Insulin degludec bei speziellen Patientengruppen

Zusammenfassung

Insulin degludec (IDeg) ist ein Basalinsulin mit einem stabilen, flachen Wirkprofil und einer gleichmäßigen Verteilung des blutzuckersenkenden Effekts über 24 Stunden. Mit der arzneimittelrechtlichen Zulassung stellen sich Fragen zur klinisch-praktischen Anwendung bei speziellen Patientengruppen. Pharmakokinetische Daten weisen darauf hin, dass eine generelle Dosisanpassung von IDeg aufgrund einer Nieren- oder Leberfunktionseinschränkung nicht notwendig ist. Jedoch sind als Vorsichtsmaßnahme intensivierte Überwachungen des Blutzuckers und individuelle Anpassungen der Insulindosis erforderlich. Zu älteren Patienten ab 65 Jahren liegen Daten aus dem Phase-3-Studienprogramm zu IDeg vor, da die Studien volljährige Patienten ohne Alterslimit einschlossen. Eine Metaanalyse der Daten zu Patienten ab 65 Jahren aus sieben Studien ergab die Nicht-Unterlegenheit für IDeg im Vergleich zu Insulin glargin (IGlar) hinsichtlich der HbA1c-Reduktion. In den fünf Studien zum Typ-2-Diabetes waren zudem signifikant weniger bestätigte Hypoglykämien in der IDeg-Gruppe (n = 589) mit 6,19 Ereignissen pro Patientenjahr versus 6,89 Ereignisse pro Patientenjahr in der IGlar-Gruppe (n = 265) zu verzeichnen (geschätzte Ereignisrate 0,76, 95 % CI: 0,61; 0,95, p < 0,05). In den beiden Studien zum Typ-1-Diabetes waren die Patientenzahlen für separate statistische Analysen zu gering (n = 43 IDeg; n = 18 IGlar). IDeg kann aufgrund des geringeren Risikos für nächtliche Hypoglykämien und wegen der Möglichkeit zur tageszeitlich flexiblen Gabe einen großen Fortschritt für die Behandlung von Menschen mit Typ-1- oder Typ-2-Diabetes – besonders im höheren Alter – darstellen.

Abstract

Insulin degludec (IDeg) is a basal insulin with a stable, flat action profile and an even distribution of the blood-glucose-lowering effect over 24 hours. With its marketing authorisation, questions arise about the clinical routine use in specific patient groups. Pharmacokinetic data suggest that no general dose adjustment is required for IDeg in patients with renal or hepatic impairment. However, intensive monitoring of blood glucose and individual adjustments of the insulin dose are necessary as a measure of precaution. For older patients from 65 years onwards, data are available from the IDeg phase 3 trial programme, as the trials included adults over 18 without an upper age limit. A meta-analysis of data for patients over 65 years of age from seven trials showed a non-inferiority for IDeg compared with insulin glargine (IGlar) regarding HbA1c reduction. Moreover, in the five trials on type 2 diabetes, significantly less episodes of confirmed hypoglycaemia were seen in the IDeg group (n = 589), with 6.19 episodes per patient year vs 6.89 episodes per patient year in the IGlar group (n = 265) (estimated treatment difference 0.76, 95 % CI: 0.61; 0.95, p < 0.05). In the two trials on type 1 diabetes, samples sizes were too small for separate statistical analysis (IDeg n = 43; IGlar n = 18). IDeg may constitute an improvement in the treatment of people with type 1 or type 2 diabetes, especially in older patients, due to its lower risk of nocturnal hypoglycaemia and the possibility of flexible dosing.

Schlüsselwörter

Diabetes - Basalinsulin - Insulin degludec - Leberinsuffizienz - Niereninsuffizienz - ältere Patienten

Key words

diabetes - basal insulin - insulin degludec - liver insufficiency - renal insufficiency - older patients

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