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Initiation of hypertension treatment with a fixed-dose combination or its monocomponents -- does it really matter?
1University Hospital Charité Campus Charité Mitte Outpatient Department, Berlin, Germany. juergen.scholze@charite.de
Insights
Starting hypertension treatment with a fixed-dose combination of ramipril and felodipine ER is more effective and safer than using single drugs. This combination significantly lowers blood pressure (BP) levels more than monotherapy.
Area of Science:
- Cardiology
- Pharmacology
Background:
- Effective hypertension management remains a challenge, often due to monotherapy limitations.
- Initiating treatment with single antihypertensive agents rarely achieves target blood pressure (BP) goals.
Purpose of the Study:
- To evaluate the safety and efficacy of a first-line fixed-dose combination (FDC) of ramipril/felodipine ER.
- To compare the FDC against its individual monocomponents (ramipril and felodipine ER) over a 4-week period.
Main Methods:
- A randomized study involving 149 patients with essential hypertension.
- Patients received either ramipril 2.5 mg, felodipine ER 2.5 mg, or a fixed-dose combination of ramipril 2.5 mg/felodipine ER 2.5 mg.
- Blood pressure (BP) and heart rate were monitored using conventional and 24-hour ambulatory measurements.
Main Results:
- The ramipril/felodipine ER FDC demonstrated significantly greater BP reduction (-15.8/-9.2 mmHg) compared to ramipril (-7.6/-3.8 mmHg) and felodipine ER (-8.0/-5.0 mmHg).
- No significant differences in early BP fall (6 hours post-dose) were observed between the groups.
- Adverse events were mild, with fewer reported in the FDC group.
Conclusions:
- First-line treatment with a low-dose fixed combination of ramipril/felodipine ER is more effective for lowering BP in hypertensive patients.
- Initiating therapy with this FDC offers improved safety and efficacy compared to monotherapy with ramipril or felodipine ER.
Abstract:
Despite efforts to diagnose and treat hypertension effectively, the goal of lowering blood pressure (BP) levels is rarely achieved, as treatment is often initiated with a single antihypertensive agent. The aim of this study was to assess the safety and efficacy of a first-line fixed-dose combination treatment compared with treatment with its monocomponents over a period of 4 weeks. Patients (n = 149) with essential hypertension were randomised to receive 2.5 mg of either ramipril or felodipine ER or the fixed-dose combination of ramipril 2.5 mg/felodipine ER 2.5 mg over a 4-week treatment period. BP and heart rate were measured by conventional methodology and 24-hour ambulatory blood pressure measurements. Treatment with the fixed-dose combination was significantly more effective in reducing systolic and diastolic BP (-15.8/-9.2 mmHg) compared with its monocomponents, ramipril (-7.6/-3.8 mmHg) and felodipine ER (-8.0/-5.0 mmHg). No significant difference could be observed in the occurrence of a greater fall in systolic and diastolic BP 6 h after the first dose of the three study medications. The adverse effects reported were mild, and less number of patients in the fixed-dose combination complained of adverse events. It can be concluded that initiating antihypertensive treatment with a low fixed-dose combination of ramipril/felodipine ER is more effective and safe when compared with treatment with its monocomponents.
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