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Diabetes drug insulin degludec but no added benefit
Insulin degludec (trade name Tresiba) has been approved for adolescents and children with type 1 or type 2 diabetes mellitus since January of this year, but the drug does not provide added value to those affected, according to the latest communication from the Institute for Quality and Efficiency in Health Care ( IQWiG). Instead, more serious side effects may even occur.
The IQWiG reviewed in an early benefit assessment under the German Medicines Market Reorganization Act (AMNOG) whether insulin degludec "alone or in combination with other antihyperglycaemic drugs offers added value compared with the ACT." For adolescents and children with type 1 diabetes mellitus, the dossier submitted can be excluded derive no added benefit for insulin degludec from the manufacturer Novo Nordisk and "because the manufacturer has not provided data for adolescents and children with type 2 diabetes, no statement to greater or lesser benefit is possible here," said the IQWiG. Furthermore, girls had shown evidence of "greater harm in terms of serious adverse events".
Lifelong administration of insulin is still a key element of therapy, especially in type 1 diabetes. (Image: Henrik Gerold Vogel / pixelio.de) No additional benefit recognizable
According to the IQWiG, the only study presented in the dossier examined children and adolescents with Type 1 diabetes, with no "mortality, symptoms and symptoms" and most side effects (adverse reactions, severe and symptomatic hypoglycaemia, ketoacidosis) Differences between the treatment groups ". An added benefit is therefore not recognizable. When looking at the sexes, it became clear that boys with diabetes mellitus type 1 showed no additional positive or negative effects. However, the girls treated with insulin degludec developed "serious adverse events" more frequently than those in the control group.
Indications of a lesser benefit
About 15 out of 100 young type 1 diabetics who received insulin degludec had severe side effects within 52 weeks, according to the IQWiG. Among the girls who received the standard therapy, only about three out of 100 showed similar complaints. For example, "insulin degludec would be an indication of lesser benefit compared to the ACT in the treatment of girls," reports the IQWiG. The current dossier assessment forms the basis for the following commenting procedure of the Joint Federal Committee (G-BA), at the end of which the G-BA will make a final decision on the extent of the added benefit. (Fp)