Dual Therapies for Black African Patients: Randomized Trial

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Combination therapies including amlodipine improve blood pressure (BP) control in sub-Saharan African patients with hypertension, concludes a trial in The New England Journal of Medicine.

The randomized controlled “Comparison of Three Combination Therapies in Lowering Blood Pressure in Black Africans” (CREOLE) trial included 728 black patients with uncontrolled hypertension in six sub-Saharan African countries. Enrolled patients had BP of 140/90 mm Hg or higher on no antihypertensive therapy or a single-drug regimen. The patients’ average age was 51 years; 63% were women.

Patients were assigned to one of three antihypertensive drug combinations: the calcium-channel blocker amlodipine (5 mg) plus the thiazide diuretic (HCTZ) (12.5 mg); amlodipine plus the angiotensin-converting enzyme inhibitor perindopril (4 mg); or perindopril plus HCTZ. After 2 months, the dose of each drug was doubled for another 4 months (amlodipine 10 mg, hydrochlorothiazide 25 mg, perindopril 8 mg). Change in 24-hour ambulatory systolic BP from baseline to 6 months was compared between groups.

On analysis of primary outcome data in 621 patients, reductions in BP were greater with the two amlodipine-containing regimens. Compared to perindopril plus HCTZ, between-group differences in systolic BP were 3.14 mm Hg with amlodipine plus HCTZ and 3.00 mm Hg with amlodipine plus perindopril. There was no significant difference between the two amlodipine regimens.

Other outcomes showed a similar pattern, including ambulatory diastolic BP, office BP, and BP response rate. Six-month BP control rates were 76% with amlodipine-HCTZ and 74% with amlodipine-perindopril versus 60% with perindopril-HCTZ. Patients receiving amlodipine-HCTZ had significant reductions in plasma potassium and higher rates of hypokalemia.

Black African patients have a high prevalence of hypertension and typically need at least two antihypertensive drugs to achieve BP control. There is uncertainty regarding the most effective two-drug regimen for black patients with hypertension, reflected by differences in current recommendations.

The CREOLE results suggest a better response with amlodipine, combined with either HCTZ or perindopril, compared to HCTZ plus perindopril in black African patients with uncontrolled hypertension. The researchers note some limitations of their study, including whether the findings can be generalized to black patients with diabetes or those outside of sub-Saharan Africa [Ojji DB, et al. Comparison of dual therapies for lowering blood pressure in black Africans. N Engl J Med 2019; DOI: 10.1056/NEJMoa1901113].