Safety and tolerability of fixed-dose irbesartan/hydrochlorothiazide for rapid control of severe hypertension. Clinical and experimental hypertension (New York, N.Y. : 1993) [Clin Exp Hypertens] Journal article | | Title | Safety and tolerability of fixed-dose irbesartan/hydrochlorothiazide for rapid control of severe hypertension. | | Author(s) | Neutel JM, Franklin SS, Bhaumik A, Lapuerta P, Oparil S | | Institution | Orange County Research Center, Tustin, CA. | | Source | Clin Exp Hypertens 2009 Oct; 31(7):572-84. | | Abstract | This prospective, double-blind, multicenter trial compared the safety and tolerability of irbesartan/hydrochlorothiazide (HCTZ) fixed-dose combination therapy with irbesartan monotherapy in patients with severe hypertension (seated diastolic blood pressure (SeDBP) >/=110 mm Hg, mean BP 172/113 mm Hg at baseline). Patients were randomized 2:1 to 7 weeks' irbesartan/HCTZ 150/12.5 mg to 300/25 mg (n = 468) or irbesartan 150 mg to 300 mg (n = 227). The incidence of treatment-related adverse events (AEs) was similar with combination and monotherapy (11.3% and 10.1%), and most AEs were mild-to-moderate. The combined incidence of prespecified AEs was lower with irbesartan/HCTZ than with irbesartan (8.8% vs. 11.5%). There were no treatment-related serious AEs or deaths. At week 5, more patients achieved SeDBP < 90 mm Hg compared to irbesartan (47% vs. 33%; P = 0.0005). Despite more rapid and aggressive BP lowering, initial fixed-dose irbesartan/HCTZ demonstrated a comparable AE profile to irbesartan monotherapy in patients with severe hypertension. | | Language | eng | | Pub Type(s) | Journal Article
| | PubMed ID | 19886855 |
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