Rash in multicenter trials of lamotrigine in mood disorders: Clinical relevance and management

被引:121
作者
Calabrese, JR
Sullivan, JR
Bowden, CL
Suppes, T
Goldberg, JF
Sachs, GS
Shelton, MD
Goodwin, FK
Frye, MA
Kusumakar, V
机构
[1] Dalhousie Univ, Dept Psychiat, Halifax, NS, Canada
[2] Univ Calif Los Angeles, Dept Psychiat, Los Angeles, CA USA
[3] Georgetown Univ, Dept Psychiat, Washington, DC USA
[4] Harvard Univ, Sch Med, Dept Psychiat, Boston, MA 02115 USA
[5] Cornell Univ, Weill Med Coll, Dept Psychiat, New York, NY USA
[6] Univ Texas, SW Med Ctr, Bipolar Disorder Clin, Dallas, TX 75230 USA
[7] Univ Texas, Hlth Sci Ctr, Dept Psychiat, San Antonio, TX USA
[8] Univ Sydney, Westmead Hosp, Dept Dermatol, Sydney, NSW 2006, Australia
[9] Case Western Reserve Univ, Univ Hosp Cleveland, Dept Psychiat, Cleveland, OH 44106 USA
关键词
D O I
10.4088/JCP.v63n1110
中图分类号
B849 [应用心理学];
学科分类号
040203 ;
摘要
Background: The rate of lamotrigine-associated rash in patients with mood disorders has not been well characterized. The objective of this report was to determine rash rates in clinical trials of lamotrigine in DSM-IV unipolar depression or bipolar disorder. Method: A retrospective analysis was conducted of rates of lamotrigine-related rash in 12 multicenter studies, including 1 open study, 7 randomized controlled acute trials, and 4 randomized controlled maintenance trials from 1996 to 2001. Results: A total of 1955 patients were treated with lamotrigine in open-label settings (open-label phases preceding or following randomization and 1 stand-alone open-label study); 1198 patients received lamotrigine in controlled settings, and 1056 patients received placebo. In controlled settings, rates of benign rash were 8.3% and 6.4% in lamotrigine- and placebo-treated patients, respectively. Rates of serious rash were 0% with lamotrigine, 0.1% (N = 1) with placebo, and 0% with comparators. In the open-label setting the overall rate of rash for lamotrigine was 13.1% (N = 257) and of serious rash, 0.1% (N = 2). One mild case of Stevens-Johnson syndrome not requiring hospitalization occurred in a patient treated with lamotrigine. There were no cases of toxic epidermal necrolysis in any setting. Conclusion: Serious drug eruptions associated with lamotrigine were rare. Although rash is a potentially life-threatening reaction, the risk of serious rash due to lamotrigine should be weighed against more common risks associated with untreated or undertreated bipolar depression.
引用
收藏
页码:1012 / 1019
页数:8
相关论文
共 34 条
[1]  
ASCHER J, 2001, 154 ANN M AM PSYCH A, P108
[2]   Successful re-introduction of lamotrigine after initial rash [J].
Besag, FMC ;
Ng, GYT ;
Pool, F .
SEIZURE-EUROPEAN JOURNAL OF EPILEPSY, 2000, 9 (04) :282-286
[3]  
BOWDEN C, 2000, 39 ANN M AM COLL NEU, P291
[4]  
BOWDEN CL, IN PRESS ARCH GEN PS
[5]   A double-blind placebo-controlled study of lamotrigine monotherapy in outpatients with bipolar I depression [J].
Calabrese, JR ;
Bowden, CL ;
Sachs, GS ;
Ascher, JA ;
Monaghan, E ;
Rudd, GD .
JOURNAL OF CLINICAL PSYCHIATRY, 1999, 60 (02) :79-+
[6]  
Calabrese JR, 1999, AM J PSYCHIAT, V156, P1019
[7]   A double-blind, placebo-controlled, prophylaxis study of lamotrigine in rapid-cycling bipolar disorder [J].
Calabrese, JR ;
Suppes, T ;
Bowden, CL ;
Sachs, GS ;
Swann, AC ;
McElroy, SL ;
Kusumakar, V ;
Ascher, JA ;
Earl, NL ;
Greene, PL ;
Monaghan, ET .
JOURNAL OF CLINICAL PSYCHIATRY, 2000, 61 (11) :841-850
[8]   Adding lamotrigine to valproate: Incidence of rash and other adverse effects [J].
Faught, E ;
Morris, G ;
Jacobson, M ;
French, J ;
Harden, C ;
Montouris, G ;
Rosenfeld, W .
EPILEPSIA, 1999, 40 (08) :1135-1140
[9]  
Fervenza FC, 2000, AM J KIDNEY DIS, V36, P1034
[10]   A placebo-controlled study of lamotrigine and gabapentin monotherapy in refractory mood disorders [J].
Frye, MA ;
Ketter, TA ;
Kimbrell, TA ;
Dunn, RT ;
Speer, AM ;
Osuch, EA ;
Luckenbaugh, DA ;
Corá-Locatelli, G ;
Leverich, GS ;
Post, RM .
JOURNAL OF CLINICAL PSYCHOPHARMACOLOGY, 2000, 20 (06) :607-614