A program that bundled two generic, low-cost drugs - a cholesterol-lowering statin and a blood pressure-lowering drug - and gave daily doses to 68,560 people with diabetes or heart disease for two years is estimated to have prevented 1,271 heart attacks and strokes in the first year following the study period, according to a Kaiser Permanente study published online in the American Journal of Managed Care.
Kaiser Permanente developed the ALL initiative (Aspirin, Lisinopril and Lipid-Lowering Medication) in 2003 to reduce heart attacks and strokes by aggressively enrolling patients with heart disease or patients over 55 with diabetes in a therapeutic program that included the use of a triad of medications: low-dose aspirin, lovastatin and lisinopril.
The three-year clinical observational study found that offering 40 milligrams of lovastatin and 20 milligrams of lisinopril daily for two years to people not already on both drugs reduced their risk of hospitalization for heart attack or stroke the following year by more than 60 percent. Aspirin was not part of the study because it was over-the-counter and its use could not be measured through pharmacy records. However, it was separately estimated that 75 percent of study participants were already taking aspirin. The study was conducted by Kaiser Permanente's Care Management Institute in Oakland, Calif., which synthesizes knowledge on the best clinical practices to develop evidence-based care programs at Kaiser Permanente.
While previous research and clinical trials have shown that statins and angiotensin-converting enzyme inhibitors / angiotensin receptor blockers (ACE-I/ARB) individually reduce heart attacks and strokes, this is the first study to evaluate whether a consistent process could be developed to deliver the combined drugs to large numbers of people with diabetes and/or heart disease in realistic settings across a health care delivery system. It is also the first study to evaluate how dramatically this program would affect clinical outcomes and hospitalization rates for heart attack and stroke.
The study followed 170,024 ethnically diverse Kaiser Permanente members in California with heart disease and/or diabetes for two years during the medication phase and for one year during the outcome monitoring phase. The study cohort was broken into three groups: 21,292 members in the high-exposure group who took the bundled drugs more than half of the time in 2004 and 2005 based on their prescription refill habits; a low-exposure group of 47,268 people who took the drug bundle less than half of the time during 2004 and 2005 based on their prescription refill habits, and a no-exposure group of 101,464 people who either took neither or just one type of the two tracked drugs during 2004 and 2005.
The researchers found that among the study population as a whole, there were 21 heart attacks and strokes per 1,000 people in 2006. Among the 47,268 people in the group that had low exposure to the drugs, there were 726 fewer heart attacks and strokes than in the no exposure group, equivalent to a reduction of 15 heart attacks and strokes per 1,000 people. Among the 21,292 people in the high- exposure group, there were 545 fewer heart attacks and strokes, equivalent to a reduction of 26 heart attacks and strokes per 1,000 people. The study estimated this effect to be a 60 percent savings of these events.
"Heart disease is the number one killer in the United States, and 23 million Americans have diabetes. This is a proven program that can be applied in many settings to reduce heart attacks and strokes, and at the same time decrease the cost of care for those events," said the study's lead author, R. James Dudl, MD, the diabetes clinical lead at Kaiser Permanente's Care Management Institute.