Simvastatin in the prevention of recurrent pancreatitis: a triple-blinded randomised clinical trial (the SIMBA trial).

Statins, due to their anti-inflammatory properties, have been proposed as a potential prophylactic treatment.

由于他汀类药物具有抗炎特性，已被提议作为潜在的预防性治疗。

We aimed to evaluate whether simvastatin could reduce the recurrence of pancreatitis.

我们旨在评估辛伐他汀是否能减少胰腺炎的复发。

Methods

At 23 centres, we conducted a triple-blind, randomised, controlled, superiority trial enrolling patients with at least two episodes of RAP or CP flares in the previous 12 months.

我们在23个中心进行了一项三盲、随机、对照、优效性试验，招募了过去12个月内至少有两次急性复发性胰腺炎（RAP）或慢性胰腺炎（CP）发作的患者。

Participants were randomly assigned to receive simvastatin or placebo for 1 year.

参与者被随机分配接受辛伐他汀或安慰剂治疗1年。

The primary endpoint was the recurrence of pancreatitis.

主要终点是胰腺炎的复发。

The target sample size was 144 patients; however, an interim analysis was planned in the event of slow recruitment.

目标样本量为144名患者；然而，如果招募速度缓慢，则计划进行中期分析。

Results

A total of 85 patients (42.1% women) were included in the interim analysis.

中期分析共纳入了85名患者（女性占42.1%）。

In the intention-to-treatanalysis, no significant differences were observed regarding recurrence: 46.2% simvastatin versus 44.4% placebo; OR 1.07, 95% CI 0.43 to 2.66; p=0.88, or time to recurrence.

在意向性治疗分析中，未观察到关于复发的显著差异：46.2%的他汀类药物组与44.4%的安慰剂组；比值比（OR）为1.07，95%置信区间为0.43至2.66；p=0.88，或复发时间。

No statistically significant differences were observed in recurrence in per-protocol analysis (35.5% simvastatin vs 41.9% placebo; OR 0.76, 95% CI 0.27 to 2.12; p=0.60).

在按方案分析中，未观察到复发的统计学显著差异（35.5%他汀类药物组对比41.9%安慰剂组；比值比（OR）为0.76，95%置信区间为0.27至2.12；p=0.60）。

Development of diabetes mellitus was more frequent in the simvastatin group (4 vs 0 patients; OR not calculable, p=0.04).

在辛伐他汀组中，糖尿病的发生率更高（4比0名患者；OR无法计算，p=0.04）。

Conclusions

This trial, evaluating simvastatin versus placebo for the prevention of pancreatitis, did not demonstrate a reduction in recurrence rate, although results might be underpowered due to early termination.

这项评估辛伐他汀与安慰剂预防胰腺炎的试验，并未显示出复发率的降低，尽管由于早期终止，结果可能缺乏足够的统计功效。

The relationship between statins in these patients and new-onset diabetes requires further investigation.

这些患者中他汀类药物与新发糖尿病之间的关系需要进一步研究。

trial_registration_number

NCT04021498.

NCT04021498。