Abstract
Objective:
This post hoc analysis examined efficacy and tolerability of open-label desvenlafaxine in patients with major depressive disorder switched from blinded placebo, venlafaxine extended release (ER), or desvenlafaxine.
Research design and methods:
Patients who completed 8 weeks of double-blind therapy with placebo (n = 176), venlafaxine ER (n = 175), or desvenlafaxine (n = 143) enrolled in a 10-month, open-label extension study and received desvenlafaxine 200 to 400 mg/d. Efficacy (17-item Hamilton Depression Rating Scale [HDRS17]) was assessed separately for nonresponders and responders to double-blind treatment. Tolerability during the first month of open-label desvenlafaxine was assessed.
Results:
Among nonresponders (n = 134) to double-blind placebo, venlafaxine ER, and desvenlafaxine, mean decreases in HDRS17 scores were −10.9, −7.3, and −7.7, respectively; HDRS17 response rates were 67%, 53%, and 48%, respectively. Although responders (n = 360) to double-blind placebo, venlafaxine ER, and desvenlafaxine had more modest decreases on the HDRS17, response rates were higher (84%, 87%, and 83%, respectively). Rates of adverse events were highest during week 1, and decreased afterward for the remainder of the first month of treatment.
Conclusions:
Among nonresponders to 8 weeks of double-blind venlafaxine ER, desvenlafaxine, or placebo, 48% to 67% subsequently responded to open-label desvenlafaxine. Over 80% of responders to double-blind therapy maintained response on open-label desvenlafaxine. The switch from venlafaxine ER to desvenlafaxine was well tolerated.
Transparency
Declaration of funding
This analysis was sponsored by Wyeth Research, Collegeville, PA, USA, which was acquired by Pfizer Inc. in October 2009.
Declaration of financial/other relationships
C.J.G.-P., Q.J., and P.T.N. are employees of Pfizer Inc., formerly Wyeth Research, and own stock in Pfizer, formerly Wyeth. M.E.T. has been an advisory/consultant for AstraZeneca, Bristol-Myers Squibb, Lilly, Forest, GlaxoSmithKline, Janssen, MedAvante, Neuronetics, Novartis, Schering-Plough, Shire US, Supernus, Transcept, and Pfizer, formerly Wyeth; has received grants from Lilly, GlaxoSmithKline, the National Institute of Mental Health, and Sepracor; has been on the speakers bureau for AstraZeneca, Bristol-Myers Squibb, Lilly, and Pfizer, formerly Wyeth; holds equity in MedAvante; and receives royalties from American Psychiatric Press, Guilford Publications, Herald House, and WW Norton. M.E.T.’s spouse is an employee of Embryon, LLC, A Division of Advanced Health Media, LLC (formerly Medesta Publications Group, A Business of Advogent).
Acknowledgments
This analysis was sponsored by Wyeth Research, Collegeville, PA, USA, which was acquired by Pfizer Inc. in October 2009. Medical writing support was funded by Pfizer and provided by Sherri Jones, PharmD, of Embryon, LLC, A Division of Advanced Health Media, LLC.
This analysis was previously presented at the American Psychiatric Association annual meeting, Washington, DC, USA, May 3–8, 2008; the American Psychiatric Association annual meeting, San Diego, CA, USA, May 19–24, 2007 and the U.S. Psychiatric and Mental Health congress, Orlando, FL, USA, Oct 11–14, 2007.