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

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

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.

Keywords: cardiovascular risk reduction; effectiveness; hypercholesterolemia; nutraceuticals.

Conflict of interest statement

Disclosure The authors report no conflicts of interest in this work.

Figures

Figure 1
Figure 1
CONSORT flow diagram showing the flow of patients through the study. Abbreviations: AP, Armolipid Plus®; LOPI, LopiGLIK®.
Figure 2
Figure 2
Kaplan–Meier curve showing effect of LOPI and AP on 38.67 mg/dL LDL-C reduction. Abbreviations: AP, Armolipid Plus®; LDL-C, high-density lipoprotein cholesterol; LOPI, LopiGLIK®.
Figure 3
Figure 3
Kaplan–Meier curve showing effect of LOPI and AP on 1% reduction of HbA1c. Abbreviations: AP, Armolipid Plus®; LOPI, LopiGLIK®.

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