Clinical utility of desvenlafaxine 50 mg/d for treating MDD: A review of two randomized placebo-controlled trials for the practicing physician

Current Medical Research and Opinion

Volumn 26, Issue 1, 2010, Pages 139-150

  Reddy, Sujana ^a   Kane, Cecelia ^a   Pitrosky, Bruno ^a   Musgnung, Jeff ^a   Ninan, Philip T ^a   Guico Pabia, Christine J ^a  

^a PFIZER INC   (United States)

Author keywords

Desvenlafaxine; Low dose; Review article; Serotonin Norepinephrine Reuptake Inhibitor

Indexed keywords

DESVENLAFAXINE; PLACEBO; ANTIDEPRESSANT AGENT; CYCLOHEXANOL DERIVATIVE; NEUROTRANSMITTER UPTAKE INHIBITOR; O-DESMETHYLVENLAFAXINE;

ABNORMAL DREAMING; ANORGASMIA; CLINICAL GLOBAL IMPRESSION SCALE; CLINICAL GLOBAL IMPRESSIONS SEVERITY SCORE; DIARRHEA; DIZZINESS; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG DISTRIBUTION; DRUG EFFICACY; DRUG ELIMINATION; DRUG HALF LIFE; DRUG METABOLISM; DRUG SAFETY; DRUG TOLERABILITY; EJACULATION DISORDER; ERECTILE DYSFUNCTION; HAMILTON SCALE; HEADACHE; HUMAN; INSOMNIA; IRRITABILITY; LIBIDO; MAJOR DEPRESSION; MONTGOMERY ASBERG DEPRESSION RATING SCALE; NAUSEA; PHYSICIAN; RANDOMIZED CONTROLLED TRIAL (TOPIC); RATING SCALE; REVIEW; SCORING SYSTEM; SEXUAL DYSFUNCTION; SHEEHAN DISABILITY SCALE; SIDE EFFECT; SOCIAL PSYCHOLOGY; SYSTEMATIC REVIEW; TIME TO MAXIMUM PLASMA CONCENTRATION; WITHDRAWAL SYNDROME; WORLD HEALTH ORGANIZATION 5 ITEM WELL BEING INDEX SCORE; DOUBLE BLIND PROCEDURE; PSYCHOLOGICAL ASPECT; RANDOMIZED CONTROLLED TRIAL; TREATMENT OUTCOME;

ANTIDEPRESSIVE AGENTS; CYCLOHEXANOLS; DEPRESSIVE DISORDER, MAJOR; DOUBLE-BLIND METHOD; HUMANS; NEUROTRANSMITTER UPTAKE INHIBITORS; PLACEBOS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; TREATMENT OUTCOME;

EID: 77649206093     PISSN: 03007995     EISSN: 14734877     Source Type: Journal    
DOI: 10.1185/03007990903408678     Document Type: Review

References (54)

