Gerd Bönner1, Winfried Fuchs. 1. MEDIAN Kliniken, Herbert-Hellmann-Allee 38, 79189 Bad Krozingen, Germany. gerd.boenner@dgn.de
Abstract
OBJECTIVE: The new guidelines for treatment of hypertension by the JNC VII in 2003 permit the initial use of a combination therapy, if blood pressure has to be lowered more than 20/10 mmHg. The aim of this investigation was to document the efficacy and safety of a combination therapy with candesartan cilexetil and hydrochlorothiazide in severe hypertension. METHODS:116 patients freshly diagnosed as having severe primary hypertension (Grade III) and untreated for this condition were enrolled. The study was performed without a placebo control group for ethical reasons. Thus, all patients were treated for 6 weeks with 16 mg candesartan cilexetil plus 12.5mg hydrochlorothiazide daily after forced titration with 8 and 16 mg candesartan cilexetil each for <or= 2 weeks. Sitting trough BP was measured always with the same device in the morning after 15 min at rest, and the median of three measurements was used for analysis. Safety parameters included alanyl aminotransferase (ALAT), aspartyl aminotransferase (ASAT), creatinine, urea, BUN and electrolytes. RESULTS: The mean reduction in systolic/diastolic BP at the end was 38.1/29.4 mmHg. 90.1% of patients were considered to be responders, while 39.6% of patients treated became normotensive (< 140/< 90 mmHg). No drug-related adverse events or changes in laboratory parameters were reported. CONCLUSION: Although this was an open-label, single-group study, on the basis of efficacy and safety, the combination therapy appears to offer a promising treatment for patients with severe primary hypertension.
RCT Entities:
OBJECTIVE: The new guidelines for treatment of hypertension by the JNC VII in 2003 permit the initial use of a combination therapy, if blood pressure has to be lowered more than 20/10 mmHg. The aim of this investigation was to document the efficacy and safety of a combination therapy with candesartan cilexetil and hydrochlorothiazide in severe hypertension. METHODS: 116 patients freshly diagnosed as having severe primary hypertension (Grade III) and untreated for this condition were enrolled. The study was performed without a placebo control group for ethical reasons. Thus, all patients were treated for 6 weeks with 16 mg candesartan cilexetil plus 12.5mg hydrochlorothiazide daily after forced titration with 8 and 16 mg candesartan cilexetil each for <or= 2 weeks. Sitting trough BP was measured always with the same device in the morning after 15 min at rest, and the median of three measurements was used for analysis. Safety parameters included alanyl aminotransferase (ALAT), aspartyl aminotransferase (ASAT), creatinine, urea, BUN and electrolytes. RESULTS: The mean reduction in systolic/diastolic BP at the end was 38.1/29.4 mmHg. 90.1% of patients were considered to be responders, while 39.6% of patients treated became normotensive (< 140/< 90 mmHg). No drug-related adverse events or changes in laboratory parameters were reported. CONCLUSION: Although this was an open-label, single-group study, on the basis of efficacy and safety, the combination therapy appears to offer a promising treatment for patients with severe primary hypertension.