Comparison of pegvisomant and long-acting octreotide in patients with acromegaly naïve to radiation and medical therapy

Laura De Marinis Grasso, E Ghigo, Bmk Biller, A Colao, Ia Kourides, N Rajicic, Rk Hutson, A. Klibanski

Risultato della ricerca: Contributo in rivistaArticolo in rivista

45 Citazioni (Scopus)

Abstract

Background: Normalization of IGF-I in patients with acromegaly is associated with a decrease in mortality. Pegvisomant may be more effective in lowering IGF-I than octreotide. Subjects and methods: The efficacy and safety of pegvisomant and octreotide long-acting release (LAR) were compared in 118 patients with acromegaly in this 52-week, multicenter, open-label, randomized study. The primary endpoint was IGF-I normalization at week 52. Secondary endpoints included mean changes from baseline in IGF-I, IGF binding protein 3, acromegaly signs and symptom scores, ring size, acromegaly quality of life questionnaire scores, and safety. Results: Fifty-six patients received pegvisomant and 57 received octreotide LAR. IGF-I normalized in 51% of pegvisomant patients and 34% treated with octreotide LAR (p=0.09, ns). Patients with baseline IGF-I ≥2×upper limit of normal had a higher rate of IGF-I normalization with pegvisomant vs octreotide LAR (p=0.05). Among the patients who did not achieve a normalized IGF-I, pegvisomant-treated patients were more likely to be receiving <30 mg of study drug (71% vs 16%). Treatment-related adverse events were mild-to-moderate in both groups. Mean fasting glucose decreased in diabetic and non-diabetic patients on pegvisomant whereas octreotide LAR was associated with an increase at week 52 (p=0.005 and p=0.003 between groups, respectively). Mean change in tumor volume during treatment was similar between groups. Conclusions: Pegvisomant and octreotide LAR were equally effective in normalizing IGF-I in the overall population, and pegvisomant was more effective in patients with higher baseline IGF-I levels. Pegvisomant had a more favorable effect on parameters of glycemic control. ©2009, Editrice Kurtis.
Lingua originaleEnglish
pagine (da-a)924-933
Numero di pagine10
RivistaJournal of Endocrinological Investigation
Volume32
DOI
Stato di pubblicazionePubblicato - 2009

Keywords

  • Adult
  • Blood Glucose
  • Delayed-Action Preparations
  • Female
  • Gallbladder
  • Human Growth Hormone
  • Humans
  • Insulin-Like Growth Factor I
  • Male
  • Middle Aged
  • Octreotide
  • acromegaly
  • adult
  • aged
  • alanine aminotransferase blood level
  • article
  • aspartate aminotransferase blood level
  • bile duct dilatation
  • cholelithiasis
  • clinical trial
  • controlled clinical trial
  • controlled study
  • diabetes mellitus
  • diarrhea
  • diet restriction
  • drug dose increase
  • drug dose reduction
  • drug dose titration
  • drug efficacy
  • drug hypersensitivity
  • drug induced headache
  • drug safety
  • drug withdrawal
  • female
  • finger
  • gallstone
  • gastrointestinal symptom
  • glucose
  • glucose blood level
  • glycemic control
  • growth hormone
  • growth hormone blood level
  • human
  • hypophysis tumor
  • injection site reaction
  • major clinical study
  • male
  • multicenter study
  • nausea
  • non insulin dependent diabetes mellitus
  • octreotide
  • optimal drug dose
  • pegvisomant
  • protein blood level
  • quality of life
  • randomized controlled trial
  • scoring system
  • side effect
  • somatomedin C, abdominal pain
  • somatomedin binding protein 3
  • sustained drug release
  • symptom
  • tumor volume
  • vomiting, Acromegaly

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