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Author Notes:

Whitney W. Woodmansee whitney.woodmansee@medicine.ufl.edu

All authors contributed equally and each was involved in study design, data acquisition, or data analysis/interpretation and in drafting or critically revising the manuscript.

All authors reviewed the final manuscript and gave approval for submission.

The authors would like to thank the patients and investigators of each participating center in this study.

The authors also thank Olga V. Gambetti, MD, PhD, formerly of Ipsen Biopharmaceuticals, Inc, for her assistance with this study and Kathleen Allen, study manager.

This manuscript was prepared according to the International Society for Medical Publication Professionals’ ‘Good Publication Practice for Communicating Company-Sponsored Medical Research: The GPP3 Guidelines.’

WWW: Clinical trial investigator: Ipsen, Versartis; Advisor/consultant: Ipsen. MBG: Research support: Chiasma, Corcept, Ipsen, Novartis, Novo Nordisk, Pfizer, OPKO, Strongbridge, Teva.

MEM: Research support: Bayer, Ipsen, Johnson & Johnson, Novartis, Novo Nordisk, Prolor; Advisor/consultant: Corcept, Ipsen, Merck, Novartis, Novo Nordisk, Pfizer.

AGI: Research support: Chiasma, Ipsen, Novartis, Pfizer; Advisor/consultant: Chiasma, Ionis, Ipsen, Pfizer.

DWC: Ipsen consultant. BM, DC: Full-time employees: Ipsen Biopharmaceuticals, Inc. RS: Research support: Chiasma, Novartis, Novo Nordisk, Pfizer, Prolor, Strongbridge; Advisor/consultant: Pfizer.

The SODA study was conducted in accordance with the International Conference on Harmonization Good Clinical Practice Guidelines, current Food and Drug Administration regulations and guidelines, local ethical and legal requirements, and the United States Code of Federal Regulations and the Health Insurance Portability and Accountability Act for the collection, transmission, and storage of study data.

All procedures performed involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Signed informed consent was obtained from each patient at study inclusion.

Subjects:

Research Funding:

Sarah Mizne, PharmD, and Michelle Jones, PhD, of MedVal Scientific Information Services, LLC, and Nicole Coolbaugh, BSc, and Philip Sjostedt, BPharm, of The Medicine Group, LLC provided medical writing and editorial assistance, which was funded by Ipsen Biopharmaceuticals, Inc.

This study was funded by Ipsen Biopharmaceuticals, Inc.

Keywords:

  • Science & Technology
  • Life Sciences & Biomedicine
  • Endocrinology & Metabolism
  • Acromegaly
  • Comorbidities
  • Extended-Release
  • Lanreotide Depot/Autogel
  • Observational Study
  • Registry
  • AUTOGEL 120 MG
  • GROWTH-HORMONE
  • UNITED-STATES
  • ACROMEGALY REGISTRY
  • BIOCHEMICAL CONTROL
  • COLORECTAL-CANCER
  • SLEEP-APNEA
  • SOMATOSTATIN ANALOGS
  • CLINICAL-PRACTICE
  • RISK-FACTORS

Screening for comorbid conditions in patients enrolled in the SODA registry: a 2-year observational analysis

Tools:

Journal Title:

Endocrine

Volume:

Volume 61, Number 1

Publisher:

, Pages 105-117

Type of Work:

Article | Final Publisher PDF

Abstract:

Purpose: This 2-year analysis assessed frequency of comorbidities and comorbidity screening in the Somatuline®(lanreotide, LAN) Depot for Acromegaly (SODA) registry. Methods: Patient data collected included pituitary hormone deficiencies, sleep studies, echocardiograms, gallbladder sonographies, colonoscopies, and glycated hemoglobin (HbA1c) levels. Insulin-like growth factor-1 (IGF-1) and growth hormone levels in patients with (DM) and without (non-DM) diabetes mellitus were analyzed. Results: There were 241 patients enrolled. Pituitary hormone deficiencies were reported more frequently at enrollment in male (56.9%) vs female patients (32.0%; p < 0.001). TSH deficiency was the most common endocrine deficiency (69.8%), followed by gonadotropin deficiency (62.3%). Screening tests reported at enrollment: sleep studies in 29.9% (79.2% had sleep apnea), echocardiogram in 46.1% (46.8% abnormal), gallbladder sonography in 18.7% (17.8% had gallstones), and colonoscopy in 48.1% (35.3% had polyps). Follow-up studies were reported less frequently at 1 and 2 years. HbA1c data were reported in 30.8% and 41.2% after 1 and 2 years. HbA1c levels were similar at 1 and 2 years of LAN therapy among DM and non-DM patients with available data. Fewer DM vs non-DM patients achieved IGF-1 below upper limit of normal at Month 24 (58.3% vs 80.6%; p = 0.033). Conclusions: Fewer than half of patients in SODA had screening results reported at enrollment for sleep apnea, cardiomyopathy, and colon polyps. Gallbladder imaging was reported in a minority of patients. Lower IGF-1 control rates were observed in DM vs non-DM patients at Month 24. These data suggest a need for better monitoring of comorbidities in US acromegaly patients.

Copyright information:

© The Author(s) 2018

This is an Open Access work distributed under the terms of the Creative Commons Attribution 4.0 International License (https://creativecommons.org/licenses/by/4.0/).
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