Background: Current clinical guidelines recognize that the use of more than one agent is necessary to achieve target BP in the majority of patients. The ASCOT-BPLA trial demonstrated that the free combination of amlodipine and perindopril effectively controlled BP and was better than a beta-adrenoceptor antagonist (beta-blocker)/diuretic combination in reducing total mortality and cardiovascular outcomes.

Objective: To evaluate the efficacy and tolerability of a fixed combination of perindopril and amlodipine in the clinical setting.

Study design: The STRONG (SafeTy & efficacy analysis of coveRsyl amlodipine in uncOntrolled and Newly diaGnosed hypertension) study was a prospective, observational, multicenter trial.

Setting: This was a naturalistic, real-world, clinic-based, outpatient study involving 336 general practitioners/primary care physicians in 65 cities in India.

Patients: Adults aged 40-70 years with newly diagnosed/untreated stage 2 hypertension (BP >/=160/100 mmHg), hypertension uncontrolled with monotherapy (BP >140/90 mmHg), or hypertension inadequately managed with another combination therapy.

Intervention: Fixed combination perindopril 4 mg/amlodipine 5 mg once daily for 60 days.

Main outcomes measure: The primary outcomes were the mean change in BP from baseline and the proportion of patients achieving adequate BP control (</=140/90 mmHg, or </=130/80 mmHg in patients with diabetes mellitus) in the intent-to-treat (ITT) population. Secondary analyses included incidence of adverse events (ITT) and treatment adherence rate (completers).

Results: In total, 1250 patients comprised the ITT population: 32.6% with newly diagnosed hypertension; 40.5% with hypertension uncontrolled with monotherapy; and 26.9% with hypertension inadequately managed with another combination therapy. Mean SBP/DBP decreased significantly from baseline (167.4 +/- 15.2/101.4 +/- 9.1 mmHg) over 60 days (-41.9 +/- 34.8/-23.2 +/- 21.8 mmHg; p < 0.0001). Target BP was achieved in 66.1% of patients in the total population, 68.3% of untreated patients, 68.4% of patients uncontrolled with monotherapy, and 59.9% of patients inadequately managed with combination therapy. In 161 patients with SBP >180 mmHg at baseline (newly diagnosed: n = 50; uncontrolled on monotherapy: n = 53; inadequately managed on combination therapy: n = 58), BP was reduced by 63.2 +/- 32.5/29.0 +/- 21.9 mmHg (p < 0.0001) at day 60. The fixed combination was safe and well tolerated. All 1175 patients completing the 60-day study (94%) adhered to their treatment regimen.

Conclusion: Fixed combination perindopril/amlodipine was found to be an effective and well tolerated antihypertensive treatment, with an excellent rate of treatment adherence in the clinical setting. Fixed combination perindopril/amlodipine is expected to be useful in the management of hypertension in primary healthcare, with a positive impact on treatment adherence.