Abstract 3881: Simvastatin versus Therapeutic Lifestyle Changes and Supplements: A Randomized Primary Prevention Trial
The primary goal of this study is to examine an alternative treatment (AT) for hyperlipidemia in a primary prevention population by comparing it to established therapy with simvastatin (S). This study compares S 40 mg/d to AT with supplements consisting of fish oil and red yeast rice.
Methods: 227 patients who met ATP III criteria for therapy with a statin were screened, 75 subjects were enrolled. Currently we have completed data on 66 of them. Patients were randomized to either S 40 mg/d for 12 wks, with traditional dietary and exercise counseling, or to a 12 wk intensive lifestyle change program with a Mediterranean Diet, aerobic exercise, and supplements (pharmaceutical grade fish oil 3 grams twice per day, and red yeast rice 1.2–1.8 grams twice per day). Blood work was obtained at the end of the 12 weeks of the study.
Results: Simvastatin group consisted of 31 subjects 15M/16F, with mean age of 59 y. The supplement group consisted of 35 subjects 17M/18F, with an a mean age of 57 y. Mean LDL in S group was 155 ± 22mg/dl, HDL 60 ± 13 mg/dl, TG 121 ± 69 mg/dl, TC 239 ± 26 mg/dl. The AT group had a mean LDL of 154 ± 22 mg/dl, HDL 56 ± 12 mg/dl, TG 139 ± 71mg/dl, TC 238 ± 26 mg/dl. After 12 wks, the S group had a mean LDL of 91 ± 27 mg/dl (−41%, p=<0.001), HDL of 60± 13 mg/dl (−0%), TG 106 ± 76 mg/dl(−12%, p=0.04), and TC of 172 ± 36 mg/dl.(−28%, p=<0.001). The post treatment AT group had an LDL of 87 ± 22 mg/dl(−44%, p=<0.001}, HDL 54 ± 14mg/dl,(−10%, p= 0.16} TG 86 ± 48 mg/dl (−38%, p=0.01), and TC 159 ± 28mg/dl.(−33%, p=<0.001). There was a significant within group reduction in LDL, TC and TG. There was no significant difference in LDL (p=0.8) or TC (p=0.145) between groups while serum TG decreased more in the AT group (p=0.002). HDL reduction was more in AT group but did not reach statistical significance (p=0.169).
Conclusions: Simvastatin and the alternative treatment group were both equally effective in lowering LDL cholesterol, with a mean decrease in LDL of 41% and 44%, respectively. The alternative group had significanly more TG lowering effects. To the best of our knowledge, this is the first clinical trial to show robust LDL lowering effects similiar to that of statins, and a significant reduction in TG compared with statins, using an alternative regimen based on non-prescription products and lifestyle changes.