ACROBAT Edge: Safety and Efficacy of Switching Injected Somatostatin Receptor Ligand (SRLs) to Oral Paltusotine in Patients With Acromegaly
Authors' conclusion
These results suggest once-daily oral paltusotine was effective in maintaining IGF-I values in patients with acromegaly who switched from injected SRLs. Paltusotine was well tolerated with a safety profile consistent with other SRLs.
Study context
- Population
- Patients with acromegaly on injected SRL-based therapy, 26 global sitesenrolled
- Participants
- 47 patients
- Exposure
- Switch from injected SRLs to once-daily oral paltusotine
- Group 1n = 25
- Outcome
- Change from baseline in IGF-I in group 1
- Follow-up
- Week 13
Methodological detailsphase 2, open-label, prospective, multicenter, multinational, nonrandomized, double-blinded dosage uptitrations, 13-week once-daily oral paltusotine (10-40 mg/d), then 4-week washout (wk 13-17)
- Phase 2
- Open-label
- Prospective
- Multicenter
- Multinational
- Nonrandomized
- Double-blinded dosage uptitrations
- 13-week once-daily oral paltusotine (10-40 mg/d), then 4-week washout (wk 13-17)
Main finding
As reported in the abstract
Change in IGF-I from SRL baseline
Group 1
−0.03
median change · ×ULN
Observational data: associations, not effects.
Further findings
| Outcome | Values |
|---|---|
| Change in GH from SRL baseline · week 13 | Group 1 median change −0.05 ng/mL |
| Change in IGF-I after 4-week paltusotine washout · wk 13-17 | Group 1 median change 0.55 ×ULN |
| Change in GH after 4-week paltusotine washout · wk 13-17 | Group 1 median change 0.72 ng/mL |
- Change in IGF-I after 4-week paltusotine washout — Median increase
- 39%
- Change in growth hormone (GH) after 4-week paltusotine washout — Increase
- 109.1%
Change in GH from SRL baseline · week 13
- No significant change in GH (P = .6285)
Change in IGF-I after 4-week paltusotine washout · wk 13-17
- Significant rise, P < .0001
Change in GH after 4-week paltusotine washout · wk 13-17
- Significant rise, P < .0001
Safety
Adverse events
- Discontinued because of adverse events (AEs)
- 0
- Treatment-related serious AEs
- 0
Original publication
ACROBAT Edge: Safety and Efficacy of Switching Injected SRLs to Oral Paltusotine in Patients With Acromegaly. J Clin Endocrinol Metab. Published 10 November 2022. doi:10.
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