Efficacy, safety, and pharmacokinetics of sustained-release lanreotide (lanreotide Autogel) in Japanese patients with acromegaly or pituitary gigantism.

Abstract

The somatostatin analog lanreotide Autogel has proven to be efficacious for treating acromegaly in international studies and in clinical practices around the world. However, its efficacy in Japanese patients has not been extensively evaluated. We examined the dose-response relationship and long-term efficacy and safety in Japanese patients with acromegaly or pituitary gigantism. In an open-label, parallel-group, dose-response study, 32 patients (29 with acromegaly, 3 with pituitary gigantism) received 5 injections of 60, 90, or 120 mg of lanreotide Autogel over 24 weeks. Four weeks after the first injection, 41% of patients achieved serum GH level of <2.5 ng/mL and insulin-like growth factor-I (IGF-I) level was normalized in 31%. Values at Week 24 were 53% for GH and 44% for IGF-I. Dose-dependent decreases in serum GH and IGF-I levels were observed with dose-related changes in pharmacokinetic parameters. In an open-label, long-term study, 32 patients (30 with acromegaly, 2 with pituitary gigantism) received lanreotide Autogel once every 4 weeks for a total of 13 injections. Dosing was initiated with 90 mg and adjusted according to clinical responses at Weeks 16 and/or 32. At Week 52, 47% of patients had serum GH levels of <2.5 ng/mL and 53% had normalized IGF-I level. In both studies, acromegaly symptoms improved and treatment was generally well tolerated although gastrointestinal symptoms and injection site induration were reported. In conclusion, lanreotide Autogel provided early and sustained control of elevated GH and IGF-I levels, improved acromegaly symptoms, and was well tolerated in Japanese patients with acromegaly or pituitary gigantism.

• Authors: Akira Shimatsu, Akira Teramoto, Naomi Hizuka, Kazuo Kitai, Joaquim Ramis, Kazuo Chihara
• Journal: Endocrine journal (Endocr J) Vol. 60 Issue 5 Pg. 651-63 ( 2013) ISSN: 1348-4540 [Electronic] Japan
• PMID: 23337477 (Publication Type: Clinical Trial, Phase II, Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antineoplastic Agents
• Delayed-Action Preparations
• Gels
• IGF1 protein, human
• Peptides, Cyclic
• lanreotide
• Human Growth Hormone
• Somatostatin
• Insulin-Like Growth Factor I

Topics

• Acromegaly (etiology, prevention & control)
• Adenoma (blood, drug therapy, physiopathology)
• Adult
• Aged
• Antineoplastic Agents (administration & dosage, adverse effects, pharmacokinetics, therapeutic use)
• Delayed-Action Preparations (administration & dosage, adverse effects, pharmacokinetics, therapeutic use)
• Dose-Response Relationship, Drug
• Down-Regulation (drug effects)
• Drug Monitoring
• Female
• Gastrointestinal Diseases (chemically induced)
• Gels
• Gigantism (blood, drug therapy)
• Growth Hormone-Secreting Pituitary Adenoma (blood, drug therapy, physiopathology)
• Human Growth Hormone (blood)
• Humans
• Insulin-Like Growth Factor I (analysis)
• Japan
• Male
• Middle Aged
• Peptides, Cyclic (administration & dosage, adverse effects, pharmacokinetics, therapeutic use)
• Pituitary Gland (drug effects)
• Somatostatin (administration & dosage, adverse effects, analogs & derivatives, pharmacokinetics, therapeutic use)