A Noninferiority Comparison of Valsartan/Hydrochlorothiazide Combination Versus Amlodipine in Black Hypertensives

Weir, Matthew R.; Ferdinand, Keith C.; Flack, John M.; Jamerson, Kenneth; Daley, William; Zelenkofske, Steven L.

doi:10.1161/01.hyp.0000180457.82483.6b

Cited by 36 publications

(18 citation statements)

References 27 publications

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“…Diuretics or salt restriction are ineffective in alleviating this adverse effect. Combination therapy with angiotensin converting enzyme inhibitors or angiotensin receptor blockers may provide benefit in this setting [5,6]. Another alternative may be switching to a different and newer generation dihydropyridine CCB.…”

Section: Discussionmentioning

confidence: 99%

A different dihydropyridine calcium channel blocker in hypertensive patients who developed pedal edema on dihydropyridine calcium channel blocker therapy

et al. 2014

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Aim. Dihydropyridine calcium channel blockers (CCB) are widely preferred for the treatment of hypertension for their efficacy, metabolic neutrality and low side effect profile. However pedal edema formation limits their usage. The aim of the present study is to evaluate the incidence of pedal edema formation with a different dihydropyridine CCB in hypertensive patients who developed pedal edema during a dihydropyridine CCB therapy. Method. Fifty-eight hypertensive patients (34 female, 24 male, mean age: 65.3±10.5) in whom pedal edema developed during treatment with a dihydropyridine CCB (amlodipine 10mg/day in 40 patients, amlodipine 5mg/day in 14 patients, nifedipine GITS 30mg/day in 4 patients) were enrolled. CCB which caused pedal edema was withdrawn and a different CCB (felodipine or lacidipine) were initiated after the resolution of the pedal edema. CCB therapy was continued as long as the patient tolerated pedal edema. Results. At the end of one year, 44 out of 58 patients (36 [81.8%] free of pedal edema, 8 [19.2%] with pedal edema) continued CCB therapy. Eleven (37.9%) patients in the felodipine group and 9 (31.0%) patients in the lacidipine group developed pedal edema. In 7 patients in felodipine group and in 5 patients in the lacidipine group the study drug was withdrawn due to pedal edema. In two patients, study drug was withdrawn due to intractable headache (felodipine group) or due to flushing (lacidipine group). Conclusion. A different group of dihydropyridine CCB be used as an alternative therapy for hypertension whenever pedal edema develops during treatment with a dihydropyridine CCB.Keywords: Hypertension, dihydropyridine calcium channel blockers, edema Özet Amaç. Dihidropiridin kalsiyum kanal blokerleri (KKB) etkinlikleri, metabolik nötraliteleri ve düşük yan etki profilleri nedeniyle hipertansiyon tedavisinde yaygın olarak tercih edilirler. Ancak tedavi sırasında ayak bileği ödemi gelişimi kullanımlarını kısıtlar. Bu çalışmanın amacı dihidropiridin KKB tedavisi sırasında ayak bileği ödemi gelişen hipertansif hastalarda farklı bir dihidropiridin KKB' ne geçilmesiyle ayak bileği ödemi gelişim oranının araştırılmasıdır. Yöntem. Dihidropiridin KKB tedavisi sırasında ayak bileği ödemi gelişen 58 hipertansif hasta (34 kadın, 24 erkek, ortalama yaş 65,3±10,5) çalışmaya alındı. Bunlardan 40'ında ayak bileği ödemine yol açan KKB amlodipin 10mg/gün, 14'ünde amlodipin 5mg/gün ve 4'ünde nifedipine GITS 30mg/gün idi. Ayak bileği ödemi yapan KKB kesilerek ödem kaybolduktan sonra farklı bir dihidropiridin KKB (felodipin ya da lasidipin) başlandı. Yeni başlanan KKB tedavisine hasta ayak bileği ödemini tolere ettikçe devam edildi. Bulgular. grubunda 11 (%37,9) ve lasidipin grubunda 9 (%31,0) hastada ayak bileği ödemi gelişti. Felodipin grubunda 7, lasidipin grubunda 5 hastada ayak bileği ödemi geliştiği için tedavi kesildi. Felodipin grubunda bir hastada şiddetli başağrısı, lasidipin grubunda bir hastada ise flushing nedeniyle tedavi sonlandırıldı. Sonuç. Dihidropiridin KKB tedavisi sırasında ayak bile...

