Statins Effective in Two Studies: Dramatically
Lowering Risk of Heart Attack, Blood Clots
Both studies important
to senior citizens are from
JUPITER data presented at
American College of Cardiology’s Scientific Session
March 30, 2009 - Healthy men and women who achieved
low levels of both low-density lipoprotein (LDL) cholesterol and high
sensitivity C-reactive protein (hsCRP) after starting statin therapy
dramatically lowered their risk of a future heart attack, stroke, need
for bypass surgery, or cardiovascular death, according to new data
presented at the American College of Cardiology‟s 58th Annual
Scientific Session in Orlando.
The study – the first to prospectively examine
clinical benefits of “dual targets” after initiating statin therapy –
demonstrates significantly lowered cardiovascular risk of up to 80
percent among patients who achieved more aggressive reductions in
on-treatment LDL and hsCRP levels.
Researchers suggest that clinicians consider
screening for hsCRP, a marker of underlying inflammation, in addition to
LDL cholesterol when identifying patients at high risk for heart disease
or monitoring the success of treatment among patients starting statin
therapy.
“Our data strongly confirms that statins reduce
vascular risk by lowering both inflammation and cholesterol, and we
found that achieving low levels of both matters for heart health,” said
Paul Ridker, M.D., Brigham & Women‟s Hospital, Boston.
“Reducing cholesterol is clearly important, but a
reduction in hsCRP with statin therapy appears equally important, and
patients who lower both simply do better than those who lower only
cholesterol or only hsCRP.”
In this analysis of 15,548 initially healthy men
and women participating in the JUPITER trial, researchers prospectively
evaluated the effects of rosuvastatin (20 mg) versus placebo on rates of
heart attack, stroke, hospitalization for unstable angina, arterial
revascularization, or cardiovascular death according to achieved levels
of LDL and hsCRP.
Rosuvastatin is marketed as Crestor.
Compared to those given placebo in the JUPITER
trial, those taking rosuvastatin who achieved target levels of LDL less
than 70mg/L (1.8 mmol/L) and hsCRP less than 2 mg/L experienced a 65
percent reduction in CV risk compared to only a 36 percent reduction
among those treated with rosuvastatin who did not achieve one or both of
these target levels.
Event-free survival was even greater among patients
achieving more aggressive LDL and hsCRP levels (LDL less than 70mg/dL
and hsCRP less than 1mg/L); these patients had an 80 percent reduction
in cardiovascular risk. The effects remained after adjustment for all
available baseline characteristics that varied between groups, including
pre-randomization levels of both LDL cholesterol and hsCRP.
JUPITER was a randomized, double-blind, placebo
controlled trial. Study participants were followed for a maximum of five
years (median 1.9 years). Enrolled patients had an LDL of less than 130
mg/dL, which meant they did not qualify for statin therapy under current
guidelines.
“JUPITER previously showed that statin therapy is
highly effective among patients with low cholesterol who are at risk due
to increased levels of inflammation as picked up by elevated hsCRP. We
now know that the large benefit gained is due not only to reduction in
cholesterol, but to reduction in hsCRP as well,” Ridker said. “A patient
can be at risk for heart attack or stroke even when cholesterol levels
are low. Inflammation is a major determinant of CV risk, and statin
drugs are „two-fers‟ that lower both inflammation and cholesterol.”
It is critical to identify new strategies to detect
patients at high risk, and then link those strategies to treatment
approaches that work and are cost-effective, he added.
“For any patient with high cholesterol or a high
hsCRP level, the first steps remain diet, exercise, and smoking
cessation,” Ridker said. “However, for those electing to start drug
therapy, both reductions in LDL and hsCRP appear to be indicators of the
success of statin therapy.”
These results will be simultaneously published in
The Lancet. JUPITER was conducted by investigators in 26 countries and
was overseen by an academic statistician and an independent Data and
Safety Monitoring Board. The study was funded by AstraZeneca.
Dr. Ridker will present the study, “Dual Treatment
Targets for LDL Cholesterol and C-Reactive Protein After Initiation of
Rosuvastatin Therapy: The JUPITER Trial,” on Monday, March 30 at 2:00
p.m. in Hall WF1.
Statins Ward Off Blood Clots In
Veins - Venous Thromboembolism
Study finds rosuvastatin also prevents painful,
sometimes deadly condition
The Justification for the Use of Statins in
Prevention: an Intervention Trial Evaluating Rosuvastatin (JUPITER),
also found that daily therapy with rosuvastatin cut the risk of blood
clots in the veins, or venous thromboembolism (VTE), by more than 40
percent overall, according to another study to be presented today at the
American College of Cardiology’s 58th Annual Scientific Session.
Statins are well known to prevent heart attack and
stroke, but new evidence from a randomized controlled study of
rosuvastatin shows these medications also ward off blood clots in the
veins, a common and potentially life-threatening condition.
Venous thromboembolism, a serious and sometimes
fatal condition, occurs when a blood clot forms in a vein. The most
common form of VTE is deep vein thrombosis (DVT), which usually occurs
in the 'deep veins' in the legs or pelvis. An embolism is created if the
clot travels through the venous system. Blood clots lodging in the lungs
are known as a pulmonary embolism (PE).
