Pituitary & hypothalamus

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

J Clin Endocrinol MetabPublished Open-label extension of the MPOWERED randomised trial

Authors' conclusion

Patient-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.

Study context

Population
Patients with acromegaly who previously responded to and tolerated both oral octreotide capsules (OOC) and injectable octreotide/lanreotide and completed the MPOWERED core phase
Primary endpoint
Proportion of biochemical responders (IGF-1 < 1.3 × upper limit of normal) at end of each extension year among those entering that year as responders
Follow-up
End of each extension year
Methodological detailswithin-patient transition between OOC and injectable somatostatin receptor ligands (iSRLs)
  • Within-patient transition between OOC and iSRLs

Primary result

As reported in the abstract

Biochemical responders

Responders at year 1 extension end (monotherapy and combination therapy)

52 of 58

89.7%; 95% CI 78.8–96.1

Responders in year 2

36 of 41

87.8%; 95% CI 73.8–95.9

Responders in year 3

29 of 31

93.5%; 95% CI 78.6–99.2

Further findings

Patient-reported outcomes after transition from iSRLs to OOC

Improved treatment convenience/satisfaction and symptom control reported

Safety

Withdrew owing to treatment failure
1 patient
No new or unexpected safety signals

Original publication

MPOWERED Trial Open-Label Extension: Long-term Efficacy and Safety Data for Oral Octreotide Capsules in Acromegaly. J Clin Endocrinol Metab. Published 16 June 2023. doi:10.1210/clinem/dgad365

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