Desvenlafaxine for major depressive disorder: Incremental clinical benefits from a second-generation serotonin-norepinephrine reuptake inhibitor

Expert Opinion on Drug Metabolism and Toxicology

Volumn 6, Issue 12, 2010, Pages 1565-1574

  Nichols, Alice I ^a   Tourian, Karen A ^a   Tse, Susanna Y ^a   Paul, Jeffrey ^b  

^a PFIZER INC   (United States)

^b Astellas Inc   (United States)

Author keywords

Antidepressant; CYP; CYP2D6; CYP3A4; Permeability glycoprotein transport; Serotoninnorepinephrine reuptake inhibitor

Indexed keywords

AMITRIPTYLINE; CITALOPRAM; CYTOCHROME P450; DESIPRAMINE; DESVENLAFAXINE; DULOXETINE; ESCITALOPRAM; FLUOXETINE; FLUVOXAMINE; GLYCOPROTEIN; IMIPRAMINE; NORTRIPTYLINE; PAROXETINE; PLACEBO; REBOXETINE; SERTRALINE; VENLAFAXINE; VERAPAMIL;

AREA UNDER THE CURVE; CLINICAL TRIAL; DRUG BIOAVAILABILITY; DRUG DISTRIBUTION; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG METABOLISM; DRUG PROTEIN BINDING; DRUG SAFETY; DRUG TOLERABILITY; ENZYME ACTIVITY; HAMILTON SCALE; HUMAN; LIVER FUNCTION; MAJOR DEPRESSION; MAXIMUM PLASMA CONCENTRATION; NAUSEA; NONHUMAN; RECOMMENDED DRUG DOSE; REVIEW; TREATMENT DURATION; TREATMENT RESPONSE;

ADRENERGIC UPTAKE INHIBITORS; ANIMALS; ANTIDEPRESSIVE AGENTS; CYCLOHEXANOLS; CYTOCHROME P-450 ENZYME SYSTEM; DEPRESSIVE DISORDER, MAJOR; DRUG INTERACTIONS; HUMANS; P-GLYCOPROTEIN; SEROTONIN UPTAKE INHIBITORS;

EID: 78649248800     PISSN: 17425255     EISSN: None     Source Type: Journal    
DOI: 10.1517/17425255.2010.535810     Document Type: Review

References (53)

