pp 1–9 | Cite as

Treatment adherence to pegvisomant in patients with acromegaly in Spain: PEGASO study

  • Rosa Cámara
  • Eva Venegas
  • Juan Antonio García-Arnés
  • Fernando Cordido
  • Javier Aller
  • M. Luz Samaniego
  • Nuria Mir
  • Laura Sánchez-CenizoEmail author



The burden of chronic daily subcutaneous administration of pegvisomant on adherence has not been previously studied. This study was aimed to determine the adherence to pegvisomant treatment in acromegaly patients in the real-world clinical practice setting in Spain.


Multicenter, observational, descriptive, cross-sectional study in patients with acromegaly treated with pegvisomant for at least 12 months. Patient adherence was indirectly determined by Batalla and Haynes-Sackett questionnaires and directly by prescription record review. Additionally, treatment satisfaction was assessed by the Treatment Satisfaction with Medicines Questionnaire (SATMED-Q) and treatment convenience by an ad-hoc Pegvisomant questionnaire. Errors in reconstitution and administration process were determined by direct observation.


108 patients were included in the analysis. Rates of adherence varied from 60.7 to 92.1% and did not correlate with disease control. Older patient age and alternative schedules other than daily pegvisomant dosing were associated with lower adherence. Treatment satisfaction and convenience was high, with a mean (SD) total SATMED-Q score of 74.6 ± 15.4 over 100 and a total ad-hoc Pegvisomant questionnaire score of 71.2 ± 15.2 over 100. 34.3% of patients made mistakes during the reconstitution /administration process.


Patient adherence to pegvisomant was high (60.7–92.1%), but more than a third of the patients in the study made mistakes during the administration process, with a potential impact on disease control. Besides dosing compliance, correct administration of medication should be carefully assessed in these patients.


Patient compliance Medication adherence Patient satisfaction Pegvisomant Medication errors Acromegaly 



The authors thank all the investigators of PEGASO study and participant patients at Hospital Universitario La Paz (Dr. Cristina Álvarez), Hospital Universitario La Princesa (Dr. Ana Mª Ramos), Hospital Regional Universitario Carlos Haya (Dr. Juan Antonio García-Arnés), Hospital Universitario Virgen del Rocío (Dr. Eva Venegas), Hospital Universitario y Politécnico La Fe (Dr. Rosa Cámara), Hospital Universitario La Ribera (Dr. Carmen Fajardo), Hospital General Universitario de Valencia (Dr. Juan Carlos Ferrer), Hospital General Universitario de Alicante (Dr. Antonio Picó), Hospital Universitario Vall d’Hebrón (Dr. Jordi Mesa), Hospital Universitario de Bellvitge (Dr. Carles Villabona), Hospital Universitario Puerta de Hierro (Dr. Javier Aller), Hospital Universitario de Getafe (Dr. Isabel Pavón), Hospital General Universitario Gregorio Marañón (Dr. Rogelio García), Hospital Universitario Marqués de Valdecilla (Dr. Fernando Pazos), Hospital Universitario de Cruces (Dra. Sonia Gaztambide), Hospital Universitario Basurto (Dr. Miguel Paja), Hospital Universitario Miguel Servet (Dr. Javier Acha), Complejo Hospitalario Universitario Santiago (Dr. Ignacio Bernabéu), Complejo Hospitalario Universitario A Coruña (Dr. Fernando Cordido).


This study was funded by Pfizer (Spain). Medical writing support was provided by Esther Tapia PhD as a freelance medical writer and was funded by Pfizer (Spain).

Compliance with ethical standards

Conflict of interest

NM and LS-C are employees of Pfizer (Spain). MLS works for Pfizer (Spain). RC, EV, JAG-A, FC and JA have received compensation from Pfizer (Spain) for their participation as investigators of PEGASO study. RC has received compensation from Pfizer (Spain) for their participation as research coordinator of PEGASO study. RC, EV, FC and JA have received speaker honoraria from Pfizer (Spain).

Ethical approval

The study was approved by the Clinical Research Ethics Committee of every participant site. All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional research committees and with the 1964 Helsinki declaration and its later amendments.

Informed consent

Informed consent was obtained from all individual participants included in the study.

