Objective Low dose methotrexate (LD-MTX) has been associated with a reduced risk of cardiovascular disease (CVD) among patients with systemic rheumatic diseases but not among the general population. Prior reports suggest that LD-MTX may reduce blood pressure (BP). We studied the effect of LD-MTX on blood pressure. Method We examined data that compared LD-MTX to placebo in a randomized double-blind controlled clinical trial conducted among patients that had known CVD but without rheumatic disease. Systolic and diastolic BP (SBP, DBP) were collected as vital sign measurements at each scheduled study visit during 5-years of follow-up. Longitudinal SBP and DBP were compared between patients of LD-MTX and placebo arms using a linear mixed model. Result Data were used from 2391 patients randomized to LD-MTX and 2395 to placebo, with a mean follow-up of 26 months. At baseline, SBP and DBP were normally distributed with similar median (SBP: 128 mmHg (IQR 118–139), DBP: 74 mmHg(IQR 67–80)) between patients from both treatment groups. 93% patients reported at baseline using at least one type of medicaton for hypertension. After treatment, compared with placebo, the estimated differences in changes of SBP and DBP in the LD-MTX group were <1 mm (SBP: β = -0.75 mmHg, 95% CI -0.02 to -1.49; DBP: β = -0.56 mmHg, 95% CI -0.12 to -1.01). Conclusion Patients randomized to LD-MTX without systemic rheumatic disease had no clinically meaningful difference in BP compared with placebo.

中文翻译：

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甲氨蝶呤治疗期间的血压变化：心血管风险患者随机安慰剂对照试验的结果


目的 低剂量甲氨蝶呤 （LD-MTX） 与系统性风湿病患者心血管疾病 （CVD） 风险降低相关，但在普通人群中则无关。先前的报告表明，LD-MTX 可能会降低血压 （BP）。我们研究了 LD-MTX 对血压的影响。方法 我们在一项随机双盲对照临床试验中检查了将 LD-MTX 与安慰剂进行比较的数据，该试验在已知 CVD 但没有风湿性疾病的患者中进行。在 5 年的随访期间，在每次预定的研究访问中收集收缩压和舒张压 BP （SBP， DBP） 作为生命体征测量值。使用线性混合模型比较 LD-MTX 组和安慰剂组患者的纵向 SBP 和 DBP。结果使用了 2391 例随机分配至 LD-MTX 组和 2395 例安慰剂组的患者的数据，平均随访时间为 26 个月。基线时，SBP 和 DBP 呈正态分布，两个治疗组的患者之间中位数相似 （SBP： 128 mmHg （IQR 118-139），DBP： 74 mmHg （IQR 67-80））。93% 的患者在基线时报告使用至少一种类型的高血压药物。治疗后，与安慰剂相比，LD-MTX 组 SBP 和 DBP 变化的估计差异为 <1 mm（SBP：β = -0.75 mmHg，95% CI -0.02 至 -1.49;DBP：β = -0.56 mmHg，95% CI -0.12 至 -1.01）。结论 与安慰剂相比，随机分配至 LD-MTX 组而无全身性风湿病的患者在血压方面无临床意义差异。