“VTE is a serious, sometimes fatal, event that is
costly and inconvenient to treat,” said Robert J. Glynn, Ph.D., Sc.D., a
biostatistician at the Brigham and Women’s Hospital and an associate
professor of medicine at Harvard Medical School, in Boston.
“When patients and their doctors discuss initiation
of statin therapy, prevention of VTE is an important additional
consideration beyond proven benefits in the prevention of heart attack
and stroke.”
Though it does not get as much attention as heart
attack or stroke, VTE is a very common disorder with an incidence that
increases with age. Obesity, use of hormone replacement therapy and
certain genetic defects also increase the risk, as do long periods of
inactivity and injury to the blood vessels.
Deep vein thrombosis, which can cause pain in the
legs, is an early form of VTE, while pulmonary embolism is a frequently
fatal, advanced form of the condition caused by a blood clot that
travels to the lungs.
JUPITER is the first randomized trial to
prospectively investigate whether statin therapy can prevent VTE. The
trial recruited 17,802 apparently healthy men and women with low-density
lipoprotein (LDL) cholesterol levels of less than
130 mg/dL and high-sensitivity C-reactive protein (hsCRP) levels of 2.0
mg/L or higher, randomly assigning them to rosuvastatin, 20 mg/day, or
placebo. The median age of study participants was 66 years, and 38
percent were obese.
During follow-up, 34 participants in the
rosuvastatin group and 60 in the placebo group developed symptomatic VTE,
a 43 percent reduction (hazard ratio, 0.57; p = 0.007). Similar
reductions in risk were observed in people who had certain triggers for
VTE, including cancer or recent hospitalization, surgery, or trauma
(provoked VTE), and in those who did not have any of these triggers
(unprovoked VTE). Risk reductions were seen for both deep vein
thrombosis and for pulmonary embolism.
“Our findings require confirmation, but they have
the potential to broaden our perspective on the treatment targets for
statin therapy,” Glynn said.
“Including consideration of VTE, in addition to
conditions caused by arterial thrombosis such as heart attack and
stroke, increases the estimated benefits associated with statin use.”
“The clinical bottom line here is simple,” said
Paul Ridker, M.D., also of the Brigham and Women’s Hospital and JUPITER
trial chairman. “In addition to reducing risks of heart attack and
stroke, we now have hard evidence that aggressive statin therapy reduces
life-threatening blood clots in the veins. In contrast to drugs like
warfarin and heparin, we got this benefit with no bleeding hazard at
all, so the new data are an exciting advance for our patients.”
Information Source:
The American College of Cardiology (www.acc.org)
represents the majority of board certified cardiovascular care through
education, research, promotion, development and application of standards
and guidelines – and to influence health care policy. ACC.09 is the
largest cardiovascular meeting, bringing together cardiologists and
cardiovascular specialists to share the newest discoveries in treatment
and prevention, while helping the ACC achieve its mission to address and
improve issues in cardiovascular medicine.
ACC.09 is the premier cardiovascular medical
meeting, connecting cardiologists and cardiovascular specialists to the
latest and most innovative findings in cardiovascular science.
Dr. Glynn presented “A Randomized Trial of
Rosuvastation in the Prevention of Venous Thromboembolism: The JUPITER
Trial” on Sunday, March 29.
About JUPITER:
JUPITER (Justification for the Use of statins in
Primary prevention: an Intervention Trial Evaluating Rosuvastatin) was a
long-term, randomized, double-blind, placebo-controlled, large-scale
study of 17,802 patients designed to determine if rosuvastatin 20 mg
decreases the risk of heart attack, stroke and other major
cardiovascular events in patients with low to normal LDL-C but at
increased cardiovascular risk as identified by elevated high-sensitivity
C-reactive protein (hsCRP) and age. The majority of patients had at
least one other risk factor including hypertension, low HDL-C, family
history of premature coronary heart disease (CHD) or smoking. hsCRP is a
recognized marker of inflammation which is associated with an increased
risk of atherosclerotic cardiovascular events.
JUPITER is a part of AstraZeneca's extensive GALAXY
clinical trials program, designed to address important unanswered
questions in statin research. Currently, more than 69,000 patients have
been recruited from 55 countries worldwide to participate in the GALAXY
Program.
About AstraZeneca
Crestor is a product of AstraZeneca, a major
international healthcare business engaged in the research, development,
manufacturing and marketing of meaningful prescription medicines and
supplier for healthcare services. AstraZeneca is one of the world's
leading pharmaceutical companies with healthcare sales of $31.6 billion
and is a leader in gastrointestinal, cardiovascular, neuroscience,
respiratory, oncology and infectious disease medicines. For more
information about AstraZeneca, please visit: www.astrazeneca.ca.
Keep up with the latest news for senior citizens, baby
boomers
March 30, 2009 - Healthy men and women who achieved
low levels of both low-density lipoprotein (LDL) cholesterol and high
sensitivity C-reactive protein (hsCRP) after starting statin therapy
dramatically lowered their risk of a future heart attack, stroke, need
for bypass surgery, or cardiovascular death, according to new data
presented at the American College of Cardiology‟s 58th Annual
Scientific Session in Orlando. 