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Fixed‐dose combination of nifedipine gastrointestinal therapeutic system and candesartan cilexetil in patients with moderate‐to‐severe essential hypertension: an open‐label, long‐term safety and efficacy study
Author(s) -
Kjeldsen S. E.,
Dzongowski P.,
Li N.,
Wang L.,
Radlmaier A.
Publication year - 2016
Publication title -
journal of clinical pharmacy and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.622
H-Index - 73
eISSN - 1365-2710
pISSN - 0269-4727
DOI - 10.1111/jcpt.12451
Subject(s) - candesartan , medicine , adverse effect , nifedipine , blood pressure , fixed dose combination , antihypertensive drug , diastole , anesthesia , angiotensin ii , calcium
Summary What is known and objective The nifedipine gastrointestinal therapeutic system ( GITS )/candesartan cilexetil (N/C) combination was demonstrated to be an effective, well‐tolerated antihypertensive therapy in a short‐term study. The current study investigated the long‐term safety and efficacy of a fixed‐dose combination ( FDC ) of N/C therapy in moderate‐to‐severe essential hypertension. Methods A multinational, 70‐centre, open‐label study of N/C treatment for 28 or 52 weeks at a target dose of N60 mg/C32 mg. The primary assessment included the incidence of treatment‐emergent adverse events ( TEAE s). Efficacy assessments included change from baseline in systolic and diastolic blood pressure ( BP ). Results and discussion A total of 508 patients were enrolled, with 417 (82·1%) completing week 28 of treatment. Of these, 200 patients continued treatment, as planned, to week 52, with 193 (96·5%) completing this period. At least one TEAE or drug‐related TEAE were reported in 76·8% and 45·3% patients up to week 28, and in 80·7% and 46·9% up to week 52/end of study. Most TEAE s and drug‐related TEAE s to week 52 (93·9% and 95·4%, respectively) were mild or moderate in intensity. Rates of drug‐related serious AE s were low (0·6%). TEAE ‐related discontinuations occurred in 10% patients before week 28 and in no additional patients thereafter. N/C provided substantial, sustained reductions in mean systolic and diastolic BP from baseline: 30·1 ± 18·4 and 12·8 ± 10·7 mmHg, respectively, at week 52. What is new and conclusions Nifedipine GITS /candesartan cilexetil FDC at the target dose of 60 mg/32 mg was well tolerated for a study duration up to 52 weeks and provided sustained reductions in systolic and diastolic BP .