Objectives Most patients with hypertension require more than one drug to attain recommended blood pressure (BP) targets. Initiating therapy with two agents is recommended for patients at high risk of a cardiovascular event or with a Bp >20/10 mm Hg above goal. OBJECTIVE: To demonstrate the efficacy and tolerability of amlodipine/telmisartan combination therapy in hypertensive patients with cardiovascular risk factors.

Methods After a washout period of 2 week, all patients with mean sitting systolic blood pressure (MSSBP) of 140–179 mm Hg and/or mean sitting diastolic blood pressure (MSDBP) of 90–109 mm Hg were randomised to receive a design to the two treatment comparisons: amlodipine 2.5 mg once daily (o.d.) and amiloride/hydrochlorothiazide 1.25/12.5 mg o.d (Group A) or amlodipine 2.5 mg o.d and telmisartan 40 mg o.d. (Group B). Following the initial 2 week treatment period, patients were force titrated to amlodipine/telmisartan 5/80 mg o.d. or amlodipine/amiloride/hydrochlorothiazide 5/2.5/25 mg o.d for the remainder of the trial. Primary efficacy variable was change from baseline in MSSBP and MSDBP at study end. Secondary efficacy variables included control rate (MSSBp <140 mm Hg and MSDBp <90 mm Hg). Safety was also assessed.

Results 54 (mean age: 59.5 years) were randomised. Statistically significantly greater reductions in MSSBP/MSDBP were observed in both group A (21.3/15.8 mm Hg, p<0.0001) and group B (21.6/16.1 mm Hg, p<0.0001). Control rates were higher in both combination therapy groups (99% and 94.5%, respectively). Peripheral oedema was the most frequent adverse event, reported in group A (4.5%) and group B (4.7%). No patient was discontinued due to edema.

Conclusions The combination of amlodipine/telmisartan in this 52-week study provided additional BP control and was well-tolerated in patients with cardiovascular risk factors. Clinically significant and persistent reductions in blood pressure were achieved.