Paroxetine Response and Tolerability Among Ethnic Minority Patients With Mood or Anxiety Disorders:A Pooled Analysis

Peter P. Roy-Byrne, M.D.; Philip Perera, M.D.; Cornelius D. Pitts, Pharm.D.; and Jacquie A. Christi, M.Sc.

Background: Because of the poor quality of mental health care received by minorities, analyses documenting comparable response to and tolerability of medications for anxiety and depression in large samples of minority and majority populations could increase the willingness of providers and patients to use medications in minority populations.

Method: A pooled analysis of 14,875 adults who participated in 104 double-blind, placebo-controlled paroxetine clinical trials investigating major depression, panic disorder, generalized anxiety disorder, social anxiety disorder, obsessive-compulsive disorder, posttraumatic stress disorder, or premenstrual dysphoric disorder from March 1984 through March 2002. An intent-to-treat analysis with last observation carried forward used the Clinical Global Impressions (CGI) scale to measure dichotomous outcome, classified as either response (CGI score of 1 or 2) or more complete response (CGI score of 1) ("full response"). Minority group differences were examined using logistic regression for the entire sample and repeated for those with major depression. Adverse events greater than 5% and twice the rate of placebo were descriptively tabulated. Finally, a survival analysis examined group differences in speed of onset of response.

Results: Hispanic and Asian subjects had a slightly lower response rate, while Asians had the highest rates and Hispanics had the lowest rates of "full response." The more consistent Hispanic outcome differences appeared to be due to a higher placebo response rate. There was no treatment by minority group interaction for depressed patients. Speed of response and adverse effects were similar across groups.

Conclusions: There were few consistent differences in medication response and tolerability. These findings may serve to counteract the greater rate of negative attitudes toward medication use among minorities and reinforce the value of medications used to treat anxiety and depression in minorities.

(J Clin Psychiatry 2005;66:1228-1233)

Received Oct. 5, 2004; accepted March 28, 2005. From the Department of Psychiatry and Behavioral Sciences, University of Washington at Harborview Medical Center, Seattle (Dr. Roy-Byrne); GlaxoSmithKline, Philadelphia, Pa. (Drs. Perera and Pitts); and GlaxoSmithKline, Harlow, United Kingdom (Ms. Christi).

Dr. Roy-Byrne's time for literature review, data interpretation, and writing of this paper was supported by National Institute of Mental Health (NIMH) grant #1 K24 MH065324, "Treating Anxiety in Public Sector Medical Settings."

Dr. Roy-Byrne has received grant/research support from GlaxoSmithKline, Pfizer, and Forest and serves on the speakers or advisory boards of GlaxoSmithKline, Forest, Eli Lilly, Wyeth, Shire, Roche, Cephalon, and Pfizer. Dr. Perera was an employee of GlaxoSmithKline at the time of authorship. Dr. Pitts is an employee of GlaxoSmithKline Pharmaceuticals. Ms. Christi is an employee of and a major stock shareholder in GlaxoSmithKline.

We acknowledge Kevin Kane, M.Sc., for providing statistical assistance.

Corresponding author and reprints: Peter P. Roy-Byrne, M.D., Harborview Medical Center, Box 359911, 325 Ninth Ave., Seattle, WA 98104 (e-mail: roybyrne@u.washington.edu).