title: Efficacy and Tolerability of Nilvadipine in Combination with an Angiotensin II Receptor Antagonist in Patients with Essential Hypertension: A Multicenter, Open-Label, Uncontrolled Study.
abstract: BACKGROUND
  Combination therapy with different classes of antihypertensive drugs often is needed to achieve controlled blood pressure (BP). The combination of an angiotensin II receptor antagonist (AIIA) and a calcium antagonist is a preferred option for reducing uncontrolled BP.
  
  
  OBJECTIVE
  The aim of this study was to assess the clinical efficacy and tolerability of nilvadipine, a dihydropyridine calcium antagonist, in combination with an AIIA.
  
  
  METHODS
  Patients with essential hypertension whose BP was not controlled by an AIIA alone were eligible for this multicenter, open-label, uncontrolled study. One of 3 AIIAs (candesartan cilexetil, losartan potassium, or valsartan) was given for at least 10 weeks before the addition of nilvadipine (daily dose, 4 or 8 mg orally). This combination therapy was given for 8 weeks. BP and heart rate were measured between 2 and 4 weeks before and 0, 4, and 8 weeks after the start of combination therapy. Adverse events were monitored at each visit.
  
  
  RESULTS
  Thirty-one patients (18 women [58.1%], 13 men [41.9%]; mean [SD] age, 58.5 [10.5] years) were enrolled. At weeks 4 and 8 of combination therapy, mean systolic BP (SBP) and diastolic BP (DBP) were significantly decreased (P<0.01) (at week 8, by 22.0 mm Hg and 12.5 mm Hg, respectively). The mean BP-lowering effect did not differ significantly between the 3 AIIAs tested. Pulse pressure also decreased significantly at week 8, by 9.6 mm Hg (P<0.01). The responder rate (ie, the percentage of patients with DBP <90 mm Hg or a decrease in DBP ≥10 mm Hg) was 72.0% at week 8. Three patients experienced a total of 4 adverse events: mild or severe flushing, mild headache, and mild palpitation. All of these symptoms resolved after nilvadipine treatment was discontinued.
  
  
  CONCLUSIONS
  Nilvadipine in combination with an AIIA showed good antihypertensive efficacy and was well tolerated in the hypertensive patients in this study. This combination also significantly decreased pulse pressure, suggesting that this combination therapy also may have a beneficial effect in elderly patients with isolated systolic hypertension.
authors: Department of Cardiology, Fukuoka University School of Medicine, Fukuoka, Japan.
authors: Keita
authors: K
authors: Noda
authors: Department of Cardiology, Fukuoka University School of Medicine, Fukuoka, Japan.
authors: Munehito
authors: M
authors: Ideishi
authors: Department of Cardiology, Fukuoka University School of Medicine, Fukuoka, Japan.
authors: Eiichiro
authors: E
authors: Tashiro
authors: Department of Internal Medicine, Fukuoka Dental College Hospital, Fukuoka, Japan.
authors: Yoshiyuki
authors: Y
authors: Nakashima
authors: Department of Internal Medicine, Fukuoka Dental College Hospital, Fukuoka, Japan.
authors: Mitsuhide
authors: M
authors: Imamura
authors: Seki Clinic, Fukuoka, Japan.
authors: Masahiko
authors: M
authors: Seki
authors: Fujino Clinic, Fukuoka, Japan.
authors: Masanori
authors: M
authors: Fujino
authors: Sou Clinic, Fukuoka, Japan.
authors: Toshimitsu
authors: T
authors: Sou
authors: Kohara Clinic, Fukuoka, Japan.
authors: Masaki
authors: M
authors: Kohara
authors: Kanaya Clinic, Fukuoka, Japan.
authors: Hisashi
authors: H
authors: Kanaya
authors: Fukuyoshi Hospital, Fukuoka, Japan.
authors: Nishiki
authors: N
authors: Saku
authors: Kamei Clinic, Fukuoka, Japan.
authors: Ritsu
authors: R
authors: Kamei
authors: Yamasaki Clinic, Fukuoka, Japan.
authors: Misao
authors: M
authors: Yamasaki
authors: Sakai Clinic, Fukuoka, Japan.
authors: Hiroshi
authors: H
authors: Sakai
authors: Nishinihon Clinic, Fukuoka, Japan.
authors: Naoki
authors: N
authors: Gondo
authors: Department of Cardiology, Fukuoka University School of Medicine, Fukuoka, Japan.
authors: Keijiro
authors: K
authors: Saku
keywords: angiotensin II receptor antagonist; combination therapy; essential hypertension; nilvadipine