Trusted Resources: Evidence & Education
Scientific literature and patient education texts
Prospective, Systematically Recorded Mycophenolate Safety Data in Graves’ Orbitopathy
source: Journal of Endocrinological Investigation
year: 2016
authors: Riedl M, Kuhn A, Krämer I, Kolbe E, Kahaly GJ
summary/abstract:Context:
The antiproliferative mechanism of mycophenolate acid (MPA) suggests a beneficial effect in patients with Graves’ orbitopathy (GO).
Objective:
To systematically analyze for the first time adverse events (AEs) during MPA treatment in GO.
Design:
Prospective longitudinal study.
Setting:
Academic tertiary referral center with a joint thyroid-eye clinic.
Patients:
Fifty-three consecutive, unselected patients with clinically active and moderate-to-severe GO.
Methods:
MPA 0.720 g was given once daily for 24-weeks in GO patients. AEs were documented and coded according to the standardized medical dictionary for regulatory activities (MedDRA). AE were followed up and seriousness as defined by ICH-guideline E6 was documented. All AEs were analyzed regarding a possible underlying cause and if not, graded as side effect (SE).
Results:
Fifty GO patients (93 %) had Graves’ disease, 37 (70 %) and 29 (54.7 %) were female and smoker, respectively. Thirty-six patients (68 %) reported at least one AE. A total of 88 AEs were documented, most frequent AEs were insomnia (N = 6), fatigue (N = 5) and optic neuropathy (N = 5), while other AEs occurred in up to three patients (5.6 %), only. In 12 (23 %) patients, at least one SE occurred. All 17 reported SE, i.e. mild infections and gastrointestinal intolerance were within the known safety profile of MPA. No patient dropped MPA medication because of drug-induced SE. Most AEs showed a recovered (76 %) or recovering (16 %) outcome. Seven (13 %) patients were hospitalized, five (62 %) due to optic neuropathy, none of these events was graded as SE.
Conclusions:
MedDRA-coded data documented the good tolerance of a moderate MPA dose in GO patients.
DOI: 10.1007/s40618-016-0441-9
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