(Ivanhoe Newswire) -- 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 new report.
Kaiser Permanente's Care Management Institute in Oakland, CA, 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 diabetic patients over 55 in a therapeutic program that
included the use of 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 available 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 taking
This is the first study to evaluate a consistent process that could deliver
the combined drugs to large numbers of people with diabetes and heart
disease in realistic settings across a health care delivery system.
The study followed 170,024 Kaiser Permanente members in California who
suffered from heart disease 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 took neither or just one type of the two tracked drugs during
2004 and 2005.
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 low exposure group, 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," lead author R. James Dudl, M.D., the diabetes
clinical lead at Kaiser Permanente's Care Management Institute, is quoted as
saying. "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."
Currently more than 256,000 Kaiser Permanente members in Hawaii, California,
Oregon, Washington, Colorado, Ohio, Georgia, Maryland, Virginia and
Washington, D.C. are participating in the drug medication bundle program.
Study co-author Jim Bellows, Ph.D., Kaiser Permanente Care Management
Institute's director of the Center for Evaluation and Innovation, is quoted
as saying, "We have long known from clinical trials that aspirin,
cholesterol-lowering therapies such as statins, and ACE inhibitors such as
lisinopril reduce the risk of future heart attacks and strokes in patients
who have had a prior cardiovascular event or who have diabetes. Our primary
goal here was to increase the use of the drugs."
SOURCE: American Journal of Managed Care, October 1, 2009