Study: TZDs may increase risk for bone fractures in older women
NEW YORK Women with Type 2 diabetes who take a commonly prescribed class of medications to treat insulin resistance may be at a higher risk for developing bone fractures, according to a study published in the Journal of Clinical Endocrinology & Metabolism.
The study, led by L. Keoki Williams, M.D., MPH, Center for Health Services Research and Department of Internal Medicine at Henry Ford Hospital and colleagues, sought to determine the relationship between thiazolidinedione use and fracture risk in patients with Type 2 diabetes. Williams and his colleagues conducted a retrospective study from Jan. 2, 2000 to May 31, 2007 of 19,070 Henry Ford patients. Among the study group, 9,620 were women and 9,450 were men. During the study period, 4,511 patients had at least one prescription fill for a TZD. The researchers used electronically maintained medical claims data to identify nontraumatic bone fractures.
After taking a thiazolidinedione for one year, the women were 50% more likely to have a bone fracture than patients not taking TZDs. Similar findings were observed in treated women older than 65 years, who were shown to have a 70% increased risk for developing fractures. Men, regardless of age, were not at an increased risk for fractures.
“Older women are already at a higher risk of osteoporosis and osteoporosis-related fractures, which might explain why they appeared to be the most affected by TZDs,” said study senior author L. Keoki Williams, M.D., MPH, Center for Health Services Research and Department of Internal Medicine at Henry Ford Hospital.
Williams also suggested that Type 2 diabetics should discuss other suitable treatment options with their doctors.
Such TZDs as pioglitazone and rosiglitazone are designed help keep blood glucose levels on target by decreasing insulin resistance and making body tissues more sensitive to insulin’s effects. TZDs also cut down on the amount of glucose made by the liver in patients with Type 2 diabetes.
Biovail, Alexza develop inhaled mental health treatment
MOUNTAIN VIEW, Calif. An inhaled mental health drug could appear on the market in the near future under a collaboration announced Wednesday by Biovail Corp. and Alexza Pharmaceuticals.
Biovail subsidiary Biovail Labs International SRL and Alexza said they would work together to develop and commercialize AZ-004 (loxapine) in the United States and Canada. The drug is based on Alexza’s proprietary Staccato technology and is an inhaled drug designed to treat agitation in patients with bipolar disorder and schizophrenia. Alexza submitted an approval application for the drug to the Food and Drug Administration in December 2009.
Under the terms of the deal, Biovail will pay Alexza $40 million upfront and up to $90 million in milestone payments, if the drug is approved, as well as royalty payments of 10% to 25%.
“We are very excited to be partnering our lead program with Biovail,” Alexza president and CEO Thomas King said in a statement. “Their key strategic focus and their [central nervous system] commercial plans match our view of an ideal partner for AZ-004. We believe that AZ-004, if approved, has the potential to change the treatment practices for acute agitation, as the only product able to meet both the patients’ desire for quickly and comfortably gaining control of their agitation and the clinicians’ goal of rapidly and reliably calming an agitated patient.”
Novartis to develop, market hepatitis C drug
BASEL, Switzerland Novartis has gained exclusive rights to develop and market a hepatitis C drug that is the first of its kind, the Swiss drug maker announced Tuesday.
Novartis acquired control of Debio 025 (alisporivir) from Debiopharm Group. The drug is the first of a drug class known as cyclophilin inhibitors, which target host proteins involved in the growth of the virus. The drug is currently in phase 2b clinical trials.
Under the terms of the agreement, Novartis will pay unspecified upfront and milestone payments to Debiopharm, as well as royalties on sales, in exchange for the exclusive right to develop and market the drug worldwide, except in Japan.
“Hepatitis C is sometimes referred to as a ‘silent epidemic’ because the virus can lie dormant in the body for years or even decades before the symptoms become apparent,” Novartis Pharmaceuticals Division CEO David Epstein said. “Novartis is dedicated to developing medicines that will reduce the impact of this disease on patients, and we believe that Debio 025 could prove an important step forward by significantly enhancing the efficacy of existing therapy that forms the standard of care for hepatitis C.”