1. Kessler RC, Berglund P, Demler O, et al. The epidemiology of major depressive disorder: results from the National Comorbidity Survey Replication (NCS-R). JAMA 2003;289:3095-105 (Pubitemid 37432885)
2. Yiend J, Paykel E, Merritt R, et al. Long term outcome of primary care depression. J Affect Disord 2009;118:79-96
3. Moussavi S, Chatterji S, Verdes E, et al. Depression, chronic diseases, and decrements in health: results from the World Health Surveys. Lancet 2007;370:851-8 (Pubitemid 47362344)
4. Mathers CD, Loncar D. Projections of global mortality and burden of disease from 2002 to 2030. PLoS Med 2006;3:e442
5. Schatzberg AF. Safety and tolerability of antidepressants: weighing the impact on treatment decisions. J Clin Psychiatry 2007;68(Suppl. 8):26-34 (Pubitemid 47184568)
6. Stahl SM. The psychopharmacology of painful physical symptoms in depression. J Clin Psychiatry 2002;63:382-3 (Pubitemid 34507213)
7. Blier P. Crosstalk between the norepinephrine and serotonin systems and its role in the antidepressant response. J Psychiatry Neurosci 2001;26 (Suppl.):S3-10
8. Fava M, Davidson KG. Definition and epidemiology of treatment-resistant depression. Psychiatr Clin North Am 1996;19:179-200
9. Trivedi MH, Rush AJ, Wisniewski SR, et al. Evaluation of outcomes with citalopram for depression using measurement-based care in STAR*D: implications for clinical practice. Am J Psychiatry 2006;163:28-40 (Pubitemid 43050100)
10. Hansen RA, Gartlehner G, Lohr KN, et al. Efficacy and safety of second-generation antidepressants in the treatment of major depressive disorder. Ann Intern Med 2005;143:415-26 (Pubitemid 41341413)
11. Ereshefsky L, Jhee S, Grothe D. Antidepressant drug-drug interaction profile update. Drugs R D 2005;6:323-36 (Pubitemid 41633387)
12. Masand PS. Tolerability and adherence issues in antidepressant therapy. Clin Ther 2003;25:2289-304 (Pubitemid 37076320)
13. Viale G. An economic analysis of physician prescribing of selective serotonin reuptake inhibitors. Hosp Pharm 1998;33:847-50 (Pubitemid 28350140)
14. Rosenzweig-Lipson S, Beyer CE, Hughes ZA, et al. Differentiating antidepressants of the future: efficacy and safety. Pharmacol Ther 2007; 113:134-53 (Pubitemid 46017069)
15. Pincus HA, Pettit AR. The societal costs of chronic major depression. J Clin Psychiatry 2001;62:5-9 (Pubitemid 32298431)
16. Pristiq [package insert]. Philadelphia, PA: Wyeth Pharmaceuticals, 2008
17. Cymbalta [package insert]. Indianapolis, IN: Eli Lilly and Company, 2007
18. Effexor XR [package insert]. Philadelphia, PA: Wyeth Pharmaceuticals, 2008
19. Deecher DC, Beyer CE, Johnston G, et al. Desvenlafaxine succinate: a new serotonin and norepinephrine reuptake inhibitor. J Pharmacol Exp Ther 2006;318:657-65 (Pubitemid 44061240)
20. Effexor [package insert]. Philadelphia, PA: Wyeth Pharmaceuticals, 2004
21. DeMartinis NA, Yeung PP, Entsuah R, et al. A double-blind, placebo-controlled study of the efficacy and safety of desvenlafaxine succinate in the treatment of major depressive disorder. J Clin Psychiatry 2007; 68:677-88 (Pubitemid 46841850)
22. Septien-Velez L, Pitrosky B, Padmanabhan SK, et al. A randomized, double-blind, placebo-controlled trial of desvenlafaxine succinate in the treatment of major depressive disorder. Int Clin Psychopharmacol 2007; 22:338-47 (Pubitemid 47530838)
23. 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
24. Liebowitz M, Manley AL, Padmanabhan SK, et al. Efficacy, safety, and tolerability of desvenlafaxine 50 mg/d and 100 mg/d in outpatients with major depressive disorder. Curr Med Res Opin 2008;24:1877-90
25. Thase ME, Kornstein SG, Germain J-M, 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
26. 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
27. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, 4th edn. Washington, DC, 1994
28. Hamilton M. A rating scale for depression. J Neurol Neurosurg Psychiatry 1960;23:56-62
29. Guy W. Clinical Global Impressions. Publication ADM 76-338. In: ECDEU Assessment Manual for Psychopharmacology. Rockville, MD: US Department of Health, Education, and Welfare, 1976:217-22
30. Montgomery SA,Åsberg M. A new depression scale designed to be sensitive to change. Br J Psychiatry 1979;134:382-9 (Pubitemid 9136500)
