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Title: Bupropion XL and Venlafaxine XR for Treatment of Major Depression: Presented at APA

"Bupropion XL and Venlafaxine XR for Treatment of Major Depression: Presented at APA"

By Danny Kucharsky TORONTO, CANADA -- May 25, 2006 -- Sexual functioning worsened in patients with major depressive disorder (MDD) treated with venlafaxine XR but improved in depressed patients treated with bupropion XL, finds a study presented here. The 12-week, multicenter, randomized, double-blind, double-dummy, active-controlled, escalating-dose study was presented here on May 23[^rd at the American Psychiatric Association Annual Meeting (APA).

The study compared the effects of bupropion XL (150-450 mg/day) and venlafaxine XR (75-225 mg/day) on sexual functioning, antidepressant efficacy, and tolerability.

"In previous trials, bupropion was not considered [in MDD]," and head-to-head comparisons between once-daily bupropion XL and venlafaxine XR were lacking, said investigator Anita Clayton, MD, medical director, University of Virginia Center for Psychiatric Clinical Research, University of Virginia Health System, Charlottesville, Virginia.

The study included a 1- to 2-week screening phase, a 12-week treatment phase, a 2-week taper phase, and a 1-week observational phase.

The researchers enrolled 342 patients with moderate to severe MDD in the safety population; 168 on bupropion and 174 on venlafaxine XR. The study was completed by 211 patients (62%); 105 in the bupropion XL group (63%) and 106 in the venlafaxine XR group (61%).

As measured with the Changes in Sexual Functioning Questionnaire (CSFQ), sexual functioning worsened in venlafaxine XR-treated patients relative to bupropion XL-treated patients. Differences between treatments in CSFQ total score were statistically significant and favored bupropion XL beginning at week 2 to week 12 (P <.05).

There were no significant differences observed between the 2 study drugs in HAMD-17 mean total scores at any point during the study.

Remission rates favored bupropion XL over venlafaxine XR at week 12 (46% vs 33%, respectively; 95% Confidence Interval [CI] = 1.07, 3.46). Favorable remission rates "is really what you're trying to get," Dr. Clayton noted.

Adverse events reported by more than 5% of patients in either treatment group during the treatment phase was greater with venlafaxine XR for 15 of 19 adverse events and with bupropion XL for 4 of 19 adverse events. Dr. Clayton said she would expect differences in adverse effects "because of the different mechanisms of action" of the 2 drugs.

Anxiety symptoms and depression endpoints improved equally well in both groups, with the exception of remission rates, which favored bupropion XL, Dr. Clayton said.

Both drugs were generally well tolerated, except for venlafaxine XR's negative impact on sexual functioning, she said.

The study was sponsored by GlaxoSmithKline.

[Presentation title: A Comparison of Bupropion XL With Venlafaxine XR for the Treatment of MDD: An Evaluation of the Relative Effects on Sexual Functioning, Efficacy, Safety, and Tolerability. Abstract NR600]

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