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Title: Sertraline HCl and Venlafaxine-XR Show Comparable Efficacy in Major Depression: Presented at CINP

"Sertraline HCl and Venlafaxine-XR Show Comparable Efficacy in Major Depression: Presented at CINP"

By Jill Stein PARIS, FRANCE -- June 23, 2004 -- Sertraline HCl (Zoloft), a selective serotonin reuptake inhibitor (SSRI), is as effective as venlafaxine-XR (Effexor-XR), a serotonin norepinephrine reuptake inhibitor (SNRI), in treating patients with major depressive disorder (MDD). The findings were reported here on June 23rd at the XXIV Collegium Internationale Neuro-Psychopharmacologicum Congress. Results showed that patients treated with sertraline HCl or venlafaxine-XR had similar response and remission rates in addition to similar quality of life improvements. "While it is commonly believed that dual-action agents like venlafaxine-XR are more effective than single-action agents like sertraline HCl, our study strongly demonstrates that this is not the case," said Tom George, MD, Clinical Associate Professor of Psychiatry, University of Queensland, Brisbane, Australia, and Staff Psychiatrist, Northwest Specialist Centre, Everton Park, one of the study sites. In the double-blind trial, 163 outpatients with MDD as defined by Diagnostic and Statistical Manual – Revision IV criteria were randomized to 8 weeks of treatment with sertraline HCl 50 to 150 mg/day or venlafaxine-XR 75 to 225 mg/day followed by a 2-week taper period. The primary efficacy end point was quality of life, which was assessed by the widely validated Quality of Life Enjoyment & Satisfaction Questionnaire (Q-LES-Q). The secondary efficacy measures included the Hamilton Rating Scale for Depression (HAM-D) and Clinical Global Impression Improvement Scale (CGI-I). Response was defined as a 50% or greater decrease in HAM-D scores. The study found similar quality of life improvements in both groups (16.8 versus 17.5, P =.74).. Response rates were 71% in sertraline HCl-treated patients and 71% in venlafaxine-XR-treated patients (P =.57). Remission rates were 60% and 54% in the two groups, respectively (P =.47). While both treatments were similarly well tolerated in the acute treatment phase, discontinuation rates were 16% in the sertraline cohort versus 30% in the venlafaxine-XR cohort (P =.06). Venlafaxine-XR significantly increased supine systolic and diastolic blood pressure compared to sertraline HCl (P =.056). "While the blood pressure increase associated with venlafaxine-XR treatment was not significant enough to warrant stopping treatment, it is important to remember that these patients had normal blood pressure before treatment," Dr. George said. "So patients treated with venlafaxine-XR should probably have their blood pressure closely monitored throughout treatment." In a subgroup analysis of severely depressed patients, response rates were similar in the sertraline HCl and venlafaxine-XR groups (71% versus 71%, respectively, P =.82). Remission rates were also similar (63% versus 52%, respectively, P =.27). Comparable response and remission rates were also noted in a subgroup of patients with anxious-depression, a common clinical subtype of MDD that is associated with both a greater severity of illness and functional impairment. Major depressive disorder is a common, chronic, and recurring mood disorder, with a lifetime prevalence of 5% to 12% in men and 10% to 25% in women. The study was supported by Pfizer Inc. [Presentation titles: "Tolerability and Discontinuation Effects for Sertraline Versus Venlafaxine-XR in Depression." Abstract #P01.05. "Comparative Efficacy of Sertraline and Venlafaxine-XR in Major Depression." Abstract #P01.116. "Comparative Efficacy of Sertraline Versus Venlafaxine-XR in Anxious Depression." Abstract #P01.246. "Comparative Efficacy of Sertraline Versus Venlafaxine-XR in Severe Depression." Abstract #P02.172]

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