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Title: Atorvastatin Shows Preventive Effect Against Cardiovascular Events in Diabetics: Presented at DALM

"Atorvastatin Shows Preventive Effect Against Cardiovascular Events in Diabetics: Presented at DALM"

By Chris Berrie VENICE, ITALY -- October 25, 2004 -- Atorvastatin is safe and highly efficacious at a dose of 10 mg daily for reducing the risk of cardiovascular disease (CVD) events, including stroke, in patients with type 2 diabetes who have no history of CVD and normal LDL-C levels, according to a combined UK-Ireland randomised study. John Betteridge, MD, PhD, professor of endocrinology and metabolism, University College London, London, United Kingdom, presented the findings on behalf of the Collaborative Atorvastatin Diabetes Study (CARDS) here on October 24th at the XV International Symposium on Drugs Affecting Lipid Metabolism. In presenting their recently published data (Lancet. 21 August 2004;364[9435]:685-696) Dr. Betteridge stressed that, "With a simple intervention you can change the outcome dramatically in terms of protecting patients with diabetes from heart disease, and in particular, stroke." According to the researchers, atorvastatin is intended to combat the growing problem of diabetes -- which is affecting individuals at an earlier age than ever before. In fact, Dr. Betteridge said, the number of people with diabetes throughout the world is likely to double over the next 25 years. The CARDS study group designed their randomised study as a result of previous subgroup analyses that showed that statin therapy has similar advantages in diabetic patients as in other patient groups. The CARDS researchers therefore designed their study as an evaluation of atorvastatin for primary prevention of cardiovascular events in patients with type 2 diabetes mellitus as defined by the 1985 WHO criteria. Inclusion criteria required 1 or more added risk factors, including a history of hypertension, retinopathy, or albuminuria, or for the patients to be current smokers. Subjects were excluded if they had a past history of myocardial infarction or CVD. Following these criteria, 2,838 who were 40 to 75 years old entered the initial randomisation stage. While the study was intended to be completed in 2005, the Data Safety Monitoring Board ended the trial early, after the second interim analysis, as a result of the significant reduction in incidence of cardiovascular events seen with atorvastatin. Patients' baseline characteristics were equivalent and standard in the placebo and atorvastatin groups. The 1412 placebo subjects had a mean age of 61.8 years, women made up 32% of the group, they had a diabetes duration of 7.8 years, mean body mass index (BMI) of 28.8 kg/m[², and 38% were obese. The 1429 subjects in the atorvastatin 10 mg daily group had a mean age of 61.5 years, 32% were women, diabetes duration was 7.9 years, mean BMI was 28.7 kg/m², and 36% were obese.

The researchers evaluated levels of low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), non-HDL-C, total cholesterol, triglycerides, and apolipoprotein B (apoB).

After a mean of 4.75 years of treatment, atorvastatin showed mean reductions compared to placebo of 1.20 mmol/L (40% baseline) in LDL-C (P <.0001), 1.40 mmol/L (26% baseline) in total cholesterol (P <.0001), 1.42 mmol/L (36% baseline) in non-HDL-C (P <.0001), 0.39 mmol/L (19% baseline) in triglycerides (P <.0001), and 27 mg/L (23% baseline) in apoB (P <.0001).

There was a 37% relative risk reduction in the primary end point of major cardiovascular events (P =.001) in the atorvastatin group over placebo, seen as rates of 5.8% and 9.0% over 4.75 years, respectively, with similar improvements seen in the secondary end points. There were no significant differences in adverse events between the placebo and atorvastatin groups.

Dr. Betteridge highlighted the overall benefits for these diabetic patients, while stressing that they also displayed relatively low baseline LDL-C levels, according to the present guidelines for European targets. Thus, not only did atorvastatin reduce these levels further, but it also provided significant risk reductions in patient subgroups whose LDL-C levels would normally be considered to be above the threshold for statin use.

These data indicate that there is no justification for having a threshold level based solely on LDL-C level for deciding if patients with type 2 diabetes should receive statin treatment, Dr. Betteridge said, and suggested that the overall cardiovascular risk should be the principle determinant. The only caveat, she said, is that "the debate as to whether or not all patients with diabetes should get statin treatment should now focus on really how we identify any patients at low enough risk not to offer this very safe and efficacious treatment."

[Presentation title: Expanding the Scope of Clinical Benefits Across Different Risk Cohorts: Diabetic Patients. Abstract 612]

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