Comparison of the Efficacy and Safety of Fixed-Dose Amlodipine/Losartan and Losartan in Hypertensive Patients Inadequately Controlled with Losartan

Hong, Bum Kee; Park, Chang Gyu; Kim, Ki Sik; Yoon, Myeong‐Ho; Yoon, Ho Joong; Yoon, Jeong Han; Yang, Joo Young; Choi, Young Jin; Cho, Seung Yun

doi:10.2165/11597410-000000000-00000

Cited by 16 publications

(26 citation statements)

References 20 publications

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“…More patients in the combination therapy groups responded to achieve the target BP compared with component monotherapies and with comparable adverse events (72–75). Trials performed in South Korea and Japan have also shown beneficial effects of adding amlodipine to losartan and candesartan but these combinations of losartan/amlodipine and candesartan/amlodipine are not approved in the U.S. (76–77). …”

Section: Efficacy Of Arbsmentioning

confidence: 99%

The Comparative Efficacy and Safety of the Angiotensin Receptor Blockers in the Management of Hypertension and Other Cardiovascular Diseases

2014

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All national guidelines for the management of hypertension recommend angiotensin receptor blockers (ARBs) as an initial or add-on antihypertensive therapy. The 8 available ARBs have variable clinical efficacy when used for control of hypertension. Additive blood pressure (BP) lowering effects have been demonstrated when ARBs are combined with thiazide diuretics or dihydropyridine calcium channel blockers, augmenting hypertension control. Furthermore, therapeutic use of ARBs goes beyond their antihypertensive effects with evidence-based benefits in heart failure and diabetic renal disease particularly among ACE inhibitor intolerant patients. On the other hand, combining renin-angiotensin system blocking agents, a formerly common practice among medical subspecialists focusing on the management of hypertension, have ceased to do so as there is not only evidence of cardiovascular benefit, but modest evidence of harm, particularly with regard to renal dysfunction. The ARBs are very well tolerated as monotherapy as well as in combination with other anti-hypertensive medications that improve adherence to therapy and have become a mainstay in the treatment of stage 1 and 2 hypertension.

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Section: Efficacy Of Arbsmentioning

confidence: 99%

The Comparative Efficacy and Safety of the Angiotensin Receptor Blockers in the Management of Hypertension and Other Cardiovascular Diseases

2014

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“…Amlodipine is a calcium channel blocker (CCB) of the third generation dihydropyridine CCB group, used as monotherapy or in combination, for treatment of hypertension and angina [1–4]. Peripheral edema, particularly of the lower limbs, is a common adverse effect of dihydropyridine CCB.…”

Section: Introductionmentioning

confidence: 99%

Leg edema with (S)-amlodipine vs conventional amlodipine given in triple therapy for hypertension: a randomized double blind controlled clinical trial

Galappatthy

Waniganayake

Sabeer

et al. 2016

BMC Cardiovasc Disord

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BackgroundLeg 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.MethodsThis 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.ResultsAltogether 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.ConclusionsIn 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 registrationSri Lanka Clinical Trials registry: www.slctr.lk, SLCTR/2013/006

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“…Data were pooled from four randomized, double‐blind, clinical trials (three phase III and one phase II) that included essential hypertensive patients treated with amlodipine/losartan (HM‐ALOS‐201 [clinicaltrials.gov: NCT00942344]; HM‐ALOS‐301 [ClinicalTrials.gov: NCT00940667; HM‐ALOS‐302 [ClinicalTrials.gov: NCT00940680], HM‐ALOS‐303 [ClinicalTrials.gov: NCT01127217]) . In all studies, patients provided written informed consent, and study protocols were approved by the appropriate local ethical review boards of each study site.…”

Section: Methodsmentioning

confidence: 99%

“…COZAAR XQ (Merck & Co., Inc. Whitehouse Station, NJ) is an FDC therapy of amlodipine (5 mg, 10 mg) and losartan (50 mg, 100 mg) for the treatment of essential hypertension. Clinical trials have consistently shown that this FDC has resulted in significantly greater BP reduction compared with amlodipine or losartan monotherapy among patients with both essential hypertension and stage 2 hypertension . Losartan and amlodipine are frequently used as first‐line therapies in hypertensive patients, and other studies have also outlined the benefits of combining these two drugs…”

mentioning

confidence: 99%

Evaluation of Blood Pressure Reduction Response and Responder Characteristics to Fixed‐Dose Combination Treatment of Amlodipine and Losartan: A Post Hoc Analysis of Pooled Clinical Trials

Unniachan

Wormser

Rajagopalan³

et al. 2014

J of Clinical Hypertension

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Data from four clinical trials compared reductions in systolic blood pressure (SBP) and diastolic blood pressure (DBP) among patients treated with amlodipine/losartan 5/50 mg vs 5/100 mg and amlodipine/losartan 5/50 mg vs amlodipine 5 mg and 10 mg. Response rate was assessed as reduction in SBP or DBP (>20/10 mm Hg) and proportion of patients achieving SBP <140 mm Hg or DBP <90 mm Hg. Patients were grouped into quartiles based on baseline SBP and DBP. Mean SBP and DBP were reduced in amlodipine/ losartan 5/50 mg (n=182) and amlodipine/losartan 5/100 mg (n=95) users across all baseline quartiles. Patients using amlodipine/losartan 5/50 mg had significantly greater SBP and DBP reductions vs amlodipine 5 mg (P=.001 and P=.02, respectively). Amlodipine/losartan 5/50 mg users had significantly greater SBP reduction vs amlodipine 10 mg (SBP P=.02; DBP P=not significant). The odds of responding to therapy were significantly greater with amlodipine/losartan 5/50 mg vs amlodipine 5 mg (odds ratio, 5.33; 95% confidence interval, 1.42-25.5) and were similar vs amlodipine 10 mg (odds ratio, 0.67; 95% confidence interval, 0.017-9.51). These results support the use of combination therapy early in the treatment of hypertension.

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Comparison of the Efficacy and Safety of Fixed-Dose Amlodipine/Losartan and Losartan in Hypertensive Patients Inadequately Controlled with Losartan

Abstract: Registered at Clinicaltrials.gov as NCT00940680.

Cited by 16 publications

References 20 publications

The Comparative Efficacy and Safety of the Angiotensin Receptor Blockers in the Management of Hypertension and Other Cardiovascular Diseases

The Comparative Efficacy and Safety of the Angiotensin Receptor Blockers in the Management of Hypertension and Other Cardiovascular Diseases

Leg edema with (S)-amlodipine vs conventional amlodipine given in triple therapy for hypertension: a randomized double blind controlled clinical trial

Evaluation of Blood Pressure Reduction Response and Responder Characteristics to Fixed‐Dose Combination Treatment of Amlodipine and Losartan: A Post Hoc Analysis of Pooled Clinical Trials

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