One hundred two patients from the cardiology unit of Sterling Hospital were included in the present study. All of them had angiographically documented CAD and had undergone percutaneous transluminal coronary angioplasty. Twenty-five patients each were enrolled in atorvastatin, atorvastatin-fenofibrate combination and simvastatin-fenofibrate combination treatment groups, and 27 patients were enrolled in the simvastatin treatment group. There were four dropouts each in the atorvastatin-fenofibrate group and the simvastatin monotherapy group, and three dropouts in the simvastatin-fenofibrate group, all due to nontechnical reasons. Therefore, the analysis is based on a total of 91 patients who completed the follow-up successfully. The baseline demographic characteristics such as age, sex, body mass index, smoking, tobacco and alcohol habits, past history of diabetes, hypertension or family history, and other hemodynamic parameters such as hemoglobin, urea and creatinine were recorded (). These parameters were found to be identical in all the four treatment groups, indicating a symmetrical study design and population.
Baseline demographic and hemodynamic characteristics of the patients
The effects of all the treatments on lipid parameters are given in . Atorvastatin and simvastatin monotherapy reduced serum LDL-C and, interestingly, increased serum HDL-C significantly (P<0.05). The atorvastatin-fenofibrate combination therapy produced a significant decrease in TG and VLDL-C (P<0.05), and also increased HDL-C significantly compared with atorvastatin alone (P<0.05). Similar to simvastatin monotherapy, simvastatin-fenofibrate combination produced a significant increase in HDL-C and decrease in LDL-C levels (P<0.05). It, however, did not reduce TG significantly. All treatments except atorvastatin-fenofibrate significantly reduced the total cholesterol/HDL-C ratio, and all treatments significantly reduced the LDL-C/HDL-C ratio (P<0.05). ANOVA was applied to find whether there was any difference in the effects among the four groups. The results, however, indicated that the percentage change in lipoprotein levels obtained were not significantly different from each other among the four treatment groups ().
Effect of treatments on serum lipoprotein levels at baseline and at three months after the start of treatment
Figure 1 Mean percentage change in lipid levels among treatment groups. *Significant change from baseline values, Student’s t test, P<0.05; #Significant change compared with the respective statin monotherapy or combination, unpaired Student’s (more ...)
The effect of the treatments on plasma fibrinogen are given in . Atorvastatin and simvastatin were both found to decrease plasma fibrinogen significantly (P<0.05). Combination of statins with fenofibrate also showed a significant decrease in plasma fibrinogen (P<0.05). However, the treatment groups were not significantly different from each other when analyzed by ANOVA. Statins in the present study decreased plasma fibrinogen significantly, while the addition of fenofibrate enhanced this effect, although not significantly.
Effect of treatments on plasma fibrinogen levels
No correlation was found between fibrinogen levels and various demographic, hemodynamic and biochemical parameters (). Thus, plasma fibrinogen was found to be an independent risk factor for CAD and was lowered significantly by atorvastatin and simvastatin alone and in combination with fenofibrate.
Correlation coefficient between fibrinogen and other study parameters
No significant elevations in the serum bilirubin concentration, transaminases (SGPT and SGOT) and alkaline phosphatase levels were observed in any treatment group (). Thus, it appeared that all the treatments were safely tolerated in the given doses without any adverse hepatotoxic effects. Two patients in the simvastatin group had complaints of mild muscle pain, but the pain was self-resolving and not severe enough to cause discontinuation of the therapy. The rest of the patients had no complaints of muscle pain, weakness or myalgia. Thus, statin therapy alone or in combination did not lead to undesirable myopathy, as anticipated.
Effect of treatments on liver function parameters at the end of three months