1. Kessler RC, Berglund P, Demler O, et al. Lifetime prevalence and age-of-onset distributions of DSM-IV disorders in the National Comorbidity Survey Replication. Arch Gen Psychiatry 2005;62:593-602 (Pubitemid 40973434)
2. Andrews G. Should depression be managed as a chronic disease? BMJ 2001;322:419-21
3. Vuorilehto MS, Melartin TK, Isometsa ET. Course and outcome of depressive disorders in primary care: a prospective 18-month study. Psychol Med 2009;39:1697-707
4. *D: implications for clinical practice. Am J Psychiatry 2006;163:28-40
5. Masand PS. Tolerability and adherence issues in antidepressant therapy. Clin Ther 2003;25:2289-304
6. Trivedi MH, Hollander E, Nutt D, Blier P. Clinical evidence and potential neurobiological underpinnings of unresolved symptoms of depression. J Clin Psychiatry 2008;69:246-58
7. Rausch JL, Johnson ME, Fei YJ, et al. Initial conditions of serotonin transporter kinetics and genotype: influence on SSRI treatment trial outcome. Biol Psychiatry 2002;51:723-32
8. Zhou SF, Liu JP, Chowbay B. Polymorphism of human cytochrome P450 enzymes and its clinical impact. Drug Metab Rev 2009;41:89-295
9. Wang JS, Zhu HJ, Gibson BB, et al. Sertraline and its metabolite desmethylsertraline, but not bupropion or its three major metabolites, have high affinity for P-glycoprotein. Biol Pharm Bull 2008;31:231-4
10. Kato M, Fukuda T, Serretti A, et al. ABCB1 (MDR1) gene polymorphisms are associated with the clinical response to paroxetine in patients with major depressive disorder. Prog Neuropsychopharmacol Biol Psychiatry 2008;32:398-404
11. Pristiq [package insert]. Wyeth Pharmaceuticals, Inc., Philadelphia, PA; 2009
12. Pfizer Pipeline-our medicine in development. Pfizer Web site. 2010. Available from: http://www.pfizer.com/research/pipeline/pipeline.jsp. [Accessed 1 October 2010]
13. Sandson NB, Armstrong SC, Cozza KL. An overview of psychotropic drug-drug interactions. Psychosomatics 2005;46:464-94
14. Preskorn SH, Nichols AI, Paul J, et al. Effect of desvenlafaxine on the cytochrome P450 2D6 enzyme system. J Psychiatr Pract 2008;14:368-78
15. Preskorn S, Patroneva A, Silman H, et al. Comparison of the pharmacokinetics of venlafaxine extended release and desvenlafaxine in extensive and poor cytochrome P450 2D6 metabolizers. J Clin Psychopharmacol 2009;29:39-43
16. Otton SV, Ball SE, Cheung SW, et al. Venlafaxine oxidation in vitro is catalysed by CYP2D6. Br J Clin Pharmacol 1996;41:149-56
17. Fogelman SM, Schmider J, Venkatakrishnan K, et al. O-and N-demethylation of venlafaxine in vitro by human liver microsomes and by microsomes from cDNA-transfected cells: effect of metabolic inhibitors and SSRI antidepressants. Neuropsychopharmacology 1999;20:480-90
18. Howell SR, Husbands GE, Scatina JA, Sisenwine SF. Metabolic disposition of 14C-venlafaxine in mouse, rat, dog, rhesus monkey and man. Xenobiotica 1993;23:349-59
19. Lantz RJ, Gillespie TA, Rash TJ, et al. Metabolism, excretion, and pharmacokinetics of duloxetine in healthy human subjects. Drug Metab Dispos 2003;31:1142-50
20. Cymbalta [package insert]. Eli Lilly & Co., Indianapolis, IN; 2004
21. Lobo ED, Bergstrom RF, Reddy S, et al. In vitro and in vivo evaluations of cytochrome P450 1A2 interactions with duloxetine. Clin Pharmacokinet 2008;47:191-202
22. Effexor XR [package insert]. Wyeth Pharmaceuticals, Philadelphia, PA; 2003
23. Lobello KW, Preskorn SH, Guico-Pabia CJ, et al. Cytochrome P450 2D6 phenotype predicts antidepressant efficacy of venlafaxine: a secondary analysis of 4 studies in major depressive disorder. J Clin Psychiatry 2010. [Epub ahead of print]
24. Paxil CR [package insert]. Glaxo Smith Kline, Research Triangle Park, NC; 2004
25. Patroneva A, Connolly SM, Fatato P, et al. An assessment of drug-drug interactions: the effect of desvenlafaxine and duloxetine on the pharmacokinetics of the CYP2D6 probe desipramine in healthy subjects. Drug Metab Dispos 2008;36:2484-91
26. Nichols AI, Fatato P, Shenouda M, et al. The effects of desvenlafaxine and paroxetine on the pharmacokinetics of the cytochrome P450 2D6 substrate desipramine in healthy adults. J Clin Pharmacol 2009;49:219-28
27. Oganesian A, Shilling AD, Young-Sciame R, et al. Desvenlafaxine and venlafaxine exert minimal in vitro inhibition of human cytochrome p450 and p-glycoprotein activities. Psychopharmacol Bull 2009;42:47-63
28. US Department of Health & Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER). Guidance for Industry - Drug Interaction Studies - Study Design, Data Analysis, and Implications for Dosing and Labeling (2006). Available from: www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ ucm072101.pdf. [Accessed 16 November 2009]
