一项单盲、多中心、随机对照试验，旨在评估一种新型营养保健品（LopiGLIK）降低心血管疾病风险的有效性和成本。

A single blind, multicenter, randomized controlled trial to evaluate the effectiveness and cost of a novel nutraceutical (LopiGLIK) lowering cardiovascular disease risk.

作者信息

Manfrin Andrea, Trimarco Valentina, Manzi Maria Virginia, Rozza Francesco, Izzo Raffaele

机构信息

Sussex Pharmacy, School of Life Sciences, University of Sussex, Falmer, Brighton, UK,

Hypertension Research Centre, University of Naples Federico II, Naples, Italy.

出版信息

Clinicoecon Outcomes Res. 2018 Oct 8;10:601-609. doi: 10.2147/CEOR.S172838. eCollection 2018.

DOI:10.2147/CEOR.S172838

PMID:30349338

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6181120/

Abstract

CONTEXT

Cardiovascular disease (CVD) costs the economy €210 billion per year in Europe. There is an association between low-density lipoprotein cholesterol (LDL-C) and CVD risk.

OBJECTIVE

To evaluate the cost and effectiveness of LopiGLIK (LOPI) in lowering LDL-C and CVD risk.

DESIGN

Single blind multicenter randomized controlled trial; patients were divided into two groups, subjected to centralized randomization.

SETTING

Four Italian regions.

PARTICIPANTS

Thirty-one physicians enrolled 573 adult patients with mild hypercholesterolemia between January 2016 and January 2018.

INTERVENTION

Patients were treated for 16 weeks either with LOPI (intervention) or Armolipid Plus (AP; control).

OUTCOME MEASURES

Primary outcome: percentage of patients who achieved LDL-C <130 mg/dL. Secondary outcomes: reduction of HbA1c, survival analysis and HR linked to 38.67 mg/dL reduction of LDL-C and 1% reduction of HbA1c. Costs were assessed per unit and cure.

RESULTS

Three hundred and seventy patients treated with LOPI and 203 treated with AP were randomized and completed the study. At baseline 8.9% (n=18) patients treated with AP and 9.5% (n=35) treated with LOPI had LDL-C levels <130 mg/dL (=0.815). At the 16-week follow-up, 41.4% (n=84) of patients treated with AP and 67.6% (n=250) with LOPI achieved LDL-C levels <130 mg/dL (<0.001). LOPI patients were three times more likely to achieve LDL-C levels <130 mg/dL; adjusted OR 2.97 (95% CI; 2.08-4.24; <0.001), number needed to treat was four (95% CI; 5.60-2.90; <0.001). Survival analysis demonstrated the superiority of LOPI vs AP relative to 38.67 mg/dL LDL-C reduction (<0.002); HR was 0.761 (95% CI; 0.62-0.94; <0.001). Both products reduced the HbA1c without a significant difference between them (=0.156). Survival analysis and HR (0.91; 95% CI; 0.70-1.18) estimated for 1% HbA1c reduction, showed differences between LOPI and AP, which were not significant (=0.411; =0.464). The cost of LOPI was €2.11 (unit), €211 (cure), and AP €3.77 and €377, respectively.

CONCLUSION

LOPI appeared more effective and less expensive than AP in lowering LDL-C and CVD risk.

TRIAL REGISTRATION

NCT02898805, September 8, 2016.

摘要

背景

在欧洲，心血管疾病（CVD）每年给经济造成2100亿欧元的损失。低密度脂蛋白胆固醇（LDL-C）与心血管疾病风险之间存在关联。

目的

评估LopiGLIK（LOPI）在降低LDL-C和心血管疾病风险方面的成本和效果。

设计

单盲多中心随机对照试验；患者被分为两组，进行集中随机分组。

地点

意大利四个地区。

参与者

2016年1月至2018年1月期间，31名医生招募了573例轻度高胆固醇血症成年患者。

干预措施

患者接受16周的治疗，一组使用LOPI（干预组），另一组使用Armolipid Plus（AP；对照组）。

观察指标

主要指标：LDL-C<130mg/dL的患者百分比。次要指标：糖化血红蛋白（HbA1c）的降低、生存分析以及与LDL-C降低38.67mg/dL和HbA1c降低1%相关的风险比（HR）。按单位和疗程评估成本。

结果

370例接受LOPI治疗的患者和203例接受AP治疗的患者被随机分组并完成研究。基线时，接受AP治疗的患者中有8.9%（n=18）和接受LOPI治疗的患者中有9.5%（n=35）的LDL-C水平<130mg/dL（P=0.815）。在16周的随访中，接受AP治疗的患者中有41.4%（n=84）和接受LOPI治疗的患者中有67.6%（n=250）的LDL-C水平<130mg/dL（P<0.001）。LOPI组患者LDL-C水平<130mg/dL的可能性是AP组的三倍；校正后的比值比为2.97（95%置信区间；2.08-4.24；P<0.001），治疗所需人数为4（95%置信区间；5.60-2.90；P<0.001）。生存分析表明，相对于LDL-C降低38.67mg/dL，LOPI优于AP（P<0.002）；风险比为0.761（95%置信区间；0.62-0.94；P<0.001）。两种产品均降低了HbA1c，二者之间无显著差异（P=0.156）。针对HbA1c降低1%的生存分析和风险比（0.91；95%置信区间；0.70-1.18）显示，LOPI和AP之间存在差异，但不显著（P=0.411；P=0.464）。LOPI的成本分别为每单位2.11欧元、每个疗程211欧元，AP的成本分别为3.77欧元和377欧元。