OBJECTIVESTo analyse the control rate of irbesartan/hydrochlorothiazide (HCTZ) combination tablets (COAPROVEL) in the treatment of patients with mild to moderate primary hypertension.

METHODSIn this multi-center, open, single therapy trial, the enrolled patients aged 18-75 were treated with irbesartan/HCTZ combination tablets for 8 weeks. The initial dose comprised one tablet of irbesartan (150 mg)/HCTZ (12.5 mg) once a day during the first 2 weeks. If diastolic blood pressure was greater than 85 mm Hg at the end of the second or fourth weeks, irbesartan (300 mg)/HCTZ (12.5 mg) once a day or irbesartan (300 mg)/HCTZ (25 mg) once a day were added respectively.

RESULTSIn 968 patients with mild to moderate hypertension enrolled, 920 patients were followed up for 8 weeks. (1) After 1 week of treatment, irbesartan/HCTZ combination tablets lowered systolic blood pressure by 11.87 mm Hg and diastolic blood pressure by 8.54 mm Hg (P < 0.01). After 8 weeks of treatment, the corresponding decreases were 21.97 mm Hg and 16.08 mm Hg, respectively (P < 0.01). (2) After 2, 4 and 8 weeks of treatment, 526, 703 and 769 patients reached blood pressure target (diastolic blood pressure less than 85 mm Hg). The control rates were 57.17%, 76.41% and 83.59%, respectively. (3) Among the 920 patients who completed the trial, 637 patients took irbesartan (150 mg)/HCTZ (12.5mg) once a day (69.24%), 211 patients took irbesartan (300 mg)/HCTZ (12.5 mg) once a day (22.93%), and 72 patients took irbesartan (300 mg)/HCTZ (25 mg) once a day (7.82%). (4) In the intention-to-treat analysis, no adverse reaction was observed in 903 patients (93.29% of the patients enrolled).

CONCLUSIONSWhen irbesartan/HCTZ combination regimen are used in the treatment of patients with mild to moderate primary hypertension, the proportion of patients reaching blood pressure target is high and adverse reactions are rare.

Adolescent ; Adult ; Aged ; Antihypertensive Agents ; adverse effects ; therapeutic use ; Biphenyl Compounds ; adverse effects ; therapeutic use ; China ; Drug Combinations ; Humans ; Hydrochlorothiazide ; adverse effects ; therapeutic use ; Hypertension ; drug therapy ; Middle Aged ; Tablets ; Tetrazoles ; adverse effects ; therapeutic use ; Young Adult

OBJECTIVETo assess the efficacy and safety of valsartan/hydrochlorothiazide (HCTZ) 80/12.5 mg once daily (o.d.) in Chinese patients with mild to moderate essential hypertension who was not adequately controlled by valsartan 80 mg o.d. monotherapy.

METHODSIn this multi-center, double-blind, randomized, active controlled, parallel group trial, 1051 out of 1175 Chinese patients with mild to moderate essential hypertension [DBP >or= 95 mm Hg and < 110 mm Hg (1 mm Hg = 0.133 kPa)] completed single-blind run-in period (valsartan 80 mg o.d. therapy for 4 weeks) after 2 week's wash-out period. At the end of the single-blind run-in period, those patients with DBP >or= 95 mm Hg (n = 864) were randomized in 1:1 ratio to Valsartan and Valsartan 80 mg (n = 429)/HCTZ80/12.5 mg (n = 435) treatment o.d. for 8 weeks. Safety and efficacy was assessed every 4 weeks during double blind phase.

RESULTSAt the end of study, valsartan/HCTZ 80/12.5 mg combination treatment further reduced systolic (-3.5 mm Hg) and diastolic (-2.2 mm Hg) pressures and increased the rate of patients reaching goal BP level (53.9% vs. 40.9%) compared to valsartan 80 mg o.d. monotherapy. Incidence of side effects was similar between the combination therapy and monotherapy groups (8.9% vs. 5.1%, P > 0.05).

