PMID- 17050502
OWN - NLM
STAT- MEDLINE
DCOM- 20070129
LR  - 20191110
IS  - 0741-238X (Print)
IS  - 0741-238X (Linking)
VI  - 23
IP  - 4
DP  - 2006 Jul-Aug
TI  - Tolerability to 1-year treatment with once-daily molsidomine in patients with 
      stable angina.
PG  - 601-14
AB  - Prolonged-release molsidomine 16 mg once daily) QD (has proved effective in the 
      short-term treatment of patients with stable angina. The purpose of this 
      multicenter study was to assess its long-term tolerability and clinical 
      effectiveness. A total of 320 patients with stable angina were treated for 1 year 
      with molsidomine 16 mg QD administered open label as monotherapy or add-on 
      therapy, when beta blockers and/or calcium antagonists were prescribed 
      concomitantly) in 128 patients, ie, 40% of cases), depending on the severity of 
      disease and/or local therapeutic policies. In all, 293 patients (91.6%) completed 
      the study. The proportion of patients who reported drug-related adverse events 
      (AEs) was 9.1%, which is not significantly different (P=.13) from the 5.9% 
      observed during previous short-term (2-4 wk) treatment. Headache accounted for 
      80.6% of all drug-related AEs and required discontinuation of the drug in one 
      quarter of patients who reported the symptom (ie, 1.9% of the 320 patients 
      involved in the study). No serious drug-related AEs occurred during the study. 
      Tolerability to molsidomine, evaluated with use of a visual analog scale (VAS), 
      improved by 20% from beginning to end of 1-year follow-up. Two-by-two 
      Bonferroni's comparisons were significant at the .05 level between the 2-month 
      assessment and assessments performed at 8, 10, and 12 months. No age-time 
      interaction was noted (P=.82). Heart rate, blood pressure, electrocardiogram, and 
      blood parameters showed no statistically significant or clinically relevant 
      changes during the study. Compliance with treatment was satisfactory throughout 
      the follow-up period. There was no significant change in the weekly frequency of 
      anginal attacks and consumption of short-acting nitroderivatives during the 
      1-year study (P=.07 and P=.12,respectively), but their frequency was 
      significantly (ie, approximately 50%) lower than during a preceding short-term 
      treatment period (P<.0001 and P=.014, respectively). Subjective clinical status, 
      evaluated through an appropriate VAS, improved by 38% from start to end of 1-year 
      follow-up. Bonferroni's comparisons between baseline and subsequent 2-month 
      evaluations were all significant at the .05 level. No age-time interaction could 
      be seen for frequency of anginal attacks and consumption of short-acting 
      nitroderivatives, nor for clinical status )P=.10, P=.11, and P=.51, 
      respectively). Neither tolerability to molsidomine nor effectiveness of the drug 
      was biased by concomitant antianginal therapies, insofar as none of these 
      parameters showed a significant treatment type (ie, molsidomine administered as 
      monotherapy or add-on therapy)-time interaction (VAS for tolerability: P=.44; 
      angina: P=.39; nitroderivatives: P=.72; VAS for clinical status: P=.62). 
      Molsidomine 16 mg QD administered for 1 y to patients with stable angina was well 
      tolerated and remained effective during the entire treatment period, independent 
      of age and concomitant antianginal therapy.
FAU - Messin, Roger
AU  - Messin R
AD  - Therabel Pharma SA/NV, Brussels, Belgium.
FAU - Bruhwyler, Jacques
AU  - Bruhwyler J
FAU - Dubois, Claude
AU  - Dubois C
FAU - Famaey, Jean-Pierre
AU  - Famaey JP
FAU - Geczy, Joseph
AU  - Geczy J
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Adv Ther
JT  - Advances in therapy
JID - 8611864
RN  - 0 (Adrenergic beta-Antagonists)
RN  - 0 (Calcium Channel Blockers)
RN  - 0 (Vasodilator Agents)
RN  - D46583G77X (Molsidomine)
MH  - Adrenergic beta-Antagonists/therapeutic use
MH  - Adult
MH  - Aged
MH  - Angina Pectoris/*drug therapy
MH  - Calcium Channel Blockers/therapeutic use
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  - Time Factors
MH  - Vasodilator Agents/administration & dosage/adverse effects/*therapeutic use
EDAT- 2006/10/20 09:00
MHDA- 2007/01/30 09:00
CRDT- 2006/10/20 09:00
PHST- 2006/10/20 09:00 [pubmed]
PHST- 2007/01/30 09:00 [medline]
PHST- 2006/10/20 09:00 [entrez]
AID - 519 [pii]
AID - 10.1007/BF02850048 [doi]
PST - ppublish
SO  - Adv Ther. 2006 Jul-Aug;23(4):601-14. doi: 10.1007/BF02850048.