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.
Introduction: Statins have shown protective effects on Graves' orbital lesions in previous studies, and it is speculated that they may have therapeutic effects
.
For this reason, researchers designed this study to evaluate the efficacy of adding statin atorvastatin to intravenous glucocorticoids (ivGCs) on Graves orbital lesions in patients with hypercholesterolemia
.
This is a randomized, open, phase 2, adaptive clinical trial conducted at a tertiary referral hospital in Pisa, Italy
.
Patients with moderate to severe active Graves' ophthalmopathy with a low-density lipoprotein cholesterol concentration of 2.
97-4.
88 mmol/L were included
.
After screening, 88 participants were randomly assigned to the ST group and the NST group according to 1:1: ➤ST group: Give intravenous glucocorticoid therapy (methylprednisolone 500mg, once a week for 6 weeks, followed by 250mg, Once a week for 6 consecutive weeks), a total of 12 weeks
.
At the same time, continued oral atorvastatin treatment (20 mg, once a day) for 24 weeks; ➤NST group: only received the ivGC regimen
.
The primary endpoint of the study was the outcome of Graves ophthalmopathy in the two groups at 24 weeks of treatment (comprehensive evaluation of protrusion, clinical activity score, eyelid hole and diplopia)
.
When the patient meets at least the following two criteria in one of the most severely affected eyes, and none of the indicators in both eyes deteriorates, the patient is considered to be a responder: (1) Reduction of exophthalmos ≥ 2mm , The other eye increased by ≤ 2 mm; (2) the clinical activity score decreased by ≥ 2 points; (3) the eyelid aperture was reduced by ≥ 2 mm, and the other eye increased by ≤ 2 mm; (4) diplopia was restored or improved; (5) ) Improved visual acuity ≥0.
2
.
The results showed that the proportion of responders to Graves' comprehensive assessment of eye disease at 24 weeks was significantly higher in the ST group (51%, 21/41) than in the NST group (28%, 11/39), p=0.
042
.
This study shows that the addition of oral atorvastatin to the ivGC regimen can improve the outcome of Graves ophthalmopathy in patients with moderate to severe active eye disease with hypercholesterolemia
.
The researchers said that in the future, when recruiting subjects for the Phase 3 study, it will consider no longer setting limits on the concentration of low-density lipoprotein cholesterol in order to confirm the correlation between drug-effects
.
Source: Lanzolla G, Sabini E, Leo M, et al.
Statins for Graves' orbitopathy(STAGO): a phase 2, open-label, adaptive, single centre, randomised clinical trial.
The lancet.
Diabetes & endocrinology.
2021 Sep 27.
DOI: 10.
1016/S2213-8587(21)00238-2.
.
Introduction: Statins have shown protective effects on Graves' orbital lesions in previous studies, and it is speculated that they may have therapeutic effects
.
For this reason, researchers designed this study to evaluate the efficacy of adding statin atorvastatin to intravenous glucocorticoids (ivGCs) on Graves orbital lesions in patients with hypercholesterolemia
.
This is a randomized, open, phase 2, adaptive clinical trial conducted at a tertiary referral hospital in Pisa, Italy
.
Patients with moderate to severe active Graves' ophthalmopathy with a low-density lipoprotein cholesterol concentration of 2.
97-4.
88 mmol/L were included
.
After screening, 88 participants were randomly assigned to the ST group and the NST group according to 1:1: ➤ST group: Give intravenous glucocorticoid therapy (methylprednisolone 500mg, once a week for 6 weeks, followed by 250mg, Once a week for 6 consecutive weeks), a total of 12 weeks
.
At the same time, continued oral atorvastatin treatment (20 mg, once a day) for 24 weeks; ➤NST group: only received the ivGC regimen
.
The primary endpoint of the study was the outcome of Graves ophthalmopathy in the two groups at 24 weeks of treatment (comprehensive evaluation of protrusion, clinical activity score, eyelid hole and diplopia)
.
When the patient meets at least the following two criteria in one of the most severely affected eyes, and none of the indicators in both eyes deteriorates, the patient is considered to be a responder: (1) Reduction of exophthalmos ≥ 2mm , The other eye increased by ≤ 2 mm; (2) the clinical activity score decreased by ≥ 2 points; (3) the eyelid aperture was reduced by ≥ 2 mm, and the other eye increased by ≤ 2 mm; (4) diplopia was restored or improved; (5) ) Improved visual acuity ≥0.
2
.
The results showed that the proportion of responders to Graves' comprehensive assessment of eye disease at 24 weeks was significantly higher in the ST group (51%, 21/41) than in the NST group (28%, 11/39), p=0.
042
.
This study shows that the addition of oral atorvastatin to the ivGC regimen can improve the outcome of Graves ophthalmopathy in patients with moderate to severe active eye disease with hypercholesterolemia
.
The researchers said that in the future, when recruiting subjects for the Phase 3 study, it will consider no longer setting limits on the concentration of low-density lipoprotein cholesterol in order to confirm the correlation between drug-effects
.
Source: Lanzolla G, Sabini E, Leo M, et al.
Statins for Graves' orbitopathy(STAGO): a phase 2, open-label, adaptive, single centre, randomised clinical trial.
The lancet.
Diabetes & endocrinology.
2021 Sep 27.
DOI: 10.
1016/S2213-8587(21)00238-2.
