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Efficacy and Tolerability of Nilvadipine in Combination with an Angiotensin II Receptor Antagonist in Patients with Essential Hypertension: A Multicenter, Open-Label, Uncontrolled Study |
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| Authors: | Keita Noda Munehito Ideishi Eiichiro Tashiro Yoshiyuki Nakashima Mitsuhide Imamura Masahiko Seki Masanori Fujino Toshimitsu Sou Masaki Kohara Hisashi Kanaya Nishiki Saku Ritsu Kamei Misao Yamasaki Hiroshi Sakai Naoki Gondo Keijiro Saku |
| Institution: | 1 Department of Cardiology, Fukuoka University School of Medicine, Fukuoka, Japan 2 Department of Internal Medicine, Fukuoka Dental College Hospital, Fukuoka, Japan 3 Seki Clinic, Fukuoka, Japan 4 Fujino Clinic, Fukuoka, Japan 5 Sou Clinic, Fukuoka, Japan 6 Kohara Clinic, Fukuoka, Japan 7 Kanaya Clinic, Fukuoka, Japan 8 Fukuyoshi Hospital, Fukuoka, Japan 9 Kamei Clinic, Fukuoka, Japan 10 Yamasaki Clinic, Fukuoka, Japan 11 Sakai Clinic, Fukuoka, Japan 12 Nishinihon Clinic, Fukuoka, Japan |
| 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. |
| Keywords: | nilvadipine angiotensin II receptor antagonist combination therapy essential hypertension |
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