title: Treatment of mild-to-moderate hypertension with calcium channel blockers: a multicentre comparison of once-daily nifedipine GITS with once-daily amlodipine.
abstract: 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 dihydropyrldine derivatives. However, the value of nifedipine GITS(Adalat-Crono), the long-acting dihydropyrldine, is in need of being re-established.
  
  
  OBJECTIVE
  To compare the effectiveness, safety and tolerability of once-daily nifedipine and amlodipine treatment in patients with mild-to-moderate essential hypertension.
  
  
  METHODS
  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 enrollment 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).
  
  
  METHODS
  Nine centres (all university hospitals) in Turkey.
  
  
  METHODS
  155 patients with essential hypertension(diastolic blood pressure 95-109 mmHg).
  
  
  METHODS
  Initial treatment (step 1) consisted of 30 mg nifedipine GlTS (n = 76; (Adalat-Crono tablets), or 5 mg amlodipine (n = 79; Norvasct5-mg tablets), either administered once daily, as a morning dose, or f 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 nifadipine and amlodipine groups, respectively) and the mean decrease in diastolic blood pressure (16.4A +/- 7.0 and 17.5 +/- 6.9 mmHg in the nifedipine and amlodipine groups, respectively), as well as the responder rates (88.1%and 92.1%, in the nifediplne and amlodipine groups, respectively) were comparable at the end of the study. No significant differences between groups were detected In the efficacy parameters assessed in this study. Both drugs were well tolerated. The overall incidence of adverse events was 7.9% in the nifadipine group and 10.1% In the amlodipine group. However, more patients discontinued treatment prematurely in the amlodipine group (13 patients; 19.7%), than in the nifedipine group (four patients; 5.6%).
  
  
  CONCLUSIONS
  The results of this study demonstrated that once-daily nifedipine in GITS formation and amlodipine are comparably safe and effective treatment options in patients with mild-to-moderate essential hypertension.
authors.affiliation: Department of Cardiology, Hacettepe University Faculty of Medicine, Ankara, Turkey.
authors.forename: Sirri
authors.initials: S
authors.lastname: Kes
authors.forename: Nail
authors.initials: N
authors.lastname: Caglar
authors.forename: Aykan
authors.initials: A
authors.lastname: Canberk
authors.forename: Necmi
authors.initials: N
authors.lastname: Deger
authors.forename: Mustafa
authors.initials: M
authors.lastname: Demirtas
authors.forename: Halis
authors.initials: H
authors.lastname: Dortlemez
authors.forename: Bulent
authors.initials: B
authors.lastname: Kiliccioglu
authors.forename: Omer
authors.initials: O
authors.lastname: Kozan
authors.forename: Kenan
authors.initials: K
authors.lastname: Ovunc
authors.forename: Cuneyt
authors.initials: C
authors.lastname: Turkoglu
mesh_terms: D000328:Adult; D000368:Aged; D017311:Amlodipine / Q000008:administration & dosage*; D001794:Blood Pressure / Q000187:drug effects; D002121:Calcium Channel Blockers / Q000008:administration & dosage*; D004334:Drug Administration Schedule; D004361:Drug Tolerance; D005260:Female; D006801:Humans; D006973:Hypertension / Q000188:drug therapy* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D009543:Nifedipine / Q000008:administration & dosage*; D012449:Safety
chemical_list: D002121:Calcium Channel Blockers; D017311:Amlodipine; D009543:Nifedipine