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| |  Effexor Provides Effective Relief Of Anxiety Symptoms GLASGOW, SCOTLAND -- July 15, 1998 -- New data presented today shows that Wyeth-Ayerst Laboratories’ antidepressant, Effexor(R) XR (venlafaxine HCl) Extended-Release Capsules, also has the potential to relieve anxiety symptoms. "Many patients with depression also experience symptoms of anxiety, which can exacerbate depression and increase a patient's risk of suicide if not adequately diagnosed and treated," said David Bakish, M.D., a study investigator and professor of psychiatry at the University of Ottawa. "There is a real need for antidepressants, such as Effexor XR, that can provide effective relief of anxiety -- without causing side effects associated with many anti-anxiety medications." In the study, presented at the Collegium Internationale Neuro-Psychopharmacologicum (CINP) annual meeting, 377 outpatients with generalized anxiety disorder (GAD) were randomized to receive venlafaxine XR 75 mg, 150 mg and 225 mg per day or placebo for eight weeks. At the end of the study, patients taking venlafaxine XR 225 mg experienced statistically-significant improvement (decreases in HAM-A total score of 12.3 and HAM-A psychic anxiety factor score of 7.3) versus placebo (decreases in HAM-A total score of 9.4 and HAM-A psychic anxiety factor score of 5.6). It is estimated that 95 percent of people with depression experience at least one symptom of anxiety, including excessive or uncontrollable worry, apprehension, irritability and muscle tension. Studies suggest that co-morbid depression and anxiety may have an impact on a patient's social functioning and is associated with a 30 percent to 60 percent increase in the utilization of healthcare services. A second placebo-controlled study compared the efficacy of venlafaxine XR 75 mg and 150 mg per day and the anti-anxiety medication buspirone (BuSpar(R)) 30 mg per day for eight weeks in 405 outpatients with GAD. Patients taking venlafaxine XR reported significantly greater improvement in their anxiety symptoms according to the Hospital Anxiety and Depression (HAD) Scale, compared with those who received buspirone. Effexor XR, a once-daily formulation of Effexor(R) (venlafaxine HCl), received U.S. regulatory clearance for the treatment of depression in October 1997. Unlike SSRIs (Prozac), which selectively inhibit the reuptake of the neurotransmitter serotonin in the brain, Effexor XR inhibits the reuptake of both serotonin and norepinephrine (SNRI). Effexor XR is sold by prescription in eight countries worldwide. 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 a MAOI or within at least 14 days of discontinuing treatment with a 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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