Acromegaly Disease Control Maintained After Switching From Injected Somatostatin Receptor Ligands to Oral Paltusotine
Primary result · Maintained IGF-1 ≤1.0× ULNResult — go to the resultOdds ratio 126.53 95% CI 13.73->999.99Authors' conclusion
Replacement of injected SRLs by once-daily oral paltusotine was effective in maintaining both biochemical and symptom control in patients with acromegaly and was well tolerated.
Study context
- Population
- Adults with acromegaly with IGF-1 ≤1.0× ULN on a stable dose of depot octreotide or lanreotide, switched from injected somatostatin receptor ligands (SRLs)
- Participants
- 30 vs 28
- Comparison
- Oral paltusotine vs placebo after switch from injected SRLs
- Paltusotinen = 30
- Placebon = 28reference
- Primary endpoint
- Proportion of patients maintaining IGF-1 ≤1.0× ULN
- Follow-up
- 36 weeks
Methodological detailsphase 3, double-blind, placebo-controlled
- Phase 3
- Double-blind
- Placebo-controlled
Primary result
Maintained IGF-1 ≤1.0× ULN
Odds ratio
126.53
95% CI 13.73->999.99
P < 0.0001
Events by treatment group
Paltusotinevs Placebo
OR 126.53 (95% CI 13.73->999.99); P < 0.0001
As reported in the abstract
Secondary outcomes
| Outcome | Paltusotine | Placebo | OR (95% CI) | P value | |
|---|---|---|---|---|---|
| Mean GH maintained <1.0 ng/mL | 87.0% | 27.8% | 16.61 (2.86–181.36) | P = 0.0003 | |
| 0.050.21520Odds ratio (log scale) |
| Outcome | Paltusotine | Placebo | P value |
|---|---|---|---|
| Change in IGF-1 | mean 0.04 (SE 0.09) × ULN | mean 0.83 (SE 0.1) × ULN | P < 0.0001 |
| Change in Acromegaly Symptom Diary scoreMean | −0.6 (SE 1.5) | 4.6 (SE 1.6) | P = 0.02 |
Safety
Adverse events
- Most common AEs were acromegaly symptoms and gastrointestinal effects characteristic of SRLs
Original publication
Acromegaly Disease Control Maintained After Switching From Injected Somatostatin Receptor Ligands to Oral Paltusotine. J Clin Endocrinol Metab. Published 3 June 2024. doi:10.
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