A single blind, multicenter, randomized controlled trial to evaluate the effectiveness and cost of a novel nutraceutical (LopiGLIK®) lowering cardiovascular disease risk
Andrea Manfrin,1 Valentina Trimarco,2,3 Maria Virginia Manzi,2,4 Francesco Rozza,2,4 Raffaele Izzo2,5 1Sussex Pharmacy, School of Life Sciences, University of Sussex, Falmer, Brighton, UK; 2Hypertension Research Centre, University of Naples Federico II, Naples, Italy; 3Department o...
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| Format: | Article |
| Language: | English |
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Dove Medical Press
2018-10-01
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| Series: | ClinicoEconomics and Outcomes Research |
| Subjects: | |
| Online Access: | https://www.dovepress.com/a-single-blind-multicenter-randomized-controlled-trial-to-evaluate-the-peer-reviewed-article-CEOR |
| _version_ | 1818152977366515712 |
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| author | Manfrin A Trimarco V Manzi MV Rozza F Izzo R |
| author_facet | Manfrin A Trimarco V Manzi MV Rozza F Izzo R |
| author_sort | Manfrin A |
| collection | DOAJ |
| description | Andrea Manfrin,1 Valentina Trimarco,2,3 Maria Virginia Manzi,2,4 Francesco Rozza,2,4 Raffaele Izzo2,5 1Sussex Pharmacy, School of Life Sciences, University of Sussex, Falmer, Brighton, UK; 2Hypertension Research Centre, University of Naples Federico II, Naples, Italy; 3Department of Neurosciences, Federico II University, Naples, Italy; 4Department of Advanced Biomedical Sciences, Federico II University, Naples, Italy; 5Department of Translational Medical Science Sciences, Federico II University, Naples, Italy 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: hypercholesterolemia, nutraceuticals, effectiveness, cardiovascular risk reduction |
| first_indexed | 2024-12-11T14:03:17Z |
| format | Article |
| id | doaj.art-6393475391f04b5196335ecb3fc00f92 |
| institution | Directory Open Access Journal |
| issn | 1178-6981 |
| language | English |
| last_indexed | 2024-12-11T14:03:17Z |
| publishDate | 2018-10-01 |
| publisher | Dove Medical Press |
| record_format | Article |
| series | ClinicoEconomics and Outcomes Research |
| spelling | doaj.art-6393475391f04b5196335ecb3fc00f922022-12-22T01:03:47ZengDove Medical PressClinicoEconomics and Outcomes Research1178-69812018-10-01Volume 1060160941209A single blind, multicenter, randomized controlled trial to evaluate the effectiveness and cost of a novel nutraceutical (LopiGLIK®) lowering cardiovascular disease riskManfrin ATrimarco VManzi MVRozza FIzzo RAndrea Manfrin,1 Valentina Trimarco,2,3 Maria Virginia Manzi,2,4 Francesco Rozza,2,4 Raffaele Izzo2,5 1Sussex Pharmacy, School of Life Sciences, University of Sussex, Falmer, Brighton, UK; 2Hypertension Research Centre, University of Naples Federico II, Naples, Italy; 3Department of Neurosciences, Federico II University, Naples, Italy; 4Department of Advanced Biomedical Sciences, Federico II University, Naples, Italy; 5Department of Translational Medical Science Sciences, Federico II University, Naples, Italy 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: hypercholesterolemia, nutraceuticals, effectiveness, cardiovascular risk reductionhttps://www.dovepress.com/a-single-blind-multicenter-randomized-controlled-trial-to-evaluate-the-peer-reviewed-article-CEORHypercholesterolemiaNutraceuticalsEffectivenessCardiovascular risk reduction |
| spellingShingle | Manfrin A Trimarco V Manzi MV Rozza F Izzo R A single blind, multicenter, randomized controlled trial to evaluate the effectiveness and cost of a novel nutraceutical (LopiGLIK®) lowering cardiovascular disease risk ClinicoEconomics and Outcomes Research Hypercholesterolemia Nutraceuticals Effectiveness Cardiovascular risk reduction |
| title | A single blind, multicenter, randomized controlled trial to evaluate the effectiveness and cost of a novel nutraceutical (LopiGLIK®) lowering cardiovascular disease risk |
| title_full | A single blind, multicenter, randomized controlled trial to evaluate the effectiveness and cost of a novel nutraceutical (LopiGLIK®) lowering cardiovascular disease risk |
| title_fullStr | A single blind, multicenter, randomized controlled trial to evaluate the effectiveness and cost of a novel nutraceutical (LopiGLIK®) lowering cardiovascular disease risk |
| title_full_unstemmed | A single blind, multicenter, randomized controlled trial to evaluate the effectiveness and cost of a novel nutraceutical (LopiGLIK®) lowering cardiovascular disease risk |
| title_short | A single blind, multicenter, randomized controlled trial to evaluate the effectiveness and cost of a novel nutraceutical (LopiGLIK®) lowering cardiovascular disease risk |
| title_sort | single blind multicenter randomized controlled trial to evaluate the effectiveness and cost of a novel nutraceutical lopiglik reg lowering cardiovascular disease risk |
| topic | Hypercholesterolemia Nutraceuticals Effectiveness Cardiovascular risk reduction |
| url | https://www.dovepress.com/a-single-blind-multicenter-randomized-controlled-trial-to-evaluate-the-peer-reviewed-article-CEOR |
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