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

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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 end-point was IGF-I normalization at week 52. Secondary end-points 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 ≥2xupper 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.

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Authors and Affiliations

  1. Division of Endocrinology and Metabolism, Department of Internal Medicine, University of Turin, Molinette Hospital, Corso Dogliotti 14, 10126, Torino, Italy

    E. Ghigo MD

  2. Neuroendocrine Unit, Massachusetts General Hospital, Boston, Massachusetts, USA

    B. M. K. Biller & A. Klibanski

  3. Department of Endocrinology, Federico II University of Naples, Naples, Italy

    A. Colao

  4. global Endocrine Care, Pfizer Inc., New York, New York, USA

    I. A. Kourides

  5. Global Medical Research and Development, Statistics, Pfizer Inc., New York, New York, USA

    N. Rajicic

  6. Department of Radiology, Erlanger Health System and University of Tennessee College of Medicine, Chattanooga, Tennessee, USA

    R. K. Hutson

  7. Department of Endocrinology, Catholic University, Rome, Italy

    L. De Marinis

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  1. E. Ghigo MD
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Ghigo, E., Biller, B.M.K., Colao, A. et al. Comparison of pegvisomant and long-acting octreotide in patients with acromegaly naïve to radiation and medical therapy. J Endocrinol Invest 32, 924–933 (2009). https://doi.org/10.1007/BF03345774

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  • DOI: https://doi.org/10.1007/BF03345774

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