A Pareek1, S D Zawar, S B Salagre, N B Chandurkar, N D Karnik. 1. Medical Affairs and Clinical Research, Ipca Laboratories Ltd., 142 AB, Kandivli Industrial Estate, Kandivli (West), Mumbai 400067, India. anilpareek@ipca.co.in
Abstract
OBJECTIVE: High blood pressure is one of the most important risk factors, directly responsible for increasing the cardiovascular morbidity and mortality. The primary objective was to evaluate the efficacy of metoprolol XL/chlorthalidone against metoprolol XL/hydrochlorothiazide with respect to mean fall in systolic and diastolic blood pressure. The secondary objective was to compare the response rates and to evaluate the tolerability of study medications in patients with mild-to-moderate essential hypertension. METHODS:Total 130 eligible patients (65: metoprololXL 25 mg/chlorthalidone 6.25 mg; 65: metoprolol XL 25 mg/HCTZ 12.5 mg) were enrolled in this randomized, comparative, multicentric, 12-weeks study. Sixty-two patients from each group completed the study. After 4-weeks of treatment, non-responders from chlorthalidone 6.25 mg combination group were shifted to metoprolol XL 50 mg/chlorthalidone 12.5 mg and non-responders from HCTZ 12.5 mg combination group were escalated to metoprolol XL 50 mg/HCTZ 12.5 mg. RESULTS: The study treatment groups were comparable with respect to demography and baseline disease characteristics. Both the starting therapies were comparable with respect to mean fall in SBP (p = 0.788) and DBP (p = 0.939), and response rates (p = 1.0) after 4-weeks of therapy. Also both the step-up therapies showed similar mean fall in SBP (p = 0.277) and DBP (p = 0.507) at the end of 12-weeks. However, significantly more number of patients from chlorthalidone 12.5 mg/metoprolol XL 50 mg group responded to therapy as compared to that from HCTZ 12.5 mg/metoprolol XL 50 mg group (p = 0.045). All the reported adverse events were of mild-to-moderate intensity. There were no clinically significant trends in electrolytes (Na (+), K(+), Cl(-)) and fasting blood sugar, evident across the treatment groups. CONCLUSION:Chlorthalidone in combination with metoprolol XL is as effective and well tolerated as widely used combination of metoprolol XL/HCTZ, thus providing an alternative therapeutic option.
RCT Entities:
OBJECTIVE: High blood pressure is one of the most important risk factors, directly responsible for increasing the cardiovascular morbidity and mortality. The primary objective was to evaluate the efficacy of metoprolol XL/chlorthalidone against metoprolol XL/hydrochlorothiazide with respect to mean fall in systolic and diastolic blood pressure. The secondary objective was to compare the response rates and to evaluate the tolerability of study medications in patients with mild-to-moderate essential hypertension. METHODS: Total 130 eligible patients (65: metoprolol XL 25 mg/chlorthalidone 6.25 mg; 65: metoprolol XL 25 mg/HCTZ 12.5 mg) were enrolled in this randomized, comparative, multicentric, 12-weeks study. Sixty-two patients from each group completed the study. After 4-weeks of treatment, non-responders from chlorthalidone 6.25 mg combination group were shifted to metoprolol XL 50 mg/chlorthalidone 12.5 mg and non-responders from HCTZ 12.5 mg combination group were escalated to metoprolol XL 50 mg/HCTZ 12.5 mg. RESULTS: The study treatment groups were comparable with respect to demography and baseline disease characteristics. Both the starting therapies were comparable with respect to mean fall in SBP (p = 0.788) and DBP (p = 0.939), and response rates (p = 1.0) after 4-weeks of therapy. Also both the step-up therapies showed similar mean fall in SBP (p = 0.277) and DBP (p = 0.507) at the end of 12-weeks. However, significantly more number of patients from chlorthalidone 12.5 mg/metoprolol XL 50 mg group responded to therapy as compared to that from HCTZ 12.5 mg/metoprolol XL 50 mg group (p = 0.045). All the reported adverse events were of mild-to-moderate intensity. There were no clinically significant trends in electrolytes (Na (+), K(+), Cl(-)) and fasting blood sugar, evident across the treatment groups. CONCLUSION:Chlorthalidone in combination with metoprolol XL is as effective and well tolerated as widely used combination of metoprolol XL/HCTZ, thus providing an alternative therapeutic option.
Authors: William C Cushman; Charles E Ford; Jeffrey A Cutler; Karen L Margolis; Barry R Davis; Richard H Grimm; Henry R Black; Bruce P Hamilton; Joanne Holland; Chuke Nwachuku; Vasilios Papademetriou; Jeffery Probstfield; Jackson T Wright; Michael H Alderman; Robert J Weiss; Linda Piller; Judy Bettencourt; Sandra M Walsh Journal: J Clin Hypertens (Greenwich) Date: 2002 Nov-Dec Impact factor: 3.738
Authors: Henry R Black; William J Elliott; Gregory Grandits; Patricia Grambsch; Tracy Lucente; William B White; James D Neaton; Richard H Grimm; Lennart Hansson; Yves Lacourciere; James Muller; Peter Sleight; Michael A Weber; Gordon Williams; Janet Wittes; Alberto Zanchetti; Robert J Anders Journal: JAMA Date: 2003 Apr 23-30 Impact factor: 56.272
Authors: Aram V Chobanian; George L Bakris; Henry R Black; William C Cushman; Lee A Green; Joseph L Izzo; Daniel W Jones; Barry J Materson; Suzanne Oparil; Jackson T Wright; Edward J Roccella Journal: JAMA Date: 2003-05-14 Impact factor: 56.272
Authors: Bruce M Psaty; Thomas Lumley; Curt D Furberg; Gina Schellenbaum; Marco Pahor; Michael H Alderman; Noel S Weiss Journal: JAMA Date: 2003-05-21 Impact factor: 56.272