Supplementary material

11102_2019_943_MOESM1_ESM.pdf (465 kb)
Supplementary material 1 (PDF 465 KB)
11102_2019_943_MOESM2_ESM.pdf (84 kb)
Supplementary material 2 (PDF 83 KB)
11102_2019_943_MOESM3_ESM.pdf (167 kb)
Supplementary material 3 (PDF 167 KB)


  1. 1.
    Melmed S, Colao A, Barkan A, Molitch M, Grossman AB, Kleinberg D et al (2009) Guidelines for acromegaly management: an update. J Clin Endocrinol Metab 94:1509–1517CrossRefGoogle Scholar
  2. 2.
    Holdaway IM, Rajasoorya C (1999) Epidemiology of acromegaly. Pituitary 2:29–41CrossRefGoogle Scholar
  3. 3.
    Lavrentaki A, Paluzzi A, Wass JA, Karavitaki N (2017) Epidemiology of acromegaly: review of population studies. Pituitary 20:4–9CrossRefGoogle Scholar
  4. 4.
    Sesmilo G (2013) Epidemiology of acromegaly in Spain. Endocrinol Nutr 60:470–474CrossRefGoogle Scholar
  5. 5.
    Lugo G, Pena L, Cordido F. Clinical manifestations and diagnosis of acromegaly. Int J Endocrinol. 2012,540398 (2012)Google Scholar
  6. 6.
    Katznelson L, Laws ER Jr, Melmed S, Molitch ME, Murad MH, Utz A et al (2014) Acromegaly: an endocrine society clinical practice guideline. J Clin Endocrinol Metab 99:3933–3951CrossRefGoogle Scholar
  7. 7.
    Giustina A, Arnaldi G, Bogazzi F, Cannavo S, Colao A, De ML et al (2017) Pegvisomant in acromegaly: an update. J Endocrinol Invest 40:577–589CrossRefGoogle Scholar
  8. 8.
    van der Lely AJ, Hutson RK, Trainer PJ, Besser GM, Barkan AL, Katznelson L et al (2001) Long-term treatment of acromegaly with pegvisomant, a growth hormone receptor antagonist. Lancet 358:1754–1759CrossRefGoogle Scholar
  9. 9.
    Trainer PJ, Drake WM, Katznelson L, Freda PU, Herman-Bonert V, van der Lely AJ et al (2000) Treatment of acromegaly with the growth hormone-receptor antagonist pegvisomant. N Engl J Med 342:1171–1177CrossRefGoogle Scholar
  10. 10.
    van der Lely AJ, Biller BM, Brue T, Buchfelder M, Ghigo E, Gomez R et al (2012) Long-term safety of pegvisomant in patients with acromegaly: comprehensive review of 1288 subjects in ACROSTUDY. J Clin Endocrinol Metab 97:1589–1597CrossRefGoogle Scholar
  11. 11.
    Bernabeu I, Pico A, Venegas E, Aller J, Alvarez-Escola C, Garcia-Arnes JA et al (2016) Safety of long-term treatment with Pegvisomant: analysis of Spanish patients included in global ACROSTUDY. Pituitary 19:127–137CrossRefGoogle Scholar
  12. 12.
    Schofl C, Grussendorf M, Honegger J, Tonjes A, Thyroke-Gronostay D, Mayr B et al (2015) Failure to achieve disease control in acromegaly: cause analysis by a registry-based survey. Eur J Endocrinol 172:351–356CrossRefGoogle Scholar
  13. 13.
    Dunbar-Jacob J, Mortimer-Stephens MK (2001) Treatment adherence in chronic disease. J Clin Epidemiol 54(Suppl 1,S):57–60CrossRefGoogle Scholar
  14. 14.
    Simpson SH, Eurich DT, Majumdar SR, Padwal RS, Tsuyuki RT, Varney J et al (2006) A meta-analysis of the association between adherence to drug therapy and mortality. BMJ 333:15CrossRefGoogle Scholar
  15. 15.
    WHO (2003) Adherence to long-term therapies: evidence for action. World Health Organization, Geneva.
  16. 16.
    Joosten EA, DeFuentes-Merillas L, de Weert GH, Sensky T, van der Staak CP, de Jong CA (2008) Systematic review of the effects of shared decision-making on patient satisfaction, treatment adherence and health status. Psychother Psychosom 77:219–226CrossRefGoogle Scholar
  17. 17.
    Saarti S, Hajj A, Karam L, Jabbour H, Sarkis A, El ON et al (2016) Association between adherence, treatment satisfaction and illness perception in hypertensive patients. J Hum Hypertens 30:341–345CrossRefGoogle Scholar
  18. 18.
    Witek P, Mucha S, Ruchala M (2016) Patient satisfaction and preferences of lanreotide Autogel treatment in acromegaly. Endokrynol Pol 67:572–579CrossRefGoogle Scholar
