PMID- 17542346
OWN - NLM
STAT- MEDLINE
DCOM- 20070626
LR  - 20190608
IS  - 0946-1965 (Print)
IS  - 0946-1965 (Linking)
VI  - 45
IP  - 5
DP  - 2007 May
TI  - Comparative clinical study of the efficacy and safety of a S-metoprolol ER tablet 
      versus a racemate metoprolol ER tablet in patients with chronic stable angina.
PG  - 253-8
AB  - OBJECTIVE: To compare the efficacy and safety of a S-metoprolol extended release 
      (ER) tablet (50 mg) versus a racemate metoprolol ER tablet (100 mg) in the 
      management of angina. METHODS: An open-label, prospective, comparative study in a 
      clinical setting was conducted in Indian patients. Patients (n = 50 in each 
      group) with a history of angina pectoris, with or without hypertension, were 
      administered study medications in a sequential 1:1 manner once daily for 8 weeks. 
      The primary efficacy variable was a mean change from baseline in the number of 
      angina attacks. The secondary efficacy variables were: mean change from baseline 
      in the proportion of patients with no angina attacks, systolic blood pressure, 
      diastolic blood pressure, heart rate, and proportion of blood pressure 
      responders. Number of patients reporting adverse effects (AEs) and severity of 
      AEs in both of the groups were compared. RESULTS: All patients (n = 100) 
      completed the study. In the S-metoprolol group the number of angina attacks (mean 
      +/- SEM) at baseline and after 2, 4 and 8 weeks of therapy were 6.3 +/- 0.8, 3 
      +/-0.4, 1.8 +/- 0.4 and 0.7 +/- 0.2, respectively. In the metoprolol group these 
      values were 5.8 +/-1, 3 +/- 0.7, 1.4 +/- 0.3 and 0.7 +/- 0.2, respectively. The 
      reduction in the number of angina attacks from baseline was significant (p < 
      0.0001) in both groups with no between-group difference. The response rate in 
      angina (percentage of patients completely relieved of angina attacks clinically) 
      was greater in the S-metoprolol group (72%) when compared to the metoprolol group 
      (62%) (p > 0.05, NS). Both study groups showed significant (p < 0.0001) reduction 
      in baseline systolic blood pressure (SBP), diastolic blood pressure (SBP) and 
      heart rate (HR) in hypertensive patients and a clinically non-significant (p > 
      0.05, NS) change in normotensive patients. Among hypertensive patients, the 
      response rate in angina was higher in the S-metoprolol group (74%) when compared 
      to the metoprolol group (61%) (p > 0.05, NS). In the S-metoprolol group four 
      patients reported AEs: fatigue (n = 4), dry mouth (n = 1), dizziness (n = 1), 
      dyspnea (n = 2), and mild rash (n = 1). In the metoprolol group three patients 
      reported AEs: fatigue (n = 2), dyspnea (n = 1) and dizziness (n = 1). No 
      statistically significant difference was detected between the groups in AE 
      frequency/severity. CONCLUSION: In routine clinical practice in the management of 
      angina (with or without coexisting hypertension), S-metoprolol administered at 
      half the dose of the racemate, shows similar efficacy, safety and a trend towards 
      a higher response rate.
FAU - Aneja, P
AU  - Aneja P
AD  - Care and Cure, New Delhi. pankajaneja@hotmail.com
FAU - Srinivas, A
AU  - Srinivas A
FAU - Biswas, A Das
AU  - Biswas AD
LA  - eng
PT  - Clinical Trial
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PL  - Germany
TA  - Int J Clin Pharmacol Ther
JT  - International journal of clinical pharmacology and therapeutics
JID - 9423309
RN  - 0 (Adrenergic beta-Antagonists)
RN  - 0 (Delayed-Action Preparations)
RN  - GEB06NHM23 (Metoprolol)
SB  - IM
MH  - Adrenergic beta-Antagonists/administration & dosage/*adverse effects/*therapeutic 
      use
MH  - Aged
MH  - Analysis of Variance
MH  - Angina Pectoris/*drug therapy
MH  - Blood Pressure/drug effects
MH  - Chronic Disease
MH  - Delayed-Action Preparations/therapeutic use
MH  - Female
MH  - Heart Rate/drug effects
MH  - Humans
MH  - Hypertension/complications
MH  - India
MH  - Male
MH  - Metoprolol/administration & dosage/*adverse effects/*therapeutic use
MH  - Middle Aged
MH  - Prospective Studies
MH  - Stereoisomerism
EDAT- 2007/06/05 09:00
MHDA- 2007/06/27 09:00
CRDT- 2007/06/05 09:00
PHST- 2007/06/05 09:00 [pubmed]
PHST- 2007/06/27 09:00 [medline]
PHST- 2007/06/05 09:00 [entrez]
AID - 10.5414/cpp45253 [doi]
PST - ppublish
SO  - Int J Clin Pharmacol Ther. 2007 May;45(5):253-8. doi: 10.5414/cpp45253.