AN OPEN COMPARATIVE AND RANDOMIZED STUDY ON VALPROATE’S EFFECT IN THE LONG-TERM TREATMENT OF BIPOLAR DISORDERS VERSUS LITHIUM CARBONATE AND CARBAMAZEPINE
Keywords:
Bipolar disorder, Comparative and Randomize study, survival analysis Kaplan Meier, mood stabilizer
Abstract
Bipolar disorder is a chronic disorder, with a large diversity range of clinical manifestations that affects around 1% of total population around the world.
Objective: Evaluation of differences in efficacy between Sodium Valproate and Lithium Carbonate and Carbamazepine in maintenance treatment of patients with bipolar disorder during a 2 years follow-up period.
Design: an open comparative and randomized study.
Setting: UHC Tirana “Mother Teresa”, Psychiatric Service, Emergency Ward Participants: A total of 235 inpatient and outpatient, diagnosed with bipolar disorder I and II (at least two mood episodes) based on DSM-IV-TR. Main Outcome measures: Time survival analyses to any events (relapse/recurrence) for entire population in study, comparing three separated groups (n=60) valproate (Vp) versus lithium (Li) versus carbamazepine (Cbz).
Results: Cumulative survival of Vp was 26% higher than Cbz (p=0.001) and 4.3% than Li (p=0.4304). The mean survival time for Vp was 35 +/- 7% higher than Cbz and 10 +/- 6% higher than Li, while median time for Vp was respectively 53 +/- 7% and 14 +/- 13% higher than Cbz and Li groups. Hazard ratio of Cbz has been 108.5% higher than Vp (B=0.735, p=0.001), for Li was 20.4% higher than Vp (B=0.186).
Concerning the predictors: Vp was more effective than Li in non-classic BD I (p=0.031), also superior to Li in mixed, rapid cycling subtypes and in co-morbidities. Vp was more effective than Cbz in classic BD-I (p=0.0312).
Conclusions: Vp is significantly more effective than Cbz in long-term treatment of BD, Vp is superior than Li in non-classic form of BD.
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References
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Medico Research Chronicles, 2017 240
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31. Tondo L, Baldessarini RJ, et al., (1998) Lithium maintenance treatment of depression and mania in bipolar I and bipolar II disorders. American Journal of Psychiatry; 155:638-645
32. Macritchie K.A.N, et al (2002) Valproic acid, valproate and divalproex in the maintenance treatment of bipolar disorder. The Cochrane Library, Issue 1.
33. Post RM, Leverich GS et al (1997) Loss of efficacy (tolerance) during long-term prophylaxis. Biological Psychiatry:42, 77-78.
34. Post RM. (1990) Alternatives to Lithium for Bipolar Affective Illness. In: Review of Psychiatry. Tasmana. Ed. American Psychiatric Press. 170-202.
35. Grunze H, et al (2004) Maintenance treatment. The World Federation of Societies of Biological Psychiatry guidelines for the biological treatment of bipolar disorders, part III: 120-135.
36. Clothier J, Swann AC, Freeman T (1992) Dysphoric mania. Journal Clinical of Psychopharmacology February;12 (suppl):13S-16S.
37. Calabrese JR, et al (2003) a 20-month, double-blind, maintenance study of lithium versus divalproex monotherapy in bipolar I and II disorders accompanied by rapid cycling. Europian Neuropsychopharmacology 23 (Suppl 4):227
38. Kusumakar V, Yatham LN, Haslam DR et al (1997) Treatment of mania, mixed state, and rapid cycling. Canadian Journal of Psychiatry. (8) 42 Suppl 2:79s-86s.
39. Solomon D.A, MD, Keitner G.I, MD, et al (2000) Lithium plus valproate as maintenance polypharmacy for patients with bipolar disorder: A review. CNS
Spectrums; 5(2) (suppl 1): 19-28.
