Researchers continue to search for therapies that are effective in treating Type 2 Diabetes patients who are not responsive to first-line treatments, changes in diet, exercise, and other lifestyles changes. The German Institute for Quality and Efficiency in Health Care (IQWiG) examined a recent drug – Empagliflozin – that was approved as a treatment for type two diabetes adults who, even with exercise and a controlled diet, still had hyperglycemia. The study focused on understanding whether Empagliflozin added a significant therapeutic value when compared with other standard therapies.
The authors concluded, after revising the drugs’ dossier, that no added benefit was reported. Specifically, four research questions out of five lacked data supporting the recommendations.
The report focused on the lack of data for several points. First, the manufacturer compared empagliflozin with sulfonylurea glimepiride but different dosages were used – 1 to 4 mg glimepiride against empagliflozin administration of 25 mg daily. Thus, the results reported by the manufacturer — blood glucose levels rapidly decreasing and more frequent hypoglycaemias — for the comparator therapeutics may have in fact been caused by the different dosages of the therapeutics. Additionally, the report stated that the constant administration of 25 mg empagliflozin is in fact higher (2.5 times) than the approved dose. Thus, the effects of empagliflozin administered at 10 mg were not able to be determined from these studies. Although the administration of 25 mg of empagliflozin resulted in fewer hypoglycemic events, other complications — genital infections and renal and urinary disorders — were registered more frequently in the 25 mg empagliflozin therapeutics. Finally, a comparison of the effect of empagliflozin 25 mg combined with other drugs, metformin or glimepiride, was also determined to be unsuitable due to differences in treatment regimens.
Physicians still recommend that the best solution for controlling type 2 Diabetes is a combination of prescribed drugs along with healthy lifestyle choices. However, for those patients who are resistant to standard therapeutic approaches, the need for second-line therapies is a pressing one that researchers continue to pursue.
The report is part of the Act on the Reform of the Market for Medicinal Products (AMNOG) supervised by the G-BA.