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Article: 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

TitleRapid 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
Authors
KeywordsAcromegaly
Growth hormone
Insulin-like growth factor-1
Lanreotide Autogel
Somatostatin analogue
Issue Date2010
PublisherSpringer New York LLC. The Journal's web site is located at http://springerlink.metapress.com/openurl.asp?genre=journal&issn=1386-341X
Citation
Pituitary, 2010, v. 13 n. 1, p. 18-28 How to Cite?
AbstractThe study was designed to evaluate the long-term efficacy and safety of the 28-day prolonged-release Autogel formulation of the somatostatin analogue lanreotide (Lan-Autogel) in unselected patients with acromegaly. The study comprised four phases: washout; a double-blind comparison with placebo, at a single randomized dose (60, 90 or 120 mg) of Lan-Autogel; a single-blind, fixed-dose phase for four injections (placebo group was re-allocated to active treatment); and eight injections with doses tailored according to biochemical response. Serum samples were assessed for growth hormone (GH) and insulin-like growth factor-1 (IGF-1) levels, at weeks 4, 13, 14, 15, 16, 32 and 52. 108 patients were enrolled and 99 completed 52 weeks' treatment. Four weeks after the first injection, serum GH levels decreased by >50% from baseline in 63% of patients receiving Lan-Autogel compared with 0% receiving placebo (P < 0.001). After four injections, 72% of patients had a >50% reduction in GH levels; 49% patients achieved GH levels ≤ 2.5 ng/ml; 54% had normalized IGF-1; and 38% achieved the combined criterion of GH level ≤ 2.5 ng/ml and normalized IGF-1. The corresponding proportions by week 52 were 82, 54, 59 and 43%, respectively. In patients not requiring dose escalation to 120 mg, 85% achieved biochemical control (combined criterion). Treatment was well tolerated by all patients. In conclusion, Lan-Autogel was effective in controlling GH and IGF-1 hypersecretion in patients with acromegaly and showed a rapid onset of action.
Persistent Identifierhttp://hdl.handle.net/10722/144956
ISSN
2015 Impact Factor: 3.407
2015 SCImago Journal Rankings: 0.791
PubMed Central ID
ISI Accession Number ID
Funding AgencyGrant Number
Ipsen
OTKA68660
Funding Information:

The authors take full responsibility for the content of the paper, and thank Caudex Medical and ESP Bioscience (supported by Ipsen) for their assistance in preparation of the manuscript and its revision addressing the authors' comments. M. Goth is supported by an OTKA Grant (no. 68660).

References

 

