Randomized study to compare valsartan ± HCTZ versus amlodipine ± HCTZ strategies to maximize blood pressure control
Dion Zappe1, Cheraz Cherif Papst2, Philippe Ferber3, On behalf of the PROMPT investigators
1Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA; 2Novartis Pharma Ag, Basel, Switzerland; 3Roche Pharmaceuticals, Basel, Switzerland
Objective: Delays in achieving blood pressure (BP) control may increase morbidity and mortality in patients with hypertension. Thus, deciding which antihypertensive agent to use and at what dosage, in addition to determining when to initiate combination therapy and which agents to combine, is important for achieving BP control.
Methods: This randomized, double-blind, 14-week study was conducted to compare the efficacy and tolerability of various doses of valsartan ± hydrochlorothiazide (HCTZ) versus amlodipine ± HCTZ for maximizing BP control in 1,285 patients with uncontrolled hypertension. Patients with stage 1 hypertension and naïve to antihypertensive therapy (33.9%) started valsartan 160 mg or amlodipine 5 mg. Treatment-naïve patients with stage 2 hypertension (13.5%) or those uncontrolled on current antihypertensive monotherapy (52.6%) started valsartan 160 mg/HCTZ 12.5 mg or amlodipine 10 mg. At weeks 4, 8, and 11, patients not achieving BP control were up-titrated (maximum: valsartan 320 mg/HCTZ 25 mg, amlodipine 10 mg/HCTZ 25 mg).
Results: At study end, 78.8% of patients on valsartan ± HCTZ were controlled (BP < 140/90 mmHg) and still on study medication versus 67.8% on amlodipine ± HCTZ (P < 0.0001). Amlodipine-treated patients had a higher incidence of peripheral edema (22.4% vs 2.2%) and associated discontinuations (7.3% vs <1%). Initiating therapy earlier with valsartan/HCTZ, rather than titrating monotherapy to its maximum dose before adding a second agent, was superior to amlodipine monotherapy or amlodipine ± HCTZ for achieving BP control, and avoided excessive treatment adjustments and maintained tolerability.
Keywords: efficacy, hydrochlorothiazide, hypertension, combination therapy, titration, tolerability
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