Treatment of RA, Annals article 11/2008
2002 treatment guidelines
Saturday, November 24, 2007
Tuesday, November 13, 2007
Relation Between Oral Contraceptive Use and Cervical Cancer
Use of oral contraceptives for 5 or more years doubles the risk for invasive cervical cancer, but the risk decreases progressively after stopping use, according to a Lancet study.
Researchers examined data on oral contraceptive use from 24 studies comprising some 11,200 women with invasive cervical cancer and 35,500 controls. The risk for cancer increased with duration of use, was highest in current users, and declined with time since last use. Among those who'd stopped using oral contraceptives for 10 years or more, the risk was similar to that of never users.
To give a sense of the additional risk, the authors estimate that 10 years' use starting at age 20 would raise the cumulative cancer incidence at age 50 from 3.8 to 4.5 per 1000 women.
An editorialist points out a potential confounding factor: "Women using oral contraceptives are more likely to be exposed to HPV than are those using barrier methods or not having sexual intercourse."
Lancet article (Free abstract; full text requires subscription)
Researchers examined data on oral contraceptive use from 24 studies comprising some 11,200 women with invasive cervical cancer and 35,500 controls. The risk for cancer increased with duration of use, was highest in current users, and declined with time since last use. Among those who'd stopped using oral contraceptives for 10 years or more, the risk was similar to that of never users.
To give a sense of the additional risk, the authors estimate that 10 years' use starting at age 20 would raise the cumulative cancer incidence at age 50 from 3.8 to 4.5 per 1000 women.
An editorialist points out a potential confounding factor: "Women using oral contraceptives are more likely to be exposed to HPV than are those using barrier methods or not having sexual intercourse."
Lancet article (Free abstract; full text requires subscription)
Monday, November 5, 2007
Sunday, November 4, 2007
Tuesday, October 30, 2007
Monday, October 29, 2007
FDA Clears Genetic Lab Test for Warfarin Sensitivity
The U.S. Food and Drug Administration today cleared for marketing a new genetic test that will help physicians assess whether a patient may be especially sensitive to the blood-thinning drug warfarin (Coumadin), which is used to prevent potentially fatal clots in blood vessels.
One-third of patients receiving warfarin metabolize it quite differently than expected and experience a higher risk of bleeding. Research has shown that some of the unexpected response to warfarin depends on variants of two genes, CYP2C9 and VKORC1. The Nanosphere Verigene Warfarin Metabolism Nucleic Acid Test detects some variants of both genes.
"Today’s action offers physicians the first FDA cleared genetic test for warfarin sensitivity, which is another step in our commitment to personalized medicine,” said Daniel Schultz, M.D., director, FDA’s Center for Devices and Radiological Health. “With this test, physicians may be able to use genetic information along with other clinical information to treat their patients.”
Warfarin can be a difficult drug to use because the optimal dose varies depending on many risk factors, including a patient's diet, age, and the use of other medications. Rapidly achieving the correct dose is important. Patients who receive doses that are higher than needed to correctly thin the blood are at risk of life-threatening bleeding. Those who receive doses that are too low may remain at risk of life-threatening blood clots.
Warfarin is the second most common drug, after insulin, implicated in emergency room visits for adverse drug events.
In August, FDA approved updated labeling for Coumadin, the brand name version of warfarin, explaining that people with variations of the genes CYP2C9 and VKORC1 may respond differently to the drug. Manufacturers of generic warfarin are adding similar information to their products' labeling.
Physicians and other health care professionals who prescribe warfarin regularly check to see if the drug is working properly by ordering a test called the PT or prothrombin time that evaluates the blood's ability to clot properly. The results are measured in seconds and compared with the expected value in healthy people, known as the International Normalized Ratio or INR.
The Nanosphere test is not intended to be a stand-alone tool to determine optimum drug dosage, but should be used along with clinical evaluation and other tools, including INR, to determine the best treatment for patients.
FDA cleared the test based on results of a study conducted by the manufacturer of hundreds of DNA samples as well as on a broad range of published literature. In a three site study, the test was accurate in all cases where the test yielded a result; 8 percent of the tests could not identify which genetic variants were present.
The new test was cleared for use on the Verigene System, a clinical laboratory test system. Both products are manufactured by Nanosphere Inc., Northbrook, Ill.
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One-third of patients receiving warfarin metabolize it quite differently than expected and experience a higher risk of bleeding. Research has shown that some of the unexpected response to warfarin depends on variants of two genes, CYP2C9 and VKORC1. The Nanosphere Verigene Warfarin Metabolism Nucleic Acid Test detects some variants of both genes.
"Today’s action offers physicians the first FDA cleared genetic test for warfarin sensitivity, which is another step in our commitment to personalized medicine,” said Daniel Schultz, M.D., director, FDA’s Center for Devices and Radiological Health. “With this test, physicians may be able to use genetic information along with other clinical information to treat their patients.”
Warfarin can be a difficult drug to use because the optimal dose varies depending on many risk factors, including a patient's diet, age, and the use of other medications. Rapidly achieving the correct dose is important. Patients who receive doses that are higher than needed to correctly thin the blood are at risk of life-threatening bleeding. Those who receive doses that are too low may remain at risk of life-threatening blood clots.
Warfarin is the second most common drug, after insulin, implicated in emergency room visits for adverse drug events.
In August, FDA approved updated labeling for Coumadin, the brand name version of warfarin, explaining that people with variations of the genes CYP2C9 and VKORC1 may respond differently to the drug. Manufacturers of generic warfarin are adding similar information to their products' labeling.
Physicians and other health care professionals who prescribe warfarin regularly check to see if the drug is working properly by ordering a test called the PT or prothrombin time that evaluates the blood's ability to clot properly. The results are measured in seconds and compared with the expected value in healthy people, known as the International Normalized Ratio or INR.
The Nanosphere test is not intended to be a stand-alone tool to determine optimum drug dosage, but should be used along with clinical evaluation and other tools, including INR, to determine the best treatment for patients.
FDA cleared the test based on results of a study conducted by the manufacturer of hundreds of DNA samples as well as on a broad range of published literature. In a three site study, the test was accurate in all cases where the test yielded a result; 8 percent of the tests could not identify which genetic variants were present.
The new test was cleared for use on the Verigene System, a clinical laboratory test system. Both products are manufactured by Nanosphere Inc., Northbrook, Ill.
#
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