Efficacy and Safety of Pasireotide Long Acting Release (LAR) Versus Octreotide LAR or Lanreotide Autogel (ATG) in Patients With Inadequately Controlled Acromegaly
Summary
This study will evaluate the efficacy and safety of pasireotide LAR 40 and 60 mg versus octreotide LAR or lanreotide ATG in patients with inadequately controlled acromegaly.
Timeline
- Start
- 2010-07-19
- Primary completion
- 2013-01-22
- Completion
- 2017-02-28
Outcome
Met primary endpoint
paper At 24 weeks, ten (15%) patients in the pasireotide 40 mg group and 13 (20%) patients in the pasireotide 60 mg group achieved biochemical control PMID 25260838 ↗
paper compared with no patients in the active control group (absolute difference from control group 15·4%, 95% CI 7·6-26·5, p=0·0006 PMID 25260838 ↗
paper 20·0%, 11·1-31·8, p<0·0001 for pasireotide 60 mg group PMID 25260838 ↗
registry analysis (superiority test); Pasireotide LAR 40 mg vs Control Arm (Octreotide or Lanreotide); p = 0.0006; Odds Ratio (OR) 16.63; Regression, Logistic NCT01137682 ↗
registry analysis (superiority test); Pasireotide LAR 60 mg vs Control Arm (Octreotide or Lanreotide); p <0.0001; Odds Ratio (OR) 23.03; Regression, Logistic NCT01137682 ↗
Publications
- Colao A, Bronstein MD, Brue T, De Marinis L, Fleseriu M, Guitelman M, Raverot G, Shimon I, Fleck J, Gupta P, Pedroncelli AM, Gadelha MR. Pasireotide for acromegaly: long-term outcomes from an extension to the Phase III PAOLA study. Eur J Endocrinol. 2020 Jun;182(6):583. doi: 10.1530/EJE-19-0762.
- Gadelha MR, Bronstein MD, Brue T, Coculescu M, Fleseriu M, Guitelman M, Pronin V, Raverot G, Shimon I, Lievre KK, Fleck J, Aout M, Pedroncelli AM, Colao A; Pasireotide C2402 Study Group. Pasireotide versus continued treatment with octreotide or lanreotide in patients with inadequately controlled acromegaly (PAOLA): a randomised, phase 3 trial. Lancet Diabetes Endocrinol. 2014 Nov;2(11):875-84. doi: 10.1016/S2213-8587(14)70169-X. Epub 2014 Sep 24.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Lanreotide | Other / unclassified | 120 mg | — |
| Comparator | Octreotide | Peptide | 30 mg | — |
| Subject | Pasireotide | Other / unclassified | 40 mg | Intramuscular |
| Subject | Pasireotide | Other / unclassified | 60 mg | Intramuscular |