Inzidenz kardiovaskulärer Ereignisse bei Typ-2-Diabetespatienten unter Insulinglulisin und anderen Insulinanaloga im realen Versorgungsalltag: eine retrospektive Datenbankanalyse

Zusammenfassung

Hintergrund: Insulinglulisin hat einen rascheren Wirkungseintritt als andere schnellwirksame Insulinanaloga, was einen günstigen Einfluss auf die postprandiale Glukoseregulation hat. Zielsetzung war es, die Inzidenz von makro- und mikrovaskulären Ereignissen unter realen Versorgungsbedingungen bei Typ-2-Diabetespatienten zu vergleichen, die entweder mit Insulinglulisin oder anderen kurzwirkenden Analoga behandelt wurden.

Patienten und Methoden: Daten von 732 Glulisinpatienten und 2196 Anwendern anderer Analoga aus allgemeinmedizinischen Praxen (Disease Analyzer Datenbank; 11/2004 – 01/2011) wurden nach Matching für Alter (61 ± 10 Jahre) und Geschlecht (Männer: 51 %) retrospektiv analysiert. Hazard Ratios (HR; Cox Regression) für makro- und mikrovaskuläre Endpunkte (Follow-up: 3,5 Jahre) wurden für Arzttyp (Diabetologe), Praxisregion, antidiabetische Co-Medikation (Basalinsulin, orale Antidiabetika), arterielle Hypertonie, Hyperlipidämie, frühere Behandlung mit kurzwirksamen Insulinen, Lipidsenker, Antihypertensiva, ASS, sowie dem Charlson Komorbiditätsindex adjustiert.

Ergebnisse: Das Risiko für makrovaskuläre Ereignisse war bei den mit Insulinglulisin behandelten Patienten insgesamt um 22 % geringer als bei anderen Analoga (p = 0,01). Es fand sich ein vermindertes Risiko für koronare Herzkrankheit (HR, 95 %; KI: 0,72; 0,57 – 0,91) und inzidenten Apoplex/TIA (0,66; 0,44 – 0,98). Es zeigte sich ebenfalls ein Trend für ein erniedrigtes Risiko (0,76; 0,56 – 1,03) für das Auftreten einer Retinopathie, während sich für Nephropathie und Neuropathie keine Unterschiede fanden.

Folgerungen: Die Behandlung mit Insulinglulisin ist im Vergleich zu anderen Insulinanaloga mit einer reduzierten Inzidenz von makrovaskulären Ereignissen bei Typ-2-Diabetespatienten assoziiert. Dieses Ergebnis aus einer retrospektiven Beobachtungsstudie muss durch eine prospektive randomisierte kontrollierte Studie überprüft werden.

Abstract

Background: Insulin glulisine has a more rapid onset of action than other fast-acting insulin analogues, which has a beneficial effect on postprandial glucose regulation. The objective was to compare the incidence of macro-and microvascular outcomes in type 2 diabetes patients treated with either insulin glulisine or other short-acting analogues under real-life conditions.

Patients and Methods: Data from 732 type 2 diabetes patients with glulisine and 2196 users of other analogues in general practices (Disease Analyzer database; 11/2004 to 01/2011) were retrospectively analyzed after matching for age (61 ± 10 years) and gender (men: 51 %). Hazard ratios (HR, Cox regression) for macro- and microvascular outcomes (follow-up: 3.5 years) were adjusted for type of physician (diabetologist) and region, antidiabetic co-medication (basal insulin, oral hypoglycemic agents), hypertension, hyperlipidemia, previous treatment with short-acting insulins, lipid-lowering drugs, antihypertensives, aspirin use, and the Charlson comorbidity index.

Results: A reduced risk (22 %) of macrovascular events was found in patients with insulin glulisine compared to other rapid-acting analogues (p = 0.01). In particular, a decreased risk of coronary heart disease (HR, 95 %; CI: 0.72, 0.57 to 0.98) and incident stroke or TIA (0.66, 0.44 to 0.98) was observed. There was also a trend for a decreased risk (0.76, 0.56 to 1.03) for incident retinopathy, whereas for nephropathy and neuropathy no differences were observed.

Conclusions: Treatment with insulin glulisine in type 2 diabetic patients is associated with a reduced incidence of macrovascular events compared to other rapid-acting insulin analogues. These results from a retrospective observational study must be verified by a randomized prospective controlled trial.

Schlüsselwörter

Insulintherapie - mikro- und makrovaskuläre Komplikationen - Insulinglulisin

Key words

insulin treatment - micro- and macrovascular outcomes - insulinglulisine

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