Effectiveness and tolerability of a fixed-dose combination of olmesartan and amlodipine in clinical practice

Peter Bramlage¹, Wolf-Peter Wolf², Thomas Stuhr², Eva-Maria Fronk³, Wolfhard Erdlenbruch², Reinhard Ketelhut⁴, Roland E Schmieder⁵

¹Institute for Cardiovascular Pharmacology and Epidemiology, Mahlow; ²Daiichi Sankyo Deutschland GmbH, Munich, Germany; ³Daiichi Sankyo Europe GmbH, Munich, Germany; ⁴Department of Sports Medicine, Universitätsklinikum Berlin; ⁵Department of Nephrology and Hypertension, University Hospital of Erlangen, Germany

Objectives: To assess the efficacy and tolerability of a fixed-dose combination of olmesartan and amlodipine in an unselected population of patients in primary care and to compare the results with recent randomized controlled trial evidence.

Methods: A multicenter, noninterventional, noncontrolled observational study with 8241 hypertensive patients seen by 2187 physicians in daily practice. Blood pressure (BP) reduction, comorbid disease, pharmacotherapy, and tolerability were documented over a 12–18-week observational period.

Results: Patients had a mean age of 62.8 ± 11.8 years (48.1% female), and 74.8% had at least one comorbid risk factor or condition. In total, 51.3% received olmesartan-amlodipine 20/5 mg, 30.6% received 40/5 mg, and 17.9% received 40/10 mg at baseline, mostly because of lack of efficacy on prior antihypertensive therapy (73.8%). BP at baseline was 161.8 ± 16.6/93.6 ± 10.2 mmHg (39.8% had Grade 2 hypertension), and the observed BP reduction was -29.0 ± 17.1/-13.5 ± 10.9 mmHg (P < 0.0001), with a significant correlation between BP at baseline and BP reduction (Spearman’s Rho -0.811 for systolic BP and -0.759 for diastolic BP). BP reduction appeared to be dependent on dose and prior antihypertensive therapy, but not on age, gender, body mass index, duration of hypertension, or the presence of diabetes. At the final visit, 69.4% (4.3% at baseline) were controlled (<140/90 mmHg). Adverse drug reactions were observed in 2.76% of the study population; 94.25% of these adverse drug reactions were judged as nonserious events, and 31.5% of all adverse drug reactions reported were peripheral edema.

Conclusion: The fixed-dose olmesartan-amlodipine combination was effective and well tolerated in an unselected population of patients in primary care practice. These results confirm prior randomized controlled trial evidence.

Keywords: blood pressure, cardiovascular risk, antihypertensive treatment, observation