Long-term safety, tolerability and efficacy of aliskiren in combination with valsartan in patients with hypertension: a 6-month interim analysis
Autor: | Jack Zhang, Samir Patel, Dan Dattani, Steven G. Chrysant, Alexander V. Murray, Huang Hsu, Uta C. Hoppe |
---|---|
Rok vydání: | 2008 |
Předmět: |
Male
Angiotensin receptor medicine.medical_specialty Time Factors Combination therapy Urology Tetrazoles Angiotensin-Converting Enzyme Inhibitors Blood Pressure Pharmacology Renin-Angiotensin System chemistry.chemical_compound Hydrochlorothiazide Fumarates Risk Factors Renin medicine Humans Antihypertensive Agents Aged business.industry Valine General Medicine Middle Aged Aliskiren Interim analysis Amides Tolerability Valsartan chemistry Hypertension ACE inhibitor Hyperkalemia Drug Therapy Combination Female business Angiotensin II Type 1 Receptor Blockers medicine.drug |
Zdroj: | Current Medical Research and Opinion. 24:1039-1047 |
ISSN: | 1473-4877 0300-7995 |
DOI: | 10.1185/030079908x280581 |
Popis: | Renin-angiotensin system (RAS) blockade with ACE inhibitor and/or angiotensin receptor blocker therapy can lead to increased potassium levels, hence the need to assess dual blockade involving a direct renin inhibitor. Here we report the results of a pre-planned 6-month interim analysis of a long-term, open-label study examining the safety, tolerability and efficacy of the aliskiren/valsartan 300/320-mg combination in patients with hypertension.A total of 601 patients with hypertension (msDBPor = 90 and110 mmHg) received a combination of aliskiren/valsartan 150/160 mg for 2 weeks followed by forced titration to aliskiren/valsartan 300/320 mg once daily for a targeted duration of 52 weeks. Optional hydrochlorothiazide (HCTZ) addition was allowed from week 8 for inadequate BP control (or = 140/90 mmHg). The primary objective was to assess the safety of combination therapy; potassium elevations were a predefined safety outcome. BP was measured at regular intervals during the study.At the 6-month cut-off date, 512 patients (85.2%) were still ongoing with study treatment, and 192 patients had received at least one dose of HCTZ add-on during this period. Combination therapy was generally well-tolerated; the most commonly reported adverse events were headache (7.5%), dizziness (7.3%) and nasopharyngitis (7.2%). Ten patients (2.5%) receiving aliskiren/valsartan and two patients (1.0%) receiving aliskiren/valsartan/HCTZ had serum potassium elevations5.5 mmol/L. Only one patient (0.2%) exhibited potassium levelsor = 6.0 mmol/L during this period and the patient was treated with aliskiren/valsartan. Mean msSBP/DBP reductions of 22.3/14.4 mmHg were observed at 6-month endpoint (LOCF analysis) and 73.4% of patients achieved BP control (140/90 mmHg; LOCF).Although lack of an active comparator group is a limitation of the study, our findings show that long-term treatment with the aliskiren/valsartan 300/320-mg combination provided clinically significant BP lowering, was well-tolerated and was associated with a very low rate of potassium elevations in patients with hypertension. |
Databáze: | OpenAIRE |
Externí odkaz: |