Treatment of mild-to-moderate hypertension with calcium channel blockers: a multicentre comparison of once-daily nifedipine GITS with once-daily amlodipine

• Published in: Current medical research and opinion 2003, Vol.19 (3), p.226-237
• Main Authors: Kes, Sirri, Caglar, Nail, Canberk, Aykan, Deger, Necmi, Demirtas, Mustafa, Dortlemez, Halis, Kiliccioglu, Bulent, Kozan, Omer, Ovunc, Kenan, Turkoglu, Cuneyt
• Format: Article
• Language: English
• Subjects: Adult; Aged; Amlodipine; Amlodipine - administration & dosage; Antihypertensive agents; Biological and medical sciences; Blood Pressure - drug effects; Calcium channel blockers; Calcium Channel Blockers - administration & dosage; Clinical trials -GITS; Drug Administration Schedule; Drug Tolerance; essential; Female; Humans; Hypertension; Hypertension - drug therapy; Hypertension - physiopathology; Male; Medical sciences; Middle Aged; Nifedipine; Nifedipine - administration & dosage; Safety
• ISSN: 0300-7995; 1473-4877
• DOI: 10.1185/030079903125001677

SUMMARY Background: Hypertension is one of the most important causes of cardiovascular disease, and treatment of hypertension leads to a significant reduction in cardiovascular mortality and morbidity. Although calcium channel blockers are regarded as an important part of the therapeutic armamentarium against cardiovascular diseases, and are among the most frequently prescribed antihypertensive medications, concern has been aroused about these drugs, particularly the short-acting dihydropyridine derivatives. However, the value of nifedipine GITS (Adalat-Crono*), the long-acting dihydropyridine, is in need of being re-established. *Adalat-Crono is a registered tradename of Bayer AG, Leverkusen, Germany Objective:To compare the effectiveness, safety and tolerability of once-daily nifedipine and amlodipine treatment in patients with mild-to-moderate essential hypertension. Design: Randomised multicentre trial with an open comparison of treatments for 12 weeks, with a preceding placebo run-in period of 2 weeks (patients on beta-blockers at the time of enrolment entered a mandatory 2-week wash-out period before being allowed in the placebo run-in period; this wash-out period was one week for patients using any antihypertensive medication other than beta-blockers). Setting: Nine centres (all university hospitals) in Turkey. Patients: 155 patients with essential hypertension (diastolicblood pressure 95-109 mmHg). Interventions: Initial treatment (step 1) consisted of 30mg nifedipine GITS (n = 76; (Adalat-Crono tablets), or 5mg amlodipine (n = 79; Norvasc* 5-mg tablets), either administered once daily, as a morning dose, or if the blood pressure was not below 140/90 mmHg, or the reduction in diastolic blood pressure was lower than 10 mmHg after a treatment period of 6 weeks, the dose was increased (Step 2) to 60 mg once daily in the nifedipine group, or 10 mg once daily in the amlodipine group. Main efficacy parameter: Diastolic blood pressure at trough after 12 weeks of active compound therapy adjusted to baseline. Results: After 12 weeks of treatment, the mean diastolic blood pressure was 83.1 and 81.9 mmHg, in the nifedipine and amlodipine groups, respectively (p = 0.436). The mean decrease in systolic blood pressure (28.5 ± 11.9 and 28.2 ± 11.2 mmHg in the nifedipine and amlodipine groups, respectively) and the mean decrease in diastolic blood pressure (16.4 ± 7.0 and 17.5 ± 6.9 mmHg in the nifedipine and amlodipine groups, respectively), as well as the respon