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Leg edema with (S)-amlodipine vs conventional amlodipine given in triple therapy for hypertension: a randomized
Priyadarshani Galappatthy1, Yasindu C Waniganayake2, Mohomad I M Sabeer2
1Department of Pharmacology and Pharmacy, Faculty of Medicine, University of Colombo, PO Box 271, Kynsey Road, Colombo, Sri Lanka. p.galappatthy@pharm.cmb.ac.lk.
Insights
(S)-amlodipine significantly reduced leg edema incidence compared to racemic amlodipine in hypertensive patients, with similar blood pressure control. This offers a better tolerability option for managing hypertension.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Trials
Background:
- Dihydropyridine Calcium Channel Blockers (CCB) can cause leg edema, impacting antihypertensive efficacy.
- (S)-amlodipine is associated with lower incidence of leg edema than racemic amlodipine.
- This study investigated leg edema and antihypertensive efficacy of (S)-amlodipine versus conventional amlodipine.
Purpose of the Study:
- To compare the incidence of leg edema as a primary outcome between (S)-amlodipine and conventional amlodipine.
- To evaluate the antihypertensive efficacy of (S)-amlodipine compared to conventional amlodipine.
- To assess the tolerability and safety profile of (S)-amlodipine in hypertensive patients.
Main Methods:
- A prospective, double-blind, controlled clinical trial involving 172 hypertensive patients.
- Patients were randomized to receive either conventional amlodipine (5-10 mg) or (S)-amlodipine (2.5-5 mg) while continuing prior antihypertensive medications.
- Statistical analyses included Fischer's exact test for edema incidence and Mann-Whitney test for edema scores.
Main Results:
- The incidence of new leg edema was significantly lower with (S)-amlodipine (31.40%) compared to conventional amlodipine (46.51%) (p=0.03).
- Both treatments demonstrated high antihypertensive efficacy, with responder rates of 98.57% for (S)-amlodipine and 98.68% for conventional amlodipine.
- Edema scores (pitting and patient-rated) were significantly lower in the (S)-amlodipine group.
Conclusions:
- (S)-amlodipine at half the dose of conventional amlodipine offers improved tolerability by reducing peripheral edema incidence.
- The antihypertensive efficacy of (S)-amlodipine is comparable to conventional amlodipine.
- (S)-amlodipine represents a viable option for hypertensive patients experiencing edema with standard amlodipine therapy.
Background:
Leg edema is a common adverse effect of dihydropyridine Calcium Channel Blockers (CCB) that may need dose reduction or drug withdrawal, adversely affecting the antihypertensive efficacy. Leg edema is reported to occur less often with (S)-amlodipine compared to conventional racemic amlodipine. We aimed to find the incidence of leg edema as a primary outcome and antihypertensive efficacy with (S)-amlodipine compared to conventional amlodipine.
Methods:
This prospective, double-blind, controlled clinical trial randomized 172 hypertensive patients, not controlled on beta-blockers (BB) and angiotensin converting enzyme inhibitors/angiotensin receptor blockers (ACEI/ARB), to either conventional amlodipine (5-10 mg; n = 86) or (S)-amlodipine (2.5-5 mg; n = 86), while continuing their previous anti-hypertensive medications. Sample was sufficient to find a difference in edema between the interventions with 80 % power at 5 % significance level. Intension to treat analysis (ITT) for safety data and per protocol analysis for efficacy data was performed. Fischer's exact test was applied to observe difference between responder rates and proportions of subjects having peripheral edema in the two groups. Pitting edema test scores were compared using Mann-Whitney test.
Results:
Altogether 146 patients (amlodipine, n = 76 and (S)-amlodipine, n = 70) completed 120 days treatment. Demographic variables and treatment adherence were comparable in the two groups. Incidence of new edema after randomization was 31.40 % in test group and 46.51 % in control group [p = 0.03; absolute risk reduction (ARR) = 15.1 %; Number Needed to Treat (NNT) = 7, ITT analysis]. Pitting edema score and patient rated edema score increased significantly in the control compared to test group (p = 0.038 and 0.036 respectively) after treatment period. Edema scores increased significantly in the control group from baseline (p < 0.0001). Responders in blood pressure were 98.57 % in test and 98.68 % in control group. Most common adverse events (AE) were pitting edema and increased urinary frequency. Incidence of all AEs other than edema was similar in both groups. Two serious AEs occurred unrelated to therapy. Biochemical and ECG parameters in the two groups were comparable.
Conclusions:
In hypertensive patients not controlled on prior BB and ACEI/ARB therapy, addition of (S)-amlodipine besylate at half the dose of conventional amlodipine provides better tolerability with reduced incidence of peripheral edema, and equal antihypertensive efficacy compared to amlodipine given at usual doses.
Trial Registration:
Sri Lanka Clinical Trials registry: www.slctr.lk, SLCTR/2013/006.
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