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Safety of long-term treatment with Pegvisomant: analysis of Spanish patients included in global ACROSTUDY

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An Erratum to this article was published on 04 May 2016

Abstract

Purpose

To evaluate the long-term safety of Pegvisomant (PEG) in the Spanish cohort of ACROSTUDY.

Methods

As of July 2013, 199 Spanish patients were included in ACROSTUDY, a global non interventional safety PEG surveillance study. Patients were observed for safety, biochemical outcome and magnetic resonance imaging evaluations.

Results

PEG was administered during an average period of 6.7 ± 2.1 years and a mean daily dose of 15.5 ± 7.5 mg. 48.2 % of patients received PEG monotherapy. 90.9 % of patients had received other medical treatment before PEG start. 195 adverse events (AEs) were reported in 88 patients (44.2 %), and serious AEs were described in 31 patients (15.6 %). There were no cases of liver tests >10 ULN, or permanent liver damage. Tumor size changes were locally reported in 61 cases (33.5 %), with increases observed in 11 patients (6 %). In acromegalic patients with diabetes mellitus a decrease in fasting serum glucose value was reported, reaching statistical significance after 1 and 4 years of treatment (−24.6 and −25.9 mg/dl, p = 0.04). After 60 months, normal or lower limit of normal (LLN) IGF-I levels were found in 67.9 % of patients. 85.5 % of patients showed an IGF-I normal or <LLN at any time after PEG start. Most patients with uncontrolled IGF-I levels were on submaximal PEG doses.

Conclusions

ACROSTUDY carried out with the Spanish cohort confirmed that PEG has a favorable safety and efficacy profile. The percentage of patients considered under control was similar to data reported globally and in other local ACROSTUDY results.

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Acknowledgments

Spanish ACROSTUDY group members: Acha J, Aguillo E, Albero R, Aller J, Alonso N, Álvarez-Escolà C, Ballesteros MD, Bernabeu I, Bernal C, Calvo F, Casanueva F, Cordido F, Cuatrecasas G, Cuellar L, Díaz JA, Domínguez JR, Egido J, Enciso FJ, Fajardo C, Ferrer JC, Gálvez MA, García-Arnés JA, Gavilán I, Gilsanz A, González MN, Gonzalo MA, Halperin I, Herrera MT, Isidro L, Lucas T, Luque M, Marazuela M, Mesa J, De Miguel P, Monreal M, Mora M, Morales F, Novoa FJ, Obiols G, Ojeda A, Pavón I, Pardo C, Pérez B, Pomares FJ, Picó A, Recio JM, Salinas I, Soler J, Soto A, Terroba C, Tofé S, Torres E, Villabona C, Webb S.

Funding

ACROSTUDY is sponsored by Pfizer, Inc.

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    Authors and Affiliations

    1. Complejo Hospitalario Universitario de Santiago, Santiago de Compostela, Spain

      I. Bernabeu

    2. Hospital General Universitario de Alicante, Alicante, Spain

      A. Pico

    3. Hospital Universitario Virgen del Rocío, Seville, Spain

      E. Venegas

    4. Hospital Universitario Puerta de Hierro - Majadahonda, Madrid, Spain

      J. Aller

    5. Hospital Universitario La Paz, Madrid, Spain

      C. Alvarez-Escolá

    6. Hospital Regional Universitario de Málaga, Málaga, Spain

      J. A. García-Arnés

    7. Hospital Universitario de La Princesa, Madrid, Spain

      M. Marazuela

    8. Pfizer Endocrine Care, Sollentuna, Sweden

      P. Jonsson

    9. Pfizer Medical Department, Madrid, Spain

      N. Mir & M. García Vargas

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    1. I. Bernabeu
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    Correspondence to A. Pico.

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    Disclosures

    IB., E.V., C.A-E., JA.G, M.M and A.P. received honoraria from Pfizer as speakers fees as Advisor fees. I.B., M.M and A.P also received an IIR from Pfizer. T.L. received honoraria from Pfizer as speaker fees. P.J., M.G.V, N.M. are full time employees of Pfizer.

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    I. Bernabeu and A. Pico have equally contributed to this work.

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    Bernabeu, I., Pico, A., Venegas, E. et al. Safety of long-term treatment with Pegvisomant: analysis of Spanish patients included in global ACROSTUDY. Pituitary 19, 127–137 (2016). https://doi.org/10.1007/s11102-015-0691-0

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