A phase 2 trial investigating the effects of the angiotensin II type 2 receptor agonist C21 in systemic sclerosis-related Raynaud’s
| العنوان: | A phase 2 trial investigating the effects of the angiotensin II type 2 receptor agonist C21 in systemic sclerosis-related Raynaud’s |
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| المؤلفون: | Ariane L Herrick, Rohit Batta, Kamilla Overbeck, Johan Raud, Joanne Manning, Andrea Murray, Graham Dinsdale, Göran Tornling |
| المصدر: | Rheumatology. 62:824-828 |
| بيانات النشر: | Oxford University Press (OUP), 2022. |
| سنة النشر: | 2022 |
| مصطلحات موضوعية: | Rheumatology, Pharmacology (medical) |
| الوصف: | Objective Our main aim was to investigate the effect of a single oral dose of C21, a selective angiotensin II type 2 receptor agonist, on cold-induced vasoconstriction in SSc-related RP. Methods This was a phase IIa, randomized, double-blind, cross-over, single-dose, placebo-controlled, single-centre study. Twelve female patients with SSc (median age 58.5 years, median duration of RP 19.0 years) attended on four occasions: screening, treatment visits 1 and 2 (separated by 3–7 days) and follow-up. At the first treatment visit, patients were randomized to receive either a single oral dose of C21 (200 mg) or placebo, then the opposite treatment on the second visit. Forty min after each treatment, each patient underwent a standard hand cold challenge. The primary end point was the area under the curve (AUC) for rewarming for each finger (eight fingers) over 15 min. Secondary end points included the maximum finger temperature after rewarming (MAX). Statistical analyses were performed by multiplicative ANCOVA models. Results For all eight fingers combined, mean AUC for rewarming was higher after treatment with C21 than after placebo (geometric mean 20 046°C*s vs 19 558°C*s), but not significantly (P = 0.380) and MAX (at 15 min) was also higher (geometric mean 23.5°C vs 22.5°C; P = 0.036). C21 was well tolerated. Conclusion Despite the small trial size, a signal emerged suggesting that even in patients with established SSc, C21 may confer benefit for RP and deserves further investigation. Trial registration ClinicalTrials.gov, https://clinicaltrials.gov, NCT04388176. |
| تدمد: | 1462-0332 1462-0324 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::833fa8fb4104460318d5d31efccd186f https://doi.org/10.1093/rheumatology/keac426 |
| حقوق: | OPEN |
| رقم الأكسشن: | edsair.doi.dedup.....833fa8fb4104460318d5d31efccd186f |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 14620332 14620324 |
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