medigraphic.com
ISSN 1561-2988 (Print)

2011, Number 1

<< Back Next >>

Rev Cubana Farm 2011; 45 (1)

Pharmaceutical surveillance of sertraline in Cuban patients affected by major depression episode

Pérez RL; Ramos CAM; Cordero JJR; Fernández LOI

Language: Spanish
References: 20
Page: 69-75
PDF size: 53.98 Kb.


ABSTRACT

Some predominant symptoms in depression are lack of interest, fatigue, feeling of uselessness, lack of concentration, desire of being dead and insomnia. One of the drugs to treat this illness is Sertraline. For the purpose of evaluating its safety, 40 medical histories and data collection logs with information on patients included in a double-blind, controlled, randomized phase III clinical trial "Use of Sertraline in patients suffering episodes of great depression" were reviewed. These patients were seen at "Gustavo Aldereguía Lima" hospital. Demographic, clinical and adverse event data were obtained to undertake a descriptive, observational and cross-sectional study, which was classified as a study of practical consequences of drug use. The information was analyzed by SPSS, 13.0 version for Windows software. Of the 40 patients, 24 presented with adverse events for 60 %; 16 (67 %) came from the Sertraline-treated group and 8 (33 %) from the placebo group. The most frequent adverse events were loss of weight, dry mouth, headache, diarrheas and nauseas. Most of them were mild, probable causality and treatment was not required. The use of this drug was regarded as safe in treating this type of patients.


REFERENCES

  1. Del Rio J. Fármacos antidepresivos y antimaníacos. En: Florez J. Farmacología humana. Cap. 32. Madrid: Ed: Masson; 2001. p. 549, 551-3.

  2. Kaplan HI, Sadock BJ. Terapias biológicas. En: Kaplan HI, Sadock BJ. Sinopsis de Psiquiatría. 7ma ed. México, DF: Editorial Médica Panamericana; 1996. p. 884-905.

  3. Kessler RC, McGonagle KA, Zhao S. Lifetime and 12-month prevalence of DSMII- R pschyatric disorders in United States. Results from the National Comorbidity Survey. Arh Gen Psychiatry. 1994;51(1):8-19.

  4. Colectivo de autores. CIE-10. Trastornos mentales y del comportamiento. Pautas diagnósticas y de actuación en la atención primaria. Madrid: OMS; 1996.

  5. Vademecum de Psiquiatría. Colección Científica en Neurociencias. Ciudad de Guatemala: Editorial Medita; 1998.

  6. Parikh S, Lam R and the CANMAT Depression Workgroup. Definitions, prevalence and health burden: clinical guidelines for the treatment of depressive disorders. Can J Psychiatry. 2001;46 Suppl 1:13S-20S.

  7. Ballenger JC. Anxiety and depression: optimizing treatments. Primary Care Companion J Clin Psychiatry. 2000 June;2(3):71-9.

  8. Preskorn SH. Clinical Pharmacology of the selective serotonin reuptake inhibitors. Washington: Professional Communications, Inc.; 1996.

  9. Preskorn SH, Lane RM. Sertraline 50 mg daily: the optimal dose in the treatment of depression. Int Clin Psychopharmacol. 1995;10(3):129-41.

  10. Cipla [homepage on the internet]. Medical Catalog. Serdep Tablets. [citado 16 Nov 2006]. [aprox. 2 pantallas]: Disponible en: http://www.cipla.com/admin.php?mode=cat&action=disp&parentid=2&catid=37

  11. Laporte JR, Capella D. Mecanismos de producción y diagnóstico clínico de los efectos indeseables producidos por medicamentos. En: Laporte JR, Tognoni G. Principios de epidemiología del medicamento. 2da ed. Barcelona: Masson-Salvat; 1993. p. 105.

  12. Moscovitch A, Blashko CA, Eagles JM, Darcourt G, Thompson C, Kasper S, et al. A placebo-controlled study of Sertraline in the treatment of outpatients with seasonal affective disorder. Psychopharmacology (Berl). 2004 Feb;171(4):390-7.

  13. Wagner KD, Ambrosini P, Rynn M, Wohlberg C, Yang R, Greenbaum MS, et al. Efficacy of Sertraline in the Treatment of Children and Adolescents With Major Depressive Disorder: Two Randomized Controlled Trials for the Sertraline Pediatric Depression Study Group. JAMA. 2003 Aug 27;290(8):1033-41.

  14. Keller MB, Gelenberg AJ, Hirschfeld RM, Rush AJ, Thase ME, Kocsis JH. The treatment of chronic depression, part 2: a double-blind, randomized trial of sertraline and imipramine. J Clin Psychiatry. 1998;59(11):598-607.

  15. Bondareff W, Alpert M, Friedhoff AJ, Richter EM, Clary CM, Batzar E. Comparison of Sertraline and Nortriptyline in the Treatment of Major Depressive Disorder in Late Life. Am J Psychiatry. 2000;157:729-36.

  16. George T, Theodoros MT, Chiu E, Krapivensky N, Hokin A and Tiller JW. An open study of sertraline in patients with major depression who failed to respond to moclobemide. Aust N Z J Psychiatry. 1999;33(6):889.

  17. Schneider LS, Nelson JC, Clary CM, Newhouse P, Krishnan KR, Shiovitz T, et al. An 8-Week Multicenter, Parallel-Group, Double-Blind, Placebo-Controlled Study of Sertraline in Elderly Outpatients with Major Depression. Am J Psychiatry 2003;160(7):1277-85.

  18. Fabre LF, Abuzzahab FS, Amin M, Claghorn JL, Mendels J, Petrie WM, et al. Sertraline safety and efficacy in major depression: a double-blind fixed-dose comparison with placebo. Biol Psychiatry. 1995;38(9):592-602.

  19. Haddjeri N, Blier P, de Montigny C, Croft H, Settle E Jr, Houser T, et al. A placebo-controlled comparison of the antidepressant efficacy and effects on sexual functioning of sustained-release bupropion and sertraline. Clin Ther. 1999;21(4):643- 58.

  20. Altruline. Diccionario de Especialidades Farmacéuticas. 49 ed. México, DF, 2003. Disponible en: http://plm.wyeth.com.mx/




2020     |     www.medigraphic.com