PMID- 26886940
OWN - NLM
STAT- MEDLINE
DCOM- 20170420
LR  - 20181113
IS  - 1720-8386 (Electronic)
IS  - 0391-4097 (Linking)
VI  - 39
IP  - 6
DP  - 2016 Jun
TI  - Prospective, systematically recorded mycophenolate safety data in Graves' 
      orbitopathy.
PG  - 687-94
LID - 10.1007/s40618-016-0441-9 [doi]
AB  - 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.
FAU - Riedl, M
AU  - Riedl M
AD  - Departments of Medicine I, Johannes Gutenberg University Medical Center, Mainz, 
      Germany.
AD  - Interdisciplinary Center for Clinical Trials, Johannes Gutenberg University 
      Medical Center, Mainz, Germany.
FAU - Kuhn, A
AU  - Kuhn A
AD  - Interdisciplinary Center for Clinical Trials, Johannes Gutenberg University 
      Medical Center, Mainz, Germany.
FAU - Kramer, I
AU  - Kramer I
AD  - Pharmacy Department, Johannes Gutenberg University Medical Center, Mainz, 
      Germany.
FAU - Kolbe, E
AU  - Kolbe E
AD  - Departments of Medicine I, Johannes Gutenberg University Medical Center, Mainz, 
      Germany.
FAU - Kahaly, G J
AU  - Kahaly GJ
AD  - Departments of Medicine I, Johannes Gutenberg University Medical Center, Mainz, 
      Germany. gkahaly@uni-mainz.de.
LA  - eng
PT  - Journal Article
DEP - 20160217
PL  - Italy
TA  - J Endocrinol Invest
JT  - Journal of endocrinological investigation
JID - 7806594
RN  - 0 (Antibiotics, Antineoplastic)
RN  - HU9DX48N0T (Mycophenolic Acid)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antibiotics, Antineoplastic/*therapeutic use
MH  - Female
MH  - Graves Ophthalmopathy/*drug therapy
MH  - Humans
MH  - Longitudinal Studies
MH  - Male
MH  - Middle Aged
MH  - Mycophenolic Acid/*therapeutic use
MH  - Patient Safety
MH  - Prospective Studies
MH  - Tertiary Care Centers
MH  - Young Adult
OTO - NOTNLM
OT  - Graves' orbitopathy
OT  - ICH guideline
OT  - Medical dictionary for regulatory activities (MedDRA)
OT  - Mycophenolate
OT  - Safety
EDAT- 2016/02/18 06:00
MHDA- 2017/04/21 06:00
CRDT- 2016/02/18 06:00
PHST- 2016/01/25 00:00 [received]
PHST- 2016/02/02 00:00 [accepted]
PHST- 2016/02/18 06:00 [entrez]
PHST- 2016/02/18 06:00 [pubmed]
PHST- 2017/04/21 06:00 [medline]
AID - 10.1007/s40618-016-0441-9 [pii]
AID - 10.1007/s40618-016-0441-9 [doi]
PST - ppublish
SO  - J Endocrinol Invest. 2016 Jun;39(6):687-94. doi: 10.1007/s40618-016-0441-9. Epub 
      2016 Feb 17.