Hostname: page-component-5c6d5d7d68-ckgrl Total loading time: 0 Render date: 2024-08-18T09:33:28.518Z Has data issue: false hasContentIssue false
  • English
  • Français

Global Benefit-risk Evaluation of Antidepressant Action: Comparison of Pooled Data for Venlafaxine, SSRIs, and Placebo

Published online by Cambridge University Press:  07 November 2014

Richard Entsuah  and
Bo Gao
Get access Rights & Permissions [Opens in a new window]

Abstract

Do antidepressants have an equivalent risk-benefit ratio? Venlafaxine, a serotonin-norepinephrine reuptake inhibitor, is an effective antidepressant for treating major depression. The results of some clinical studies have suggested that venlafaxine may have more potent efficacy in sustaining remission in patients with major depression. Comparative clinical studies, however, lack suitable power to discern treatment differences in safety and also lack a quantitative basis for comparing risk and benefit. A global benefit-risk analysis of pooled data from eight randomized, double-blind, clinical trials of the safety and efficacy of venlafaxine and selective serotonin reuptake inhibitors (SSRIs) was performed. By using the ratio measure of risk-benefit, patients treated with venlafaxine (n=851) for 6–8 weeks experienced a relative gain of 1.57 compared with SSRI-treated patients (n=743) and a relative gain of 2.27 compared with placebo-treated patients (n=439). Subgroup analyses showed a relative gain of 1.35 for venlafaxine-treated patients (n=538) compared with fluoxetine-treated patients (n=549) and a relative gain of 2.53 compared with placebo-treated patients (n=357). A dose-response relationship was apparent between low (<75 mg/day), medium (75–150 mg/day), and high (>150 mg/day) dosages of venlafaxine; r values were 0.758, 0.822, and 1.181, respectively (P=.023, high dosage versus placebo; P=.030, medium dosage versus placebo). Important differences in risk and benefit exist between venlafaxine and SSRIs as a group compared with fluoxetine alone. A significant gain in benefit-risk in the treatment of major depression was observed with an increase in venlafaxine dosage from 75–>150 mg/day.

Type
Original Research
Information
CNS Spectrums , Volume 7 , Issue 12: Investigating Neuropsychiatric Disorders , December 2002 , pp. 882 - 888
Copyright
Copyright © Cambridge University Press 2002

