Management of hypertension with the fixed combination of perindopril and amlodipine in daily clinical practice: results from the STRONG prospective, observational, multicenter study.
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.


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


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


METHODS
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.


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


METHODS
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.


CONCLUSIONS
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.
Bahl
Vinay K
VK
Department of Cardiology, All India Institute of Medical Sciences, New Delhi, India.
Jadhav
Uday M
UM
Thacker
Hemant P
HP
D000328:Adult; D000368:Aged; D017311:Amlodipine / Q000008:administration & dosage* / Q000009:adverse effects; D000959:Antihypertensive Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001794:Blood Pressure / Q000187:drug effects; D015510:Clinical Medicine; D004338:Drug Combinations; D004351:Drug Resistance; D005260:Female; D006801:Humans; D006973:Hypertension / Q000175:diagnosis / Q000188:drug therapy*; D008297:Male; D055118:Medication Adherence; D008875:Middle Aged; D020913:Perindopril / Q000008:administration & dosage* / Q000009:adverse effects
D000959:Antihypertensive Agents; D004338:Drug Combinations; D017311:Amlodipine; D020913:Perindopril