A multicenter, observational study of lanreotide depot/autogel (LAN) in patients with acromegaly in the United States: 2-year experience from the SODA registry

摘要

Abstract Purpose This analysis evaluates the 2-year effectiveness and safety of lanreotide depot/autogel (LAN), as well as treatment convenience and acromegaly symptom relief, from the Somatuline ? Depot for Acromegaly (SODA) registry, a post-marketing, open-label, observational, multicenter, United States registry study. Methods Patients with acromegaly treated with LAN were eligible for enrollment. Demographics, LAN dose, extended dosing interval (EDI) (interval of injections ≥42 days), insulin-like growth factor 1 (IGF-1), growth hormone (GH), glycated hemoglobin, adverse events (AEs), injection convenience, and symptom data were collected. Results As of September 29, 2014, 241 patients were enrolled in SODA. IGF-1 levels below age- and gender-adjusted upper normal limit (ULN) were achieved in 71.2% at month (M) 12 and 74.4% at M24; GH ≤2.5?μg/L in 83.3% at M12 and 80.0% at M24; GH Conclusions SODA indicates 2-year biochemical control with majority of patients achieving both IGF-1? clinicaltrials.gov Clinical Trial Identifier: NCT00686348