Kurzwirksame Insulinanaloga - Kritische Bewertung metaanalytischer Betrachtungen

Zusammenfassung

Kurzwirksame Insulinanaloga werden seit fast 10 Jahren bei der Behandlung des Diabetes mellitus Typ 1 und 2 eingesetzt. Es gibt eine ausführliche potentielle wissenschaftliche und praktische Evidenz für deren potentielle Überlegenheit gegenüber Normalinsulin. Daher werden diese Insuline bereits von den meisten führenden Fachgesellschaften in ihren Leitlinien empfohlen. Im klinischen Alltag stellen sie eine wesentliche Komponente des therapeutischen Portfolios dar, die insbesondere bei selektivem Einsatz zu einer deutlichen Verbesserung der Insulintherapie führen kann. Andererseits muss insbesondere auch in Deutschland dem wachsenden ökonomischen Druck Rechnung getragen werden. Dennoch darf die Kritik vorgetragen werden, dass Metaanalysen zu diesem Thema, die im Auftrag von Versicherungsträgern oder Regierungsbehörden erstellt worden sind, der wissenschaftlichen und Versorgungsrealität nicht gerecht werden. Aktuelle Metaanalysen zu den kurzwirksamen Insulinanaloga schließen entscheidende Vorteile von Insulinanaloga aus Analysen aus und vergleichen sehr heterogene Gruppen. Es wird nicht differenziert zwischen unterschiedlichen Hypoglykämieprävalenzen bei unterschiedlichen HbA _1c-Werten sowie konventioneller und intensivierter Therapie. Zudem schließt man positive Daten und positive Major-Studien aus, während Zulassungsstudien oder Studien mit gänzlich differenter Fragestellung zitiert werden. Zu kritisieren ist häufig auch die kurze Studiendauer. Die International Diabetes Federation (IDF) hat daher das Cochrane-Review aus dem Jahr 2005 methodisch abgelehnt, und auch aus dem IQWiG-Gutachten lassen sich keine reliablen therapeutische Empfehlungen ableiten.

Summary

Short-acting insulin analogs have for nearly ten years been prescribed for type 1 and 2 diabetes mellitus. There is extensive scientific and practical evidence of their being better than normal insulin. For this reason these insulins have been recommended in the guidelines of most leading specialist societies. In everyday practice they are an important component of the therapeutic portfolio which can produce an improvement in insulin treatment, especially of selective cases. On the other hand, there is growing economic pressure, especially in Germany, affecting their use. However, it must be critically asserted that those meta-analyses on insulin analogs, which have been commissioned by insurance companies or governmental organisations, do not do justice to their advantage. Current meta-analyses of short-acting insulin analogs exclude decisive advantages of insulin analogs from their analyses and compare highly heterogeneous groups. They do not distinguish between differing incidences of hypoglycemia associated with different HbA1c values as well as between conventional and intensive treatment. Furthermore positive data and positive major studies are excluded, while approval studies or trials with completely different aims are cited. Short study duration is also often neglected. As a result, the International Diabetes Federation (IDF) has rejected the Cochrane Review for 2005 for methodological reasons. Also, no recommendations can be derived from the recommendations of of the Institut für Qualitätssicherung und Wirtschaftlichkeit in der Medizin (IQWiG: Institute for Quality Assurance and Cost Effectiveness in Medicine). After critical assessment of meta-analyses the IDF concluded in its guidelines that insulin analogs should generally be used.

Schlüsselwörter

kurzwirksame Insulinanaloga - Insulin Lispro - Insulin Aspart - Insulin Glulisin

Key words

Short-acting insulin analogs - insulin lispro - insulin aspart - insulin glulisin

Literatur

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