A randomized, comparative study evaluating the efficacy and tolerability of losartan-low dose chlorthalidone (6.25 mg) combination with losartan-hydrochlorothiazide (12.5 mg) combination in Indian patients with mild-to-moderate essential hypertension.
OBJECTIVE
The relationship of blood pressure (BP) to cardiovascular risk is linear, positive, and continuous. Lowering elevated BP reduces the risk of cardiovascular events. The primary objective of this randomized, multicenter, comparative, 3-month, open-label study was to evaluate the antihypertensive efficacy of losartan/chlorthalidone versus losartan/hydrochlorothiazide in mild-to-moderate essential hypertension.


METHODS
A total of 137 eligible patients underwent a 2-week placebo washout period, following which 131 patients were randomized to losartan (L) 25mg/chlorthalidone (C) 6.25 mg (66/131) or to losartan 25 mg/hydrochlorothiazide (H) 12.5 mg (65/131) at three centers. Patients not responding after 4 weeks of therapy were escalated to losartan 25 mg/chlorthalidone 12.5 mg and losartan 50 mg/hydrochlorothiazide 12.5 mg, respectively.


RESULTS
Both treatment groups were similar with respect to demography and baseline characteristics. Altogether, 120 patients completed the study. After 4 weeks of therapy, both treatments showed a significant fall from baseline in systolic BP (SBP) and diastolic BP (DBP) (L/C: -20.17/-10.30; L/H: -17.63/-10.20). Both treatments were similar with respect to mean fall in SBP (p = 0.258), DBP (p = 0.934) and response rate (p = 0.769). Both step-up therapies were similar with respect to mean fall in SBP (p = 0.418), DBP (p = 0.389) from baseline and response rate (p = 0.769). All reported adverse events were of mild-to-moderate intensity, except for two serious AEs that occurred in patients who received L/H.


CONCLUSIONS
The losartan/low-dose chlorthalidone (6.25 mg) combination is as effective as the widely used losartan/hydrochlorothiazide combination in lowering BP and is well tolerated, thus providing a useful therapeutic option for treating mild-to-moderate hypertension.
Pareek
Anil
A
Medical Affairs and Clinical Research, Ipca Laboratories Ltd, 142 AB, Kandivli Industrial Estate, Kandivli (West), Mumbai 400067, India. anilpareek@ipca.co.in
Basavanagowdappa
Hathur
H
Zawar
Shyamsundar
S
Kumar
Anil
A
Chandurkar
Nitin
N
D000293:Adolescent; D000328:Adult; D000368:Aged; D047228:Angiotensin II Type 1 Receptor Blockers / Q000008:administration & dosage / Q000378:metabolism; D000959:Antihypertensive Agents / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D004361:Drug Tolerance; D005260:Female; D006801:Humans; D006852:Hydrochlorothiazide / Q000627:therapeutic use*; D006973:Hypertension / Q000188:drug therapy*; D007194:India / Q000453:epidemiology; D019808:Losartan / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010919:Placebos / Q000008:administration & dosage; D016896:Treatment Outcome; D055815:Young Adult
D047228:Angiotensin II Type 1 Receptor Blockers; D000959:Antihypertensive Agents; D010919:Placebos; D006852:Hydrochlorothiazide; D019808:Losartan