title: Control of IGF-I levels with titrated dosing of lanreotide Autogel over 48 weeks in patients with acromegaly.
abstract: BACKGROUND
  An essential criterion for control of acromegaly is normalization of IGF-I levels. Somatostatin analogues act to suppress IGF-I and GH levels.
  
  
  OBJECTIVE
  To assess the efficacy and safety of 48 weeks titrated dosing of lanreotide Autogel.
  
  
  METHODS
  Open-label, multicentre, phase III, 48-week trial.
  
  
  METHODS
  Patients with active acromegaly (IGF-I levels > 1.3 times upper limit of age-adjusted normal range) were recruited. Twelve injections of lanreotide Autogel were given at 28-day intervals: during the 16-week fixed-dose phase, patients received 90 mg; in the 32-week dose-titration phase, patients received 60, 90 or 120 mg according to GH and IGF-I levels. Intention-to-treat analysis was performed to determine the proportion of patients with normalized age-adjusted IGF-I levels at study end. Secondary evaluations included GH levels, clinical acromegaly signs and safety.
  
  
  RESULTS
  Fifty-seven of 63 patients completed the study. Lanreotide Autogel resulted in normalized age-adjusted IGF-I levels in 27 patients (43%, 95% CI 31-55). Mean GH levels decreased from 6.2 to 1.5 microg/l at study end, with 53 of 62 patients (85%) having GH levels < or = 2.5 microg/l (95% CI 76.7-94.3) and 28 of 62 patients (45%) with levels < 1 microg/l (95% CI 32.8-57.6). Twenty-four (38%) had both normal IGF-I levels and GH levels < or = 2.5 microg/l. Acromegaly symptoms reduced significantly in most patients throughout the study. The most common adverse events were gastrointestinal, as expected for somatostatin analogues.
  
  
  CONCLUSIONS
  Using IGF-I as primary end-point, 48 weeks lanreotide Autogel treatment, titrated for optimal hormonal control, controlled IGF-I and GH levels effectively, reduced acromegaly symptoms and was well tolerated.
authors.affiliation: Université Paris-Sud 11 and Assistance Publique-Hôpitaux de Paris, Endocrinology and Reproductive Diseases, Bicêtre Hospital, and INSERM U693, Le Kremlin-Bicêtre, France. philippe.chanson@bct.aphp.fr
authors.forename: Philippe
authors.initials: P
authors.lastname: Chanson
authors.forename: Françoise
authors.initials: F
authors.lastname: Borson-Chazot
authors.forename: Jean-Marc
authors.initials: JM
authors.lastname: Kuhn
authors.forename: Joëlle
authors.initials: J
authors.lastname: Blumberg
authors.forename: Pascal
authors.initials: P
authors.lastname: Maisonobe
authors.forename: Brigitte
authors.initials: B
authors.lastname: Delemer
mesh_terms: D000172:Acromegaly / Q000097:blood* / Q000188:drug therapy*; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000032:analysis; D004334:Drug Administration Schedule; D054796:Drug Dosage Calculations; D005260:Female; D005782:Gels; D019382:Human Growth Hormone / Q000097:blood; D006801:Humans; D007334:Insulin-Like Growth Factor I / Q000032:analysis / Q000378:metabolism*; D008297:Male; D008875:Middle Aged; D010456:Peptides, Cyclic / Q000008:administration & dosage* / Q000009:adverse effects / Q000032:analysis*; D013004:Somatostatin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000032:analysis; D013997:Time Factors; D017186:Titrimetry; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000970:Antineoplastic Agents; D005782:Gels; D010456:Peptides, Cyclic; C060347:lanreotide; D019382:Human Growth Hormone; D013004:Somatostatin; D007334:Insulin-Like Growth Factor I