  19. 19.
    Brody DS, Miller SM, Lerman CE, Smith DG, Caputo GC (1989) Patient perception of involvement in medical care: relationship to illness attitudes and outcomes. J Gen Intern Med 4:506–511CrossRefGoogle Scholar
  20. 20.
    Kepicoglu H, Hatipoglu E, Bulut I, Darici E, Hizli N, Kadioglu P (2014) Impact of treatment satisfaction on quality of life of patients with acromegaly. Pituitary 17:557–563CrossRefGoogle Scholar
  21. 21.
    Batalla A, Blanquer R, Ciurana M, García M, Jordi E, Pérez A (1984) Cumplimiento de la prescripción farmacológica en pacientes hipertensos. Aten Primaria 1:185–191Google Scholar
  22. 22.
    Barnestein-Fonseca P, Leiva-Fernandez J, Vidal-Espana F, Garcia-Ruiz A, Prados-Torres D, Leiva-Fernandez F (2011) Is it possible to diagnose the therapeutic adherence of patients with COPD in clinical practice? A cohort study. BMC Pulm Med 11:6CrossRefGoogle Scholar
  23. 23.
    Haynes RB, Taylor DW, Sackett DL, Gibson ES, Bernholz CD, Mukherjee J. Can simple clinical measurements detect patient noncompliance? Hypertension. 2,757–764 (1980)CrossRefGoogle Scholar
  24. 24.
    Ruiz MA, Pardo A, Rejas J, Soto J, Villasante F, Aranguren JL (2008) Development and validation of the “Treatment Satisfaction with Medicines Questionnaire” (SATMED-Q). Value Health 11:913–926CrossRefGoogle Scholar
  25. 25.
    Haynes RB, Taylor DL, Sackett D (1979) Compliance in Health Care. John Hopkins University Press, BaltimoreGoogle Scholar
  26. 26.
    Pineiro F, Gil V, Donis M, Orozco D, Pastor R, Merino J (1997) The validity of 6 indirect methods for assessing drug treatment compliance in arterial hypertension. Aten Primaria 19(372-4):376Google Scholar
  27. 27.
    Nazir SU, Hassali MA, Saleem F, Bashir S, Aljadhey H (2016) Association between diabetes-related knowledge and medication adherence: results from cross-sectional analysis. Altern Ther Health Med 22:8–13Google Scholar
  28. 28.
    Slabaugh SL, Bouchard JR, Li Y, Baltz JC, Meah YA, Moretz DC (2015) Characteristics relating to adherence and persistence to basal insulin regimens among elderly insulin-naive patients with type 2 diabetes: pre-filled pens versus vials/syringes. Adv Ther 32:1206–1221CrossRefGoogle Scholar
  29. 29.
    Freda PU, Gordon MB, Kelepouris N, Jonsson P, Koltowska-Haggstrom M, van der Lely AJ (2015) Long-term treatment with pegvisomant as monotherapy in patients with acromegaly: experience from ACROSTUDY. Endocr Pract 21:264–274CrossRefGoogle Scholar
  30. 30.
    McDowell SE, Mt-Isa S, Ashby D, Ferner RE (2010) Where errors occur in the preparation and administration of intravenous medicines: a systematic review and Bayesian analysis. Qual Saf Health Care 19:341–345CrossRefGoogle Scholar
  31. 31.
    Ramos-Levi AM, Bernabeu I, Alvarez-Escola C, Aller J, Lucas T de (2016) MP et al. Long-term treatment with pegvisomant for acromegaly: a 10-year experience. Clin Endocrinol (Oxf) 84:540–550CrossRefGoogle Scholar
  32. 32.
    Strasburger CJ, Karavitaki N, Stormann S, Trainer PJ, Kreitschmann-Andermahr I, Droste M et al (2016) Patient-reported outcomes of parenteral somatostatin analogue injections in 195 patients with acromegaly. Eur J Endocrinol 174:355–362CrossRefGoogle Scholar

Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature 2019

Authors and Affiliations

  1. 1.Hospital Universitario y Politécnico La FeValenciaSpain
  2. 2.Hospital Universitario Virgen del RocíoSevillaSpain
  3. 3.Hospital Regional Universitario Carlos HayaMálagaSpain
  4. 4.Complejo Hospitalario Universitario A CoruñaLa CoruñaSpain
  5. 5.Hospital Universitario Puerta de Hierro-MajadahondaMajadahonda, MadridSpain
  6. 6.TFS Statistical ServicesAlcobendas, MadridSpain
  7. 7.Pfizer S.L.UAlcobendas, MadridSpain

Personalised recommendations