that polypill could be an affordable and effective means of reducing cardiovascular risk in low- and middle-income areas.
"The pill may address some of the barriers that contribute to disparities in health based on geography, socioeconomic class and other parameters that we know have existed in this country and other countries for a while now," Wang said.
This study, “Polypill for Cardiovascular Disease Prevention in an Underserved Population,” was published online in The New England Journal of Medicine.