Efficacy and safety of valsartan/hydrochlorothiazide fixed-dose combination compared with amlodipine monotherapy as first-line therapy for mild to moderate hypertension
Journal
Journal of International Medical Research
Journal Volume
37
Journal Issue
2
Pages
289-297
Date Issued
2009
Author(s)
Abstract
This double-blind, active- active- and randomized-controlled study compared the efficacy and safety of a fixed-dosed combination of valsartan/hydrochloro-thiazide 80 mg/12.5 mg once daily (n-32) with amlodipine monotheraphy 5 mg once daily (n=33) for 8 weeks in patients with mild to moderate hypertension. Non-inferiority of valsartan/ hydrochlothiazide to amlodipine was demonstrated by comparable reductions in sitting diastolic blood pressure (DBP, and day-time 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. Copyright ? 2009 Field House Publishing LLP.Indications:32 patients with uncomplicated mild to moderate essential hypertension. Concomitant diseases: diabetes mellitus 4 and hyperlipidemia 8.Patients:65 patients were studied. Codiovan: 32 patients, 21 male and 11 female, mean age 59 years. Amlodipine: 33 patients, 15 male and 18 female, mean age 58 years.TypeofStudy:This study compared the efficacy and safety of Codiovan with amlodipine (AMD) as first-line therapy in patients with mild to moderate hypertension. Double-blind, active- and randomized-controlled trial.DosageDuration:Valsartan 80 mg plus hydrochlorothiazide 12.5 mg once daily, orally as pills, at approximately 0800 hours. Duration: 8 weeks.ComparativeDrug:Amlodipine: 5 mg once daily, orally as pills, at approximately 0800 hours. Duration: 8 weeks.AdverseEffects:A total 13 adverse events including abdominal pain (1), chest pain (1), cough (3), diarrhea (1), dizziness (3), dyspnea (1), malaise (1) and palpitation (1) and uric acid level increase in unspecified number of patients were reported.Results:The Codiovan group demonstrated comparable and non inferior reductions in sitting SBP (P<0.01) as well as for sitting DBP day-/night-time, 24-hour-hour SBP and DBP, and ABP (P<0.05). Comparison for heart rate changes was not statistically significant. 29/32 Codiovan patients and 32/33 AMD patients achieved drug compliance between 80% and 100% with no statistically significant difference. Changes in laboratory test results were comparable between Codiovan and AMD groups except uric acid. The final mean uric acid level (7.2 mg/dL) represented 11% increase from baseline, still below the upper normal limit.AuthorsConclusions:In conclusion, the use of the FDC [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.FreeText:Tests: sitting systolic blood pressure (SBP) and diastolic blood pressure (DBP), ambulatory blood pressure (ABP), heart rate; and uric acid blood level.
SDGs
Other Subjects
amlodipine; hydrochlorothiazide plus valsartan; amlodipine; antihypertensive agent; drug derivative; hydrochlorothiazide; tetrazole derivative; valine; valsartan; abdominal pain; adult; arthralgia; article; blood pressure monitoring; clinical trial; controlled clinical trial; controlled study; coughing; diarrhea; dizziness; double blind procedure; drug efficacy; drug induced headache; drug response; drug safety; dyspnea; female; heart palpitation; human; hypertension; insomnia; leg edema; major clinical study; malaise; male; patient compliance; primary health care; pruritus; randomized controlled trial; side effect; thorax pain; comparative study; dose response; drug combination; middle aged; treatment outcome; Amlodipine; Antihypertensive Agents; Dose-Response Relationship, Drug; Double-Blind Method; Drug Therapy, Combination; Female; Humans; Hydrochlorothiazide; Hypertension; Male; Middle Aged; Tetrazoles; Treatment Outcome; Valine
Publisher
SAGE Publications Ltd
Type
journal article