Low dose ‘Quadpill’ reduces high blood pressure
CHICAGO — A pill to control hypertension by combining four blood pressure-lowering agents appeared to be effective in the American population, researchers report.
Compared with standard monotherapy, the adjusted mean drop in systolic blood pressure at week 12 was 4.8 mm Hg, a difference that trended toward statistical significance (95% CI -10.7 to 1.2), Mark Huffman, MD , Washington University in St. Louis, they reported in American Heart Association annual meeting.
In his latest scientific report, Huffman also noted that participants in the QUARTET USA trial who took a combination pill that included low doses of the four drugs had an average reduction in diastolic blood pressure of 4.9 mm Hg—a difference that was statistically significant (95 % CI -8.6 to -1.1).
“New approaches are needed to achieve lower blood pressure goals, especially for patients and communities with a high burden of hypertension and hypertension-related diseases,” Huffman said. “QUARTET USA was the first trial of a four-drug, ultra-low-dose blood pressure-lowering combination in the United States.”
The original QUARTET rehearsal was performed in Australia and showed that treatment with a combination of four drugs significantly lowered blood pressure for both systolic and diastolic measurements compared to patients treated with irbesartan 150 mg daily. There were 591 patients in that trial.
An American study used a comparator of candesartan (8 mg) daily compared with a combination of ultra-low doses of candesartan (2 mg) plus amlodipine (1.25 mg), indapamide (0.625 mg) and bisoprolol (2.5 mg) daily during a course of 12 week. The study was conducted among patients treated at Access Community Health Network in Chicago.
In an interim analysis, patients who were unable to meet targets could have amlodipine added to their regimen – 53.3% of patients receiving candesartan monotherapy were treated with additional amlodipine compared with 18.8% of those taking the quad pill , Huffman reported.
He noted that recruitment to the trial was slowed due to the COVID-19 pandemic and that ultimately 62 patients were included in the trial. A total of 32 patients received the quad pill, and 30 received candesartan monotherapy. The patients were about 52 years old, and about 45% were women. About 70% of the participants identified as Hispanic, and about 18% of the others identified as Black.
More than 50% of the entire cohort reported an annual household income of less than $25,000 per year. More than 75% of patients were on monotherapy to control high blood pressure, yet their blood pressure averaged 138 mm Hg systolic and 84 mm Hg diastolic at baseline.
Serious side effects during the trial were experienced by two people taking the quad pills, but none of the cases were thought to be related to the study drug. Two patients in the quad pill group and eight in the candesartan monotherapy group discontinued therapy.
“The direction and magnitude of the blood pressure-lowering effect were similar between QUARTET and US QUARTET, despite different study populations with lower baseline blood pressure in the current study, strengthening the case for this new approach,” Huffman said. .
Commenting on the study, AHA-appointed discussant LaPrincess Brewer, MD, MPH, of the Mayo Clinic School of Medicine in Rochester, Minnesota, said, “The majority of adults in the United States with hypertension do not have it under control. About 40% of patients with uncontrolled hypertension are taking only one drug for hypertension. Upfront low, combination drug therapy is probably a more effective and efficient approach.”
In addition, she said, in the QUARTET USA trial, “there was a greater reduction in blood pressure among the intervention group compared to the control group. The difference in systolic blood pressure reduction was not statistically significant, but it is clinically significant.”
Huffman disclosed financial relationships with George Medicines, Boehringer Ingelheim, Novartis, Bupa, Verily and AstraZeneca.
Brewer disclosed no industry ties.
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