title: Lanreotide Autogel 120 mg at extended dosing intervals in patients with acromegaly biochemically controlled with octreotide LAR: the LEAD study.
abstract: OBJECTIVE
  To evaluate extended dosing intervals (EDIs) with lanreotide Autogel 120 mg in patients with acromegaly previously biochemically controlled with octreotide LAR 10 or 20 mg.
  
  
  METHODS
  Patients with acromegaly had received octreotide LAR 10 or 20 mg/4 weeks for ≥ 6 months and had normal IGF1 levels. Lanreotide Autogel 120 mg was administered every 6 weeks for 24 weeks (phase 1); depending on week-24 IGF1 levels, treatment was then administered every 4, 6 or 8 weeks for a further 24 weeks (phase 2). Hormone levels, patient-reported outcomes and adverse events were assessed.
  
  
  METHODS
  proportion of patients on 6- or 8-week EDIs with normal IGF1 levels at week 48 (study end).
  
  
  RESULTS
  107/124 patients completed the study (15 withdrew from phase 1 and two from phase 2). Of 124 patients enrolled, 77.4% were allocated to 6- or 8-week EDIs in phase 2 and 75.8% (95% CI: 68.3-83.3) had normal IGF1 levels at week 48 with the EDI (primary analysis). A total of 88.7% (83.1-94.3) had normal IGF1 levels after 24 weeks with 6-weekly dosing. GH levels were ≤ 2.5 μg/l in > 90% of patients after 24 and 48 weeks. Patient preferences for lanreotide Autogel 120 mg every 4, 6 or 8 weeks over octreotide LAR every 4 weeks were high.
  
  
  CONCLUSIONS
  Patients with acromegaly achieving biochemical control with octreotide LAR 10 or 20 mg/4 weeks are possible candidates for lanreotide Autogel 120 mg EDIs. EDIs are effective and well received among such patients.
authors.affiliation: Department of EndocrinologyErasmus Medical Center, Rotterdam, NetherlandsDepartment of EndocrinologyI.M. Sechenov First Moscow State Medical University, Moscow, Russian FederationDepartment of EndocrinologyPauls Stradins Clinical University Hospital, Riga, LatviaDivision of Endocrinology and MetabolismSamsung Medical Center, Sungkyunkwan University, Seoul, Republic of KoreaDepartment of Neuroendocrinology and Bone DiseasesNational Endocrinology Research Centre, Moscow, Russian FederationNeuroendocrine UnitDivision of Endocrinology and Metabolism, Hospital das Clinicas, University of São Paulo Medical School, São Paulo, BrazilEndocrine SectionHospital Universitário Clementino Fraga Filho, Universidade Federal do Rio de Janeiro, Rio de Janeiro, BrazilIpsen Boulogne-BillancourtFrance s.neggers@erasmusmc.nl.
authors.forename: Sebastian J C M M
authors.initials: SJ
authors.lastname: Neggers
authors.affiliation: Department of EndocrinologyErasmus Medical Center, Rotterdam, NetherlandsDepartment of EndocrinologyI.M. Sechenov First Moscow State Medical University, Moscow, Russian FederationDepartment of EndocrinologyPauls Stradins Clinical University Hospital, Riga, LatviaDivision of Endocrinology and MetabolismSamsung Medical Center, Sungkyunkwan University, Seoul, Republic of KoreaDepartment of Neuroendocrinology and Bone DiseasesNational Endocrinology Research Centre, Moscow, Russian FederationNeuroendocrine UnitDivision of Endocrinology and Metabolism, Hospital das Clinicas, University of São Paulo Medical School, São Paulo, BrazilEndocrine SectionHospital Universitário Clementino Fraga Filho, Universidade Federal do Rio de Janeiro, Rio de Janeiro, BrazilIpsen Boulogne-BillancourtFrance.
