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Safety and effectiveness of Omnitrope® in patients with growth hormone deficiency: snapshot analysis of PATRO Adults study in the Italian population

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Abstract

Purpose

PATRO adults is an ongoing, multicenter, observational, post-marketing surveillance study aimed at investigating the long-term safety (primary endpoint) and effectiveness (secondary endpoint) of the recombinant human growth hormone (rhGH) Omnitrope® during routine clinical practice. This report describes data from Italian participants in PATRO Adults with growth hormone deficiency (GHD), up to August 2017.

Methods

Participants were adults (aged > 18 years) with GHD requiring rhGH therapy and were prescribed Omnitrope®, including those who had previously received another rhGH product. Adverse events (AEs) were evaluated in all study participants. Data were collected on insulin-like growth factor (IGF)-I levels and cardiovascular risk factors, including blood pressure, lipids, and anthropometric parameters.

Results

From September 2007 to August 2017, 88 patients (mean age 48.9 years, 58.0% male) were enrolled at 8 sites in Italy. The mean treatment duration with Omnitrope® was 51.5 ± 37 months. AEs occurred in 54 patients; the most common were asthenia (20.5%), headache (14.8%), and arthralgia (13.6%). Serious AEs occurred in 22 patients (25%), including pneumonia (n = 2) and renal failure (n = 2). Neoplasms (2 benign and 1 malignant) developed in three patients, but none were considered to be drug-related. There were no significant changes in fasting glucose or glycosylated hemoglobin (HbA1c) during the study period. Long-term Omnitrope® therapy showed slight positive effects on lipid profile, while no significant changes were observed in body weight and BMI during the study.

Conclusion

This snapshot analysis of Italian participants in PATRO Adults confirmed the long-term safety and effectiveness of Omnitrope® in adults with GHD.

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Data availability

The datasets generated/analyzed during the current study are not publicly available due to the fact that the data generated are issued from an ongoing global non-interventional study. Patient enrollment is still performed as per the objectives and the commitment with the European Medical Agency, but the data are available from the corresponding author on reasonable request.

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Acknowledgements

The authors would like to thank all investigators and patients involved in this study, plus Nishad Parkar, PhD, of Springer Healthcare Communications, who wrote the outline of the manuscript and Luca Giacomelli, PhD, who wrote the first draft of the manuscript on behalf of Springer Healthcare Communications. This medical writing assistance was funded by Sandoz, Italy.

Funding

The PATRO global study was funded by Sandoz GmbH.

Author information

Authors and Affiliations

  1. Department of Medical Sciences and Community Health, University of Milan, Milan, Italy

    M. Arosio & C. Giavoli

  2. Unit of Endocrinology, Fondazione IRCCS Ca’ Granda, Ospedale Maggiore Policlinico, pad. Zonda via F. Sforza 35, 20123, Milan, Italy

    M. Arosio & C. Giavoli

  3. Division of Endocrinology, Ospedali Riuniti Di Ancona, Ancona, Italy

    G. Arnaldi

  4. Division of Endocrinology, Diabetes and Metabolism, Department of Medical Sciences, University of Turin, Turin, Italy

    V. Gasco

  5. Department of Medicine, Section of Endocrinology, Medical School, University of Perugia, Perugia, Italy

    E. Puxeddu

  6. Internal Medicine 3, Department of Medicine-DIMED, University of Padova, Padova, Italy

    R. Vettor

  7. Section of Endocrinology and Internal Medicine, Department of Medical Sciences, S. Anna University Hospital of Ferrara, University of Ferrara, Ferrara, Italy

    M. R. Ambrosio

  8. Sandoz S.P.A., Origgio, MI, Italy

    P. Gallinari & P. Fedeli

  9. Sandoz Biopharmaceutical C/O HEXAL AG, Holzkirchen, Germany

    H. Zouater

  10. Department of Internal Medicine and Medical Specialties (DiMI), Center of Excellence for Biomedical Research (CEBR), IRCCS AOU San Martino-IST, University of Genoa, Genoa, Italy

    D. Ferone

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  1. M. Arosio
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Contributions

CG and MA contributed to the preparation of the manuscript; CG enrolled patients and conducted follow-up; GA, VG, and MRA enrolled patients, conducted follow-up, collected data, and critically revised various manuscript drafts; DF provided critical revision of the manuscript drafts and study coordination; RV enrolled patients, conducted follow-up, collected data, and read the manuscript drafts; PG, HZ, and PF contributed to the drafting of the manuscript, and critically revised the various drafts of the manuscript; EP critically revised the various drafts of the manuscript. All authors read and approved the final manuscript.

Corresponding author

Correspondence to C. Giavoli.

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Conflict of interest

MA, VG, CG, EP, RV, and DF declare that they have no conflicts of interest. GA has received lecture fees from Novartis and Otsuka, and consulting honoraria from HRA Pharma. MRA has received registration fees for scientific meetings from Ipsen, Novartis, Pfizer, and ItaPharma. PG and PF are employees of Sandoz S.p.A, Origgio (MI), Italy. HZ is an employee of Sandoz Biopharmaceutical c/o HEXAL AG, Holzkirchen, Germany.

Ethical approval

The study was approved by each study site’s Independent Ethics Committee or Institutional Review Board before initiation and was conducted in accordance with the Declaration of Helsinki.

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All patients included in the study provided written informed consent at enrolment.

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Arosio, M., Arnaldi, G., Gasco, V. et al. Safety and effectiveness of Omnitrope® in patients with growth hormone deficiency: snapshot analysis of PATRO Adults study in the Italian population. J Endocrinol Invest 44, 327–337 (2021). https://doi.org/10.1007/s40618-020-01308-3

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