MANILA, Philippines - New findings from a landmark study revealed that the cholesterol-lowering drug rosuvastatin cuts the risk of venous thromboembolism (VTE) by 43 percent.
The data were presented during the recently concluded American College of Cardiology 2009 Scientific Sessions in Orlando, Florida.
Blood clots can form in the leg veins called VTE, which is a life-threatening condition. The most common form of VTE is deep vein thrombolism (DVT), which occurs in the deep veins usually in the legs or pelvis.
This can lead to serious complications such as pulmonary embolism wherein the blood clots from the leg veins travel all the way to the lungs and clog also its blood vessels. This causes pulmonary infarction wherein part of the lung tissues die — a potentially fatal condition.
The breakthrough findings are part of the extensive analyses on the results of JUPITER (Justification for the Use of statins in Primary prevention: an Intervention Trial Evaluating Rosuvastatin) and it showed that 20 mg of the statin can also reduce the danger of developing VTE in apparently healthy individuals with elevated high-sensitivity C-reactive protein (hs-CRP), a locally available blood test to identify patients who may be at risk of various cardiovascular complications.
“This is the first time that a statin has been shown to reduce the risk of VTE in a randomized, prospective study,” said Dr. Alex Gold, executive director for clinical development of AstraZeneca US.
It is estimated that at least 350,000 and as many as 600,000 Americans annually develop DVT/PE and at least 100,000 deaths are thought to be related to this disease each year.
Although there are no definite statistics on the prevalence of VTE and/or pulmonary embolism in the Philippines, local medical experts say that it is a prevalent problem though not frequently detected.
Patients at risk to develop heart attacks and strokes may also be at risk to develop VTE since common mechanisms are shared by these serious medical conditions.
The JUPITER trial enrolled 17,802 apparently healthy men and women with low to normal cholesterol levels but raised levels of hs-CRP. The participants were randomized to receive either rosuvastatin or placebo.
The trial was stopped prematurely after a median follow-up of 1.9 years showed that rosuvastatin demonstrated a clear benefit on major cardiovascular events, which is its primary endpoint.
The findings on VTE were presented by Dr. Robert Glynn, associate professor in the Department of Biostatics at Harvard Medical School and Brigham and Women’s Hospital in Boston, Massachusetts. It was also simultaneously published in the New England Journal of Medicine.
Aside from the significant effect of the drug to VTE, the trial also showed that the reduction in VTE was achieved without an increase in bleeding. There were 258 hemorrhagic events in the rosuvastatin group versus 275 with placebo. It is in contrast with drugs like warfarin and heparin, which are also effective in preventing VTE but at a cost of more bleeds.
Glynn explained that the most likely reason for the benefit in preventing VTE is rosuvastatin’s anticoagulant effect, noting that statins downregulate the blood coagulation cascade through decreased tissue-factor expression, leading to reduced thrombin formation.
“Widening the treatment target to include prevention of VTE and death in addition to arterial thrombosis increases the estimated benefit of statin use,” Glynn said.