Table 3.
RCTs evaluating the lipid-modifying effects of statins.
Study | Population | Duration | Statin and dose | Lipids at baseline‡ (mmol/L) | Percentage or absolute change (mmol/L) | P value | Percentage reaching LDL-C treatment target of 2.6 mmol/L or below (placebo) | Harms |
Statins versus placebo | ||||||||
151 people with type 2 diabetes | Study duration 6 weeks | Simvastatin 40 mg od | LDL-C: 3.5 ± 1.0 | –41 | Less than 0.001 | 82% | Drug-related musculoskeletal events (no rise in creatine kinase): 6 people in simvastatin 40 mg od group v 2 people in simvastatin 80 mg od group v 1 person in placebo group | |
HDL-C: 0.9 ± 0.1 | +5 | Less than 0.001 | 14% | |||||
TG: 3.1 (median) | –29 | Less than 0.001 | ||||||
Simvastatin 80 mg od | LDL-C: 3.5 ± 1.0 | –47 | less than 0.001*† | 87% | Elevated alanine transaminase and aspartate aminotransferase more than 3 times upper limit (2 people simvastatin 80 mg group) | |||
HDL-C: 0.9 ± 0.1 | +8 | Less than 0.001*† | 14% | |||||
TG: 3.1 (median) | –31 | Less than 0.001 | – | |||||
(= 0.42)† | – | |||||||
25 people with type 1 diabetes | Study duration 16 weeks | Simvastatin up to 20 mg od | LDL-C: 4.6 ± 0.7 | 2.8 ± 0.3 SD(LDL-C at 16 weeks) | Less than 0.001 | – | No difference in liver enzymes or creatine kinase | |
TC: 6.7 ± 1.0 | 4.9 ± 0.4 SD(TC at 16 weeks) | Less than 0.001 | – | |||||
57 people with type 2 diabetes | Study duration 24 weeks | Simvastatin 10 mg od | LDL-C: 5.5 (95% CI 5.4 to 5.6) | –38 | Less than 0.001 | – | Did not look for adverse effects | |
HDL-C: 1.16 (95% CI 1.07 to 1.25) | +9 | Less than 0.05 | – | |||||
TC: 7.8 (95% CI 7.6 to 8.0) | –28 | Less than 0.001 | – | |||||
TG: 2.6 (95% CI 2.2 to 3.0) | –15 | Less than 0.05 | – | |||||
217 people with type 2 diabetes | Study duration 30 weeks | Atorvastatin 10 mg | LDL-C: 3.7 ± 0.1 | –40.8 | Less than 0.001 | 71% | No difference in liver and renal enzymes, muscle pain, and myopathy (with creatine kinase rise). No adverse events were reported | |
HDL-C: 1.05 ± 0.03 | +6 | Less than 0.005 | 36% | |||||
TC: 5.9 ± 0.1 | –29.8 | Less than 0.001 | – | |||||
TG: 2.54 + 0.1 | –25.4 | Less than 0.001 | 80% | |||||
(median) | ||||||||
Atorvastatin 80 mg | LDL-C: 3.7 ± 0.1 | –52.3 | Less than 0.001* | 85% | ||||
HDL-C: 1.03 ± 0.03 | +5.2 | Less than 0.005 | 44% | |||||
TC: 6.1 ± 0.2 | –39.2 | Less than 0.001 (Less than 0.005†) | – | |||||
TG: 2.85 ± 0.13 (median) | –34.6 | Less than 0.001 | 76% | |||||
49 people; 22 with type 1 and 27 with type 2 diabetes, aged 18–70 years | Study duration 24 weeks | Pravastatin 20 mg od | LDL-C: 5.03 ± 0.74 | –25.8% | Less than 0.001 | – | 1 person in placebo group withdrew with muscle pain No significant changes in biochemical parameters | |
HDL-C: 1.30 ± 0.50 | 1.8 | NS | – | |||||
TC: 7.35 ± 0.63 | –22.2% | Less than 0.001 | – | |||||
TG: 1.93 ± 0.73 | 13.6% | Less than 0.01 | – |
HDL-C, high-density lipoprotein cholesterol; LDL-C, low-density lipoprotein cholesterol; NS, not significant; od, once daily; TC, total cholesterol; TG, triglyceride. P values are change compared with placebo unless otherwise stated; *P value compared with placebo and different doses; †P value comparing different doses; ‡values are mean ± standard deviation unless otherwise stated.