Statins of cholesterol-lowering drugs have been known to
reduce heart risk in people with underlying conditions by lowering the amount
of cholesterol in the blood. However, a new study presented Sunday at a New Orleans meeting of
the American Heart Association revealed that statins are also good for healthy
people with normal cholesterol levels cutting their risk of heart attacks, stroke
and death by nearly half.
The study, published in the New England Journal of Medicine,
involved AstraZeneca’s Rosuvastatin, commercially known as Crestor. Nearly 18,000
people in 26 countries, including 7,000 women and nearly 5,000 minorities,
participated in the clinical trial, designed to last up to five years. However,
it was stopped after less than two because endpoints set by an independent
oversight committee were met.
The people involved had very good cholesterol levels but
each of them had elevated levels of “high-sensitivity C-reactive protein” or
hs-CRP, a marker that indicates inflammation in the body and can contribute to coronary
heart disease, the No. 1 killer of people in the United States.
“If you have high (C-reactive protein), we know you're at
increased risk of heart attack, stroke and cardiovascular death,” says the lead
investigator, Paul M. Ridker, of Brigham and Women's Hospital in Boston.
The participants were given 20 milligrams of Crestor or a placebo pill. Those
given Crestor were 54 percent less likely to have a heart attack, 48 percent
less likely to have a stroke, 46 percent less likely to need angioplasty or
bypass surgery to open a clogged artery, 44 percent less likely to suffer any
of those events and 20 percent less likely to die from any cause compared to those
in the placebo group, the researchers reported yesterday. While muscle weakness
and rhabdomyolysis weren't a problem with Crestor, patients taking the drug
were more likely to have trouble controlling their blood sugar levels and were
diagnosed with diabetes more often than those getting placebo. The findings
underscore the need for longer-term safety data, some doctors said.
However, “the potential public health benefits are huge. It
really changes the way we have to think about prevention of heart attack and
stroke. We were both shocked and elated,” Ridker said.
Steven E. Nissen of the Cleveland Clinic, who was not
involved in the research, considered the study a “breakthrough,” and a “blockbuster.”
“It’s absolutely paradigm-shifting,” he added.
Moreover, the findings would prompt routine screening of
middle-age patients for inflammation in order to receive Crestor if needed.
“Jupiter [as the study was called] should dramatically change prevention
guidelines,” Dr. James Willerson, director of the Texas Heart Institute in Houston, said in a
statement.
AstraZeneca, which funded the study, said it plans to submit the findings to
US regulators in the first half of 2009, seeking approval to expand use of the
drug to people with high levels of CRP. The finding could benefit Pfizer’s
Lipidor, already the biggest selling drug in the world with $12.7 billion in
2007 revenue.