Oct. 1, 2009 -- Giving two low-cost prescription drugs to reduce cholesterol and blood pressure in people with diabetes or heart disease -- along with encouraging them to take a daily aspirin -- can slash their risk of hospitalization for heart attack or stroke by 60%, according to a new study.
''If you have diabetes or heart disease, the biggest killer is likely to be a heart attack or stroke," says study researcher Robert James Dudl, MD, the director of the diabetes program at the Kaiser Permanente Care Management Institute in Oakland, Calif.
While researchers have previously shown that cholesterol-lowering statins and blood-pressure-lowering drugs taken individually reduce strokes and heart attacks, their combined effectiveness in large populations is not documented, Dudl and colleagues note.
So the researchers studied a new, simplified approach in which everyone was given a standard dose of the statin and blood-pressure-lowering drugs, rather than the common practice of starting people out on a low dose and monitoring and adjusting the dose several times.
In all, 77.8% had diabetes with or without heart disease, while 31.7% had heart disease only. The median age was 68 (half were younger, half older).
Besides being encouraged to take a daily aspirin, patients were prescribed a medication bundle, typically lovastatin (40 milligrams a day) to lower cholesterol and lisinopril (20 milligrams a day) to lower blood pressure.
During an initial doctor's office visit, patients were asked about medical history to rule out reasons they shouldn't be on the drugs, such as liver disease.
Next, patients were divided into three groups:
- 21,292 participants were in the high-exposure group, taking the drugs more than half the time in 2004 and 2005, based on their prescription refill habits.
- 47,268 people were in the low-exposure group, taking the drugs less than half the time during 2004 and 2005.
- 101,464 people were in the no-exposure group, taking neither drug or just one of the two prescription drugs during 2004 and 2005.
The aspirin could not be tracked through prescription records.
Reducing Risk of Heart Attacks and Strokes
The risk reduction in heart attacks and strokes varied by group and how faithfully participants took the medications.
Compared with the no-exposure group, the low-exposure group (whose members picked up medicines less than half the time) had a 60% reduction in hospitalizations for heart attack and stroke.
''People who picked up the medicine more than half the time had more than a 60% reduction in heart attack and stroke in the third year of follow-up," says Marc Jaffe, MD, director of the Kaiser Permanente Northern California Cardiovascular Risk Reduction Program, who oversaw more than half the study participants.
Among the 21,292 people in the high-exposure group, there were 545 fewer heart attacks and strokes. That translates to a reduction in the hospitalization rate for heart attack or stroke by 26 per 1,000 members compared to those who had no exposure to the drug.
The approach, Jaffe and Dudl say, focused less on adjusting doses, which saves time and the number of office visits for doctors and patients. "It was a focus on starting at a reasonable, fixed dose that would work for most people," Jaffe tells WebMD. That dose was adjusted when needed, however, he says.
''The simplicity [of the approach] makes it easier for people to deal with," Dudl says. Typically, patients are told to start the drugs at a low dose, then asked to come back in three or four weeks for monitoring.
Side effects, such as muscle aches with statins, were found in about the same numbers as in studies in which participants took the drugs separately, Dudl says.
The approach used in the Kaiser study is simple and doesn't require frequent doctor's office visits or blood tests, says Ravi Dave, MD, a cardiologist at Santa Monica--UCLA and Orthopaedic Hospital in Santa Monica, Calif., and associate professor of medicine at the University of California, Los Angeles David Geffen School of Medicine, who reviewed the study for WebMD.
"This [study] establishes the safety and efficacy of this approach," he says. "It's good for patients, with their busy lives.''
The study, he adds, also supports the concept of cholesterol lowering in high-risk patients whose cholesterol levels may be deemed acceptable for the general population, but not for high-risk people.