BACKGROUND AND AIM: Several trials have proved the efficacy of intravenous (IV) steroids in Graves' orbitopathy (GO). However, the impact of administered dose and therapy schedule has not been assessed yet. SUBJECTS AND METHODS: Nine randomized and 14 non-randomized controlled trials of IV steroids in GO were evaluated according to the applied single and cumulative doses with respect to outcome, efficacy on clinically relevant issues and adverse events. RESULTS: High single (1 g per day) and cumulative (>6 g) doses of IV steroids are superior to lower single (0.5 g/d) and cumulative (<5 g) doses with respect to therapy response (84 vs 75%; p=0.034 and 83 vs 77%; ns, respectively), improvement of eye symptoms (87 vs 75%, p=0.052 and 85 vs 71%; ns, respectively) and disappearance of diplopia (32 vs 27%; ns and 48 vs 27%; p=0.08, respectively). Decrease of both clinical activity score (3 vs 2.5 points and 2.5 vs 3, ns) as well as proptosis (-1.4 vs -1.2 mm, ns and 1.5 vs 1.2, ns) are similar in both groups. However, high single and/or cumulative doses are accompanied with a 2-fold higher rate of adverse events (56 vs 28%; p<0.001 and 52 vs 33%; p=0.034, respectively). CONCLUSIONS: Tailoring the IV steroid dose to severity of GO can be concluded and implies that a prospective randomized trial comparing different doses of IV steroids in active/severe GO is keenly warranted.
RCT Entities:
BACKGROUND AND AIM: Several trials have proved the efficacy of intravenous (IV) steroids in Graves' orbitopathy (GO). However, the impact of administered dose and therapy schedule has not been assessed yet. SUBJECTS AND METHODS: Nine randomized and 14 non-randomized controlled trials of IV steroids in GO were evaluated according to the applied single and cumulative doses with respect to outcome, efficacy on clinically relevant issues and adverse events. RESULTS: High single (1 g per day) and cumulative (>6 g) doses of IV steroids are superior to lower single (0.5 g/d) and cumulative (<5 g) doses with respect to therapy response (84 vs 75%; p=0.034 and 83 vs 77%; ns, respectively), improvement of eye symptoms (87 vs 75%, p=0.052 and 85 vs 71%; ns, respectively) and disappearance of diplopia (32 vs 27%; ns and 48 vs 27%; p=0.08, respectively). Decrease of both clinical activity score (3 vs 2.5 points and 2.5 vs 3, ns) as well as proptosis (-1.4 vs -1.2 mm, ns and 1.5 vs 1.2, ns) are similar in both groups. However, high single and/or cumulative doses are accompanied with a 2-fold higher rate of adverse events (56 vs 28%; p<0.001 and 52 vs 33%; p=0.034, respectively). CONCLUSIONS: Tailoring the IV steroid dose to severity of GO can be concluded and implies that a prospective randomized trial comparing different doses of IV steroids in active/severe GO is keenly warranted.
Authors: Y Nagayama; M Izumi; T Kiriyama; N Yokoyama; S Morita; F Kakezono; S Ohtakara; I Morimoto; S Okamoto; S Nagataki Journal: Acta Endocrinol (Copenh) Date: 1987-12
Authors: C Marcocci; L Bartalena; M L Tanda; L Manetti; E Dell'Unto; R Rocchi; G Barbesino; B Mazzi; M P Bartolomei; P Lepri; F Cartei; M Nardi; A Pinchera Journal: J Clin Endocrinol Metab Date: 2001-08 Impact factor: 5.958
Authors: L Bartalena; G Veronesi; G E Krassas; W M Wiersinga; C Marcocci; M Marinò; M Salvi; C Daumerie; C Bournaud; M Stahl; L Sassi; C Azzolini; K G Boboridis; M P Mourits; M R Soeters; L Baldeschi; M Nardi; N Currò; A Boschi; M Bernard; G von Arx; P Perros; G J Kahaly Journal: J Endocrinol Invest Date: 2017-02-07 Impact factor: 4.256