PMID- 16644612
OWN - NLM
STAT- MEDLINE
DCOM- 20060620
LR  - 20191109
IS  - 0741-238X (Print)
IS  - 0741-238X (Linking)
VI  - 23
IP  - 1
DP  - 2006 Jan-Feb
TI  - Efficacy and safety of once- and twice-daily formulations of molsidomine in 
      patients with stable angina pectoris: double-blind and open-label studies.
PG  - 107-30
AB  - Molsidomine, a sydnonimine acting as a heterocyclic direct nitric oxide donor, 
      has been used for many years in several European countries for the treatment of 
      patients with stable angina pectoris. The efficacy and tolerability of a novel 
      once-daily 16-mg formulation of molsidomine (M16) were compared with those of the 
      currently used twice-daily 8-mg molsidomine tablet (M8) in 666 patients. Study 1, 
      a multicenter, randomized, double-blind, placebo-controlled, twin crossover 
      study, involved 533 patients given acute and 2-week treatment with each drug 
      formulation. Study 2, a multicenter, open-label, sequential, add-on trial, 
      compared M16 and M8 in 133 patients. Drug effects on exercise capacity (study 1 
      only), frequency of anginal attacks and consumption of short-acting 
      itroderivatives, and incidence of adverse events (AEs) were evaluated. Compared 
      with placebo, M16 increased exercise capacity by 15% (P<.001) at the start of 
      study 1 and by 13% (P<.001) after 2 weeks' treatment, and was not inferior to M8. 
      In terms of anginal attack frequency and nitroderivative consumption, M16 was not 
      inferior to M8 in either study. Moreover, compared with M8, M16 produced a 
      statistically and clinically significant reduction in the incidence of anginal 
      attacks in elderly (>/=75 y) but not in younger patients (<75 y) (study 2), nor 
      in patients from study 1. No significant difference from M8 was found in either 
      study in short-acting nitroderivative consumption. No tolerance to M8 or M16 was 
      observed after 2-week treatment. No statistically significant differences in 
      incidences of all AEs and drug-related AEs were observed between M16 and M8 in 
      either study. The same held true for proportions of patients experiencing AEs and 
      drug-related AEs on M16 vs M8: in study 1-14.3% and 11.8% for all AEs (P=.218), 
      6.9% and 5.4% for drug-related AEs (P=.280); in study 2-1.3% and 1.3% for all 
      AEs, 0% and 1.3% for drug-related AEs (P>.10) in young patients; and in the 
      elderly, 3.6% and 0% for drug-related AEs (P>.10). Only the proportion of elderly 
      patients with all AEs was significantly higher with M16 than with M8: 14.5% vs 
      1.8% (P=.039). M16 once daily was effective and well tolerated in investigated 
      patients with stable angina pectoris, particularly the elderly, affording 24 
      hours of therapeutic activity. M16 was not inferior to M8 given twice daily in 
      terms of efficacy, safety profile, and tolerability.
FAU - Messin, Roger
AU  - Messin R
AD  - Therabel Pharma S.A./N.V., Brussels, Belgium.
FAU - Cerreer-Bruhwyler, Fabienne
AU  - Cerreer-Bruhwyler F
FAU - Dubois, Claude
AU  - Dubois C
FAU - Famaey, Jean-Pierre
AU  - Famaey JP
FAU - Geczy, Joseph
AU  - Geczy J
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Adv Ther
JT  - Advances in therapy
JID - 8611864
RN  - 0 (Delayed-Action Preparations)
RN  - 0 (Vasodilator Agents)
RN  - D46583G77X (Molsidomine)
RN  - G59M7S0WS3 (Nitroglycerin)
MH  - Aged
MH  - Aged, 80 and over
MH  - Angina Pectoris/*drug therapy
MH  - Cross-Over Studies
MH  - Delayed-Action Preparations
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Drug Therapy, Combination
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Molsidomine/administration & dosage/adverse effects/*therapeutic use
MH  - Nitroglycerin/administration & dosage/therapeutic use
MH  - Patient Compliance
MH  - Vasodilator Agents/administration & dosage/adverse effects/*therapeutic use
EDAT- 2006/04/29 09:00
MHDA- 2006/06/21 09:00
CRDT- 2006/04/29 09:00
PHST- 2006/04/29 09:00 [pubmed]
PHST- 2006/06/21 09:00 [medline]
PHST- 2006/04/29 09:00 [entrez]
AID - 453 [pii]
AID - 10.1007/BF02850352 [doi]
PST - ppublish
SO  - Adv Ther. 2006 Jan-Feb;23(1):107-30. doi: 10.1007/BF02850352.