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

REFERENCES

1.Chuang-Stein, C, Mohberg, NR, Sinkula, MS. Three measures for simultaneously evaluating benefits and risks using categorical data from clinical trials. Stat Med. 1991;10:1349–1359.CrossRefGoogle ScholarPubMed
2.Muth, EA, Haskins, JT, Moyer, JA, Husbands, GEM, Nielsen, ST, Sigg, EB. Antidepressant biochemical profile of the novel bicyclic compound Wy-45,030, an ethyl cyclohexanol derivative. Biochem Pharmacol. 1986;35:4493–4497.CrossRefGoogle ScholarPubMed
3.Rudolph, RL, Fabre, LF, Feighner, JP, et al.A randomized, placebo-controlled, dose-response trial of venlafaxine hydrochloride in the treatment of major depression. J Clin Psychiatry. 1998;59:116–122.CrossRefGoogle ScholarPubMed
4.Laird, LK, Benefield, WH Jr.Mood disorders I: major depressive disorders. In: Young, LY, Koda-Kimble, MA, eds. Applied Therapeutics: The Clinical Use of Drugs. Vancouver, Wash: Applied Therapeutics, Inc.; 1995;76–1–76-28.Google Scholar
5.Thase, ME, Entsuah, AR, Rudolph, RL. Remission rates during treatment with venlafaxine or selective serotonin reuptake inhibitors. Br J Psychiatry. 2001;178:234–241.CrossRefGoogle ScholarPubMed
6.Clerc, GE, Ruimy, P, Verdeau-Paillès, J, on behalf of the Venlafaxine French Inpatient Study Group. A double-blind comparison of venlafaxine and fluoxetine in patients hospitalized for major depression and melancholia. Int Clin Psychopharmacol. 1994;9:139–143.CrossRefGoogle Scholar
7.Dierick, M, Ravizza, L, Realini, R, Martin, A. A double-blind comparison of venlafaxine and fluoxetine for treatment of major depression in outpatients. Prog Neuropsychopharmacol Biol Psychiatry. 1996;20:57–71.CrossRefGoogle ScholarPubMed
8.Rudolph, RL, Feiger, AD. A double-blind, randomized, placebo-controlled trial of once-daily venlafaxine extended release (XR) and fluoxetine for the treatment of depression. J Affect Disord. 1999;56:171–181.CrossRefGoogle ScholarPubMed
9.Silverstone, PH, Ravindran, A. For the Venlafaxine XR 360 Study Group. Once-daily venlafaxine extended release (XR) compared with fluoxetine in outpatients with depression and anxiety. J Clin Psychiatry. 1999;60:22–28.CrossRefGoogle Scholar
10.Rudolph, R, Entsuah, R, Aguiar, L, Derivan, A. Early onset of antidepressant activity of venlafaxine compared with placebo and fluoxetine in outpatients in a double-blind study [abstract]. Eur Neuropsychopharmacol. 1998;8(suppl 2):S142.CrossRefGoogle Scholar
11.Salinas, E. Once-daily venlafaxine XR vs. paroxetine in outpatients with major depression [abstract]. Eur Neuropsychopharmacol. 1998;8(suppl 2):S197.CrossRefGoogle Scholar
12.Hamilton, M. A rating scale for depression. J Neurol Neurosurg Psychiatry. 1960;23:56–62.CrossRefGoogle ScholarPubMed
13.American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 3rd, revised ed. Washington, DC: American Psychiatric Association, 1987.Google Scholar
14.American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 4th ed. Washington, DC: American Psychiatric Association; 1994.Google Scholar
15.Montgomery, SA, Åsberg, M. A new depression scale designed to be sensitive to change. Br J Psychiatry. 1979;134:382–389.CrossRefGoogle ScholarPubMed
16.National Institute of Mental Health. Clinical Global Impressions. Psychopharmacol Bull. 1985;21:839–843.Google Scholar
17.Frank, E, Prien, RF, Jarrett, RB, et al.Conceptualization and rationale for consensus definitions of terms in major depressive disorder. Remission, recovery, relapse, and recurrence. Arch Gen Psychiatry. 1991;48:851–855.CrossRefGoogle ScholarPubMed
18.American Psychiatric Association. Practice guideline for major depressive disorder in adults. Am J Psychiatry. 1993;150(suppl 4):1–26.CrossRefGoogle Scholar
19.Clinical Practice Guideline Number 5: Depression in Primary Care, 2. Treatment of Major Depression. Rockville, Md: Agency for Health Care Policy and Research, US Department of Health and Human Services; 1993. AHCPR publication No. 93-0551.Google Scholar
20.Entsuah, AR, Rudolph, RL, Hackett, D, Miska, S. Efficacy of venlafaxine and placebo during long-term treatment of depression: a pooled analysis of relapse rates. Int Clin Psychopharmacol. 1996;11:137–145.Google ScholarPubMed
21.Khan, A, Upton, GV, Rudolph, RL, et al.The use of venlafaxine in the treatment of major depression and major depression associated with anxiety: a dose-response study. J Clin Psychopharmacol. 1998;18:19–25.CrossRefGoogle ScholarPubMed
22.Poirier, M-F, Boyer, P. Venlafaxine and paroxetine in treatment-resistant depression: double-blind, randomised comparison. Br J Psychiatry. 1999;175:12–16.CrossRefGoogle ScholarPubMed
23.Ballús, C, Quiros, G, de Flores, T, et al.The efficacy and tolerability of venlafaxine and paroxetine in outpatients with depressive disorder or dysthymia. Int Clin Psychopharmacol. 2000;15:43–48.CrossRefGoogle ScholarPubMed
24.Diaz-Martinez, A, Benassinni, O, Ontiveros, A, et al.A randomized, open-label comparison of venlafaxine and fluoxetine in depressed outpatients. Clin Ther. 1998;20:467–476.CrossRefGoogle ScholarPubMed
25.McPartlin, GM, Reynolds, A, Anderson, C, Casoy, J. A comparison of once-daily venlafaxine XR and paroxetine in depressed outpatients treated in general practice. Primary Care Psychiatry. 1998;4:127–132.Google Scholar
26.Tzanakaki, M, Guazzelli, M, Nimatoudis, I, et al.Increased remission rates with venlafaxine compared with fluoxetine in hospitalized patients with major depression and melancholia. Int Clin Psychopharmacol. 2000;15:29–34.CrossRefGoogle ScholarPubMed
27.Alves, C, Cachola, I, Brandao, J. Efficacy and tolerability of venlafaxine and fluoxetine in outpatients with major depression. Primary Care Psychiatry. 1999;5:57–63.Google Scholar
28.Entsuah, R, Chitra, R. A benefit-risk analysis of once-daily venlafaxine extended release (XR) and venlafaxine immediate release (IR) in outpatients with major depression. Psychopharmacol Bull. 1997;33:671–676.Google ScholarPubMed
29.Entsuah, R, Gorman, JM. Global benefit-risk assessment of antidepressants: venlafaxine XR and fluoxetine. J Psychiatr Res. 2002;36:111–118.CrossRefGoogle ScholarPubMed
30.Ballenger, JC. Clinical guidelines for establishing remission in patients with depression and anxiety. J Clin Psychiatry. 1999;60(suppl 22):29–34.Google ScholarPubMed
31.Thase, ME. Redefining antidepressant efficacy toward long-term recovery. J Clin Psychiatry. 1999;60(suppl 6):15–19.Google ScholarPubMed
32.Costa e Silva, J. Randomized, double-blind comparison of venlafaxine and fluoxetine in outpatients with major depression. J Clin Psychiatry. 1998;59:352–357.CrossRefGoogle ScholarPubMed
33.Corruble, E, Guelfi, JD. Is there a relationship between clinical efficacy and antidepressant dosage in major depression? Encephale. 1999;25(special issue 2):39–43.Google Scholar