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

Galappatthy, Priyadarshani; Waniganayake, Yasindu C.; Sabeer, Mohomad I. M.; Wijethunga, Thusitha J.; Galappatthy, Gamini; Ekanayaka, Ruvan

doi:10.1186/s12872-016-0350-z

Cited by 16 publications

(21 citation statements)

References 38 publications

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“…19 However, the major limitation with use of amlodipine is the higher incidence of pedal oedema, which is a common adverse effect shared by dihydropyridine CCBs. 20 This was further confirmed in our study where about two-third of physicians observed pedal oedema with amlodipine in their >10% patients. Pedal oedema has also been of concern with newer CCB like cilnidipine; one-third of the physicians observed pedal oedema even with use of cilnidipine.…”

Section: Discussionsupporting

confidence: 83%

Management of Hypertension- Insights Into Real-World Clinical Practice for Differential Usage of Calcium Channel Blockers (Ccbs)

Dasbiswas¹,

Tamboli²,

Ingole³

et al. 2017

jebmh

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BACKGROUND Calcium channel blockers (CCB) like amlodipine, S (-) amlodipine and cilnidipine, etc. have established place in the treatment of hypertension (HTN). As perceived by most of the physicians, they have comparative antihypertensive efficacy. However, available evidences suggest varied differences in incidence of pedal oedema. Aim-This survey was planned to understand real-world clinical practice pattern of Indian physicians for usage of various antihypertensive agents with emphasis on CCBs and whether differential incidence of oedema with CCBs is encountered in their clinical practice. MATERIALS AND METHODS Survey questionnaire consisting of 10 questions about preferred antihypertensive choice for different subsets of patients with HTN and efficacy and safety of S (-) amlodipine was prepared and validated in small group of physicians. Overall, 494 general physicians and cardiologists practising in India were approached for seeking their opinion on usage of various CCBs. Statistical Analysis-Data were expressed in percentage. Design-Prospective, cross sectional, questionnaire-based survey. RESULTS Amongst various anti-hypertensive agents, majority of the physicians preferred CCB as their initial drug of choice for patients with HTN (53.8%), HTN with CKD (41.1%), elderly (55.3%), and young (30.8%) patients. Though amlodipine was preferred by 75.7% physicians, pedal oedema was observed in >10% patients by 40.5% physicians. Most of the physicians rated S (-) amlodipine to have better efficacy (79.4%) and safety profile (88.3%) with decreased incidence of pedal oedema than racemic Amlodipine. CONCLUSION Available evidences suggest comparative efficacy of S (-) amlodipine and racemic amlodipine with varied differences in incidence of pedal oedema. However, our survey suggests better efficacy and safety of S (-) amlodipine over racemic amlodipine as opined by most of the physicians of India. The survey findings need to be further evaluated in randomised clinical trials.

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Section: Discussionsupporting

confidence: 83%

Management of Hypertension- Insights Into Real-World Clinical Practice for Differential Usage of Calcium Channel Blockers (Ccbs)

Dasbiswas¹,

Tamboli²,

Ingole³

et al. 2017

jebmh

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“…Nevertheless, it has been reported that leg edema is less prevalent with S-amlodipine compared with racemic amlodipine. 20 , 25 In the present study, pretibial edema was determined in 2 patients (one at a dose of 2.5 mg/d and one at a dose of 5 mg/d).…”

Section: Discussionmentioning

confidence: 95%

Efficacy and Safety of S-Amlodipine 2.5 and 5 mg/d in Hypertensive Patients Who Were Treatment-Naive or Previously Received Antihypertensive Monotherapy

