Midodrine for the Prevention of Vasovagal Syncope
Por:
Sheldon R., Faris P., Tang A., Ayala-Paredes F., Guzman J., Marquez M., Morillo C.A., Krahn A.D., Kus T., Ritchie D., Safdar S., Maxey C., Raj S.R., McCrae M., Eronmwon C., Jean C., Chinchilla R., Frechette A., Ruíz-Siller T., Luna-Limón G., del Rivero-Morfin P., Reyes-Quintero A., Fernández-González L., Leather R., Parfett D., Patterson C., Langlois A., Black B., Benditt D., Dicken J., Talajic M., Billo M.J., 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., 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 S.M., Medina E.
Publicada:
1 ene 2021
Resumen:
Background: 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. © 2021 American College of Physicians
Filiaciones:
Libin Cardiovascular Institute, University of Calgary, 3280 Hospital Drive NW, Calgary, AB T2N 4Z6, Canada
The University of Calgary, Calgary, AB, Canada
Department of Community Health Sciences, Faculty of Medicine, University of Calgary, Calgary, AB T2N 2T9, Canada
Department of Medicine, Western University, C6-116, University Hospital, London Health Sciences Centre, 339 Windermere Road, London, ON N6A 5A5, Canada
Victoria Heart Institute, Victoria, BC, Canada
Ottawa Heart Institute, Ottawa, ON, Canada
London Health Sciences Centre, London, ON, Canada
University Hospital of Sherbrooke (CHUS), Sherbrooke, QC J1H 5N4, Canada
University of Sherbrooke, Sherbrooke, QC, Canada
McMaster Clinics, Hamilton General Hospital, 237 Barton Street, Hamilton, ON L6L 2X2, Canada
Hamilton Health Sciences Centre, Hamilton, ON, Canada
Clinical Investigation Department, Instituto Nacional de Cardiología Ignacio Chávez, Juan Badiano 1, Col. Seccion XVI, Mexico City, CP 14080, Mexico
Instituto Nacional de Cardiología Ignacio Chávez, Mexico City, Mexico
69821 Gordon & Leslie Diamond Health Care Centre, 2775 Laurel Street, Room 9117 - 9th Floor, Vancouver, BC V5Z 1M9, Canada
Hôpital du Sacre-Coeur de Montreal, Centre de recherche, HSC, 5400, Boulevard Gouin Ouest, Montreal, QC H4J 1C5, Canada
Sacre Coeur Hospital, Montreal, QC, Canada
Vanderbilt University Medical Center, Nashville, TN, United States
University of Minnesota, Minneapolis, MN, United States
Institute de Cardiologie de Montreal, Montreal, QC, Canada
Queen Elizabeth II Hospital, Halifax, NS, Canada
South Tees Hospitals, South Tees, United Kingdom
Musgrove Park Hospital, Taunton, United Kingdom
Imperial College Healthcare, United Kingdom
Wellmont CVA Heart Institute, Kingsport, TN, United States
Universite Laval, Quebec City, QC, Canada
Horizon Health, Saint John, NB, Canada
St. Boniface General Hospital, Winnipeg, MB, Canada
Regina General Hospital, Regina, SK, Canada
Royal Alexandra Hospital, Edmonton, AB, Canada
King's College Hospital, London, United Kingdom
University of Alberta Hospital, Edmonton, AB, Canada
New York Medical College, New York, NY, United States
Newcastle upon Tyne Hospitals, Newcastle, United Kingdom
University Hospitals Coventry & Warwickshire, Coventry, United Kingdom
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