Division of Medical Science, Ninewells Hospital and Medical School, Dundee DD1 9SY, UK.
BMJ. 2013 Nov 26;347:f6954. doi: 10.1136/bmj.f6954.
To determine whether patients taking formulations of drugs that contain sodium have a higher incidence of cardiovascular events compared with patients on non-sodium formulations of the same drugs.
Nested case-control study.
UK Primary Care Patients registered on the Clinical Practice Research Datalink (CPRD).
All patients aged 18 or over who were prescribed at least two prescriptions of sodium-containing formulations or matched standard formulations of the same drug between January 1987 and December 2010.
Composite primary outcome of incident non-fatal myocardial infarction, incident non-fatal stroke, or vascular death. We performed 1:1 incidence density sampling matched controls using the UK Clinical Practice Research Datalink (CPRD). For the secondary analyses, cases were patients with the individual components of the primary study composite endpoint of hypertension, incident heart failure, and all cause mortality.
1,292,337 patients were included in the study cohort. Mean follow-up time was 7.23 years. A total of 61,072 patients with an incident cardiovascular event were matched with controls. For the primary endpoint of incident non-fatal myocardial infarction, incident non-fatal stroke, or vascular death the adjusted odds ratio for exposure to sodium-containing drugs was 1.16 (95% confidence interval 1.12 to 1.21). The adjusted odds ratios for the secondary endpoints were 1.22 (1.16 to 1.29) for incident non-fatal stroke, 1.28 (1.23 to 1.33) for all cause mortality, 7.18 (6.74 to 7.65) for hypertension, 0.98 (0.93 to 1.04) for heart failure, 0.94 (0.88 to 1.00) for incident non-fatal myocardial infarction, and 0.70 (0.31 to 1.59) for vascular death. The median time from date of first prescription (that is, date of entry into cohort) to first event was 3.92 years.
Exposure to sodium-containing formulations of effervescent, dispersible, and soluble medicines was associated with significantly increased odds of adverse cardiovascular events compared with standard formulations of those same drugs. Sodium-containing formulations should be prescribed with caution only if the perceived benefits outweigh these risks.
确定服用含钠药物制剂的患者与服用相同药物非含钠制剂的患者相比，心血管事件的发生率是否更高。
巢式病例对照研究。
英国注册于临床实践研究数据库（CPRD）的初级保健患者。
1987 年 1 月至 2010 年 12 月期间，至少两次处方含钠制剂或相同药物标准制剂的年龄在 18 岁或以上的所有患者。
非致死性心肌梗死、非致死性卒中或血管死亡的复合主要终点。我们使用英国临床实践研究数据库（CPRD）进行了 1:1 发生率密度抽样匹配对照。对于次要分析，病例是原发性研究复合终点（高血压、新发心力衰竭和全因死亡率）各组成部分的患者。
研究队列共纳入 1292337 例患者。平均随访时间为 7.23 年。共有 61072 例心血管事件患者与对照组相匹配。对于非致死性心肌梗死、非致死性卒中或血管死亡的主要终点，暴露于含钠药物的调整比值比为 1.16（95%置信区间 1.12 至 1.21）。次要终点的调整比值比分别为非致死性卒中 1.22（1.16 至 1.29）、全因死亡率 1.28（1.23 至 1.33）、高血压 7.18（6.74 至 7.65）、心力衰竭 0.98（0.93 至 1.04）、非致死性心肌梗死 0.94（0.88 至 1.00）和血管死亡 0.70（0.31 至 1.59）。从首次处方（即进入队列的日期）到首次事件的中位时间为 3.92 年。
与相同药物的标准制剂相比，含钠制剂的泡腾、分散片和可溶性药物与不良心血管事件的发生风险显著增加相关。只有在认为益处超过风险的情况下，才应谨慎处方含钠制剂。