Şen

Demir

Yiğit

et al. 2018

J Cardiovasc Pharmacol Ther

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The aim of the present study was to evaluate the efficacy and safety of S-amlodipine 2.5 and 5 mg/d in patients with hypertension who were treatment-naive or previously received antihypertensive monotherapy. During the 8-week treatment period, all patients received S-amlodipine 2.5 mg/d for the first 4 weeks, followed by S-amlodipine 5 mg/d for the second 4 weeks. For efficacy assessments, ambulatory and office blood pressure (BP) measurements were performed during the baseline, fourth-week, and eighth-week visits. For safety assessments, all adverse events and abnormal laboratory findings were recorded. This study is registered with ClinicalTrials.gov (NCT03038451). Of 43 patients evaluated at the screening visit, 33 were enrolled. In the treatment-naive arm, significant reductions in both office and ambulatory systolic BP (SBP) and diastolic BP (DBP) were observed with S-amlodipine 2.5 mg/d and additional significant reductions were achieved with dose titration (S-amlodipine 5 mg/d). At the end of the study, the rate of the treatment-naive patients with BP under control (SBP/DBP <140/90 mm Hg) was 53% with S-amlodipine 2.5 mg and increased to 78% with S-amlodipine 5 mg. For the noninferiority evaluation, S-amlodipine 2.5 and 5 mg/d treatments were generally noninferior to both office and ambulatory BP levels achieved with the medications that the patients received before participating in the study. Five nonserious adverse events likely to be associated with the study drug were observed. No serious adverse event was encountered. Consequently, S-amlodipine can be suggested as an effective and safe treatment option for patients with hypertension.

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“…In conclusion, the present study investigated the clinical efficacy of combination treatment with captopril and prazosin in patients with gestational hypertension in a phase-II clinical study. Although previous studies have identified a number of drugs that exhibit direct effects on gestational hypertension, it is important to investigate the overall role of captopril and prazosin in affecting hypertension and hypertension-related indicators (36,37). The clinical outcomes presented that captopril and prazosin revealed novel options in gestational hypertension management and an increasing number of clinical reports demonstrate promising results.…”

Section: Discussionmentioning

confidence: 99%

Combination treatment of captopril and prazosin to treat patients with gestational hypertension

et al. 2018

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Gestational hypertensive disorder is a complication of pregnancy, which adversely affects mother-child health. Captopril and prazosin are two agents that are frequently applied for the treatment of patients with gestational hypertension. However, the cooperative efficacy of captopril and prazosin has been not investigated in a previous study. In the present study, the comprehensive treatment of captopril and prazosin for the treatment of patients with gestational hypertension was investigated. A total of 324 patients with gestational hypertension were recruited to analyze the therapeutic effects of captopril and prazosin in patients with gestational hypertension. The duration of the treatment, dose-limiting toxicities and maximum tolerated dose of captopril and prazosin were examined in this cohort. Furthermore, the levels of blood pressure and proteinuria were also examined in patients with gestational hypertension who received treatment with captopril and/or prazosin with placebo as a control. Serum levels of vasodilation-converting enzyme and α-adrenergic receptor were also examined prior to and during the 4-week post-treatment period. It was observed that the most common treatment-emergence adverse events were hypertension and proteinuria following 4-week treatments. The data revealed that captopril or prazosin treatments significantly ameliorated gestational hypertension and symptoms compared with placebo (P<0.01). Notably, the combination of captopril and prazosin treatments significantly ameliorated hypertension and proteinuria and reduced the expression levels of vasodilation-converting enzyme and α-adrenergic receptor (all P<0.01), which contributed to beneficial effects on complications and blood coagulation mechanism compared with either captopril or prazosin treatment. In conclusion, the present clinical study indicated that combination treatment of captopril and prazosin exhibited more efficient outcomes than the single agent by improving gestational hypertension, indicating that a comprehensive therapeutic regimen of captopril and prazosin may be a potential clinical opinion for patients with gestational hypertension.

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

Cited by 16 publications

References 38 publications

Management of Hypertension- Insights Into Real-World Clinical Practice for Differential Usage of Calcium Channel Blockers (Ccbs)

Management of Hypertension- Insights Into Real-World Clinical Practice for Differential Usage of Calcium Channel Blockers (Ccbs)

Efficacy and Safety of S-Amlodipine 2.5 and 5 mg/d in Hypertensive Patients Who Were Treatment-Naive or Previously Received Antihypertensive Monotherapy

Combination treatment of captopril and prazosin to treat patients with gestational hypertension

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