Effexor XR Produces Higher Depression Remission Rates Than Prozac
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Effexor XR Produces Higher Depression Remission Rates Than Prozac

TORONTO, ON -- June 2, 1998 -- Wyeth-Ayerst Laboratories presented data today at the American Psychiatric Association Annual Meeting in Toronto, ON, demonstrating that patients with depression who were treated with Effexor(R) XR (venlafaxine HCl) Extended-Release Capsules experienced a statistically significantly higher rate of remission as defined in the study, than patients who were treated with Prozac(R) (fluoxetine).

Results from a second study showed that Effexor XR and Prozac had comparable efficacy; however, Effexor XR produced a greater response at specific time points in reducing concomitant anxiety symptoms in patients with depression when compared to Prozac.

Effexor XR, a once-daily formulation of Effexor (venlafaxine HCl), received U.S. Food and Drug Administration market clearance for the treatment of depression in 1997. Unlike SSRIs which selectively inhibit the reuptake of the neurotransmitter serotonin in the brain, Effexor XR inhibits the reuptake of both serotonin and norepinephrine.

"In the late 1980s, SSRIs radically improved the way we treat depression," said Jeffrey Kelsey, M.D., Ph.D., assistant professor, department of psychiatry and behavioural sciences at Emory University School of Medicine, Atlanta. "These studies demonstrate that Effexor XR, which targets two neurotransmitters involved in depression, has helped many patients experience remission from this devastating disease."

In the first study, 301 patients with depression were randomised to receive venlafaxine XR, fluoxetine, or placebo for 8 weeks. The number of patients treated with venlafaxine XR who experienced remission as defined in the study (HAM-D score of eight) at the end of eight weeks was nearly twice as high (37 percent versus 22 percent) as in the fluoxetine group, a finding that was statistically significant.

The second study, another placebo-controlled study, compared the efficacy of venlafaxine XR with fluoxetine for 12 weeks in 359 outpatients with depression and concomitant anxiety. Although HAM-D remission rates were comparable, venlafaxine XR was associated with significantly greater improvement in concomitant anxiety symptoms than fluoxetine, as measured by the HAM-A at week 12.

"Many patients who suffer from depression also experience associated anxiety symptoms," Dr. Kelsey said. "Because Effexor XR also has been shown to reduce anxiety symptoms in patients with depression, it represents an efficacious treatment option, which is an important benefit for these patients."

Effexor XR is contraindicated in patients known to be hypersensitive to venlafaxine hydrochloride and in patients taking monoamine oxidase inhibitors (MAOIs). Effexor XR should not be used in combination with an MAOI or within at least 14 days of discontinuing treatment with an MAOI because of the potential for serious adverse reactions. Based on the half-life of venlafaxine, at least seven days should be allowed after discontinuing use of Effexor XR before starting a MAOI.

The most commonly reported side effects in placebo-controlled trials of Effexor XR were similar to those of Effexor (venlafaxine HCl) and included abnormal dreams, abnormal ejaculation, anorexia, dizziness, dry mouth, nausea, nervousness, somnolence, sweating and tremor. The most common side effect, nausea, subsided to levels seen in placebo-treated patients by the second week of treatment. Venlafaxine is associated with sustained increases in blood pressure in some patients, so regular blood-pressure monitoring is recommended.

In clinical trials of Effexor XR, the overall incidence of sustained increases in blood pressure was three percent. Less than one percent of patients discontinued Effexor XR due to elevated blood pressure. The incidence of sustained increases in blood pressure at doses greater than 300 mg/day has not been fully evaluated.

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