31. Sheehan DV, Lecrubier Y, Sheehan KH, et al. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry 1998;59(Suppl. 20):22-33 (Pubitemid 29001829)
32. World Health Organization. Wellbeing measures in primary health care/the depcare project. Copenhagen, Denmark: WHO Regional Office for Europe, 1998
33. Kornstein SG, Thase ME, Tummala R, et al. An integrated analysis of the efficacy of desvenlafaxine compared with placebo in patients with major depressive disorder. Poster presented at American Psychiatric Association Annual Meeting, 3-8 May 2008, Washington DC
34. Rosenbaum JF, Fava M, Hoog SL, et al. Selective serotonin reuptake inhibitor discontinuation syndrome: a randomized clinical trial. Biol Psychiatry 1998; 44:77-87 (Pubitemid 28305526)
35. Tourian KA, Leurent C, Graepel J, et al. Desvenlafaxine and weight change in major depressive disorder. Prim Care Companion J Clin Psychiatry (in press)
36. Ingelman-Sundberg M. Genetic polymorphisms of cytochrome P450 2D6 (CYP2D6): clinical consequences, evolutionary aspects and functional diversity. Pharmacogenomics J 2005;5:6-13 (Pubitemid 40220611)
37. McElroy S, Sachse C, Brockmoller J, et al. CYP2D6 genotyping as an alternative to phenotyping for determination of metabolic status in a clinical trial setting. AAPS PharmSci 2000;2:E33
38. 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
39. 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
40. Kane C, Nichols A, Focht K, et al. Assessing the pharmacokinetics of venlafaxine ER 75 mg and desvenlafaxine 50 mg in CYP2D6 extensive and poor metabolizers. Poster presented at New Clinical Drug Evaluation Unit Annual Meeting, 29 June -2 July 2009, Hollywood, FL
41. Preskorn SH, Flockhart D. 2004 Guide to psychiatric drug interactions. Prim Psychiatry 2004;11:39-60
42. Weiss J, Dormann SM, Martin-Facklam M, et al. Inhibition of P-glycoprotein by newer antidepressants. J Pharmacol Exp Ther 2003; 305:197-204 (Pubitemid 36373851)
43. Verschraagen M, Koks CH, Schellens JH, et al. P-glycoprotein system as a determinant of drug interactions: the case of digoxin-verapamil. Pharmacol Res 1999;40:301-6 (Pubitemid 29472055)
44. Kuroda Y, Saito M, Sakai H, et al. Rapid characterization of drug-drug interaction in plasma protein binding using a surface plasmon resonance biosensor. Drug Metab Pharmacokinet 2008;23:120-7
45. Buxton ILO. Pharmacokinetics and pharmacodynamics: the dynamics of drug absorption, distribution, action, and elimination. In: Bruton LL, Lazo JS, Parker KL (eds). Goodman & Gilman's The Pharmacological Basis of Therapeutics. New York, NY: McGraw-Hill, 2006:1-42
46. Sansom LN, Evans AM. What is the true clinical significance of plasma protein binding displacement interactions? Drug Saf 1995;12:227-33
47. Glueck CJ, Khalil Q, Winiarska M, et al. Interaction of duloxetine and warfarin causing severe elevation of international normalized ratio. JAMA 2006; 295:1517-18
48. Mallinckrodt CH, Prakash A, Andorn AC, et al. Duloxetine for the treatment of major depressive disorder: a closer look at efficacy and safety data across the approved dose range. J Psychiatr Res 2006;40:337-48 (Pubitemid 43668983)
49. Nemeroff CB, Entsuah R, Benattia I, et al. Comprehensive analysis of remission (COMPARE) with venlafaxine versus SSRIs. Biol Psychiatry 2008; 63:424-34
50. Silverstone PH, Ravindran A. Once-daily venlafaxine extended release (XR) compared with fluoxetine in outpatients with depression and anxiety. Venlafaxine XR 360 Study Group. J Clin Psychiatry 1999;60:22-8 (Pubitemid 29069881)
51. Thase ME, Entsuah AR, Rudolph RL. Remission rates during treatment with venlafaxine or selective serotonin reuptake inhibitors. Br J Psychiatry 2001; 178:234-41 (Pubitemid 32183606)
52. Gregorian RS, Golden KA, Bahce A, et al. Antidepressant-induced sexual dysfunction. Ann Pharmacother 2002;36:1577-89
53. Clayton AH, Kornstein SG, Rosas G, et al. Pooled analysis of the safety and tolerability of desvenlafaxine compared with placebo in the treatment of major depressive disorder. Poster presented at American Psychiatric Association Annual Meeting, 3-8 May 2008, Washington, DC
54. Howell SR, Husbands GE, Scatina JA, et al. Metabolic disposition of 14C-venlafaxine in mouse, rat, dog, rhesus monkey and man. Xenobiotica 1993;23:349-59 (Pubitemid 23166409)