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Amlodipine monotherapy vs. amlodipine-ARB combination therapy as first-line treatment for primary hypertension: a
Yusra Pintaningrum1, Claresta Salsabila Putri Evianto1, Romi Ermawan1
1Faculty of Medicine and Health Sciences, University of Mataram, Mataram, Indonesia.
Insights
Combination therapy with amlodipine and an angiotensin receptor blocker (ARB) significantly improves blood pressure control compared to amlodipine monotherapy. This combination also shows a trend towards fewer adverse events in patients with primary hypertension.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Trials
Background:
- Clinical guidelines suggest combination antihypertensive therapy over monotherapy.
- Many hypertension patients need multiple drugs for target blood pressure.
- The comparative risks and benefits of combination vs. monotherapy initiation are unclear.
Purpose of the Study:
- To compare amlodipine monotherapy with first-line amlodipine and ARB combination therapy.
- To assess blood pressure control efficacy.
- To evaluate drug-related adverse events in primary hypertension.
Main Methods:
- Systematic review and meta-analysis of randomized controlled trials.
- Searched PubMed, PubMed Central, and Cochrane Library up to November 15, 2025.
- Included trials comparing amlodipine monotherapy vs. amlodipine + ARB combination therapy for ≥8 weeks.
Main Results:
- Combination therapy showed a 2.25-fold higher odds ratio for blood pressure control (P < 0.00001).
- The risk ratio for adverse events was 0.93, indicating no statistically significant difference (P = 0.24).
- Six studies were included in the meta-analysis.
Conclusions:
- Combination therapy with a Calcium Channel Blocker (CCB) and an ARB significantly increases the likelihood of achieving blood pressure control.
- Combination therapy demonstrated a trend towards lower drug-related adverse events compared to CCB monotherapy.
- This suggests combination therapy may be a more effective first-line approach for hypertension management.
Background:
Some clinical guidelines recommend initiating combination antihypertensive therapy as first-line treatment rather than monotherapy. Evidence indicates that a substantial proportion of patients with hypertension require more than one antihypertensive agent to achieve recommended blood pressure targets. However, it remains unclear whether the benefits of initiating combination therapy outweigh the potential risks compared with antihypertensive monotherapy.
Objective:
This systematic review and meta-analysis was conducted to assess the efficacy of blood pressure control and the risk of drug-related adverse events associated with amlodipine monotherapy compared against first-line combination therapy of amlodipine and an angiotensin receptor blocker (ARB) in patients with primary hypertension.
Methods:
A systematic literature search was conducted in PubMed, PubMed Central, and the Cochrane Library up to 15 November 2025, using the following search terms: "amlodipine" AND "angiotensin receptor blocker" AND "primary hypertension" AND "randomized controlled trial." Only randomized controlled trials comparing amlodipine monotherapy with first-line combination therapy of amlodipine and an ARB, administered for at least 8 weeks, were included. The primary outcomes were blood pressure control and drug-related adverse events. Meta-analysis was performed using Review Manager (RevMan), version 5.4.
Results:
Based on six included studies, the analytical results showed that combination therapy with Calcium Channel Blocker (CCB) and an ARB was associated with 2.25 (odds ratio = 2.25: 95% CI: 1.78-2.83) times odds ratio with statistically significant overall effect (P < 0.00001) and 0.93 (risk ratio = 0.93: 95% CI: 0.82-1.05) times risk ratio with statistically insignificant overall effect (P = 0.24) compared with CCB (amlodipine 5 mg) monotherapy.
Conclusions:
The results of this study indicate that combination therapy with CCB and an ARB is associated with a 2.25-fold higher likelihood of achieving blood pressure control, with a significant correlation, and a lower risk of drug-related adverse events, without a significant correlation, compared with CCB monotherapy.
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