EFFICACY AND TOLERABILITY OF VENLAFAXINE EXTENDED RELEASE IN PATIENTS WITH MAJOR DEPRESSIVE DISORDER

Background: In this study we wanted to determine the efficacy and tolerability of venlafaxine extended release in patients with major depressive disorder. Subjects and methods: 161 patients with major depressive disorder were included in an open-label, multicentre clinical study. All patients were treated with venlafaxine extended release in flexible doses ranging from 75 to 325 mg daily over an 8-week period. Efficacy measurements included the 17-item Hamilton Depression Scale, the Clinical Global Impression-Improvement scale (CGI-I), the Severity of Illness scale (CGI-S), and the Depression and Somatic Symptom Scale (DSSS). All scales were administered at baseline and at weeks 2, 4 and 8. Results: A total of 148 (91.2%) patients completed the study. After 8 weeks of treatment with venlafaxine extended release, response and remission rates were 93% and 45% respectively. At the end of the study, 52.7% of patients were rated on CGI-S with 2 or 1 (not ill/mildly ill) and on CGI-I 81.1% of patients were rated by the physician as much/very much improved. The severity of somatic symptoms such as headache, back pain, chest pain, tenderness of more than a half of body muscles, and fatigue or loss of energy decreased towards the end of the study (p<.0001). Adverse events caused discontinuation in 4.7% of patients. No significant changes of body mass (p=.237), Body Mass Index (p=.281), and heart rate (p=.840) were present, but systolic and diastolic blood pressure significantly decreased (p<.0001) towards the end of the study. Conclusion: The data from this study indicate that venlafaxine XR is an efficient and safe therapeutic option for patients with major depressive disorder, with the additional effect of reducing associated painful physical symptoms.