Pegvisomant in acromegaly: a multicenter real-life study in Argentina

To describe the long term safety and efficacy of pegvisomant (PEGV), and the predictors of treatment response in patients with acromegaly in the real life setting. We retrospectively reviewed the clinical, hormonal and radiological data of acromegalic patients treated with PEGV in 17 Argentine cente...

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Published in:	Archives of Endocrinology and Metabolism Vol. 63; no. 4; pp. 320 - 327
Main Authors:	Basavilbaso, Natalia Ximena Garcia, Ballarino, Maria Carolina, Bruera, Darío, Bruno, Oscar D, Chervin, Alberto B, Danilowicz, Karina, Fainstein-Day, Patricia, Fidalgo, Silvina Gabriela, Frigeri, Adriana, Glerean, Mariela, Guelman, Rodolfo, Isaac, Gabriel, Katz, Debora Adela, Knoblovits, Pablo, Librandi, Fabiana, Montes, Monica López, Mallea-Gil, Maria Susana, Manavela, Marcos, Mereshian, Paula, Moncet, Daniel, Pignatta, Analia, Rogozinsky, Amelia, Sago, Laura R, Servidio, Marisa, Spezzi, Monica, Stalldecker, Graciela, Tkatch, Julieta, Vitale, Nicolas Marcelo, Guitelman, Mirtha
Format:	Journal Article
Language:	English
Published:	Brazil Sociedade Brasileira de Endocrinologia e Metabologia 22-08-2019 Brazilian Society of Endocrinology and Metabolism
Subjects:	acromegaly Acromegaly - drug therapy Adult Aged Argentina Cabergoline - administration & dosage Cabergoline - therapeutic use clinical trial Dopamine Agonists - administration & dosage Dopamine Agonists - therapeutic use Drug Therapy, Combination Female Follow-Up Studies GH receptor antagonist Human Growth Hormone - administration & dosage Human Growth Hormone - analogs & derivatives Human Growth Hormone - therapeutic use Humans Insulin-Like Growth Factor I - analysis Male Middle Aged Original Pegvisomant Predictive Value of Tests Retrospective Studies Somatostatin - administration & dosage Somatostatin - analogs & derivatives Somatostatin - therapeutic use Treatment Outcome Young Adult Argentina
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Summary:	To describe the long term safety and efficacy of pegvisomant (PEGV), and the predictors of treatment response in patients with acromegaly in the real life setting. We retrospectively reviewed the clinical, hormonal and radiological data of acromegalic patients treated with PEGV in 17 Argentine centers. Seventy-five patients (age range 22-77, 51 females) with acromegaly have been treated with PEGV for up to 118 months (median 27 months). Before PEGV, 97.3% of patients had been treated with medical therapy, surgery and/or radiotherapy, two patients had no previous treatment. At that time, all patients had an IGF-1 above the upper normal limit (ULN) (mean 2.4 x ULN ± 0.98, range 1.25-7). At diagnosis of acromegaly 84% presented macroadenomas, prior to PEGV only 23,5% of patients remained with tumor remnant > 1 cm, the remaining showed normal or less than 1 cm images. Disease control (IGF-1 ≤ 1.2 x ULN) was achieved in 62.9% of patients with a mean dose of 11.8 mg/day. Thirty-four patients (45%) received PEGV monotherapy, while 41 (55%) received combined therapy with either somatostatin analogues and/or cabergoline. Adverse events related to PEGV were: local injection site reaction in 5.3%, elevated liver enzymes in 9.3%, and tumor size growth in 9.8%. Pre-PEGV IGF-I level was the only predictor of treatment response: 2.1 x ULN vs 2.8 x ULN in controlled and uncontrolled patients respectively (p < 0.001). this long term experience indicates PEGV treatment was highly effective and safe in our series of Argentine patients with acromegaly refractory to standard therapies. Arch Endocrinol Metab. 2019;63(4):320-7.
Bibliography:	Disclosure: KD has received speaker fee from Novartis and Pfizer, advisory board fee from Sandoz. DK has received speaker fee from Novartis, Pfizer and Sanofi. MM. is Medical Manager Oncology Novartis. GBNX is Medical Science Liaison Diabetes Sanofi. GR. has received speaker fee from Biosidus, Eli Lilly and Elea. GM has received speaker fee from Novartis, Pfizer and Sanofi; and is principal investigator from Novartis. The remaining authors have nothing to disclose.
ISSN:	2359-3997 2359-4292 2359-4292
DOI:	10.20945/2359-3997000000160