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Management of hypertension with the fixed combination of perindopril and amlodipine in daily clinical practice: Results from the STRONG prospective, observational, multicenter study
American Journal of Cardiovascular Drugs, 06/03/09
Bahl VK et al. – Fixed combination perindopril/amlodipine is an effective and well tolerated antihypertensive treatment, with an excellent rate of treatment adherence in the clinical setting. Fixed combination perindopril/amlodipine will be useful in management of hypertension in primary healthcare, with a positive impact on treatment adherence.
Methods- Study of efficacy and tolerability of fixed combination of perindopril and amlodipine in the clinical setting
- Design: prospective, observational, multicenter trial – the STRONG study (SafeTy & efficacy analysis of coveRsyl amlodipine in uncOntrolled and Newly diaGnosed hypertension)
- Setting: naturalistic, real-world, clinic-based, outpatient study of 336 general practitioners/primary care physicians in 65 cities in India
- Subjects: adults age 40-70 yrs 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
- Primary outcomes: mean change in BP from baseline and proportion of pts achieving adequate BP control (<=140/90 mmHg, or <=130/80 mmHg in pts with diabetes mellitus) in intent-to-treat (ITT) population
- Secondary analyses: incidence of adverse events (ITT) and treatment adherence rate (completers)
- ITT population of 1250 pts total: 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 over 60 days
- Target BP in 66.1% of pts in total population, 68.3% of untreated pts, 68.4% of pts uncontrolled with monotherapy, and 59.9% of pts inadequately managed with combination therapy
- In 161 pts with SBP >180 mmHg at baseline, BP reduced by day 60
- Fixed combination was safe and well tolerated
- All 1175 pts completing 60-day study (94%) adhered to treatment regimen
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