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

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

SUBMITTER: Manfrin A 

PROVIDER: S-EPMC6181120 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature