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Press Release: Metanx promotes restoration of lost cutaneous sensation in Diabetic Neuropathy patients
27. January 2011 04:12
PamLab L.L.C., developer and marketer of Metanx®, announced today that the results of a study to determine if nutritional management with Metanx® improves numbness in the feet of patients with Diabetic Neuropathy (DN) was published in the fourth quarter 2010 issue of Reviews in Neurological Diseases. The study demonstrated that Metanx®, a medical food available by prescription, promotes restoration of lost cutaneous sensation in DN patients.
“There is considerable need for a therapy like Metanx®, as it has demonstrated to improve sensory loss with a favorable safety profile”
Diabetic Neuropathy, nerve damage caused by diabetes, is a chronic condition characterized by tingling, burning pain, and numbness in the feet and/or hands. It is estimated that 60-70 percent of the 23.6 million people with diabetes in the U.S. have some form neuropathy. Numbness in the feet is the most common symptom associated with diabetic neuropathy and is the most frequent cause of ulceration and amputation. Additionally, burning pain occurs in 10 to 25 percent of DN patients. Current therapies mask the painful symptoms of DN but do not address the numbness or underlying progression of the condition, a challenge currently facing health care providers.
Mackie J. Walker Jr., DPM, of the Podiatry Division of the Carolina Musculoskeletal Institute in Aiken South Carolina acted as lead study investigator. "There is considerable need for a therapy like Metanx®, as it has demonstrated to improve sensory loss with a favorable safety profile," stated Dr. Walker.
"Diabetic Neuropathy is an under-recognized and significantly underserved result of type 2 diabetes," said Harold O. Koch, Jr., Senior Vice President of Business & Scientific Affairs, and Chief Scientific Officer of Pamlab. "Unlike the current standards of care, which only mask the painful symptoms, Metanx® manages the nutritional needs of the patient with Diabetic Neuropathy, maintaining blood flow and creating an environment for increased nerve fiber density; thus, enhancing the patient's quality of life."
The efficacy of nutritional management with Metanx® in restoring sensitivity in patients with type 2 diabetes was measured in three follow-up periods: baseline to 6 months, baseline to 1 year, and 6 months to 1 year. After 6 months and 1 year of Metanx® compared to baseline, a statistically significant improvement was observed in both tactile and discriminatory testing at the right and left great toe and medial heel of patients. The results of this study were originally presented in 2008 at the New Cardiovascular Horizons Meeting in New Orleans.
Aim: Despite recent reports linking vitamin D deficiency with increased risk of diabetes mellitus and complications, there is limited data on patients with diabetic peripheral neuropathy. We aimed to evaluate the incidence and associations of vitamin D deficiency in 210 patients with Type 2 diabetes with and without diabetic peripheral neuropathy..
Methods: Renal, liver, lipid profile and HbA1c were measured. Vitamin D status was determined by measuring 25-dihydroxyvitamin D. Presence or absence of coronary heart disease was determined and early-morning urine microalbumin:creatinine ratio was measured. All patients were assessed clinically using neuropathy symptom score, neuropathy disability score and nerve conduction study.
Results: Eighty-seven patients had diabetic peripheral neuropathy and these patients had significantly longer duration of diabetes and higher HbA1c. Age, gender, incidence of retinopathy and coronary heart disease were not significantly different from those without neuropathy.. Mean (SD) vitamin D was significantly lower in those with neuropathy [36.9 (39.9) nmol/l] compared with those without [58.32 (58.9) nmol/l] and 81.5% of patients with neuropathy had vitamin D deficiency compared with 60.4% of those without. Vitamin D showed significant (P < 0.05) correlations with total cholesterol, LDL-cholesterol and urine microalbumin:creatinine ratio. Binary logistic regression analysis showed that diabetic peripheral neuropathy was significantly associated with vitamin D deficiency (odds ratio = 3.47; 95% CI = 1.04–11.56, P = 0.043) after inclusion of potential confounders such as duration of diabetes, HbA1c and LDL-cholesterol.
Conclusion: Vitamin D deficiency is an independent risk factor for diabetic peripheral neuropathy,. and further studies are required to confirm if Vitamin D supplementation could prevent or delay the onset.