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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.

Primary Funding Source:

The Canadian Institutes of Health Research.

中文翻译：

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预防血管迷走性晕厥的米多君

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背景：

复发性血管迷走性晕厥很常见，对治疗反应不佳，会导致身体创伤和生活质量差。米多君在血管迷走性晕厥患者的倾斜试验中可预防低血压和晕厥。

客观的：

确定米多君在通常的临床情况下是否可以预防血管迷走性晕厥。

设计：

随机、双盲、安慰剂对照临床试验。（ClinicalTrials.gov：NCT01456481）

环境：

加拿大、美国、墨西哥和英国的 25 所大学医院。

耐心：

复发性血管迷走性晕厥且无严重合并症的患者。

干涉：

患者以 1:1 的比例随机分配至安慰剂组或米多君组，并随访 12 个月。

测量：

主要结局指标是随访期间发生至少 1 次晕厥发作的患者比例。

结果：

该研究包括 133 名在前一年中位发生过 6 次晕厥发作的患者（中位年龄，32 岁；73% 为女性）。与接受安慰剂的患者相比，接受米多君治疗的患者发生至少 1 次晕厥发作的人数较少（66 人中有 28 人 [42%] 对 67 人中有 41 人 [61%]）。相对风险为 0.69（95% CI，0.49 至 0.97；P = 0.035）。绝对风险降低为 19 个百分点（CI，2 至 36 个百分点），预防 1 名患者发生晕厥所需的治疗次数为 5.3（CI，2.8 至 47.6）。米多君导致首次晕厥的时间更长（风险比，0.59 [CI，0.37 至 0.96]；P = 0.035；对数秩P = 0.031）。两组的不良反应相似。

局限性：

研究规模小，患者年轻健康，观察期较短，1个中心的患者比例高。

结论：

米多君可以减少晕厥负担高的年轻健康患者的晕厥复发率。

主要资金来源：

加拿大卫生研究所。