Onglyza gets label update
PRINCETON, N.J., and WILMINGTON, Del. — The makers behind a popular Type 2 diabetes treatment have included data from two clinical studies in an update to the drug’s prescribing information.
Bristol-Myers Squibb and AstraZeneca said the Food and Drug Administration approved the labeling update for Onglyza (saxagliptin), which now includes efficacy and safety information about the drug’s effects on patients with renal impairment or end-stage renal disease.
One study was a 12-week trial involving patients with severe kidney damage or end-stage kidney disease, which compared Onglyza with the patients’ current treatment plus a placebo. The results showed patients experienced greater improvements to their blood sugar levels, those the rates of side effects were the same.
In the second study, which was a 52-week trial, compared Onglyza with titrated glipizide in patients with inadequate glycemic control on metformin therapy and were dieting and exercising. The study showed that Onglyza plus metformin provided similar HbA1c reductions.
“Many people with Type 2 diabetes also experience kidney impairment, which can limit treatment options. With this update, Onglyza now includes efficacy and safety data in its label supporting its use in this important population,” said Elliott Sigal, EVP, chief scientific officer and president, research and development at Bristol-Myers Squibb. “The study comparing Onglyza to titrated glipizide provides further evidence for the use of Onglyza as an add-on therapy to metformin.”
The drug makers added that renal function should be tested prior to taking Onglyza and periodically thereafter.
Report: North Dakota pharmacy ownership bill defeated
NORTH DAKOTA — A House bill that would have paved the path for chain and big-box pharmacy retailers to set up shop in North Dakota was rejected on Tuesday, according to a local news report.
Under the current law, pharmacies must be majority-owned by a licensed pharmacist, but House Bill 1434 would have eliminated that portion of the law, the Bismarck Tribune reported. The bill was defeated 71-23.
Those in favor of the bill said the state should open up the market to competition.
However, those against the bill argued that the state’s pharmacies offered better service and cheaper prices, and the U.S. Supreme Court already has upheld the law itself, the article stated.
Study: Amphetamine use could pose Parkinson’s disease risk
ST. PAUL, Minn. — Use of amphetamines could increase the risk of Parkinson’s disease, according to a new study.
The study, supported by Kaiser Permanente and scheduled for presentation at the American Academy of Neurology’s annual meeting in Honolulu this April, found that people who have used such drugs as GlaxoSmithKline’s Benzedrine (amphetamine sulfate) and Dexedrine (dextroamphetamine sulfate) have an increased risk of developing the disease. The drugs often are prescribed for patients with attention deficit hyperactivity disorder and narcolepsy.
The study included 66,348 people in northern California who had participated in the Multiphasic Checkup Cohort Exam between 1964 and 1973 and were evaluated again in 1995. More than 1,100 patients had been diagnosed with Parkinson’s by the end of the study.
The researchers found that people who had reported using Benzedrine or Dexedrine were almost 60% more likely to develop Parkinson’s than those who didn’t take them, though there was no increased risk found for those people who had used drugs for weight loss.
“If further studies confirm these findings, the potential risk of developing Parkinson’s disease from these types of amphetamines would need to be considered by doctors before prescribing these drugs, as well as be incorporated into amphetamine abuse programs, including illicit use,” study author Stephen Van Den Eeden of Kaiser Permanente’s division of research said.