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| |  ECNP: Escitalopram Achieves Earlier Response and Better Tolerability than Venlafaxine XR in First Head-to-Head Study By Bruce Sylvester Special to DG News BARCELONA, SPAIN -- October 8, 2002 -- Subjects with major depressive disorder using the selective serotonin reuptake inhibitor (SSRI) escitalopram showed earlier sustained response to treatment and remission of symptoms and better drug tolerance than subjects using the serotonin norepinephrine reuptake inhibitor (SNRI) venlafaxine XR. The study was presented here Monday at the European College of Neuropsychopharmacology (ECNP). "SSRIs set the standard for tolerability in the treatment of major depression until venalafaxine XR appeared. This new study indicates that not only does the SSRI escitalopram offer better tolerability than venlafaxine XR but also works more quickly to produce a therapeutic response." said lead investigator Stuart Montgomery, MD, professor of psychiatry at the Imperial College School of Medicine, in London, England. “This is crucially important because so many patients quit treatment in the early weeks if seem like a drug is not working." The researchers enrolled 288 subjects, ages 18-85, in this randomised, double-blind, multi-center, active-comparator-controlled, flexible dose study. Inclusion criteria included a DSM-IV diagnosis of major depressive disorder and a total score on the Montgomery Åsberg Depression Rating Scale (MADRS) of at least 18. Subjects were randomized to eight weeks of double-blind treatment with either 10 or 20 mg escitalopram or 75 or 150 mg venlafaxine XR. For those started at 10 mg escitalopram and 75 mg venlafaxine XR who showed inadequate response, treatment could be increased to the higher dose at weeks 2 or 4. At the end of eight weeks, subjects completing the study entered a one-week single-blind wash-out phase in order to evaluate their withdrawal symptoms. Low-dose patients received placebo immediately and higher-dose patients were titrated down by getting the lower dose for four days and placebo for three days. The investigators used the standard DESS (Discontinuation Emergent Signs and Symptoms) scale, which includes 43 items such as agitation, insomnia, fatigue and dizziness. Change in mean MADRAS score for both drugs from baseline to endpoint indicated that escitalopram was at least as efficacious as venlafaxine XR. This result was supported by secondary analyses of CGI-scores. A statistically significant larger proportion of escitalopram subjects achieved a sustained response by week 6 and a sustained remission at weeks 2, 3, 4 and 6. Sustained response occurred 4.6 days sooner for escitalopram subjects (p<0.05) and sustained remission appeared 6.6 days (p<0.00) sooner for escitalopram subjects. Eleven per cent of venlafaxine XR subjects withdrew from the study due to adverse events compared to eight percent of escitalopram subjects. Sixty-nine per cent of the escitalopram subjects and 76 percent of venlafaxine XR subjects reported treatment-emergent adverse events during the 8-week treatment phase of the study. More than twice the number of venlafaxine XR subjects showed an increase in the DEES (Discontinuation Emergent Signs and Symptoms) score at a level of at least 4. Venlafaxaine XR subjects also showed a greater mean number of new or worsened symptoms at the end of the one-week wash-out phase. "When we can get an early response, we can better prevent discontinuation of treatment at the patient’s most vulnerable time and treatment’s most crucial phase. An early positive response indicates a favorable long-term outcome and potential for remission,” said Dr. Montgomery. “We are now seeing remission rates for escitalopram at 86 percent at 52 weeks for responders who stay the course of drug therapy. But to get there, patients with this terrible illness need to feel that there is hope early in treatment, as early as possible. It is becoming clear that escitalopram is going to elicit that earlier hope-and with higher tolerability-from many more people with major depression." Escitalopram was FDA-approved for marketing in the US on August 14, 2002. The research was supported by H. Lundbeck A/S.
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