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CLINICAL STUDY |
Department of Molecular and Clinical Endocrinology and Oncology, Section of Endocrinology, Federico II University of Naples, via S Pansini 5, 80131 Naples, Italy, 1 Neuroendocrine Unit Laboratories of Ludwig Maximilians University of Munich, Munich, Germany, 2 Department of Neurological Sciences, Section of Neuroradiology, Federico II University of Naples, Naples, Italy, 3 Pfizer Inc. 235 E 42 St. New York, NY 10017, USA, and 4 Department of Endocrinology, Charité University Medicine, Charité Campus Mitte, Berlin, Germany
(Correspondence should be addressed to A Colao; Email: colao{at}unina.it)
Objective: We aimed to investigate the efficacy of pegvisomant in patients with acromegaly resistant to long-term (
24-month), high-dose treatment with octreotide-LAR (40 mg/month) or lanreotide (120 mg/month).
Design: This was an open, prospective study.
Subjects and Methods: We studied 16 patients with acromegaly (nine women; aged 28–61 years). The main outcome measures were IGF-I levels, blood pressure, glucose tolerance and safety (liver function and tumor size). Pegvisomant was given at doses of 10–40 mg s.c. daily. Dose titration was performed every month by IGF-I assay.
Results: Three patients spontaneously stopped pegvisomant treatment after 6–9 months because of poor compliance; from the measurement of serum pegvisomant, another patient was found not to inject herself properly. After 6 months, IGF-I levels decreased by 63 ± 19% (767.8 ± 152.9 vs 299.8 ± 162.9 µg/l, P < 0.0001, t-test); serum IGF-I levels normalized in 57%. After 12 months, IGF-I levels normalized in nine (75%) patients and were reduced by over 50% in another three (25%). The mean tumor volume remained stable during the study (1198 ± 1234 vs 1196 ± 1351 mm3, P = 0.37): it did not change ( ± 25% vs basal) in nine patients, increased by 39.4% and 40.8% in two and decreased by 30.8–46.5% in four. The total/high-density lipoprotein (HDL):cholesterol ratio (from 4.4 ± 1.0 to 3.7 ± 0.6, P= 0.0012), glucose levels (from 5.6 ± 1.2 to 4.4 ± 1.4 mmol/l, P = 0.026), insulin levels (from 12.4 ± 6.7 to 8.1 ± 3.0 mUl/l, P = 0.0023) and homeostasis model assessment (HOMA) index (from 3.4 ± 2.1 to 1.9 ± 1.0, P = 0.0017) decreased.
Conclusions: Treatment for 12 months with pegvisomant normalized IGF-I levels, and improved cardiovascular risk parameters and insulin sensitivity in patients with acromegaly resistant to long-term, high-dose treatment with somatostatin analogs. The tolerance of treatment was good.
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 U Plockinger and T Reuter Pegvisomant increases intra-abdominal fat in patients with acromegaly: a pilot study. Eur. J. Endocrinol., April 1, 2008; 158(4): 467 - 471. [Abstract] [Full Text] [PDF]
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A. Colao, R. Pivonello, R. S Auriemma, M. Galdiero, S. Savastano, and G. Lombardi Beneficial effect of dose escalation of Octreotide-LAR as first-line therapy in patients with acromegaly Eur. J. Endocrinol., November 1, 2007; 157(5): 579 - 587. [Abstract] [Full Text] [PDF]
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R. Pivonello, M. Galderisi, R. S. Auriemma, M. C. De Martino, M. Galdiero, A. Ciccarelli, A. D'Errico, I. Kourides, P. Burman, G. Lombardi, et al. Treatment with Growth Hormone Receptor Antagonist in Acromegaly: Effect on Cardiac Structure and Performance J. Clin. Endocrinol. Metab., February 1, 2007; 92(2): 476 - 482. [Abstract] [Full Text] [PDF]
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