Nifedipine controlled-release 40 mg b.i.d. in Japanese patients with essential hypertension who responded insufficiently to nifedipine controlled-release 40 mg q.d.: a phase III, randomized, double-blind and parallel-group study.
This phase III, multicenter, randomized, double-blind, parallel-group study compared the efficacy and safety of nifedipine controlled-release (CR) 40 mg twice daily (b.i.d.) and once daily (q.d.) in 325 Japanese patients with essential hypertension uncontrolled with nifedipine CR 40 mg q.d. (ClinicalTrials.gov record: NCT01287260). The primary endpoint was the change from baseline in trough seated diastolic blood pressure (DBP) after 8 weeks. Nifedipine CR 40 mg b.i.d. showed significantly greater reductions in trough seated DBP (-7.7±0.6 mm Hg vs. -3.6±0.6 mm Hg) and trough seated systolic blood pressure (BP) (-11.1±0.9 mm Hg vs. -3.7±0.9 mm Hg) after 8 weeks of treatment compared with nifedipine CR 40 mg q.d. (both P<0.0001). At week 8, BP target achievement and responder rates were higher with nifedipine CR 40 mg b.i.d. (21.5% and 42.4% vs. 10.3% and 19.5%, respectively). Adverse events considered related to the study drug were reported in 9.0 and 9.7% of patients receiving nifedipine CR 40 mg b.i.d. and q.d., respectively. The frequency of drug-related adverse events commonly reported with nifedipine CR (headache, hot flush, palpitations, peripheral edema, hypotension, dizziness, tachycardia) was low and the results were similar between the treatment groups. In conclusion, a higher dose of nifedipine CR was associated with greater efficacy and a safety profile similar to that of the currently approved dose (40 mg q.d.) in Japanese patients with essential hypertension, and it may offer a valuable treatment choice for patients who do not achieve target BP levels with standard treatment.
Sapporo Medical University, Sapporo, Japan.
Kazuaki
K
Shimamoto
Division of Cardiology, Nephrology, Pulmonology and Neurology, Department of Internal Medicine, Asahikawa Medical University, Asahikawa, Japan.
Naoyuki
N
Hasebe
Division of Nephrology, Endocrinology and Vascular Medicine, Tohoku University School of Medicine, Sendai, Japan.
Sadayoshi
S
Ito
Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University, Shimotsuke, Japan.
Kazuomi
K
Kario
Division of Nephrology and Hypertension, Department of Internal Medicine, St. Marianna University School of Medicine, Kawasaki, Japan.
Kenjiro
K
Kimura
Department of Cardio-Renal Medicine and Hypertension, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.
Yasuaki
Y
Dohi
Division of Hypertension and Nephrology, National Cerebral and Cardiovascular Center, Suita, Japan.
Yuhei
Y
Kawano
Department of Geriatric Medicine and Nephrology, Osaka University School of Medicine, Suita, Japan.
Hiromi
H
Rakugi
Department of Molecular Cardiovascular Biology And Pharmacology, Ehime University School of Medicine, Toon, Japan.
Masatsugu
M
Horiuchi
Division of Cardiovascular Medicine, Department of Internal Medicine, Kurume University School of Medicine, Kurume, Japan.
Tsutomu
T
Imaizumi
Department of Cardiovascular Medicine, Nephrology and Neurology, University of the Ryukyus Graduate School of Medicine, Okinawa, Japan.
Yusuke
Y
Ohya
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001794:Blood Pressure / Q000502:physiology; D002121:Calcium Channel Blockers / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D023381:Endpoint Determination; D000075222:Essential Hypertension; D005260:Female; D006339:Heart Rate / Q000502:physiology; D006801:Humans; D006973:Hypertension / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009543:Nifedipine / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
D002121:Calcium Channel Blockers; D003692:Delayed-Action Preparations; D009543:Nifedipine