title: Effects of lanreotide Autogel primary therapy on symptoms and quality-of-life in acromegaly: data from the PRIMARYS study.
abstract: OBJECTIVE
  To evaluate the effects of lanreotide Autogel on patient-reported outcomes and association with biochemical control, using PRIMARYS data.
  
  
  METHODS
  PRIMARYS was a 1-year, open-label study of lanreotide Autogel (Depot in USA) 120 mg every 4 weeks in 90 treatment-naïve patients with acromegaly. Symptoms were assessed using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) and health-related quality of life (HRQoL) using the AcroQoL questionnaire. Correlations between PASQ and AcroQoL scores, and between PASQ/AcroQoL and growth hormone (GH)/insulin-like growth factor-1 (IGF-1) levels were also evaluated (post hoc).
  
  
  RESULTS
  Acromegaly symptoms and HRQoL significantly improved from week 12 to week 48, with modest correlations at week 48 between PASQ total score (R = -0.55, p < 0.0001) and AcroQoL global and physical scores (R = -0.67, p < 0.0001). Approximately 60% of patients achieved a minimal important difference (MID; improvement >50% of baseline standard deviation) in PASQ total score and >40% achieved a MID in AcroQoL global score (post hoc). Changes in PASQ scores were similar in biochemically controlled (GH levels ≤2.5 μg/L and normal IGF-1 levels) and uncontrolled groups, while changes in global and psychological AcroQoL scores were greater in the controlled group. There was no correlation between changes in PASQ or AcroQoL scores and changes in GH or IGF-1 levels.
  
  
  CONCLUSIONS
  Primary treatment with lanreotide Autogel over 1 year was associated with rapid and sustained improvements in clinical signs and symptoms and HRQoL in patients with acromegaly. Improvements in HRQoL, but not symptoms, were greater in those achieving biochemical control (ClinicalTrials.gov: NCT00690898; EudraCT: 2007-000155-34).
authors.affiliation: Department of Endocrinology and Metabolic Diseases, Centre Hospitalier Universitaire Larrey, Toulouse, France. caron.p@chu-toulouse.fr.
authors.forename: Philippe J
authors.initials: PJ
authors.lastname: Caron
authors.affiliation: Department of Endocrinology, Aberdeen Royal Infirmary, Aberdeen, UK.
authors.forename: John S
authors.initials: JS
authors.lastname: Bevan
authors.affiliation: ENDOC Center for Endocrine Tumors, Hamburg, Germany.
authors.forename: Stephan
authors.initials: S
authors.lastname: Petersenn
authors.affiliation: Ipsen, Boulogne-Billancourt, France.
authors.forename: Aude
authors.initials: A
authors.lastname: Houchard
authors.affiliation: Ipsen, Boulogne-Billancourt, France.
authors.forename: Caroline
authors.initials: C
authors.lastname: Sert
authors.affiliation: Departments of Endocrinology/Medicine, Sant Pau Biomedical Research Institute, Hospital de Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain.|Center for Biomedical Network Research on Rare Diseases (CIBERER Unit 747), ISCIII, Barcelona, Spain.
authors.forename: Susan M
authors.initials: SM
authors.lastname: Webb
mesh_terms: D000172:Acromegaly / Q000188:drug therapy* / Q000503:physiopathology / Q000523:psychology; D000328:Adult; D004304:Dosage Forms; D005260:Female; D005782:Gels; D006304:Health Status; D006801:Humans; D007279:Injections, Subcutaneous; D008297:Male; D008875:Middle Aged; D010456:Peptides, Cyclic / Q000008:administration & dosage* / Q000009:adverse effects; D011788:Quality of Life; D013004:Somatostatin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D011795:Surveys and Questionnaires
chemical_list: D004304:Dosage Forms; D005782:Gels; D010456:Peptides, Cyclic; C060347:lanreotide; D013004:Somatostatin
keywords: Acromegaly; Lanreotide Autogel; Quality of life; Symptoms