Canagliflozin exhibited significantly higher efficacy than Dapagliflozin, which should weigh the overall risk benefit profile in its favor.
"I can't imagine a situation, given what we know now, other than a screening mechanism followed by some sort of trial for the net risk and benefit versus risk, " Califf said.
According to the agency, the same risk-benefit analysis does not hold true for restless-leg syndrome.
But it's hard to tell exactly where society comes down on the balancing the risk-benefit scale.
Greater accountability, more expeditious decision-making and improved risk-benefit balancing would expend resources more efficiently.
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"Those of us who are involved in the field are concerned with more of the risk than benefit here, " he said.
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What we need is a way of balancing risk against benefit better, because for some medicines, the dangers will never justify the gains.
In recent months, Lilly-backed researchers have shown that prasugrel's risk-benefit profile looks better in diabetics and patients with certain types of heart attacks.
After all, if Vioxx was sold mainly as safer on the stomach, shouldn't the chance of heart risks have radically changed the risk-benefit assessment of the drug?
Like it or not, government is the only institution powerful enough to realign the risk-benefit ratio so that the people's interests are at least borne in mind.
Dr Anne MacGregor, who runs the menopause clinic at St Bartholomew's Hospital in London, feels women are not being given the option of weighing up the risk-benefit ratio themselves.
The latter group's highly narrow focus on "safety" ignores the fact that because all drugs have side-effects, safety cannot be evaluated in a vacuum but must be part of a risk-benefit judgment.
Given what is likely to be a small magnitude of incremental cardiovascular benefit of high potency statins over low potency statins in reality, a pressing question is how to identify patients for whom the risk-benefit balance for high potency statin treatment is unfavourable.
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Concerned about the entire class of COX-2 inhibitors, the FDA convened a joint session of their Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee on February 16, 17 and 18 to advise the FDA on the risk-benefit profile for these drugs.
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That risk changes over time, but one can have a low risk and still gain a great benefit or have a high risk and still never need any benefit.
Investment decisions always include an effort to weigh the risk vs. benefit.
Sources said they were mindful of the risk of pushing benefit claimants into poverty, but that there was potential for massive savings.
It could be that there was never any relationship between KIF6 and heart disease whatsoever, and that the earlier findings of an emhanced heart risk and enhanced benefit of statins were just due to the play of chance.
"Speeding is a risk behaviour with little benefit, but great potential costs, " says Professor McKenna.
Another high-risk group that would benefit from increased HIV testing, according to NICE, is the black African community living in England.
Because of their family and genetic history, another two in every 100 women are at moderate risk and may also benefit from preventive therapy, experts say.
When taking a drug, the benefit-risk profile must be considered.
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Summed up, for a divorcing spouse with little or no taxable income for the tax year, signing a joint tax return may pose considerable liability risk with no appreciable benefit.
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In fact, while the low-risk patients might not receive any benefit from the test, there is at least some risk from radiation--which is higher for a CT angiogram than a traditional X-ray.
Some doctors are already using the combination of the drugs to treat obesity, which is why some FDA panel members said it was important to get Qnexa on the market so that patients have appropriate benefit and risk information.
It's clear to me that most men with a low risk of prostate cancer would benefit from surveillance instead of immediate treatment.
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In fact, anyone who thought he or she was at increased risk of COPD could potentially benefit from these supplements, he adds.
People take risks, and then they get the benefit of the risk.
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