Acarbose: The Forgotten Drug Comes Back as a Generic

New study shows a 1 point drop in A1c, and the drug is now available as a generic from Mylan….

The study was done to obtain data on efficacy, safety and tolerability of acarbose monotherapy or combination therapy during daily-life treatment. 

This prospective, non-controlled, observational study enrolled patients with Type 2 diabetes, whose physicians had decided that acarbose treatment was appropriate, from China, Middle East, Indonesia, Morocco, Pakistan, Philippines, Poland and Taiwan. The observation period included an initial visit and up to three follow-up visits; an extension of 2 years was realized in Pakistan and Poland. 

The results showed that of 14,574 patients enrolled, 14,418 comprised the intent-to-treat population. At the initial visit, 74.1% of patients had been treated with a glucose-lowering agent. Fasting blood glucose was reduced from 175.2mg/dL at the initial visit to 133.7mg/dL at the last visit (mean of 11.3 weeks after initial visit; P<0.0001). Mean 2-h postprandial blood glucose decreased from 244.7mg/dL to 172.4mg/dL (P<0.0001). HbA1c reduced from 8.4% to 7.4% (P<0.0001). Glycemic efficacy was maintained over the 2-year extension period. There were 432 adverse events in 293 patients (2.03%), mainly gastrointestinal. Physicians assessed efficacy as "very good"/"good" in 85.1% of patients, and were "very satisfied"/"satisfied" with acarbose therapy in 94.3% of cases. 

From the results, it was concluded that acarbose therapy was efficacious and well tolerated in daily life in patients with Type 2 diabetes. 

Note: The US Food and Drug Administration (FDA) has granted final approval for Mylan Pharmaceuticals’ abbreviated new drug application (ANDA) for Acarbose tablets, 25mg, 50mg and 100mg. Acarbose tablets is the generic version of Bayer’s Precose tablets, a treatment to be used with diet and exercise to improve glycemic control in adults with Type 2 diabetes. Acarbose is an anti-diabetic drug used to treat Type 2 diabetes mellitus and, in some countries, prediabetes. It is sold in Europe under the brand name Glucobay (Bayer), in North America as Precose (Bayer Pharmaceuticals), and in Canada as Prandase (Bayer).

Diabetes Res Clin Pract. 2011 Jan 18. [Epub ahead of print]