Evidence map›Paper›PMID 37319438›Full record

Trial reportThe Journal of clinical endocrinology and metabolism2023

MPOWERED Trial Open-Label Extension: Long-term Efficacy and Safety Data for Oral Octreotide Capsules in Acromegaly.

Maria Fleseriu, Mark Molitch, Alexander Dreval, Yulia Pokramovich, Irina Bondar, Yury Poteshkin, Djuro Macut, Barbara Obermayer-Pietsch, Yossi Gilgun-Sherki, Asi Haviv and 2 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The Journal of clinical endocrinology and metabolism, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02685709 (A Phase 3, Randomized, Active Controlled Study to Evaluate Maintenance of Response, Safety and Patient Reported Outcomes in Acromegaly Patients Treated With Octreotide Capsules vs. Parenteral Somatostatin Receptor Ligands), which is not on this map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
3.6field-weighted citation impact, top 6% 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.

NCT02685709 phase3completednot on this map

A Phase 3, Randomized, Active Controlled Study to Evaluate Maintenance of Response, Safety and Patient Reported Outcomes in Acromegaly Patients Treated With Octreotide Capsules vs. Parenteral Somatostatin Receptor Ligands

TypeinterventionalSponsorChiasma, Inc.Ran2016 to 2021Enrolled146ConditionsAcromegalyArmsOctreotide capsules
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 18 citations in OpenAlex.

  1. Trial
  2. The acromegaly patient experience: burden of treatment and quality of life.The Journal of clinical endocrinology and metabolism · 2026
    Review
  3. Current treatment landscape of acromegaly.The Journal of clinical endocrinology and metabolism · 2026
    Review
  4. Acromegaly complications: an update.The Journal of clinical endocrinology and metabolism · 2026
    Review
  5. Review
  6. Review
  7. Review
  8. Article
  9. Review
  10. Review
  11. Review
  12. Review
  13. Article
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

12 authors at 8 institutions in 6 countries.

Maria FleseriuPituitary Center, Oregon Health & Science University, Portland, OR 97239, USA.ORCID 0000-0001-9284-6289
Mark MolitchEndocrinology, Metabolism & Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL 60611, USA.ORCID 0000-0002-8492-3587
Alexander DrevalDepartment of Clinical Endocrinology of Postgraduate Education Faculty, M.F. Vladimirsky Moscow Regional Research Clinical Institute, Moscow 129110, Russia.
Yulia PokramovichDepartment of Clinical Endocrinology of Postgraduate Education Faculty, M.F. Vladimirsky Moscow Regional Research Clinical Institute, Moscow 129110, Russia.
Irina BondarDepartment of Endocrinology, Novosibirsk State Medical University, Novosibirsk 630090, Russia.
Yury PoteshkinDepartment of Endocrinology, Pirogov Russian National Research Medical University, Moscow 117997, Russia.
Djuro MacutDepartment of Endocrine Tumors and Hereditary Cancer Syndromes, Clinic for Endocrinology, Diabetes and Metabolic Diseases, Faculty of Medicine, University of Belgrade, Belgrade 11000, Serbia.
Barbara Obermayer-PietschDivision of Endocrinology and Diabetology, Medical University Graz, Graz 8036, Austria.
Yossi Gilgun-SherkiAmryt Pharmaceuticals, Dublin D04 W2F1, Ireland.
Asi HavivAmryt Pharmaceuticals, Dublin D04 W2F1, Ireland.
Nienke BiermaszDivision of Endocrinology, Leiden University Medical Center, Leiden 2333, Netherlands.
Christian J StrasburgerDepartment of Endocrinology and Metabolism, Charite-Universitätsmedizin, Campus Mitte, Berlin 10117, Germany.
Charité - Universitätsmedizin Berlin · DELeiden University Medical Center · NLMedical University of Graz · ATNorthwestern University · USNovosibirsk State Medical University · RUOregon Health & Science University · USPirogov Russian National Research Medical University · RUUniversity of Belgrade · RS

Funding

Amryt PharmaceuticalsPRECISIONscientia
6 · The paper itself

Abstract

contextThe MPOWERED core trial (NCT02685709) and open-label extension (OLE) phase investigated long-term efficacy and safety of oral octreotide capsules (OOC) in patients with acromegaly. Core trial primary endpoint data demonstrated noninferiority to injectable somatostatin receptor ligands (iSRLs). Core trial completers were invited to participate in the OLE phase.

objectiveTo assess long-term efficacy and safety of OOC in patients with acromegaly who previously responded to and tolerated both OOC and injectable octreotide/lanreotide and completed the core phase.

methodsThe unique study design of transitioning between OOC and iSRLs allowed within-patient evaluations. The proportion of biochemical responders (insulin-like growth factor I < 1.3 × upper limit of normal) at end of each extension year who entered that year as responders was the main outcome measure.

resultsAt year 1 extension end, 52/58 patients from both the monotherapy and the combination therapy groups were responders (89.7%; 95% CI 78.8-96.1), 36/41 (87.8%; 95% CI 73.8-95.9) in year 2, and 29/31 (93.5%; 95% CI 78.6-99.2) in year 3. No new or unexpected safety signals were detected; 1 patient withdrew owing to treatment failure. Patients who transitioned from iSRLs in the core trial to OOC in the OLE phase reported improved treatment convenience/satisfaction and symptom control.

conclusionPatient-reported outcome data support for the first time that transitioning patients randomized to iSRL (who previously responded to both OOC and iSRLs) back to OOC had a significant effect on patients' symptoms score in a prospective cohort. The MPOWERED OLE showed long-term maintenance of response and sustained safety with OOC.

Indexed as

AcromegalyHuman Growth HormoneHumansInsulin-Like Growth Factor IOctreotidePeptides, CyclicProspective StudiesTreatment OutcomeHuman Growth HormoneInsulin-Like Growth Factor IOctreotidePeptides, Cyclicacromegalyclinical trialsgrowth hormone excess/acromegalyIGF-Isomatostatin

Identifiers

PMID37319438
PMCPMC10655542
OpenAlexW4380853592

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.