A single blind, multicenter, randomized controlled trial to evaluate the effectiveness and cost of a novel nutraceutical (LopiGLIK®) lowering cardiovascular disease risk.
Clinicoecon Outcomes Res
; 10: 601-609, 2018.
Article
em En
| MEDLINE
| ID: mdl-30349338
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). OUTCOMEMEASURES:
Primaryoutcome:
percentage of patients who achieved LDL-C <130 mg/dL. Secondaryoutcomes:
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.
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Ano de publicação:
2018
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Article