Introducing candesartan 32 mg plus hydrochlorothiazide 25 mg in previously untreated patients with severe essential hypertension

Peter Baumgart¹, Ingomar Naudts², Gerhard Kiel^3
1Clemenshospital Muenster, Academic Teaching Hospital of University of Muenster, Germany; ²General Practitioner, group practice, Ludwig-Erhard-Platz 9, Rodgau, Germany; ³Medical Department and Clinical Research, Takeda Pharma GmbH, Aachen, Germany

Purpose: To investigate the efficacy of candesartan 32 mg and hydrochlorothiazide (HCTZ) 25 mg combination in patients with severe essential hypertension.
Patients and methods: In this prospective, open-label, single-group study, 106 previously untreated patients with a baseline systolic blood pressure (SBP) of 150–200 mmHg, and a diastolic blood pressure (DBP) of 110 to 120 mmHg, started with candesartan 16 mg during the first week. HCTZ 12.5 mg was added at week 2 and from fourth week onwards candesartan 32 mg plus HCTZ 25 mg was given over 6 weeks. The primary efficacy endpoint was mean reduction in SBP and DBP after 9 weeks. Response was defined as a decrease in SBP to <140 mmHg and/or by ≥20 mmHg and in DBP to <90 mmHg and/or by ≥10 mmHg. A second response criterion defined blood pressure reduction below 140/90 mmHg.
Results: Blood pressure was lowered from 180.0 ± 11.7/114.7 ± 3.1 mmHg by SBP 44.4 ± 16.8 and DBP 32.0 ± 11.3 mmHg (P < 0.0001). Response was 92.4% and 64.8% achieved <140/90 mmHg. Each titration step produced a statistically significant and clinically relevant decrease in SBP and DBP, but a level below 140/90 mmHg was achieved by >50% of the patients only after the third titration step. Adverse reactions were reported by 3.8% of the patients. The disorders were in line with the known safety profile of the study drugs.
Conclusion: A stepped treatment approach with candesartan/HCTZ combinations is effective and safe to achieve a swift blood pressure reduction in newly diagnosed, severe hypertension. The target of <140/90 mmHg was reached by >50% of the patients only after taking the full dose of candesartan 32 mg and HCTZ 25 mg.

Keywords: primary therapy of newly diagnosed hypertension, fixed combination, decrease in blood pressure, response rates, candesartan