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Synergistic effect of simvastatin and ezetimibe on lipid and pro-inflammatory profiles in pre-diabetic subjects.

Kater AL, Batista MC, Ferreira SR - Diabetol Metab Syndr (2010)

Bottom Line: Such a reduction was independent of LDL-cholesterol change.We suggest an additive effect of this combination also on inflammatory status based on the reduction of C-reactive protein.Attenuation of pro-inflammatory conditions may be relevant in reducing cardiometabolic risk.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of Nutrition, School of Public Health University of Sao Paulo, Brazil. svivolo@uol.com.br.

ABSTRACT

Background: Ezetimibe specifically blocks the absorption of dietary and biliary cholesterol and plant sterols. Synergism of ezetimibe-statin therapy on LDL-cholesterol has been demonstrated, but data concerning the pleiotropic effects of this combination are controversial.

Objective: This open-label trial evaluated whether the combination of simvastatin and ezetimibe also results in a synergistic effect that reduces the pro-inflammatory status of pre-diabetic subjects.

Methods: Fifty pre-diabetic subjects were randomly assigned to one of 2 groups, one receiving ezetimibe (10 mg/day), the other, simvastatin (20 mg/d) for 12 weeks, followed by an additional 12-week period of combined therapy. Blood samples were collected at baseline, 12 and 24 weeks.

Results: Total cholesterol, LDL-cholesterol and apolipoprotein B levels decreased in all the periods analyzed (p < 0.01), but triglycerides declined significantly only after combined therapy. Both drugs induced reductions in C-reactive protein, reaching statistical significance after combining ezetimibe with the simvastatin therapy (baseline 0.59 +/- 0.14, simvastatin monotherapy 0.48 +/- 0.12 mg/dL and 0.35 +/- 0.12 mg/dL, p < 0.023). Such a reduction was independent of LDL-cholesterol change. However, mean levels of TNF-alpha and interleukin-6 and leukocyte count did not vary during the whole study.

Conclusion: Expected synergistic lowering effects of a simvastatin and ezetimibe combination on LDL-cholesterol, apolipoprotein B and triglycerides levels were confirmed in subjects with early disturbances of glucose metabolism. We suggest an additive effect of this combination also on inflammatory status based on the reduction of C-reactive protein. Attenuation of pro-inflammatory conditions may be relevant in reducing cardiometabolic risk. TITLE/ID OF TRIAL REGISTRATION: Effect of simvastatin and ezetimibe on lipid and inflammation/NCT01103648.

No MeSH data available.


Related in: MedlinePlus

Lipid profile and C reactive protein concentration of subjects initially receiving ezetimibe and simvastatin at baseline, on monotherapy and with combined therapy.
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Figure 1: Lipid profile and C reactive protein concentration of subjects initially receiving ezetimibe and simvastatin at baseline, on monotherapy and with combined therapy.

Mentions: Total cholesterol, LDL-cholesterol and apolipoprotein B had similar profiles during follow-up for both groups (Figure 1). Significant declines were observed in all the periods analyzed, as shown in Table 2. A combination of simvastatin and ezetimibe was more effective than isolated drugs in reducing lipid levels. However, simvastatin in isolation showed a greater improvement in total cholesterol, LDL-cholesterol and apolipoprotein B than did ezetimibe monotherapy. Thirty-five percent of the subjects treated with ezetimibe monotherapy reached the goal of 100 mg/dl, as did 72% with simvastatin monotherapy, and 91% with a combination of drugs. Similar percent increments were verified when apolipoprotein B levels were considered. Significant decreases in triglyceride levels were found with the combination therapy, but no significant changes were observed with monotherapies. HDL-cholesterol or apolipoprotein A-I concentrations did not change throughout the whole protocol.


Synergistic effect of simvastatin and ezetimibe on lipid and pro-inflammatory profiles in pre-diabetic subjects.

Kater AL, Batista MC, Ferreira SR - Diabetol Metab Syndr (2010)

Lipid profile and C reactive protein concentration of subjects initially receiving ezetimibe and simvastatin at baseline, on monotherapy and with combined therapy.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC2902423&req=5

Figure 1: Lipid profile and C reactive protein concentration of subjects initially receiving ezetimibe and simvastatin at baseline, on monotherapy and with combined therapy.
Mentions: Total cholesterol, LDL-cholesterol and apolipoprotein B had similar profiles during follow-up for both groups (Figure 1). Significant declines were observed in all the periods analyzed, as shown in Table 2. A combination of simvastatin and ezetimibe was more effective than isolated drugs in reducing lipid levels. However, simvastatin in isolation showed a greater improvement in total cholesterol, LDL-cholesterol and apolipoprotein B than did ezetimibe monotherapy. Thirty-five percent of the subjects treated with ezetimibe monotherapy reached the goal of 100 mg/dl, as did 72% with simvastatin monotherapy, and 91% with a combination of drugs. Similar percent increments were verified when apolipoprotein B levels were considered. Significant decreases in triglyceride levels were found with the combination therapy, but no significant changes were observed with monotherapies. HDL-cholesterol or apolipoprotein A-I concentrations did not change throughout the whole protocol.

Bottom Line: Such a reduction was independent of LDL-cholesterol change.We suggest an additive effect of this combination also on inflammatory status based on the reduction of C-reactive protein.Attenuation of pro-inflammatory conditions may be relevant in reducing cardiometabolic risk.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of Nutrition, School of Public Health University of Sao Paulo, Brazil. svivolo@uol.com.br.

ABSTRACT

Background: Ezetimibe specifically blocks the absorption of dietary and biliary cholesterol and plant sterols. Synergism of ezetimibe-statin therapy on LDL-cholesterol has been demonstrated, but data concerning the pleiotropic effects of this combination are controversial.

Objective: This open-label trial evaluated whether the combination of simvastatin and ezetimibe also results in a synergistic effect that reduces the pro-inflammatory status of pre-diabetic subjects.

Methods: Fifty pre-diabetic subjects were randomly assigned to one of 2 groups, one receiving ezetimibe (10 mg/day), the other, simvastatin (20 mg/d) for 12 weeks, followed by an additional 12-week period of combined therapy. Blood samples were collected at baseline, 12 and 24 weeks.

Results: Total cholesterol, LDL-cholesterol and apolipoprotein B levels decreased in all the periods analyzed (p < 0.01), but triglycerides declined significantly only after combined therapy. Both drugs induced reductions in C-reactive protein, reaching statistical significance after combining ezetimibe with the simvastatin therapy (baseline 0.59 +/- 0.14, simvastatin monotherapy 0.48 +/- 0.12 mg/dL and 0.35 +/- 0.12 mg/dL, p < 0.023). Such a reduction was independent of LDL-cholesterol change. However, mean levels of TNF-alpha and interleukin-6 and leukocyte count did not vary during the whole study.

Conclusion: Expected synergistic lowering effects of a simvastatin and ezetimibe combination on LDL-cholesterol, apolipoprotein B and triglycerides levels were confirmed in subjects with early disturbances of glucose metabolism. We suggest an additive effect of this combination also on inflammatory status based on the reduction of C-reactive protein. Attenuation of pro-inflammatory conditions may be relevant in reducing cardiometabolic risk. TITLE/ID OF TRIAL REGISTRATION: Effect of simvastatin and ezetimibe on lipid and inflammation/NCT01103648.

No MeSH data available.


Related in: MedlinePlus