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New Study Shows Effexor(R) XR Reduces Pain Associated With Diabetic Neuropathy.

- Significant Benefits For 6 Million Americans With Diabetes

Who Suffer From Neuropathic Pain -

SAN ANTONIO, June 12 /PRNewswire/ --

A new study presented at the 60th annual meeting of the American Diabetes Association shows that the antidepressant Effexor(R) XR (venlafaxine HCl) Extended-Release Capsules is effective in reducing pain associated with diabetic neuropathy. Diabetic neuropathic pain, which is caused by nerve damage associated with diabetes, affects 60 percent of patients with diabetes. Common symptoms of the disorder include numbness, tingling, and pain in the extremities and legs, as well as hypersensitivity to painful stimuli.

Study results showed that patients who took Effexor XR in doses ranging from 150-225 mg per day had significantly higher analgesic response rates, compared to placebo.

"The study indicates that Effexor XR, a novel compound that inhibits the brain's reuptake of serotonin and norepinephrine -- both of which are involved in mediating mood, as well as pain perception -- may be used not only to treat major depressive disorder and generalized anxiety disorder, but may also hold promise in the treatment of diabetic neuropathic pain," said Sherwyn Schwartz, M.D., Director, Diabetes and Glandular Disease Clinic.

Clinical Study Findings

The double-blind, placebo-controlled, parallel-group multi-site study evaluated the efficacy, safety, and tolerability of Effexor XR as a treatment for painful diabetic neuropathy. In the study, 244 patients 18 years of age or older with type 1 or type 2 diabetes were randomly assigned to receive treatment with Effexor XR 75 mg, 150-225 mg, or placebo for up to 6 weeks. Primary efficacy was measured by patient self-rating assessments of pain intensity and pain relief using a Visual Analog Scale (VAS-PI and VAS-PR). Secondary efficacy was determined by patient self-ratings of pain relief on the Patient Global Rating of Pain Relief scale, and by investigator-rated assessments of pain on the Clinical Global Impressions Severity of Illness (CGI-S) and Clinical Global Impressions Global Improvement (CGI-I) scales. The most common adverse event in the study associated with Effexor XR was nausea.

On both primary outcome measures, Effexor XR 150-225 mg produced significantly greater pain relief at all evaluations (p<0.05 at weeks 2-4; p<0.001 at weeks 5 and 6) compared with placebo. Effexor XR 75 mg produced significant pain relief, compared with placebo, on the VAS-PR scale at weeks 2, 3, and 5 (p<0.05). Additionally, by week 6, 56 percent of patients treated with Effexor XR 150-225 mg experienced significantly lowered pain intensity, compared with 39 percent treated with Effexor XR 75 mg and 34 percent given a placebo (p<0.05).

On all the secondary measures, similar statistical superiority (p<0.05) over placebo was demonstrated for Effexor XR 150-225 mg. Since the presence of major depressive disorder was an exclusion criterion in the study, symptom improvement was attributed to analgesic, rather than an antidepressive, effect.

"As diabetic neuropathy progresses over time, the pain caused by nerve damage may become overwhelming, and medications such as aspirin, acetaminophen, or ibuprofen do not work as well," said Dr. Schwartz. "Narcotics can relieve pain, but they are prescribed only as a last resort. Tricyclic antidepressants may be used, but many patients experience troublesome side effects that may hinder compliance. Effexor XR is an effective medication that may represent a new treatment option for patients suffering from this condition."

About Diabetes and Diabetic Neuropathy

Diabetes affects 15.7 million people in the United States, or 5.9 percent of the population. While an estimated 10.3 million people have been diagnosed, 5.4 million are not aware that they have the disease. Diabetes, a chronic disease with no cure, is one of the most costly health problems in America. Health care and other costs directly related to diabetes treatment, as well as the costs of lost productivity, are $98 billion annually.

Significant clinical diabetic neuropathy can develop within the first 10 years after diagnosis of diabetes, and the risk increases the longer a person has diabetes. Diabetic neuropathy appears to be more common in smokers, people over 40 years of age, and people who have problems controlling their blood glucose levels. Symptoms of diabetic neuropathy vary depending on which nerves and what part of the body is affected. The peripheral neuropathies associated with diabetes are more common in the legs and feet; however, other areas of the body can be affected. Regardless of the afflicted body region, the need to find treatments to alleviate or reduce symptoms is real.

About The Diabetes & Glandular Disease Clinic

The Diabetes & Glandular Disease Clinic, P.A. (DGD), founded in June 1979, offers treatment for hormonal and metabolic disorders such as type I and II diabetes, gestational diabetes, thyroid disease, osteoporosis, lipid disorders (high cholesterol), pituitary/adrenal gland problems, menstrual disorders and hirsutism. DGD is a leader in progressive use of the most current, state-of-the-art technologies and cutting-edge treatments. The Clinic is internationally renowned for its care of patients with diabetes mellitus, as well as other endocrine disorders, and has remained one of the largest endocrinology clinics in South Texas.

The study was funded by Wyeth-Ayerst Laboratories, the pharmaceutical division of American Home Products Corporation and the makers of Effexor XR .
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Date:Jun 12, 2000
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