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

Peter Baumgart1, Ingomar Naudts2, Gerhard Kiel31Clemenshospital 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, GermanyPurpose: 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