29. Weiss J, Dormann SM, Martin-Facklam M, et al. Inhibition of P-glycoprotein by newer antidepressants. J Pharmacol Exp Ther 2003;305:197-204
30. Clarke G, O'Mahony SM, Cryan JF, Dinan TG. Verapamil in treatment resistant depression: a role for the P-glycoprotein transporter? Hum Psychopharmacol 2009;24:217-23
31. Boyer P, Montgomery S, Lepola U, et al. Efficacy, safety, and tolerability of fixed-dose desvenlafaxine 50 and 100 mg/day for major depressive disorder in a placebo-controlled trial. Int Clin Psychopharmacol 2008;23:243-53
32. Liebowitz MR, Manley AL, Padmanabhan SK, et al. Efficacy, safety, and tolerability of desvenlafaxine 50 mg/day and 100 mg/day in outpatients with major depressive disorder. Curr Med Res Opin 2008;24:1877-90
33. Thase ME, Kornstein SG, Germain JM, et al. An integrated analysis of the efficacy of desvenlafaxine compared with placebo in patients with major depressive disorder. CNS Spectr 2009;14:144-54
34. Clayton AH, Kornstein SG, Rosas G, et al. An integrated analysis of the safety and tolerability of desvenlafaxine compared with placebo in the treatment of major depressive disorder. CNS Spectr 2009;14:183-95
35. Hamilton M. A rating scale for depression. J Neurol Neurosurg Psychiatry 1960;23:56-62
36. Shelton RC. Serotonin norepinephrine reuptake inhibitors: similarities and differences. Prim Psychiatry 2009;16:25-35
37. Lieberman DZ, Montgomery SA, Tourian KA, et al. A pooled analysis of two placebo-controlled trials of desvenlafaxine in major depressive disorder. Int Clin Psychopharmacol 2008;23:188-97
38. Tourian KA, Padmanabhan SK, Groark J, et al. Desvenlafaxine 50 and 100 mg/d in the treatment of major depressive disorder: an 8-week, phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial and a post hoc pooled analysis of three studies. Clin Ther 2009;31(Pt 1):1405-23
39. Soares CN, Thase ME, Clayton A, et al. Desvenlafaxine and escitalopram for the treatment of postmenopausal women with major depressive disorder. Menopause 2010;17:700-11
40. Paykel ES, Weissman MM. Social adjustment and depression. A longitudinal study. Arch Gen Psychiatry 1973;28:659-63
41. Hirschfeld RM, Montgomery SA, Keller MB, et al. Social functioning in depression: a review. J Clin Psychiatry 2000;61:268-75
42. Miller IW, Keitner GI, Schatzberg AF, et al. The treatment of chronic depression, part 3: psychosocial functioning before and after treatment with sertraline or imipramine. J Clin Psychiatry 1998;59:608-19
43. Solomon DA, Leon AC, Endicott J, et al. Psychosocial impairment and recurrence of major depression. Compr Psychiatry 2004;45:423-30
44. Sheehan DV. Sheehan disability scale. In: Rush AJ, Pincus HA, First MB, editors, Handbook of psychiatric measures. American Psychiatric Association, Washington, DC; 2000. p. 113-15
45. Soares CN, Kornstein SG, Thase ME, et al. Assessng the efficacy of desvenlafaxine for improving functioning and well-being outcome measures in patients with major depressive disorder: a pooled analysis of 9 double-blind, placebo-controlled, 8-week clinical trials. J Clin Psychiatry 2009;70:1365-71
46. Sheehan KH, Sheehan DV. Assessing treatment effects in clinical trials with the Discan metric of the Sheehan Disability Scale. Int Clin Psychopharmacol 2008;23:70-83
47. Rudolph RL, Derivan AT. The safety and tolerability of venlafaxine hydrochloride: analysis of the clinical trials database. J Clin Psychopharmacol 1996;16:54S-59S
48. Thase ME. Effects of venlafaxine on blood pressure: a meta-analysis of original data from 3744 depressed patients. J Clin Psychiatry 1998;59:502-8
49. Hudson JI, Wohlreich MM, Kajdasz DK, et al. Safety and tolerability of duloxetine in the treatment of major depressive disorder: analysis of pooled data from eight placebo-controlled clinical trials. Hum Psychopharmacol 2005;20:327-41
50. Thase ME, Tran PV, Wiltse C, et al. Cardiovascular profile of duloxetine, a dual reuptake inhibitor of serotonin and norepinephrine. J Clin Psychopharmacol 2005;25:132-40
51. Chen SY, Hansen RA, Farley JF, et al. Follow-up visits by provider specialty for patients with major depressive disorder initiating antidepressant treatment. Psychiatr Serv 2010;61:81-5
52. Silkey B, Preskorn SH, Golbeck A, et al. Complexity of medication use in the Veterans Affairs healthcare system: Part II. Antidepressant use among younger and older outpatients. J Psychiatr Pract 2005;11:16-26 (Pubitemid 40171223)
53. Bech P, Gram LF, Dein E, et al. Quantitative rating of depressive states. Acta Psychiatr Scand 1975;51:161-70