Harrogate, UK, July 27 2007 – Clinical trial data showing that Efexor* XL (venlafaxine) helped patients prevent the recurrence of depression for up to two years1a, was presented at the British Association for Psychopharmacology summer meeting in Harrogate. It is the first time that a modern antidepressant has demonstrated prevention of recurrence, versus placebo, over a two year period.2 These findings reinforce guidance from the National Institute for Health and Clinical Excellence (NICE), that anti-depressants should be continued for two years in patients who have had 2 or more episodes. 3
Results from the Prevention of Recurrent Episodes of Depression with VENlafaxine XR for Two Years (PREVENT)1b study demonstrated that 70% of patients continued to respond to treatment with venlafaxine at doses 225mg/day and less over 2 years1c, and were therefore significantly more likely to remain recurrence-free than patients taking placebo.
“These data are notable as it is the first time we have seen such results for any modern antidepressant”, said Professor David Nutt, Professor of Psychopharmacology in the Academic Unit of Psychiatry, University of Bristol. “It is pleasing that the widespread clinical beliefs about the need for long term therapy for some depressed patients have been confirmed by such controlled data”.
In monotherapy alone, no SSRIs have demonstrated the prevention of recurrence, against placebo over two years of treatment.4-10
The World Health Organization categorises depression among the most disabling clinical diagnoses in the world.11 Much of the burden of this disease is linked to its recurrent nature – up to 85% of patients are likely to experience multiple episodes of depression despite previous antidepressant treatment.12 After initial recovery, the rate of recurrence of a depressive episode is 35% within two years and 60% within 12 years.13
In the PREVENT study, using the primary definition of recurrence (the total HAM-D17 >12 and a HAM-D17 reduction of £50% from acute phase baseline at 2 consecutive visits) the probability of staying healthy in the 225mg/day and less subgroup was 70% among patients given venlafaxine extended release compared to 38% among patients given placebo (p=0.007). This subgroup contained 114 patients, 55 of whom were randomised to receive venlafaxine.14
Patients in the study were 18 years or older and had a history of two or more episodes of major depression during the past five years, including their current episode. Additionally, these patients experienced at least three episodes of depression during their lifetime. Of the original study group, 80% had received antidepressant therapy during the course of their illness.
Professor Andre Tylee, from the Institute of Psychiatry, King’s College, London commented: “Whilst depression is often thought of as an episodic condition, in many cases it can also be recurrent or chronic, requiring management strategies suitable for a chronic disease. These data suggest that venlafaxine remains an important treatment option for the management of depression, particularly for those patients with severe depression, and should give GPs further confidence to manage this common and often disabling condition within the primary care setting.”
About the Study
The PREVENT study was a randomised, multi-centre, double-blind, placebo-controlled study over 30 months, designed to measure the prevention of recurrence with a prescription antidepressant when used as monotherapy and without psychotherapy for two years.1b
It followed outpatients with major depression through acute, continuation and two phases of maintenance therapy (12 months each) with venlafaxine extended release compared to placebo.
Venlafaxine extended release is licensed for depression at 75-225mg/day in the UK. A post-hoc analysis was therefore carried for this subgroup only (n=114).
Those who achieved a satisfactory therapeutic response were entered into a six-month continuation phase where they remained on the same drug. Those who responded during the continuation phase then entered into the maintenance phase, which consisted of two consecutive 12-month periods. At the start of each maintenance period, venlafaxine extended release responders were randomly assigned to receive treatment with venlafaxine extended release or placebo, during each phase of the study. Recurrence was defined as a HAM-D17 >12 and a HAM-D17 reduction of £50% from baseline HAM-D17 for two consecutive visits.
About Efexor* XL (venlafaxine extended release)
Efexor* XL is an antidepressant and one of a group of medicines called serotonin and noradrenaline reuptake inhibitors (SNRIs). Efexor* XL is effective across a wide range of symptoms of major depressive disorder and moderate to severe generalised anxiety disorder.15-18 It has more than 10 years experience and has been prescribed to over 1.3 million patients in the UK.19
Efexor* XL has tolerability that is dose-related20-21 and has been shown to achieve remission even following failure with prior antidepressants22.