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Lookup NU author(s): Dr Nicholas Linker, David Birnie, Dr Colette Seifer
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© 2021 American College of PhysiciansBackground: Recurrent vasovagal syncope is common, responds poorly to treatment, and causes physical trauma and poor quality of life. Midodrine prevents hypotension and syncope during tilt tests in patients with vasovagal syncope. Objective: To determine whether midodrine can prevent vasovagal syncope in usual clinical conditions. Design: Randomized, double-blind, placebo-controlled clinical trial. (ClinicalTrials.gov: NCT01456481) Setting: 25 university hospitals in Canada, the United States, Mexico, and the United Kingdom. Patients: Patients with recurrent vasovagal syncope and no serious comorbid conditions. Intervention: Patients were randomly assigned 1:1 to placebo or midodrine and followed for 12 months. Measurements: The primary outcome measure was the proportion of patients with at least 1 syncope episode during follow-up. Results: The study included 133 patients who had had a median of 6 syncope episodes in the prior year (median age, 32 years; 73% female). Compared with patients receiving placebo, fewer patients receiving midodrine had at least 1 syncope episode (28 of 66 [42%] vs. 41 of 67 [61%]). The relative risk was 0.69 (95% CI, 0.49 to 0.97; P = 0.035). The absolute risk reduction was 19 percentage points (CI, 2 to 36 percentage points), and the number needed to treat to prevent 1 patient from having syncope was 5.3 (CI, 2.8 to 47.6). The time to first syncope was longer with midodrine (hazard ratio, 0.59 [CI, 0.37 to 0.96]; P = 0.035; log-rank P = 0.031). Adverse effects were similar in both groups. Limitation: Small study size, young and healthy patients, relatively short observation period, and high proportion of patients from 1 center. Conclusion: Midodrine can reduce the recurrence of syncope in healthy, younger patients with a high syncope burden.
Author(s): Sheldon R, Faris P, Tang A, Ayala-Paredes F, Guzman J, Marquez M, Morillo CA, Krahn AD, Kus T, Ritchie D, Safdar S, Maxey C, Raj SR, McCrae M, Eronmwon C, Jean C, Chinchilla R, Frechette A, Ruiz-Siller T, Luna-Limon G, del Rivero-Morfin P, Reyes-Quintero A, Fernandez-Gonzalez L, Leather R, Parfett D, Patterson C, Langlois A, Black B, Benditt D, Dicken J, Talajic M, Billo MJ, Parkash R, Fearon A, Giddens K, Linker N, Atkinson B, Dayer M, Mills H, Lim B, Elliot R, Rao A, Stover T, Nault I, Robinson J, Ottinger B, Bessoudo R, O'Blenis G, Birnie D, MacDonald K, Nyman L, Shillington M, Seifer C, Fromm R, Sultan O, Kelly S, Williams R, Martin S, Gall N, Martin K, Williams R, Sandhu R, Stewart J, Terilli C, Parry S, McAlinden P, Hayat S, Padwick A, Ansell V, Rose SM, Medina E
Publication type: Article
Publication status: Published
Journal: Annals of Internal Medicine
Year: 2021
Volume: 174
Issue: 10
Pages: 1349-1356
Print publication date: 01/10/2021
Online publication date: 03/08/2021
Acceptance date: 02/04/2020
ISSN (print): 0003-4819
ISSN (electronic): 1539-3704
Publisher: American College of Physicians
URL: https://doi.org/10.7326/M20-5415
DOI: 10.7326/M20-5415
PubMed id: 34339231
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