Drug Combos with Amlodipine Reduce Hypertension in sub-Saharan African Patients: CREOLE Study

Two blood pressure-lowering combination therapies that included amlodipine were more effective at lowering hypertension in patients in sub-Saharan Africa, new research from the American College of Cardiology Annual Scientific Sessions.

Researchers for the CREOLE study, led by Dike Ojji, MD, of the College of Health Sciences, University of Abuja, Nigeria, enrolled 728 patients with a blood pressure of at least 140/90 mm Hg and randomly assigned them to receive one of three drug combinations (amlodipine plus hydrochlorothiazide (HCT), amlodipine plus perindopril, and perindopril plus HCT) for a period of six months. Patients were drawn from six African nations (Cameroon, Kenya, Mozambique, Nigeria, South Africa, and Uganda). Ambulatory systolic blood pressure was assessed at enrollment and at six months. The primary endpoint of interest was the change in 24-hour ambulatory systolic blood pressure during the study period, with several secondary endpoints, including change in daytime (and nighttime) ambulatory systolic blood pressure, and clinical blood pressure readings.

According to the study results, patients taking amlodipine plus HCT (P=0.03), and also amlodipine plus perindopril (P=0.04), saw greater reductions in ambulatory systolic blood pressure than the combination that did not contain amlodipine (perindopril plus HCT; P=0.92). The findings were similar between study groups for the secondary endpoints as well, including notable decrease in nighttime ambulatory systolic blood pressure (amlodipine plus HCT, P=0.01; amlodipine plus perindopril, P=0.03).

For the secondary endpoint of blood pressure reading in the clinic, there was an average reduction of 7.15 mm Hg for patients taking amlodipine plus HCT and 5.55 mm Hg for those assigned to amlodipine plus perindopril. The results remained the same when adjusting for patient characteristics such as diabetes.

“In black patients in sub-Saharan Africa, the combination regimens amlodipine plus HCL and amlodipine plus perindopril were significantly more effective than perindopril plus HCL reducing average 24-hour ambulatory systolic blood pressure over a six-month period,” said Dr. Ojji said in a press release.

The authors noted that about 5% of the patients enrolled experienced drops in blood potassium levels and recommended that patients taking the combination therapies have their potassium checked regularly.

Dr. Ojji went on to share some implications as well.

“Given that amlodipine plus HCT and amlodipine plus perindopril had similar effects on blood pressure, drug choice may be further influenced by side effect considerations,” he said during his presentation. “Pending trial evidence comparing the effects of these combinations on cardiovascular outcomes, these unique data may be useful to influence antihypertensive drug selection for black patients, at least those from sub-Saharan Africa.”

The study was published at the time of presentation in the New England Journal of Medicine.

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