亲爱的研友该休息了!由于当前在线用户较少,发布求助请尽量完整地填写文献信息,科研通机器人24小时在线,伴您度过漫漫科研夜!身体可是革命的本钱,早点休息,好梦!

Statins for Graves' orbitopathy (STAGO): a phase 2, open-label, adaptive, single centre, randomised clinical trial

医学 阿托伐他汀 养生 临床终点 血脂异常 人口 复视 内科学 外科 随机对照试验 Graves眼病 格雷夫斯病 疾病 环境卫生
作者
Giulia Lanzolla,Elena Sabini,Marenza Leo,Francesca Menconi,Roberto Rocchi,Angela Tindara Sframeli,Paolo Piaggi,Marco Nardi,Claudio Marcocci,Michele Marinò
出处
期刊:The Lancet Diabetes & Endocrinology [Elsevier BV]
卷期号:9 (11): 733-742 被引量:54
标识
DOI:10.1016/s2213-8587(21)00238-2
摘要

Background A protective action of statins on development of Graves' orbitopathy suggests that statins might be used for treatment of the disease. We aimed to assess the efficacy of the addition of a statin, atorvastatin, to intravenous glucocorticoids (ivGCs) on Graves' orbitopathy outcomes in patients with hypercholesterolaemia. Methods We did a randomised, open-label, phase 2, adaptive, clinical trial at a single, tertiary, referral hospital in Pisa, Italy. Patients with moderate-to-severe, active Graves' orbitopathy, with a low-density lipoprotein cholesterol concentration between 2·97 and 4·88 mmol/L were eligible for inclusion. Patients were randomly assigned (1:1) in 11 blocks of eight, using a computer-based system, to the ST group or the NST group. The ST group received ivGCs (methylprednisolone 500 mg once a week for 6 weeks followed by 250 mg once a week for an additional six weeks) for 12 weeks and oral atorvastatin (20 mg once a day) for 24 weeks. The NST group only received the ivGC regimen. Patients were unmasked to group allocation; however, the ophthalmological investigator was masked to randomisation. The primary endpoint was the Graves' orbitopathy outcome (composite evaluation of exophthalmos, clinical activity score, eyelid aperture, and diplopia) at 24 weeks in the modified intention-to-treat (ITT) population (patients who attended the week 12 visit). Patients were considered responders when at least two of the following criteria were fulfilled in the most affected eye, without worsening in any of the same measures in both eyes: (1) reduction in exophthalmos of 2 mm or more, with no increase by 2 mm or more in the other eye; (2) reduction of clinical activity score by two or more points; (3) reduction in eyelid aperture by 2 mm or more, with no increase by 2 mm or more in the other eye; and (4) disappearance or improvement (change from constant to inconstant, intermittent, or absent, or from inconstant to intermittent or absent) of diplopia, and (5) improvement in visual acuity by 0·2 decimals or more. The trial is registered with EUDRACT, 2018-001317-33, and ClinicalTrials.gov, NCT03110848. Findings Between June 1, 2020, and Nov 30, 2020, 119 patients were screened for inclusion, of whom 88 (74%) patients were enrolled and randomly assigned to one of the two treatment groups (44 [50%] to the ST group and 44 [50%] to the NST group). Eight (9%) patients did not attend the 12 week visit; 80 (91%) patients (18 [23%] men and 62 [78%] women) were included in the modified ITT population (41 [51%] in the ST group and 39 [49%] in the NST group]. The proportion of Graves' orbitopathy composite evaluation responders at 24 weeks was higher in the ST group (21 [51%] of 41 patients) than the NST group (11 [28%] of 39 patients; attributable risk 0·23 [95% CI 0·02–0·44]; p=0·042). 26 adverse events occurred in 21 (24%) of 88 patients in the safety population. One (2%) of 44 patients in each group required treatment discontinuation, with no serious adverse events and no difference between groups. Interpretation Addition of oral atorvastatin to an ivGC regimen improved Graves' orbitopathy outcomes in patients with moderate-to-severe, active eye disease who were hypercholesterolaemic. Future phase 3 studies, which could potentially recruit patients regardless of low-density lipoprotein cholesterol concentration, are required to confirm this association. Funding Associazione Allievi Endocrinologia Pisana.
最长约 10秒,即可获得该文献文件

科研通智能强力驱动
Strongly Powered by AbleSci AI
更新
PDF的下载单位、IP信息已删除 (2025-6-4)

科研通是完全免费的文献互助平台,具备全网最快的应助速度,最高的求助完成率。 对每一个文献求助,科研通都将尽心尽力,给求助人一个满意的交代。
实时播报
4秒前
6秒前
shinian完成签到,获得积分10
7秒前
shinian发布了新的文献求助10
11秒前
13秒前
15秒前
哈尔滨发布了新的文献求助10
17秒前
背后梦安发布了新的文献求助10
20秒前
量子星尘发布了新的文献求助10
22秒前
32秒前
zhen完成签到,获得积分10
1分钟前
哈尔滨完成签到,获得积分20
1分钟前
1分钟前
米奇妙妙屋完成签到,获得积分10
1分钟前
tylscxf完成签到,获得积分10
1分钟前
YifanWang完成签到,获得积分0
1分钟前
量子星尘发布了新的文献求助30
1分钟前
2分钟前
启震发布了新的文献求助10
2分钟前
2分钟前
2分钟前
2分钟前
2分钟前
www完成签到,获得积分20
3分钟前
3分钟前
风车术完成签到,获得积分20
3分钟前
3分钟前
风车术发布了新的文献求助10
3分钟前
shinian发布了新的文献求助10
3分钟前
3分钟前
小岩完成签到 ,获得积分10
3分钟前
wanci应助风车术采纳,获得10
3分钟前
3分钟前
为神指路发布了新的文献求助30
3分钟前
3分钟前
3分钟前
为神指路完成签到,获得积分20
3分钟前
3分钟前
3分钟前
33完成签到,获得积分0
3分钟前
高分求助中
A new approach to the extrapolation of accelerated life test data 1000
Picture Books with Same-sex Parented Families: Unintentional Censorship 700
ACSM’s Guidelines for Exercise Testing and Prescription, 12th edition 500
Nucleophilic substitution in azasydnone-modified dinitroanisoles 500
不知道标题是什么 500
Indomethacinのヒトにおける経皮吸収 400
Phylogenetic study of the order Polydesmida (Myriapoda: Diplopoda) 370
热门求助领域 (近24小时)
化学 材料科学 医学 生物 工程类 有机化学 生物化学 物理 内科学 纳米技术 计算机科学 化学工程 复合材料 遗传学 基因 物理化学 催化作用 冶金 细胞生物学 免疫学
热门帖子
关注 科研通微信公众号,转发送积分 3976649
求助须知:如何正确求助?哪些是违规求助? 3520756
关于积分的说明 11204729
捐赠科研通 3257502
什么是DOI,文献DOI怎么找? 1798733
邀请新用户注册赠送积分活动 877897
科研通“疑难数据库(出版商)”最低求助积分说明 806629