CONCLUSIONEfficacy of Valsartan 80 mg/HCTZ 12.5 mg compound was superior to valsartan 80 mg on BP reduction and goal BP control rate in Chinese patients with mild to moderate essential hypertension. The combination of Valsartan 80 mg/hydrochlorothiazide (HCTZ) 12.5 mg provides a suitable treatment for Chinese patients who are not adequately controlled by valsartan 80 mg o.d. monotherapy.

Adult ; Antihypertensive Agents ; adverse effects ; therapeutic use ; Double-Blind Method ; Drug Therapy, Combination ; Female ; Humans ; Hydrochlorothiazide ; adverse effects ; therapeutic use ; Hypertension ; drug therapy ; Male ; Middle Aged ; Tetrazoles ; adverse effects ; therapeutic use ; Valine ; adverse effects ; analogs & derivatives ; therapeutic use ; Valsartan

The authors experienced two cases of hydrochlorothiazide (HCTZ)-induced acute-onset bilateral myopia and shallowing of the anterior chambers. Two middle-aged women taking HCTZ, a sulfa derivative, visited our clinic complaining of acute bilateral visual deterioration. Both had good visual acuity without corrective lenses before taking HCTZ. A complete ophthalmologic examination revealed bilateral myopic shift, intraocular pressure elevation, shallowing of the anterior chambers, choroidal effusions, radiating retinal folds, and conjunctival chemosis. Approximately one week after HCTZ discontinuance, all ocular changes disappeared completely. Physicians should be aware of the adverse ocular effects of HCTZ and should manage patients accordingly.
Acute Disease ; Adult ; Anterior Chamber/drug effects ; Choroid/drug effects/*metabolism ; Cilia/drug effects/*metabolism ; Diuretics/*adverse effects ; Exudates and Transudates/*metabolism ; Female ; Humans ; Hydrochlorothiazide/*adverse effects ; Intraocular Pressure/drug effects ; Middle Aged ; Myopia/*chemically induced

The study aims to evaluate the bioequivalence of valsartan hydrochlorothiazide tablets, and to investigate the potential cause of bioinequivalence. This was a single-center study with an open, randomized double-way crossover design. Test and reference preparations containing 160 mg of valsartan and 25 mg of hydrochlorothiazide were given to 36 healthy male volunteers. Plasma concentrations of valsartan and hydrochlorothiazide were determined simultaneously by LC-MS/MS. The pharmacokinetic parameters and relative bioavailability were calculated, while the bioequivalence between test and reference preparations were evaluated. The dissolution profiles of test and reference preparations in four different mediums were determined via dissolution test and HPLC. The similarity was investigated according to the similarity factors (f2). The F(o-t) and F(0-infinity) were (139.4 +/- 65.2)% and (137.5 +/- 61.2)% for valsartan of test preparations. It led to get the conclusion that test and reference preparations were not bioequivalent for valsartan. A significant difference was observed between test and reference tablets in the valsartan dissolution test of pH 1.2 hydrochloric acid solution. The key factor of the bioinequivalence might be that dissolution of valsartan in acid medium has marked difference between two preparations.
Administration, Oral ; Adolescent ; Adult ; Angiotensin II Type 1 Receptor Blockers ; administration & dosage ; adverse effects ; blood ; pharmacokinetics ; Antihypertensive Agents ; administration & dosage ; adverse effects ; blood ; pharmacokinetics ; Area Under Curve ; Chromatography, Liquid ; Cross-Over Studies ; Drug Liberation ; Humans ; Hydrochlorothiazide ; administration & dosage ; adverse effects ; blood ; pharmacokinetics ; Male ; Tablets ; Tandem Mass Spectrometry ; Therapeutic Equivalency ; Valsartan ; administration & dosage ; adverse effects ; blood ; pharmacokinetics ; Young Adult