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

Endocrine Journal

Joaquim Ramis²  Kazuo Kitai³  Akira Teramoto⁴  Akira Shimatsu⁶  Kazuo Chihara⁵  Naomi Hizuka¹ 

[1] Department of Medicine II, Tokyo Women’s Medical University, Tokyo 162-8666, Japan;Ipsen Innovation, Les Ulis 91940, France;Teijin Pharma Limited, Tokyo 100-8585, Japan;Department of Neurosurgery, Nippon Medical School, Tokyo 113-8603, Japan;Hyogo Prefectural Kakogawa Medical Center, Kakogawa 675-8555, Japan;Clinical Research Institute, National Hospital Organization Kyoto Medical Center, Kyoto 612-8555, Japan

关键词: Acromegaly;    Lanreotide Autogel;    Growth hormone;    Insulin-like growth factor-I;    Somatostatin analog;   

DOI  :  10.1507/endocrj.EJ12-0417

学科分类：内分泌与代谢学

来源: Japan Endocrine Society

【 摘 要 】

References(20)Cited-By(7)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.

【 授权许可】

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