Evidence map›Paper›PMID 28741071›Full record

ArticlePituitary2017

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

Roberto Salvatori, Murray B Gordon, Whitney W Woodmansee, Adriana G Ioachimescu, Don W Carver, Beloo Mirakhur, David Cox, Mark E Molitch

Registry-linked trialAbstract read
PubMed Publisher
In one paragraph

Article in Pituitary, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00686348 (Somatuline® Depot), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.1field-weighted citation impact, top 22% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00686348 completednot on this map

Somatuline® Depot (Lanreotide) Injection for Acromegaly (SODA): A Post-marketing Observational Study

TypeobservationalSponsorIpsenRan2008 to 2015Enrolled260ConditionsAcromegaly
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 12 citations in OpenAlex.

  1. Article
  2. Article
  3. Observational
  4. Review
  5. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 6 institutions in 1 country.

Roberto SalvatoriDivision of Endocrinology, Diabetes and Metabolism, and Pituitary Center, Johns Hopkins University, 1830 East Monument Street #333, Baltimore, MD, 21287, USA. salvator@jhmi.edu.ORCID http://orcid.org/0000-0001-6495-2244
Murray B GordonAllegheny Neuroendocrinology Center, Division of Endocrinology, Allegheny General Hospital, 420 E North Avenue, Suite 205, Pittsburgh, PA, 15212, USA.
Whitney W WoodmanseeDivision of Endocrinology, Diabetes and Hypertension, Brigham's and Women's Hospital, 221 Longwood Avenue, Boston, MA, 02115, USA.
Adriana G IoachimescuDepartment 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.
Don W CarverIpsen Biopharmaceuticals, Inc. Statistician Consultant, 106 Allen Road, Basking Ridge, NJ, 07920, USA.
Beloo MirakhurMedical Affairs, Ipsen Biopharmaceuticals, Inc., 106 Allen Road, Basking Ridge, NJ, 07920, USA.
David CoxMedical Affairs, Ipsen Biopharmaceuticals, Inc., 106 Allen Road, Basking Ridge, NJ, 07920, USA.
Mark E MolitchDivision of Endocrinology, Metabolism and Molecular Medicine, Northwestern University Feinberg School of Medicine, 645 North Michigan Avenue, Suite 530, Chicago, IL, 60611, USA.
Ipsen (United States) · USAllegheny General Hospital · USBrigham and Women's Hospital · USEmory University · USJohns Hopkins University · USNorthwestern University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThis 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

methodsPatients 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.

resultsAs 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.

conclusionsSODA 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.

Indexed as

AcromegalyAdultAgedFemaleHumansInsulin-Like Growth Factor IMaleMiddle AgedObservational Studies as TopicPeptides, CyclicRegistriesSomatostatinUnited StatesYoung AdultIGF1 protein, humanInsulin-Like Growth Factor IlanreotidePeptides, CyclicSomatostatinAcromegalyExtended-releaseLanreotide depot/autogel (LAN)Observational studyRegistryTreatment

Identifiers

PMID28741071
OpenAlexW2737617874

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.