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Section: Discussionmentioning

confidence: 99%

A different dihydropyridine calcium channel blocker in hypertensive patients who developed pedal edema on dihydropyridine calcium channel blocker therapy

et al. 2014

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“…13 All analyses to test for non-inferiority were calculated at the onesided 2.5% level of significance. Continuous variables were analysed using the Student's t-test and data were expressed as means ± SD.…”

Section: Discussionmentioning

confidence: 99%

“…8, 18 Several studies have compared valsartan and hydrochlorothiazide combined therapy with amlodipine monotherapy in various dosages. 10, 13,16,19,20 In most of these studies, 13,16,19,20 valsartan 160 mg plus hydrochlorothiazide 12.5 mg once daily, either in a FDC 13,19 or not, 16,20 have demonstrated similar or greater antihypertensive efficacy and better tolerability than that of amlodipine 10 mg once daily. In another study, 10 after initial treatment with valsartan 80 mg once daily and amlodipine 5 mg once daily for 4 weeks, up-titration with the FDC of valsartan/hydrochlorothiazide 80 mg/12.5 mg once daily produced a comparable BP reduction and responder rate to amlodipine 10 mg once daily after a further 8 weeks' treatment.…”

Section: Discussionmentioning

confidence: 99%

Efficacy and Safety of Valsartan/Hydrochlorothiazide Fixed-dose Combination Compared with Amlodipine Monotherapy as First-line Therapy for Mild to Moderate Hypertension

Chao

Lin

et al. 2009

J Int Med Res

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This double-blind, active- and randomized-controlled study compared the efficacy and safety of a fixed-dose combination of valsartan/hydrochlorothiazide 80 mg/12.5 mg once daily (n = 32) with amlodipine monotherapy 5 mg once daily (n = 33) for 8 weeks in patients with mild to moderate hypertension. Non-inferiority of valsartan/hydrochlorothiazide to amlodipine was demonstrated by comparable reductions in sitting systolic blood pressure (SBP), sitting diastolic blood pressure (DBP), and daytime, night-time and 24-h SBP and DBP on ambulatory blood pressure monitoring. Between-group comparisons of adverse events and changes in laboratory parameters did not reach statistical significance, except for uric acid which showed a significant increase in the valsartan/hydrochlorothiazide group compared with the amlodipine group, but was still below the laboratory's upper limit of normal. In conclusion, the use of the fixed-dose combination of valsartan/hydrochlorothiazide 80 mg/12.5 mg once daily as a starting regimen in patients with mild to moderate hypertension was shown to have non-inferior efficacy and comparable safety for daily practice compared with amlodipine 5 mg once daily monotherapy.

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“…Weir et al used this approach in evaluating a comparison of valsartin/hydrochlorthiazide (VAL/ HCTZ) with amlodipine in the reduction of mean 24-hour diastolic blood pressure. 29 Noninferiority of the VAL/HCTZ combination to amlodipine was demonstrated, and fewer adverse events were noted with the combination. The null hypothesis for this analysis was that the reduction in mean 24-hour diastolic blood pressure from baseline to the end of the study with VAL/HCTZ was ≥3 mm Hg less (the noninferiority margin) than that with amlodipine.…”

Section: Education Seriesmentioning

confidence: 94%

Clinical Trial Design Issues: At Least 10 Things You Should Look For in Clinical Trials

Glasser

Howard

2006

The Journal of Clinical Pharma

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Randomized controlled trials remain the gold standard study design and yield the highest level of scientific credence. However, recognition of the limitations of the randomized controlled trial is important. This review highlights 10 potentially problematic areas one should carefully assess when performing or reading an article reporting the results of a randomized controlled trial, problematic areas that can affect the outcome of the trial and therefore mislead the reader. These areas include ethical issues, eligibility criteria, masking (blinding), randomization, analytic methods, the selection of subjects for the interventional and comparison groups, selection of end points, and the interpretation of the results. Each of these is discussed, and examples of published articles are used to highlight the main points.

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A Noninferiority Comparison of Valsartan/Hydrochlorothiazide Combination Versus Amlodipine in Black Hypertensives

Cited by 36 publications

References 27 publications

A different dihydropyridine calcium channel blocker in hypertensive patients who developed pedal edema on dihydropyridine calcium channel blocker therapy

A different dihydropyridine calcium channel blocker in hypertensive patients who developed pedal edema on dihydropyridine calcium channel blocker therapy

Efficacy and Safety of Valsartan/Hydrochlorothiazide Fixed-dose Combination Compared with Amlodipine Monotherapy as First-line Therapy for Mild to Moderate Hypertension

Clinical Trial Design Issues: At Least 10 Things You Should Look For in Clinical Trials

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