Merck itself has acknowledged that long-term exposure to Vioxx can pose a cardiovascular risk.
Caution should be taken in prescribing statins for primary prevention among people at low cardiovascular risk.
In fact, it appeared that the NSAID, diclofenac, posed as serious a cardiovascular risk as did Vioxx.
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And the company says big clinical trials it conducted show no cardiovascular risk.
The addition of the cardiovascular risk to the skin side effects convinced the FDA to ask Pfizer to pull the drug.
But many come with new side effects, including weight gain and the potential for increased cholesterol levels and potentially increased cardiovascular risk.
Patients with primary hypertriglyceridemia be evaluated for a family history of dyslipidemia and cardiovascular disease in order to assess future cardiovascular risk.
"Had we stopped this trial after 18 months, we would have concluded that there was no cardiovascular risk associated with Vioxx, " says Kim.
In the regulatory firestorm that followed, researchers pointed at other arthritis drugs, including Pfizer 's Celebrex and ibuprofen, as also causing cardiovascular risk.
It would be great to have a new drug that had a wonderful effect on lowering cardiovascular risk with incurring any untoward risks.
Merck decided to push forward with Arcoxia after the results of a big study comparing its cardiovascular risk with Voltaren, or diclofenac, from Novartis.
Individuals with high triglyceride levels should undergo further assessment of other cardiovascular risk factors, such as obesity, hypertension, abnormal glucose metabolism, and liver dysfunction.
Nissen frets that Merck is comparing Arcoxia to diclofenac, a drug that itself is thought to be a Cox-2 inhibitor that poses some cardiovascular risk.
Vioxx's label now indicates the drug may carry some cardiovascular risk.
Patients with primary hypertriglyceridemia be screened for other cardiovascular risk factors.
Celebrex, another similar drug that is Pfizer's (nyse: PFE - news - people ) second-biggest seller, currently has not shown any cardiovascular risk.
If the FDA is not convinced that Vivus has a good handle on the potential for cardiovascular risk, that could slow things down a great deal.
The FDA and Vivus both acknowledge that the three clinical trials meant to measure Qsymia's safety and effectiveness were not designed to properly assess cardiovascular risk.
In contrast, the negative results for Vioxx and Celebrex showed a doubling or tripling of risk--about the same increase in cardiovascular risk as with obesity or smoking.
The investigators of those studies determined at the time that the differences were not meaningful and did not establish an increased or decrease cardiovascular risk for Celebrex.
Scientists observed that people who adhered to a Mediterranean diet had a lower risk of heart disease, even in the face of having other cardiovascular risk factors.
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The Senate investigation concluded that Glaxo tried "to minimize or misrepresent findings that Avandia may increase cardiovascular risk" and "attempted to intimidate independent physicians" worried about Avandia's risks.
We found that the increased cardiovascular risk associated with Vioxx could have been known as early as 2001 even though the drug was not withdrawn until 2004.
Steven Nissen, chairman of cardiology at the Cleveland Clinic, says that he "does not agree with the interpretation" that the data from MEDAL shows no cardiovascular risk for Arcoxia.
When Topol co-authored an influential paper on Vioxx and Celebrex in 2001, he and his colleagues looked at three certain signs of cardiovascular risk: heart attack, stroke and death.
Hlatky agreed the study "provides more evidence about the effectiveness of statin therapy in reducing cardiovascular risk, " even among people who don't currently meet the guidelines for this kind of therapy.
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Certainly, such cancer studies can turn up cardiovascular risk.
Subjects in the LibiGel safety study are a minimum of 50 years old and up to 80 years of age, and they must have at least two cardiovascular risk factors at enrollment.
Although the heart disease-inflammation link is promising, there is still controversy over whether heart inflammation is truly independent of other, more established cardiovascular risk factors, such as cholesterol or smoking, O'Donnell says.
Despite several studies showing an association with alcohol intake and reduced cardiovascular risk, guidance from the American Heart Association warns people not to start drinking if they do not already drink alcohol.
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