PMID-19639415 – Lanreotide Autogel RCT in Acromegaly
Melmed S, Cook D, Schopohl J, Goth MI, Lam KS, Marek J. Rapid and sustained reduction of serum growth hormone and insulin-like growth factor-1 in patients with acromegaly receiving lanreotide Autogel therapy: a randomized, placebo-controlled, multicenter study with a 52 week open extension. Pituitary. 2010;13(1):18-28.
Quick Reference
| Property | Value |
|---|---|
| PMID | 19639415 |
| DOI | 10.1007/s11102-009-0191-1 |
| Year | 2010 |
| Journal | Pituitary |
| Study Type | RCT |
| Evidence Level | I |
| Sample | 108 patients with acromegaly |
| Peptide(s) Studied | Lanreotide |
Key Findings
- Four weeks after first injection, serum GH decreased >50% from baseline in 63% of lanreotide Autogel patients vs 0% of placebo patients (p < 0.001)
- By week 52, 43% of patients achieved combined biochemical control (GH <=2.5 ng/mL and normalized IGF-1)
- 99 of 108 enrolled patients completed 52 weeks of treatment, demonstrating excellent tolerability
- Dose titration (60, 90, or 120 mg) allowed individualized therapy; 120 mg dose showed best efficacy
- Most common adverse events were GI-related (diarrhea, abdominal pain) and injection site reactions; all manageable
Study Design
Four-phase study design: (1) washout phase; (2) double-blind, randomized, placebo-controlled comparison at a single dose of lanreotide Autogel (60, 90, or 120 mg); (3) single-blind fixed-dose phase (4 injections; placebo patients re-allocated to active treatment); (4) eight injections with doses tailored to biochemical response. Total duration 52 weeks. Multicenter study across multiple countries.
Limitations
- Initial double-blind phase was only a single injection, limiting the controlled comparison period
- Open-label extension phase introduces bias in long-term efficacy estimates
- Dose randomization in the initial phase meant not all patients received optimal dose initially
- Predominantly Caucasian study population; limited diversity data
Clinical Relevance
This study provided key RCT evidence supporting lanreotide Autogel as primary medical therapy for acromegaly, demonstrating rapid onset of biochemical control within 4 weeks. The dose-titration design reflects real-world clinical practice. Together with the depot formulation allowing deep subcutaneous self-injection every 28 days, lanreotide Autogel offers a convenient alternative to octreotide LAR (which requires intramuscular injection by a healthcare provider).
Related
#research #RCT #lanreotide #evidence-level-I