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

• Type of Material: Article
• Authors: Whitney W. Woodmansee, University of Florida; Murray B. Gordon, Allegheny General Hospital; Mark E. Molitch, Northwestern University; Adriana Ioachimescu, Emory University; Don W. Carver, Ipsen Biopharmaceuticals, Inc.; Beloo Mirakhur, Ipsen Biopharmaceuticals, Inc.; David Cox, Ipsen Biopharmaceuticals, Inc.; Roberto Salvatori, Johns Hopkins University
• Language: English
• Date: 2018-07-01
• Publisher: Humana Press
• Publication Version: Final Published Version
• Copyright Statement: © The Author(s) 2018
• License: Creative Commons Attribution 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.1007/s12020-018-1615-3
• Title of Journal or Parent Work: Endocrine
• ISSN: 1355-008X
• Volume: 61
• Issue: 1
• Start Page: 105
• End Page: 117
• Grant/Funding Information: 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; BIOCHEMICAL CONTROL; ACROMEGALY REGISTRY; SLEEP-APNEA; SOMATOSTATIN ANALOGS; Observational Study; Comorbidities; RISK-FACTORS; CLINICAL-PRACTICE; COLORECTAL-CANCER; GROWTH-HORMONE; Endocrinology & Metabolism; UNITED-STATES; AUTOGEL 120 MG; Lanreotide Depot/Autogel; Acromegaly; Extended-Release; Registry
• Research Categories: Health Sciences, Medicine and Surgery; Health Sciences, General

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.