DC FieldValueLanguage
dc.contributor.authorMelmed, Sen_HK
dc.contributor.authorCook, Den_HK
dc.contributor.authorSchopohl, Jen_HK
dc.contributor.authorGoth, MIen_HK
dc.contributor.authorLam, KSLen_HK
dc.contributor.authorMarek, Jen_HK
dc.date.accessioned2012-02-21T05:44:54Z-
dc.date.available2012-02-21T05:44:54Z-
dc.date.issued2010en_HK
dc.identifier.citationPituitary, 2010, v. 13 n. 1, p. 18-28en_HK
dc.identifier.issn1386-341Xen_HK
dc.identifier.urihttp://hdl.handle.net/10722/144956-
dc.description.abstractThe study was designed to evaluate the long-term efficacy and safety of the 28-day prolonged-release Autogel formulation of the somatostatin analogue lanreotide (Lan-Autogel) in unselected patients with acromegaly. The study comprised four phases: washout; a double-blind comparison with placebo, at a single randomized dose (60, 90 or 120 mg) of Lan-Autogel; a single-blind, fixed-dose phase for four injections (placebo group was re-allocated to active treatment); and eight injections with doses tailored according to biochemical response. Serum samples were assessed for growth hormone (GH) and insulin-like growth factor-1 (IGF-1) levels, at weeks 4, 13, 14, 15, 16, 32 and 52. 108 patients were enrolled and 99 completed 52 weeks' treatment. Four weeks after the first injection, serum GH levels decreased by >50% from baseline in 63% of patients receiving Lan-Autogel compared with 0% receiving placebo (P < 0.001). After four injections, 72% of patients had a >50% reduction in GH levels; 49% patients achieved GH levels ≤ 2.5 ng/ml; 54% had normalized IGF-1; and 38% achieved the combined criterion of GH level ≤ 2.5 ng/ml and normalized IGF-1. The corresponding proportions by week 52 were 82, 54, 59 and 43%, respectively. In patients not requiring dose escalation to 120 mg, 85% achieved biochemical control (combined criterion). Treatment was well tolerated by all patients. In conclusion, Lan-Autogel was effective in controlling GH and IGF-1 hypersecretion in patients with acromegaly and showed a rapid onset of action.en_HK
dc.languageengen_US
dc.publisherSpringer New York LLC. The Journal's web site is located at http://springerlink.metapress.com/openurl.asp?genre=journal&issn=1386-341Xen_HK
dc.relation.ispartofPituitaryen_HK
dc.rightsSpringer Science+Business Media, LLCen_US
dc.rightsCreative Commons: Attribution 3.0 Hong Kong Licenseen_US
dc.subjectAcromegalyen_HK
dc.subjectGrowth hormoneen_HK
dc.subjectInsulin-like growth factor-1en_HK
dc.subjectLanreotide Autogelen_HK
dc.subjectSomatostatin analogueen_HK
dc.subject.meshAcromegaly - blood - complications - drug therapy-
dc.subject.meshHuman Growth Hormone - blood - drug effects - secretion-
dc.subject.meshInsulin-Like Growth Factor I - analysis - drug effects - secretion-
dc.subject.meshPeptides, Cyclic - administration and dosage - adverse effects-
dc.subject.meshSomatostatin - administration and dosage - adverse effects - analogs and derivatives-
dc.titleRapid 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 extensionen_HK
dc.typeArticleen_HK
dc.identifier.openurlhttp://library.hku.hk:4551/resserv?sid=springerlink&genre=article&atitle=Rapid and sustained reduction of serum growth hormone and insulin-like growth factor-1 in patients with acromegaly receiving lanreotide Autogel<sup>®</sup> therapy: a randomized, placebo-controlled, multicenter study with a 52 week open extension&title=Pituitary&issn=1386341X&date=2010-03-01&volume=13&issue=1& spage=18&authors=Shlomo Melmed, David Cook, Jochen Schopohl, <i>et al.</i>en_US
dc.identifier.emailLam, KSL:ksllam@hku.hken_HK
dc.identifier.authorityLam, KSL=rp00343en_HK
dc.description.naturepublished_or_final_versionen_US
dc.identifier.doi10.1007/s11102-009-0191-1en_HK
dc.identifier.pmid19639415-
dc.identifier.pmcidPMC2807598-
dc.identifier.scopuseid_2-s2.0-77949274556en_HK
dc.identifier.hkuros162209-
dc.relation.referenceshttp://www.scopus.com/mlt/select.url?eid=2-s2.0-77949274556&selection=ref&src=s&origin=recordpageen_HK
dc.identifier.volume13en_HK
dc.identifier.issue1en_HK
dc.identifier.spage18en_HK
dc.identifier.epage28en_HK
dc.identifier.eissn1573-7403en_US
dc.identifier.isiWOS:000273685600003-
dc.publisher.placeUnited Statesen_HK
dc.description.otherSpringer Open Choice, 21 Feb 2012en_US
dc.identifier.scopusauthoridMelmed, S=7102514728en_HK
dc.identifier.scopusauthoridCook, D=7403472446en_HK
dc.identifier.scopusauthoridSchopohl, J=7003794378en_HK
dc.identifier.scopusauthoridGoth, MI=7005453246en_HK
dc.identifier.scopusauthoridLam, KSL=8082870600en_HK
dc.identifier.scopusauthoridMarek, J=7202777201en_HK
dc.identifier.citeulike5397493-

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