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  • Alley/Pat
    New University of Pittsburgh Depression Study Shows Venlafaxine Significantly Superior to SSRIs March 2001 (Newstream) -- Results of a new study published
    Message 1 of 1 , Mar 2, 2001
      New University of Pittsburgh Depression Study Shows Venlafaxine Significantly Superior to SSRIs
      March 2001 (Newstream) -- Results of a new study published March 1 in the British Journal of Psychiatry shows that significantly more patients with depression who were treated with venlafaxine (Effexor®) or venlafaxine extended-release capsules (Effexor XR®) become virtually symptom free than patients treated with selective serotonin reuptake inhibitors (SSRIs) or a placebo.(1) The study demonstrated consistent evidence that remission rates with venlafaxine were approximately 10 percentage points higher than those observed with SSRIs. To put this in perspective, this represents a 30 percent increase in the probability of remission with venlafaxine vs. SSRIs. This difference is thought to be because venlafaxine is a selective serotonin and norepinephrine reuptake inhibitor, which may result in two modes of action.

      Antidepressant efficacy traditionally has been measured by an ability to reduce depressive symptoms by 50 percent. This is the typical mandatory benchmark that has been established in order to gain approval by regulatory authorities like the U.S. Food and Drug Administration (FDA).(2) A higher standard of efficacy measurement is known as remission, or the virtual elimination of all symptoms of depression. When patients achieve full remission they are less likely to relapse(3) and are fully restored to normal psychosocial functioning(4)-in other words, they are able to return to activities previously enjoyed before the onset of depressive symptoms.

      "For the millions of people who suffer from depression, the study results are very exciting," said Michael E. Thase, M.D., professor of psychiatry, University of Pittsburgh School of Medicine, and lead author of the study. "Given the high global prevalence of depression, coupled with its staggering associated costs, this difference represents a potentially tremendous clinical and economic advantage. This certainly is the strongest evidence yet that all antidepressants are not equally effective."

      The new data comes from eight double-blind trials that were pooled to compare remission rates of 2,045 patients with major depressive disorder who were treated with venlafaxine or venlafaxine extended-release capsules, an SSRI, or placebo. In the study, overall venlafaxine remission rates were 45 percent, compared to 35 percent for SSRIs, and 25 percent for placebo (p<0.001 for all comparisons).

      "I struggled with depression for many years and tried many different antidepressants that simply were not working," said Shelia Singleton, a depression sufferer. "But Effexor XR was the one that saved my life and got me to fully recover from depression. I'm excited to hear about the findings of this study and maybe now patients who are not getting well with other medications will be motivated to seek better treatment, and at least give them hope that it is possible to lead a happier, more productive life."

      As a selective serotonin and norepinephrine reuptake inhibitor, venlafaxine simultaneously effects both serotonin and norepinephrine neurotransmitters implicated in depression and in anxiety.(5,6) The extended-release formulation of venlafaxine (Effexor XR®) is the first and only antidepressant approved by the FDA and 33 countries worldwide to treat depression and generalized anxiety disorder (GAD). GAD, the most common anxiety disorder, is a long-term condition marked by overwhelming, chronic, and excessive worry, anxiety, and tension that persists for at least six months. Effexor XR has the proven ability to work long term to achieve and sustain remission in GAD and in depression, helping patients not only get relief from their symptoms, but also helping them to maintain a complete recovery from their disease.

      Study Findings

      Remission frees sufferers from the symptoms of depression and allows them to participate in and enjoy their normal activities. In studies of depression, it is determined clinically by a score of <7 on the 17-item Hamilton Rating Scale for Depression (HAM-D).*

      Data from eight comparable randomized, double-blind studies were pooled to compare remission rates of 851 people with major depressive disorder who were treated with venlafaxine or venlafaxine extended-release, 748 patients who were treated with SSRIs [Prozac® (fluoxetine), Paxil® (paroxetine), and Luvox® (fluvoxamine)] and 446 patients treated with placebo (from four studies), for up to eight weeks.

      Significant differences in final remission rates were observed between patients given venlafaxine and patients given an SSRI or placebo. The significant difference between venlafaxine and the SSRIs started at week two, whereas the difference between the SSRIs and placebo reached significance at week four. Additional analyses confirmed that the findings were not dependent on any one study, nor were they limited to any particular definitions of remission.

      "I believe the dual-action mechanism of action conveyed by venlafaxine increases the chances of patients obtaining the best treatment outcome - the ability to achieve remission. This, in turn, may enhance their chances of long-term recovery," said Dr. Thase.

      About Depression

      Major depressive disorders, which include depression, affect an estimated 340 million people worldwide.(7) The World Heath Organization recently concluded that depression is the world's fourth greatest public health problem. If left untreated, the effects of depression can be devastating, robbing people of the energy or motivation to perform everyday activities and, in some cases, leading to suicide. Symptoms of the disorder include feelings of sadness or emptiness, lack of interest or pleasure in nearly all activities, and feelings of worthlessness or inappropriate guilt. In addition to the personal costs of depression, the disease also results in more than $40 billion annual costs in the United States alone due to premature death, lost productivity and absenteeism.

      About The University of Pittsburgh School of Medicine

      The University of Pittsburgh School of Medicine is consistently ranked among the nation's leading medical schools. It is one of the university's six Schools of the Health Sciences, which include the schools of Nursing, Dental Medicine, Pharmacy, Health and Rehabilitation Sciences and the Graduate School of Public Health. Their combined mission is to train tomorrow's health care specialists and biomedical scientists, engage in groundbreaking research that will advance the understanding of the causes and treatments of disease and to participate in the delivery of care as a partner with the UPMC Health System. Among the many areas for which its faculty and programs are internationally recognized are oncology, psychiatry, genetics, transplantation and public health.

      * HAM-D is a common psychiatric scale on which the severity of depressive symptoms is measured to determine treatment efficacy.

      1. "Remission Rates During Treatment with Venlafaxine or SSRIs" abstract, Thase et al.
      2. Thase ME, Entsuah AH, Rudolph RI. Br J Psych. Remission Rates During Treatment with Venlafaxine or SSRIs". In Press.
      3. Judd LL, Akiskal HS, Paulus MP. J Affect Disorder. The role and clinical significance of subsyndromal depressive symptoms (SSD) in unipolar major depressive disorder. 1997;45:5-18.
      4. Sulser F. J Clin Psychiatry. Serotonin-norepinephrine receptor interactions in the brain: implications for the pharmacology and pathophysiology of affective disorders. 1999;60:213-214.
      5. Dubovsky SL. J Clin Psych. Beyond the Serotonin Reuptake Inhibitors: Rationales for the Development of New Serotonergic Agents. 1994.
      6. Brunello N, Racagni G. Human Psychopharmacology. Rationale for the Development of Noradrenaline Reuptake Inhibitors. 1998.
      7. World Health Organization. The Newly Defined Burden of Mental Problems. WHO website: www.who.int/inf-fs/en/fact217.html. Accessed September, 2000.


      Produced for Wyeth-Ayerst Laboratories

      Craig Dunhoff
      UPMC News Bureau
      (412) 624-2607

      Steven Cooper
      Edelman Public Relations
      (212) 704-8242

      Patricia / Alley
      My ICQ#:12631861<br>

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