PMID- 28741071
OWN - NLM
STAT- MEDLINE
DCOM- 20180625
LR  - 20181113
IS  - 1573-7403 (Electronic)
IS  - 1386-341X (Linking)
VI  - 20
IP  - 6
DP  - 2017 Dec
TI  - A multicenter, observational study of lanreotide depot/autogel (LAN) in patients 
      with acromegaly in the United States: 2-year experience from the SODA registry.
PG  - 605-618
LID - 10.1007/s11102-017-0821-y [doi]
AB  - 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((R)) 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 microg/L in 
      83.3% at M12 and 80.0% at M24; GH <1.0 microg/L in 61.7% at M12 and 61.4% at M24. 
      Both IGF-1 < ULN and GH </=2.5 microg/L were achieved in 65.0% at M12 and 54.8% at M24; 
      both IGF-1 < ULN and GH < 1.0 microg/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 microg/L. LAN was generally well 
      tolerated with no new or unexpected safety signals reported during the 
      observation period. clinicaltrials.gov Clinical Trial Identifier: NCT00686348.
FAU - Salvatori, Roberto
AU  - Salvatori R
AUID- ORCID: 0000-0001-6495-2244
AD  - Division of Endocrinology, Diabetes and Metabolism, and Pituitary Center, Johns 
      Hopkins University, 1830 East Monument Street #333, Baltimore, MD, 21287, USA. 
      salvator@jhmi.edu.
FAU - Gordon, Murray B
AU  - Gordon MB
AD  - Allegheny Neuroendocrinology Center, Division of Endocrinology, Allegheny General 
      Hospital, 420 E North Avenue, Suite 205, Pittsburgh, PA, 15212, USA.
FAU - Woodmansee, Whitney W
AU  - Woodmansee WW
AD  - Division of Endocrinology, Diabetes and Hypertension, Brigham's and Women's 
      Hospital, 221 Longwood Avenue, Boston, MA, 02115, USA.
FAU - Ioachimescu, Adriana G
AU  - Ioachimescu AG
AD  - Department of Medicine, Division of Endocrinology, Metabolism and Lipids and 
      Department of Neurosurgery, Emory University School of Medicine, 1365 B Clifton 
      Road, NE, B6209, Atlanta, GA, 30322, USA.
FAU - Carver, Don W
AU  - Carver DW
AD  - Ipsen Biopharmaceuticals, Inc. Statistician Consultant, 106 Allen Road, Basking 
      Ridge, NJ, 07920, USA.
FAU - Mirakhur, Beloo
AU  - Mirakhur B
AD  - Medical Affairs, Ipsen Biopharmaceuticals, Inc., 106 Allen Road, Basking Ridge, 
      NJ, 07920, USA.
FAU - Cox, David
AU  - Cox D
AD  - Medical Affairs, Ipsen Biopharmaceuticals, Inc., 106 Allen Road, Basking Ridge, 
      NJ, 07920, USA.
FAU - Molitch, Mark E
AU  - Molitch ME
AD  - Division of Endocrinology, Metabolism and Molecular Medicine, Northwestern 
      University Feinberg School of Medicine, 645 North Michigan Avenue, Suite 530, 
      Chicago, IL, 60611, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT00686348
PT  - Journal Article
PL  - United States
TA  - Pituitary
JT  - Pituitary
JID - 9814578
RN  - 0 (IGF1 protein, human)
RN  - 0 (Peptides, Cyclic)
RN  - 0G3DE8943Y (lanreotide)
RN  - 51110-01-1 (Somatostatin)
RN  - 67763-96-6 (Insulin-Like Growth Factor I)
SB  - IM
MH  - Acromegaly/*drug therapy/metabolism/pathology
MH  - Adult
MH  - Aged
MH  - Female
MH  - Humans
MH  - Insulin-Like Growth Factor I/metabolism
MH  - Male
MH  - Middle Aged
MH  - Observational Studies as Topic
MH  - Peptides, Cyclic/*therapeutic use
MH  - Registries
MH  - Somatostatin/*analogs & derivatives/therapeutic use
MH  - United States
MH  - Young Adult
OTO - NOTNLM
OT  - Acromegaly
OT  - Extended-release
OT  - Lanreotide depot/autogel (LAN)
OT  - Observational study
OT  - Registry
OT  - Treatment
EDAT- 2017/07/26 06:00
MHDA- 2018/06/26 06:00
CRDT- 2017/07/26 06:00
PHST- 2017/07/26 06:00 [pubmed]
PHST- 2018/06/26 06:00 [medline]
PHST- 2017/07/26 06:00 [entrez]
AID - 10.1007/s11102-017-0821-y [pii]
AID - 10.1007/s11102-017-0821-y [doi]
PST - ppublish
SO  - Pituitary. 2017 Dec;20(6):605-618. doi: 10.1007/s11102-017-0821-y.