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Simvastatin cuts heart risks for people with diabetes

More than 18 million Americans are currently living with diabetes. People with diabetes are two to four times more likely than others to have a coronary event such as a heart attack even though their LDL (“bad”) cholesterol levels are typically similar to those in the general population.

Many people with diabetes are not currently receiving therapy to manage their increased risk. The primary focus for most diabetes patients is on blood-glucose control, which is critical because it reduces the risk of microvascular complications such as eye, kidney and nerve damage.

Study evaluates risk for those with diabetes
The Heart Protection Study, the largest-ever study using a cholesterol-lowering medication, showed that treating these patients for their cardiovascular risk provides significant health benefits. The study demonstrated that taking a daily dose of 40 mg of simvastatin (Zocor®) reduced the risk of a first nonfatal heart attack and of major coronary events by 27 percent in patients with diabetes regardless of their cholesterol or glucose levels.

The diabetes arm of the landmark Heart Protection Study was published in The Lancet in June 2003. This study followed 5,963 men and women with diabetes, age 40-80 years, who were randomly selected to receive simvastatin or a placebo daily for five years. Of these participants, 2,912 had no prior history of heart disease. The overall study included an additional 14,573 people with cardiovascular disease but no diagnosed diabetes. Patients with a recent heart attack or stroke, abnormal liver function or evidence of muscle problems were excluded from the study.

The majority of patients (90 percent) in the diabetes arm of the study had type 2 diabetes; only 10 percent had type 1. Compared to patients without diabetes, study participants with diabetes were younger, more often female, hypertensive and with higher systolic blood pressure and body mass index at the beginning of the study. The mean duration of the follow-up was 4.8 years for those with diabetes and five years for all remaining patients.

Statin lowered LDL cholesterol
The study aimed to assess the effects of a substantial reduction in LDL cholesterol on major vascular events, maintained for several years in at-risk groups. Patients with diabetes experienced an average reduction in LDL cholesterol of 39 mg/dL during the trial. The average baseline LDL cholesterol level was 124 mg/dL at the start of the study.

Among the study participants with diabetes, those given simivastatin experienced a 27 percent (279/2,978 vs. 377/2,985 for placebo) risk reduction in the incidence of first nonfatal heart attack or coronary death compared to those given a placebo. This represented a 37 percent (105/2,978 vs. 164/2,985 for placebo) reduction in risk of first nonfatal heart attack and a 24 percent reduction (149/2,978 vs. 193/2985 for placebo) in the incidence of first nonfatal or fatal stroke. Among those with diabetes, there was also a 17 percent reduction (260/2,978 vs. 309/2,985 for placebo) in the incidence of first revascularization procedure versus the placebo patients.

Safety profile
During the five-year study, the overall safety profiles were comparable between patients treated with simvastatin and patients treated with placebo. The number of patients who discontinued the study due to adverse reactions was also comparable (4.8 percent vs. 5.1 percent for people on placebo).

In this trial, only serious adverse effects and discontinuations due to any adverse effects were recorded. The incidence of myopathy/rhabdomyolysis was less than 0.1 percent in people on simvastatin.