SubscribeBoth studies were conducted using electronic health care claims data. However, the results of the two studies are different.The published BCDSP study can be read here. With regard to the second study, a doubling of the rate of an event that occurs with low frequency in a population without risk factors (such as smoking or Factor V Leiden) still gives a very low frequency event. That is, the risk of venous thrombosis is approximately 3-4 per 10,000 woman-years for the users of oral contraceptive pills (OCPs), so the risk if the second study is true is still only 6-8 per 10,000. And it is also important to note that not every DVT (deep vein thrombosis) or PE (pulmonary embolus) is fatal. Especially in young, healthy women. So once you factor in the fatality rate for DVT/PE, you're talking about a low (approximately 4 deaths per million OCP users per year) but non-zero fatality rate.
The first study was conducted by the Boston Collaborative Drug Surveillance Program. This study found that the risk of non-fatal VTE events associated with the use of the Ortho Evra contraceptive patch is similar to the risk associated with the use of oral contraceptive pills (OCs) containing 35 micrograms of ethinyl estradiol (an estrogen) and norgestimate (a progestin hormone).
The second study, which also included patient chart review, was conducted by another group of investigators (i3 Ingenix). Results of this second case-control study show an approximate 2-fold increase in the risk of medically verified VTE events in users of Ortho Evra compared to users of norgestimate-containing oral contraceptives containing 35 micrograms of estrogen. Longer follow-up for VTE, heart attack and stroke, has been requested by FDA. [NB: my italics]
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In Britain, they have IUS (interuterine system) which is an IUD with a small amount of hormone which counteracts the side effects of IUD (heavier periods, bad cramps). It's safe for young women and women who haven't had children, but I never even heard about it before I moved to Britain.
posted by jb at 3:09 AM on November 3, 2006