| Authors |
| Wanner C, Krane V, März W, et al |
| Title |
| Atorvastatin in patients with type 2 diabetes mellitus undergoing hemodialysis |
| References |
| N Engl J Med. 2005 Jul 21;353(3):238-48. |
| Background |
| Statins reduce the incidence of cardiovascular events in persons with type 2 diabetes mellitus. However, the benefit of statins in such patients receiving hemodialysis, who are at high risk for cardiovascular disease and death, has not been examined. |
| Purpose |
| To determine if the addition of atorvastatin 20mg to a population of type II diabetics on hemodialysis would demonstrate improvement in cardiovascular endpoints. |
| Design |
- Multicenter, randomized, double-blinded, controlled trial
- 1255 patients aged 18-80 years with type II diabetes and on hemodialysis for less than 2 years
|
| Exclusion Criteria |
- LDL-C < 2.1 mmol/L or > 4.9 mmol/L
- Triglycerides > 11.3 mmol/L
- Liver function tests > 3x ULN
- Congestive heart failure
- Myocardial infarction within the 3 months preceding enrolment
- Hypertension resistant to therapy (SBP > 200mmHg or DBP >110mmHg)
|
| Follow-Up |
| Mean of 4 years |
| Treatment Regimen |
- Atorvastatin 20 mg/day or placebo
- Clinical assessment at 4 weeks and then every 6 months thereafter
- If LDL fell to < 1.3mmol/L, atorvastatin was reduced to 10 mg/day
|
| Results |
Primary Endpoints Placebo
n=636 | Atorvastatin
n=619 | HR | p |
|---|
| Composite of cardiac death, nonfatal myocardial infarction, and stroke |
|---|
| 38% | 37% | 0.92 (0.77-1.10) | 0.37 | | Cardiac death |
|---|
| 23% | 20% | 0.81 (0.64-1.03) | 0.08 | | Non-fatal myocardial infarction |
|---|
| 12% | 11% | 0.88 (0.64-1.21) | 0.42 | | Fatal stroke |
|---|
| 2% | 4% | 2.03 (1.05-3.93) | 0.04 | | Non-fatal stroke |
|---|
| 5% | 5% | 1.04 (0.64-1.69) | 0.89 | Secondary Outcomes Placebo
n=636 | Atorvastatin
n=619 | HR | p |
|---|
| All cardiac events combined |
|---|
| 39% | 33% | 0.82 (0.68-0.99) | 0.03 | | All cerebrovascular events combined |
|---|
| 11% | 13% | 1.12 (0.81-1.55) | 0.49 | | Death from all causes |
|---|
| 50% | 48% | 0.93 (0.79-1.08) | 0.33 | |
| Summary |
| Atorvastatin had no statistically significant effect on the composite primary end point of cardiovascular death, nonfatal myocardial infarction, and stroke in patients with diabetes receiving hemodialysis. |