Document Detail

Once-daily fixed-combination irbesartan 300 mg/ hydrochlorothiazide 25 mg and circadian blood pressure profile in patients with essential hypertension.
MedLine Citation:
PMID:  14693309     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: More than 60% of patients with hypertension included in morbidity and mortality trials needed >or=2 drugs to achieve a substantial, sustained reduction in blood pressure. Tolerable combinations using higher doses of antihypertensive drugs are frequently required to control blood pressure. OBJECTIVE: The goal of this study was to assess the effect of a once-daily fixed combination of irbesartan 300 mg/hydrochlorothiazide (HCTZ) 25 mg on the circadian blood pressure profile in patients with essential hypertension that was not controlled with full-dose single therapy or low-dose combined therapy. METHODS: Study patients were recruited consecutively from the outpatient hypertension clinics of 3 university hospitals in Spain. After a 1-week washout period, patients with a mean daytime blood pressure >135/85 mm Hg were treated with irbesartan 300 mg/HCTZ 25 mg once daily for 12 weeks. Twenty-four-hour ambulatory blood pressure monitoring was performed at the end of the washout period and during the last week of treatment. RESULTS: Fifty-seven patients with essential hypertension (28 men, 29 women) were enrolled; their mean (SD) age was 60.4 (7.2) years (range, 45-78 years). After treatment, a significant reduction in both clinic and ambulatory mean (SD) blood pressure values was observed in the whole group of 57 patients (from 146.0 [11.0] mm Hg to 123.3 [13.3] mm Hg, P < 0.001 for 24-hour systolic blood pressure [SBP]; from 89.9 [8.2] mm Hg to 76.5 [9.4] mm Hg, P < 0.001 for 24-hour diastolic blood pressure [DBP]. The mean lowering of ambulatory SBP and DBP at peak was 25.2 (14.5) mm Hg and 14.7 (9.5) mm Hg, respectively, and at trough, 22.3 (18.3) mm Hg and 12.3 (10.9) mm Hg. The trough-to-peak ratio of the group was 0.92 for SBP (0.97 in responders) and 0.84 for DBP (0.89 in responders). The smoothness index, calculated as the mean of all individual values, was 1.7 (1.0) for SBP (1.8 [0.9] in responders) and 1.3 (0.8) for DBP (1.5 [0.6] in responders). Seven side effects in 6 patients were reported. No metabolic changes were observed, and no patient discontinued the study because of treatment-related adverse effects. CONCLUSIONS: The fixed combination of irbesartan 300 mg/HCTZ 25 administered once daily produced a crude meaningful effect in reducing 24-hour blood pressure and was well tolerated. The circadian profile was preserved, as shown by trough-to-peak ratios and smoothness index values for both SBP and DBP.
Antonio Coca; Carlos Calvo; Javier Sobrino; Elisenda Gómez; José E López-Paz; Cristina Sierra; Ernesto Bragulat; Alejandro de la Sierra
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Publication Detail:
Type:  Clinical Trial; Journal Article; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Clinical therapeutics     Volume:  25     ISSN:  0149-2918     ISO Abbreviation:  Clin Ther     Publication Date:  2003 Nov 
Date Detail:
Created Date:  2003-12-24     Completed Date:  2004-03-25     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  7706726     Medline TA:  Clin Ther     Country:  United States    
Other Details:
Languages:  eng     Pagination:  2849-64     Citation Subset:  IM    
Hospital Clinico IDIBAPS, University of Barcelona, Barcelona, Spain.
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MeSH Terms
Antihypertensive Agents / administration & dosage*,  therapeutic use
Biphenyl Compounds / administration & dosage*,  therapeutic use
Blood Pressure / drug effects*
Circadian Rhythm*
Drug Combinations
Hydrochlorothiazide / administration & dosage*,  therapeutic use
Hypertension / drug therapy*,  physiopathology
Middle Aged
Tetrazoles / administration & dosage*,  therapeutic use
Reg. No./Substance:
0/Antihypertensive Agents; 0/Biphenyl Compounds; 0/Drug Combinations; 0/Tetrazoles; 138402-11-6/irbesartan; 58-93-5/Hydrochlorothiazide

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