Faculty Collaboration Database

A multicenter, observational study of lanreotide depot/autogel (LAN) in patients with acromegaly in the United States: 2-year experience from the SODA registry. Pituitary 2017 Dec;20(6):605-618

Date

07/26/2017

Pubmed ID

28741071

DOI

10.1007/s11102-017-0821-y

Scopus ID

2-s2.0-85025695756 (requires institutional sign-in at Scopus site)   9 Citations

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 <1.0 µg/L in 61.7% at M12 and 61.4% at M24. Both IGF-1 < ULN and GH ≤2.5 µg/L were achieved in 65.0% at M12 and 54.8% at M24; both IGF-1 < ULN and GH < 1.0 µg/L were achieved in 51.7 and 42.9% at M12 and M24, respectively. EDI regimen was 5.0% at baseline and 12.0% at M24. At M24, acromegaly symptoms appeared stable or improved. The most common AE was arthralgia (25.7%). Among 106 serious AEs reported by 42 patients, 10 were deemed related to therapy in 9 patients. At M24, 73.1% of patients rated LAN as convenient.

CONCLUSIONS: SODA indicates 2-year biochemical control with majority of patients achieving both IGF-1 < ULN and GH ≤2.5 µg/L. LAN was generally well tolerated with no new or unexpected safety signals reported during the observation period. clinicaltrials.gov Clinical Trial Identifier: NCT00686348.

Author List

Salvatori R, Gordon MB, Woodmansee WW, Ioachimescu AG, Carver DW, Mirakhur B, Cox D, Molitch ME

Author

Adriana G. Ioachimescu MD, PhD Professor in the Medicine department at Medical College of Wisconsin

MESH terms used to index this publication - Major topics in bold

Acromegaly
Adult
Aged
Female
Humans
Insulin-Like Growth Factor I
Male
Middle Aged
Observational Studies as Topic
Peptides, Cyclic
Registries
Somatostatin
United States
Young Adult