40. Denicoff KD, MD, et al (1997) Valproate prophylaxis in a prospective clinical trial of refractory bipolar disorder. American Journal of Psychiatry; 154:1456-58.
2. Thomas M.R., M.D. (2001) Psychiatric Secrets, Second edition, Part 1, Cap. 12 Bipolar Disorders, 65-71.
3. Kaplan H.I, M.D; Sadock B.J., M.D (1991) Synopsis of Psychiatry, sixth editon, cap. 16 Mood Disorders, 363-364
4. NIMH (1999) Bipolar Disorder Research at the NIMH. www.nimh.nih.gov
5. American Psychiatric Association, (1994) Diagnostic and Statistical Manual; 317-391
6. Stahl S.M., (2000) Essential Psychopharmacology of depression and Bipolar Dissorder. Chap.3 New antidepressants and mood stabilizers. 111- 163.
7. Angst J, Bowden L.C et al (2001) Guidelines for Investigating Efficacy in Bipolar Disorder European Neuropsychopharmacology 11 79–88; ECNP Consensus Meeting March 2000 Nice. www.elsevier.com
8. Coryell W, Endicott J, Keller M. (1992) Rapidly cycling affective disorder. Demographics, diagnosis, family history, and course. Archives Gen Psychiatry.; 49:126-131.
9. Grunze H. et al (2002) Guidelines for the biological treatment of bipolar disorders, Part I: Treatment of Bipolar Depression, The World Journal of Biological Psychiatry, Vol. 3, 115-124.
10. Grunze H. et al (2003) Guidelines for the biological treatment of bipolar disorders, Part II: Treatment of Mania, The World Journal of Biological Psychiatry, Vol. 4, 1 Jan., 5-11.
11. Sachs GS, et al, (2000) The Expert Consensus Guideline Series: Medication Treatment of Bipolar Disorder Postgrad Med Special Report 1-104.
12. The Experts Consensus Guideline Series: (1996) Medication Treatment of Bipolar Disorder.
13. Guy W, Bonato RR (1970) National Institute of Mental Health. CGI: Clinical Global Impressions. Manual for the ECDEU Assessment Battery.2. 12-1-12-6.
14. Rohland. M. Barbara, Winokur George, and Cook L. Brian (1997) Mood Disorders: Bipolar Disorders, Adult psychopathology and diagnosis; third edition, (edited by), Turner M. Samuel, and Hersen Michael, 254-277
15. Hamilton M. (1960) A rating scale for depression. J Neurol Neursurg Psychiatry. 23:56-62.
16. Young RC, Biggs JT, Ziegler VE, Meyer DA. A rating scale for mania: reliability, validity and sensitivity. Br J Psychiatry. 1978; 133:429-435.
17. What is Power Analysis?www.PowerAnalysis.comDownloaded from Medico Research Chronicles “An open comparative and randomized study on valproate’s effect in the long-term treatment of bipolar disorders versus lithium carbonate and carbamazepine” Elezi F., et al., Med. Res. Chron., 2017, 4 (3), 230-241
Medico Research Chronicles, 2017 240
18. Kleinbaum, D. G., and M. Klein. Survival Analysis. Statistics for Biology and Health. 2nd edition. Springer, 2005.
19. Cox, D. R., and D. Oakes. Analysis of Survival Data. London: Chapman & Hall, 1984.
20. Lawless, J. F. Statistical Models and Methods for Lifetime Data. Hoboken, NJ: Wiley-Interscience, 2002.
21. Balance trial www.psychiatry.ox.ac.uk/balance
22. Calabrese J.R, Rapport D.J, MD, Shelton M.D, PhD, Kimmel S.E, MD (2001) Evolving methodologies in bipolar disorder maintenance research. British Journal of Psychiatry 178: s 157-s 163.
23. Keck PE, Jr., M.D, McElroy S.L, M.D (2002) Carbamazepine and valproate in the maintenance treatment of bipolar disorder. Journal Clinical of Psychiatry;
63(suppl 10):13-17.