authors.forename: Vyacheslav
authors.initials: V
authors.lastname: Pronin
authors.affiliation: Department of EndocrinologyErasmus Medical Center, Rotterdam, NetherlandsDepartment of EndocrinologyI.M. Sechenov First Moscow State Medical University, Moscow, Russian FederationDepartment of EndocrinologyPauls Stradins Clinical University Hospital, Riga, LatviaDivision of Endocrinology and MetabolismSamsung Medical Center, Sungkyunkwan University, Seoul, Republic of KoreaDepartment of Neuroendocrinology and Bone DiseasesNational Endocrinology Research Centre, Moscow, Russian FederationNeuroendocrine UnitDivision of Endocrinology and Metabolism, Hospital das Clinicas, University of São Paulo Medical School, São Paulo, BrazilEndocrine SectionHospital Universitário Clementino Fraga Filho, Universidade Federal do Rio de Janeiro, Rio de Janeiro, BrazilIpsen Boulogne-BillancourtFrance.
authors.forename: Inga
authors.initials: I
authors.lastname: Balcere
authors.affiliation: Department of EndocrinologyErasmus Medical Center, Rotterdam, NetherlandsDepartment of EndocrinologyI.M. Sechenov First Moscow State Medical University, Moscow, Russian FederationDepartment of EndocrinologyPauls Stradins Clinical University Hospital, Riga, LatviaDivision of Endocrinology and MetabolismSamsung Medical Center, Sungkyunkwan University, Seoul, Republic of KoreaDepartment of Neuroendocrinology and Bone DiseasesNational Endocrinology Research Centre, Moscow, Russian FederationNeuroendocrine UnitDivision of Endocrinology and Metabolism, Hospital das Clinicas, University of São Paulo Medical School, São Paulo, BrazilEndocrine SectionHospital Universitário Clementino Fraga Filho, Universidade Federal do Rio de Janeiro, Rio de Janeiro, BrazilIpsen Boulogne-BillancourtFrance.
authors.forename: Moon-Kyu
authors.initials: MK
authors.lastname: Lee
authors.affiliation: Department of EndocrinologyErasmus Medical Center, Rotterdam, NetherlandsDepartment of EndocrinologyI.M. Sechenov First Moscow State Medical University, Moscow, Russian FederationDepartment of EndocrinologyPauls Stradins Clinical University Hospital, Riga, LatviaDivision of Endocrinology and MetabolismSamsung Medical Center, Sungkyunkwan University, Seoul, Republic of KoreaDepartment of Neuroendocrinology and Bone DiseasesNational Endocrinology Research Centre, Moscow, Russian FederationNeuroendocrine UnitDivision of Endocrinology and Metabolism, Hospital das Clinicas, University of São Paulo Medical School, São Paulo, BrazilEndocrine SectionHospital Universitário Clementino Fraga Filho, Universidade Federal do Rio de Janeiro, Rio de Janeiro, BrazilIpsen Boulogne-BillancourtFrance.
authors.forename: Liudmila
authors.initials: L
authors.lastname: Rozhinskaya
authors.affiliation: Department of EndocrinologyErasmus Medical Center, Rotterdam, NetherlandsDepartment of EndocrinologyI.M. Sechenov First Moscow State Medical University, Moscow, Russian FederationDepartment of EndocrinologyPauls Stradins Clinical University Hospital, Riga, LatviaDivision of Endocrinology and MetabolismSamsung Medical Center, Sungkyunkwan University, Seoul, Republic of KoreaDepartment of Neuroendocrinology and Bone DiseasesNational Endocrinology Research Centre, Moscow, Russian FederationNeuroendocrine UnitDivision of Endocrinology and Metabolism, Hospital das Clinicas, University of São Paulo Medical School, São Paulo, BrazilEndocrine SectionHospital Universitário Clementino Fraga Filho, Universidade Federal do Rio de Janeiro, Rio de Janeiro, BrazilIpsen Boulogne-BillancourtFrance.
authors.forename: Marcello D
authors.initials: MD
authors.lastname: Bronstein
authors.affiliation: Department of EndocrinologyErasmus Medical Center, Rotterdam, NetherlandsDepartment of EndocrinologyI.M. Sechenov First Moscow State Medical University, Moscow, Russian FederationDepartment of EndocrinologyPauls Stradins Clinical University Hospital, Riga, LatviaDivision of Endocrinology and MetabolismSamsung Medical Center, Sungkyunkwan University, Seoul, Republic of KoreaDepartment of Neuroendocrinology and Bone DiseasesNational Endocrinology Research Centre, Moscow, Russian FederationNeuroendocrine UnitDivision of Endocrinology and Metabolism, Hospital das Clinicas, University of São Paulo Medical School, São Paulo, BrazilEndocrine SectionHospital Universitário Clementino Fraga Filho, Universidade Federal do Rio de Janeiro, Rio de Janeiro, BrazilIpsen Boulogne-BillancourtFrance.
