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.
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 (TEAEs). Efficacy assessments included change from baseline in systolic and diastolic blood pressure (BP).


CONCLUSIONS
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 TEAEs and drug-related TEAEs to week 52 (93·9% and 95·4%, respectively) were mild or moderate in intensity. Rates of drug-related serious AEs 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.


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.
Oslo University Hospital Ullevaal, University of Oslo, Oslo, Norway. s.e.kjeldsen@medisin.uio.no.
S E
SE
Kjeldsen
Milestone Research, London East Medical Centre, London, ON, Canada.
P
P
Dzongowski
Bayer Pharma AG, Beijing, China.
N
N
Li
Bayer Pharma AG, Beijing, China.
L
L
Wang
Bayer Pharma AG, Berlin, Germany.
A
A
Radlmaier
D000368:Aged; D000959:Antihypertensive Agents / Q000008:administration & dosage*; D001562:Benzimidazoles / Q000008:administration & dosage*; D001713:Biphenyl Compounds / Q000008:administration & dosage*; D001794:Blood Pressure; D004359:Drug Therapy, Combination / Q000379:methods; D000075222:Essential Hypertension; D005260:Female; D006801:Humans; D006973:Hypertension / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009543:Nifedipine / Q000008:administration & dosage*; D013777:Tetrazoles / Q000008:administration & dosage*
D000959:Antihypertensive Agents; D001562:Benzimidazoles; D001713:Biphenyl Compounds; D013777:Tetrazoles; D009543:Nifedipine; C077793:candesartan cilexetil
candesartan cilexetil; combination therapy; hypertension; nifedipine GITS