24. Hartong EG, Moleman P, Hoogduin CA, Broek TG, Nolen WA; (2003) Prophylactic efficacy of lithium versus carbamazepine in patients in the treatment-naive bipolar patients. Journal Clinical Psychiatry, February; 64(2):144-51.
25. Denicoff KD, et al (1997) Comparative prophylactic efficacy of lithium and carbamazepine the combination in bipolar disorder. Journal Clinical of Psychiatry; Nov 58(11):470-8.
26. McManamy et al. (2001) Bipolar Meds part II from a webcast. The Journal of Clinical Psychiatry by from sessions and the Fourth.
27. Bowden et al (2000) A randomized, placebo-controlled 12-month trial of divalproex and lithium in treatment of outpatients with bipolar I disorder. Divalproex Maintenance Study Group. Archives General of Psychiatry. May; 57(5):481-9.
28. Lambert PA and Venaud G. (1992) Comparative study valpromide versus lithium in treatment of affective disorders. Nervure: 5(2), 57-65.
29. Solomon DA et al (1997) A pilot study of lithium carbonate plus divalproex sodium for the continuation and maintenance treatment of patients with bipolar I disorder. Journal Clinical of Psychiatry; 58:95-99.
30. Hirschfeld RMA et al (1999) Costeffectiveness evaluation of divalproex versus lithium in the treatment of bipolar disorder: Annual meeting of American Psychiatric Association, Maj, Nr686: 262-263
31. Tondo L, Baldessarini RJ, et al., (1998) Lithium maintenance treatment of depression and mania in bipolar I and bipolar II disorders. American Journal of Psychiatry; 155:638-645
32. Macritchie K.A.N, et al (2002) Valproic acid, valproate and divalproex in the maintenance treatment of bipolar disorder. The Cochrane Library, Issue 1.
33. Post RM, Leverich GS et al (1997) Loss of efficacy (tolerance) during long-term prophylaxis. Biological Psychiatry:42, 77-78.
34. Post RM. (1990) Alternatives to Lithium for Bipolar Affective Illness. In: Review of Psychiatry. Tasmana. Ed. American Psychiatric Press. 170-202.
35. Grunze H, et al (2004) Maintenance treatment. The World Federation of Societies of Biological Psychiatry guidelines for the biological treatment of bipolar disorders, part III: 120-135.
36. Clothier J, Swann AC, Freeman T (1992) Dysphoric mania. Journal Clinical of Psychopharmacology February;12 (suppl):13S-16S.
37. Calabrese JR, et al (2003) a 20-month, double-blind, maintenance study of lithium versus divalproex monotherapy in bipolar I and II disorders accompanied by rapid cycling. Europian Neuropsychopharmacology 23 (Suppl 4):227
38. Kusumakar V, Yatham LN, Haslam DR et al (1997) Treatment of mania, mixed state, and rapid cycling. Canadian Journal of Psychiatry. (8) 42 Suppl 2:79s-86s.
39. Solomon D.A, MD, Keitner G.I, MD, et al (2000) Lithium plus valproate as maintenance polypharmacy for patients with bipolar disorder: A review. CNS
Spectrums; 5(2) (suppl 1): 19-28.
40. Denicoff KD, MD, et al (1997) Valproate prophylaxis in a prospective clinical trial of refractory bipolar disorder. American Journal of Psychiatry; 154:1456-58.
How to Cite
1.
Fatime Elezi, Sonila Tomori, Eugjen Sotiri, Ardian Braho, Elizana Petrela. AN OPEN COMPARATIVE AND RANDOMIZED STUDY ON VALPROATE’S EFFECT IN THE LONG-TERM TREATMENT OF BIPOLAR DISORDERS VERSUS LITHIUM CARBONATE AND CARBAMAZEPINE. Med. res. chronicles [Internet]. 2017Jun.30 [cited 2024Dec.22];4(03):230-41. Available from: https://medrech.com/index.php/medrech/article/view/237
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