During the open-label first stage of the study, 43 percent of patients reached remission after eight weeks of therapy; this rose to 53 percent at the end of six months. The researchers defined remission as a score of seven or less on the 17-item Hamilton Rating Scale for Depression (HAM-D17), a standard depression rating scale. During the second stage of the study, investigators found a significantly higher percentage of patients maintained their remission among the 106 members of the Effexor XR group compared to the 107 participants receiving a placebo at each monthly observation point after the first month of treatment. At the end of 12 months, significantly more patients who received Effexor XR, 67 percent, maintained remission after a year of therapy, compared to 46 percent who received placebo, p <0.01. More than 19 million Americans each year suffer from depression, which interferes with the ability to work, study, sleep, eat, and enjoy once pleasurable activities. Symptoms may include a persistent sad or anxious mood; feelings of hopelessness, or guilt; irritability; loss of interest in nearly all activities; decreased energy; difficulty concentrating or making decisions and, in severe cases, thoughts of death or suicide.
“The high remission rate that Effexor® XR delivered—67 percent—meant that more patients could regain their life and possibly go on to attain recovery from their depression,” said Nemeroff. “Patients who achieve remission are less likely to relapse and may feel more capable of resuming activities enjoyed before they developed depression symptoms.”
“The high remission rates seen with Effexor XR in patients who have major depression add to the growing body of evidence supporting the use of Effexor XR as a first-line treatment for depression,” said Victoria Kusiak, MD, Vice President of Global Medical Affairs and North American Medical Director of Wyeth Pharmaceuticals.
The APA presentation was a reanalysis of previously reported data collected from a multicenter study that included 15 sites in Europe and 15 in the United States, in which investigators enrolled a total of 495 patients. All of the patients had one or more previous episodes of major depression in the five years prior to the study, with intervals of six or more months between episodes. They also had baseline HAM-D21 total scores of 20 or greater. The average age of the patients in the yearlong phase was 44 years; about 67 percent were women. Patients taking Effexor XR received the immediate-release formulation, 100 to 200 milligrams per day given in two divided doses.
About Effexor® XR
Effexor® XR is a structurally novel antidepressant chemically unrelated to any other available antidepressant. Effexor XR works simultaneously on both serotonin and norepinephrine, two of the chemicals that brain cells use to communicate, which are implicated in depression and anxiety. Serotonin may be involved in mood regulation, thus affecting, for example, impulse, appetite, and feelings of aggression. Norepinephrine may affect motivation, among other behaviors.
Effexor XR was discovered and developed by Wyeth Pharmaceuticals. The immediate-release formulation was approved by the FDA in 1993; the extended-release (XR) formulation was approved in 1997. These medications are available only by prescription.
The most common adverse events reported in Effexor XR placebo-controlled depression trials (incidence greater than or equal to 10 percent or greater than or equal to twice that of placebo) were nausea, dizziness, somnolence, delayed ejaculation, sweating, dry mouth, and nervousness; and in generalized anxiety disorder (GAD) trials were nausea, dry mouth, insomnia, delayed ejaculation, anorexia, constipation, nervousness, and sweating.
Effexor XR XR is contraindicated in patients taking monoamine oxidase inhibitors (MAOIs). Treatment with Effexor XR is associated with sustained increases in blood pressure (BP) in some patients. Regular BP monitoring is recommended. Patients should not be abruptly discontinued from antidepressant medication, including Effexor® XR; see the Dosage and Administration section of the Prescribing Information.
About Wyeth Pharmaceuticals
Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women's health care, cardiovascular disease, central nervous system, inflammation, hemophilia, oncology and vaccines. Wyeth is one of the world's largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing, and marketing of pharmaceuticals, vaccines, biotechnology products and nonprescription medicines that improve the quality of life for people worldwide. The Company's major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health.