Dataset Information

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: 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 (P=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 (P<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; P<0.001), number needed to treat was four (95% CI; 5.60-2.90; P<0.001). Survival analysis demonstrated the superiority of LOPI vs AP relative to 38.67 mg/dL LDL-C reduction (P<0.002); HR was 0.761 (95% CI; 0.62-0.94; P<0.001). Both products reduced the HbA1c without a significant difference between them (P=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 (P=0.411; P=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.

SUBMITTER: Manfrin A

PROVIDER: S-EPMC6181120 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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Publications

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

Manfrin Andrea A Trimarco Valentina V Manzi Maria Virginia MV Rozza Francesco F Izzo Raffaele R

ClinicoEconomics and outcomes research : CEOR 20181008

<h4>Context</h4>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.<h4>Objective</h4>To evaluate the cost and effectiveness of LopiGLIK<sup>®</sup> (LOPI) in lowering LDL-C and CVD risk.<h4>Design</h4>Single blind multicenter randomized controlled trial; patients were divided into two groups, subjected to centralized randomization.<h4>Setting</h4>Four Italian regions.<h4>Particip ...[more]

PMID: 30349338

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Dataset Information

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

Context

Objective

Design

Setting

Participants

Intervention

Outcome measures

Results

Conclusion

Trial registration

Publications

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

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets

Dataset Information

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

Context

Objective

Design

Setting

Participants

Intervention

Outcome measures

Results

Conclusion

Trial registration

Publications

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

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets

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