authors.forename: Mônica R
authors.initials: MR
authors.lastname: Gadelha
authors.affiliation: Department of EndocrinologyErasmus Medical Center, Rotterdam, NetherlandsDepartment of EndocrinologyI.M. Sechenov First Moscow State Medical University, Moscow, Russian FederationDepartment of EndocrinologyPauls Stradins Clinical University Hospital, Riga, LatviaDivision of Endocrinology and MetabolismSamsung Medical Center, Sungkyunkwan University, Seoul, Republic of KoreaDepartment of Neuroendocrinology and Bone DiseasesNational Endocrinology Research Centre, Moscow, Russian FederationNeuroendocrine UnitDivision of Endocrinology and Metabolism, Hospital das Clinicas, University of São Paulo Medical School, São Paulo, BrazilEndocrine SectionHospital Universitário Clementino Fraga Filho, Universidade Federal do Rio de Janeiro, Rio de Janeiro, BrazilIpsen Boulogne-BillancourtFrance.
authors.forename: Pascal
authors.initials: P
authors.lastname: Maisonobe
authors.affiliation: Department of EndocrinologyErasmus Medical Center, Rotterdam, NetherlandsDepartment of EndocrinologyI.M. Sechenov First Moscow State Medical University, Moscow, Russian FederationDepartment of EndocrinologyPauls Stradins Clinical University Hospital, Riga, LatviaDivision of Endocrinology and MetabolismSamsung Medical Center, Sungkyunkwan University, Seoul, Republic of KoreaDepartment of Neuroendocrinology and Bone DiseasesNational Endocrinology Research Centre, Moscow, Russian FederationNeuroendocrine UnitDivision of Endocrinology and Metabolism, Hospital das Clinicas, University of São Paulo Medical School, São Paulo, BrazilEndocrine SectionHospital Universitário Clementino Fraga Filho, Universidade Federal do Rio de Janeiro, Rio de Janeiro, BrazilIpsen Boulogne-BillancourtFrance.
authors.forename: Caroline
authors.initials: C
authors.lastname: Sert
authors.affiliation: Department of EndocrinologyErasmus Medical Center, Rotterdam, NetherlandsDepartment of EndocrinologyI.M. Sechenov First Moscow State Medical University, Moscow, Russian FederationDepartment of EndocrinologyPauls Stradins Clinical University Hospital, Riga, LatviaDivision of Endocrinology and MetabolismSamsung Medical Center, Sungkyunkwan University, Seoul, Republic of KoreaDepartment of Neuroendocrinology and Bone DiseasesNational Endocrinology Research Centre, Moscow, Russian FederationNeuroendocrine UnitDivision of Endocrinology and Metabolism, Hospital das Clinicas, University of São Paulo Medical School, São Paulo, BrazilEndocrine SectionHospital Universitário Clementino Fraga Filho, Universidade Federal do Rio de Janeiro, Rio de Janeiro, BrazilIpsen Boulogne-BillancourtFrance.
authors.forename: Aart Jan
authors.initials: AJ
authors.lastname: van der Lely
mesh_terms: D000172:Acromegaly / Q000188:drug therapy* / Q000378:metabolism; D000236:Adenoma / Q000188:drug therapy* / Q000378:metabolism; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D003692:Delayed-Action Preparations; D005260:Female; D049912:Growth Hormone-Secreting Pituitary Adenoma / Q000188:drug therapy* / Q000378:metabolism; D019382:Human Growth Hormone / Q000378:metabolism*; D006801:Humans; D007334:Insulin-Like Growth Factor I / Q000378:metabolism*; D008297:Male; D008875:Middle Aged; D015282:Octreotide / Q000627:therapeutic use; D010456:Peptides, Cyclic / Q000008:administration & dosage*; D013004:Somatostatin / Q000008:administration & dosage / Q000031:analogs & derivatives*; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D003692:Delayed-Action Preparations; C583557:IGF1 protein, human; D010456:Peptides, Cyclic; C060347:lanreotide; D019382:Human Growth Hormone; D013004:Somatostatin; D007334:Insulin-Like Growth Factor I; D015282:Octreotide