Comparison of the Effects of Simvastatin vs. Rosuvastatin vs. Simvastatin/Ezetimibe on Parameters of Insulin Resistance

E. Moutzouri; E. Liberopoulos; D. P. Mikhailidis; M. S. Kostapanos; A. A. Kei; H. Milionis; M. Elisaf

Disclosures

Int J Clin Pract. 2011;65(11):1141-1148. 

In This Article

Results

Recruitment took place from July 2009 through July 2010. Initially, 160 patients were enrolled. After a 12-week dietary intervention, 153 patients (56 male) continued to meet the inclusion criteria and were randomized to receive either simvastatin 40 mg (n = 55) or rosuvastatin 10 mg (n = 45) or the combination of simvastatin 10 mg with ezetimibe 10 mg (n = 53).

The clinical characteristics of study participants are listed in Table 1. The baseline clinical and laboratory characteristics did not significantly differ between groups (Table 1, Table 2, Table 3 and Table 4).

At week 12, all three treatment regimens were associated with significant increases in HOMA-IR (p < 0.05 compared with baseline) (Table 2). After correcting for baseline values, no significant difference was observed between groups.

Fasting insulin levels were significantly increased in the simvastatin, rosuvastatin and ezetimibe/simvastatin group (p < 0.05 vs. baseline in all groups, Table 2). After correcting for baseline values, no significant difference between groups was found.

Homeostasis model assessment of b-cell function, HbA1c and FPG levels did not change significantly in any of the three groups (Table 2).

The changes in HOMA-IR did not correlate with baseline HOMA-IR, age, gender, waist circumference, BMI, hsCRP, lipid or apolipoprotein levels in any of the groups. In addition, there was no correlation between changes in HOMA-IR and changes in lipids, apolipoproteins or hsCRP in any of the groups.

In a subgroup analysis in patients with IFG (n = 50), treatment with rosuvastatin 10 mg, simvastatin 40 mg or the combination of simvastatin 10 mg with ezetimibe 10 mg showed a non-significant trend towards an increase in HOMA-IR without any difference among groups (data not shown).

At the end of the 12-week treatment period, levels of TC, LDL-C, TGs, apoB and apoE were significantly reduced in all groups (p < 0.001 vs. baseline in all groups). HDL-C, apoA-I and Lp(a) levels were not significantly altered in any of the three groups (Table 3). There was no significant difference between the three groups.

All three treatment regimens were associated with significant reduction in serum hsCRP levels. There was no significant difference between the three groups (Table 3).

As outlined in study protocol, the 153 patients who were randomised to lipid-lowering treatment had participated in a 12-week dietary intervention before drug therapy commence. No significant change in BMI, waist circumference and serum ALT levels (a marker of liver fat content) was noted when preintervention, baseline pretreatment and posttreatment values were compared (Table 4).

Compliance and Tolerability

None of the participants dropped out. Compliance rate was > 80% in all patients. All regimens were well tolerated during the study. No patient in any group had liver enzyme elevation > 3-fold ULN or CK > 10-fold ULN. No patient complained of muscle aches or pain. There was no difference in compliance between groups.

Comments

3090D553-9492-4563-8681-AD288FA52ACE
Comments on Medscape are moderated and should be professional in tone and on topic. You must declare any conflicts of interest related to your comments and responses. Please see our Commenting Guide for further information. We reserve the right to remove posts at our sole discretion.

processing....