title: A randomised, double-blind trial comparing mibefradil and amlodipine: two long-acting calcium antagonists with similar efficacy but different tolerability profiles. Mibefradil International Study Group.
abstract: OBJECTIVE
  To compare the efficacy and tolerability of mibefradil and amlodipine in patients with uncomplicated mild-to-moderate essential hypertension.
  
  
  METHODS
  A double-blind, randomised, parallel group multicentre trial.
  
  
  METHODS
  239 patients received 50 mg mibefradil or 5 mg amlodipine for 4 weeks, followed by a forced titration to 100 mg mibefradil or 10 mg amlodipine for an additional 8 weeks. Patients then entered a 4-week withdrawal period either on therapy or switched to placebo.
  
  
  RESULTS
  Statistically equivalent reductions in trough sitting diastolic blood pressure (SDBP) were observed after 12 weeks of once-daily treatment with 50/100 mg mibefradil (-11.5 +/- 8.2 mm Hg) and 5/10 mg amlodipine (-13.2 +/- 7.9 mm Hg). The number of patients with normalised SDBP (< or = 90 mm Hg) increased 23.3% in the mibefradil group and 19.5% in the amlodipine group (approximately 74% in both groups). Patients on mibefradil or amlodipine during the withdrawal period had significantly larger decreases in SDBP than those on placebo. Patients on mibefradil had a decrease in heart rate of 5.5 bpm. Patients on amlodipine had no change in heart rate; however, cessation of amlodipine was associated with a decrease in heart rate.
  
  
  CONCLUSIONS
  Mibefradil was as effective as amlodipine in reducing BP; both compounds were effective treatments of hypertension.
authors.affiliation: Barzilai Medical Center, Ashkelon, Israel.
authors.forename: R J
authors.initials: RJ
authors.lastname: Viskoper
authors.forename: P J
authors.initials: PJ
authors.lastname: Bernink
authors.forename: A
authors.initials: A
authors.lastname: Schelling
authors.forename: A B
authors.initials: AB
authors.lastname: Ribeiro
authors.forename: I M
authors.initials: IM
authors.lastname: Kantola
authors.forename: M R
authors.initials: MR
authors.lastname: Wilkins
authors.forename: I
authors.initials: I
authors.lastname: Kobrin
mesh_terms: D000328:Adult; D000368:Aged; D017311:Amlodipine / Q000009:adverse effects / Q000627:therapeutic use*; D001562:Benzimidazoles / Q000009:adverse effects / Q000627:therapeutic use*; D002121:Calcium Channel Blockers / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006973:Hypertension / Q000188:drug therapy*; D008297:Male; D020748:Mibefradil; D008875:Middle Aged; D013764:Tetrahydronaphthalenes / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D001562:Benzimidazoles; D002121:Calcium Channel Blockers; D013764:Tetrahydronaphthalenes; D017311:Amlodipine; D020748:Mibefradil