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Ruboxistaurin May Change DN Drug Market

According to Decision Resources, Inc, the 2006 launch of ruboxistaurin will transform the diabetic neuropathy (DN) drug market from the focus of pain control to the focus of disease modification.

Part of the Pharmacor study – a family of studies that assess the impact of drugs that are being researched and developed on the commercial market – Eli Lilly and Company’s (Indianapolis) ruboxistaurin has the potential to be the first disease-modifying drug that will launch beyond Japan. Epalrestat, which is only considered by physicians to be moderately affective, has been available in Japan since 1995.

“Interviewed experts remain hopeful that, if this agent is administered early enough in the disease process, it will reduce disease progression of distal symmetrical polyneuropathy, the most common clinical manifestation of neuropathy among diabetic [patients],” Carilee Berg, Decision Resources analyst, said in a news release.

MedicAlert and ADA Team Up
MedicAlert Foundation (Turlock, Calif), the emergency medical information service, and the American Diabetes Association (ADA) have teamed up to develop an educational strategy designed to increase access to information about the organizations for people living with diabetes.

“The incidence of diabetes is rapidly rising and is one of the primary conditions among our members,” said Ramesh Srinivasan, MedicAlert vice president of marketing, in a news release. “The ADA is a perfect fit to educate them on how to develop and maintain healthy lifestyles.”
It is important that emergency conditions associated with diabetes be identified and relayed to medical professionals, according to a news release. “With MedicAlert, electronic health records are instantly available to emergency response professionals,” said Francie Davenport, ADA corporate membership manager. “ADA supports the MedicAlert mission to protect and save lives in an emergency, thus enhancing the quality of life for [diabetic patients].”
For more information, visit www.medicalert.org

Cinnamon Water Extract for Diabetic Patients
Hero Nutritionals (San Clemente, Calif), a provider of nutritional supplements, has launched CinnaBeticII, a dietary supplement designed to promote glucose metabolism by increasing insulin sensitivity. According to a news release, CinnaBeticII is all-natural and contains Cinnulin PF, a patented water extract of cinnamon. Water extract of cinnamon has been found to promote glucose metabolism in diabetic patients and reduce LDL cholesterol levels in individuals with type 2 diabetes.

“Cinnulin PF is a water extract of cinnamon that contains active compounds to help control glucose levels without the harmful toxins found in whole cinnamon or fat-soluble extracts,” said Richard Anderson, PhD, research scientist with the United States Department of Agriculture (USDA). “That makes CinnaBeticII safe for long-term use in managing symptoms associated with diabetes.”

A recent study in Diabetes Care found that patients treated with cinnamon for 40 days had decreases in fasting glucose levels of 18% to 29%, decreased cholesterol levels of 12% to 26%, and decreased triglycerides levels of 23% to 30%. According to recent USDA research from Dr. Anderson’s group, the water extraction process leaves type-A polymers responsible for glucose metabolism intact while removing potentially dangerous compounds found in cinnamon.
For more information, visit www.heronutritionals.com.

Walgreens Makes Large Print Prescription Instructions
Walgreens (Deerfield, Ill) is the first national drugstore chain to offer large print prescription instructions free of charge at its stores. This offering benefits millions of Americans with impaired or low vision.

Pharmacy patients can request the large print option when they drop off or call in their prescriptions. The pharmacist will provide instructions printed in 19-point type on 8 1/2-in-by-11-in paper. All prescription instructions are available in large type in both English and Spanish.

According to Lighthouse International, more than 16.5 million Americans aged 45 or older have some form of vision impairment. This number is expected to grow to 20 million in the next 6 years due to conditions such as age-related macular degeneration, diabetes, glaucoma and cataracts.

The number of prescriptions a person uses increased from nine per year for people aged 45 to 54 years to more than 17 per year for people aged over 75 years, according to industry research. For more information, visit www.walgreens.com.

Use of Xenical Delayed Onset of Type 2 Diabetes
An FDA label change shows that weight-loss with xenical (Orlistat, Roche [Nutley, NJ]) delayed the onset of type 2 diabetes in obese patients with prediabetes.

The change was due to results from the largest and longest study of a weight-loss medication – Xenical in the Prevention of Diabetes in Obese Subjects (XENDOS) – where 3,304 obese patients were assessed for weight-loss and delayed onset of diabetes during a 4-year, double-blind, placebo-controlled study. A 42% reduction in the relative risk for developing type 2 diabetes occurred among patients (n=661) who had prediabetes, however, no significant reduction was noticed in those patients (n=2,643) with normal glucose tolerance.

This study is the first time that weight-loss medication delayed or prevented the onset of type 2 diabetes. Re-searchers said this was caused by additional weight-loss from Xenical treatment and not from its independent effects on glucose or insulin metabolism.

Phase 2 Trial Initiated
A phase 2, multidose study of exenatide (Amylin Pharmaceuticals [San Diego]) long-acting release (LAR) is predicted to start in the first quarter of 2005, according to a news release.

An ongoing single-dose study using the LAR therapy, a subcutaneous injection that produces a sustained release, has shown no dose-limiting side effects in approximately 60 patients with type 2 diabetes. The 90-day study is in the dosing and follow-up stages, and patients either received a single subcutaneous exenatide LAR injection at one of four doses or placebo. During the upcoming multidose study, exenatide LAR will be used once a week by patients with type 2 diabetes.

Another previous triple-blind, placebo-controlled study revealed that a reduction in the blood glucose levels of type 2 diabetic patients was seen with the use of exenatide.

Researchers reporting in Diabetes Care enrolled 377 type 2 diabetic patients who could not use sulfonylurea as monotherapy. The study lasted 30 weeks, and was conducted at 101 US sites. A total of 237 patients had a baseline HbA1c >7%. Patients were randomized to receive either 5-µ or 10-µ doses of subcutaneous exenatide or placebo before breakfast and again before dinner.

Sonicare System Introduces Power Toothbrush
According to the ADA, diabetic patients have a greater incidence of gingivitis versus nondiabetic patients. Using the IntelliClean System, from Sonicare (Royal Philips Electronics [Netherlands]) and Crest (Proctor and Gamble [Cincinnati]), the first integrated power toothbrush and liquid toothpaste dispensor, may help combat gingivitis. The product is now available only in dental professional offices.

In laboratory studies, the IntelliClean System toothbrush system was proven to remove plaque bacteria – the leading cause of gingivitis – up to 2 mm to 3 mm beyond the reach of the bristles.

The system uses specially formulated Crest toothpaste that liquefies with the brush’s high-speed bristle motion. The toothpaste produces micro cleaning bubbles that penetrate hard-to-reach areas, and foams evenly throughout brushing.

Toothpaste can be reapplied by pushing the dispensing button while brushing, which results in a significantly greater reduction of plaque bacteria in the sulcus at the site of reapplying.

The number of people using the technology who complied with the recommended brushing regimen of two minutes twice daily, doubled compared to using their previous toothbrush and toothpaste. n