Clinical effectiveness of a fixed-dose combination therapy with ramipril plus felodipine ER compared to monotherapy with ramipril or felodipine ER or to a fixed-dose combination therapy with verapamil SR and trandolapril or amlodipine and valsartan in treatment of primary hypertension - systematic review

Background Beta-blockers, diuretics, calcium antagonists, angiotensin converting enzyme inhibitors (ACE-I) and angiotensin receptor antagonists are commonly used as a first-line therapy in arterial hypertension monotherapy. But the majority of patients (70-80%) to sufficiently control their blood pressure require treatment with more than one antihypertensive agent. Calcium channel blockers (e.g. felodipine) are recommended as a first-line antihypertensive treatment. Combined use of ACE-I and calcium channel blocker may result in a good therapeutic effect given a complementary mode of action of the two agents. The aim of the study was to assess clinical effectiveness measured by clinical efficacy and safety of a fixed-dose combination therapy with ramipril plus felodipine ER compared with monotherapy with ramipril or felodipine ER or with a fixed-dose combination therapy with verapamil SR and trandolapril or amlodipine and valsartan as treatment options of primary hypertension. Material and methods Clinical assessment was performed according to PolAHTA Guidelines; analysis and credibility evaluation were based on evidence-based medicine. In order to find the most relevant clinical publications a systematic review of medical databases was performed. Results Systematic review revealed 7 reference publications of clinical trials which were used in specific analyses. It was shown that a fixed-dose combination of ramipril and felodipine ER is more efficient than monotherapy with ramipril or felodipine ER. It was also shown that the fixed-dose combination of ramipril and felodipine ER was as efficient as other fixed-dose combinations (verapamil SR and trandolapril or amlodipine and valsartan). Apart from that it was demonstrated that the safety profile of the fixed- dose combination of ramipril and felodipine ER was good and similar to the one of other antihypertensive fixed-dose combinations.