Re: RESEARCH - WHI: further analysis of venous thrombosis risk with estrogen plus progestin

[Guest guest]

Hi ,

I got a certified letter from the makers of remicade. They told me,

they had to report what happened to me to the FDA. There concern is that it

was the remicade that caused the problem.They want my doctors information

plus access to my medical records. I am not sure what to do. It is strange

because it says this is voluntary on my part. I am wondering if I don't

give them permission they will force the issue. I don't like giving up my

medical records. My sons says to fill out the paper it can't change what

happened. What do you think??????

Lynn

wrote:

> WHI: further analysis of venous thrombosis risk with estrogen plus

> progestin

>

> Rheumawire

> Oct 6, 2004

>

>

> Chicago, IL - Closer analysis of venous thrombosis (VT) outcomes in the

> Women's Health Initiative (WHI) confirms that the use of estrogen plus

> progestin was associated with a more than 2-fold increased risk of VT

> compared with placebo. The risk was further increased with increasing

> age, obesity, and the presence of the factor V Leiden mutation.

>

> In a separate report, results of an observational study suggest that VT

> risk is increased with use of conjugated equine estrogen, but not

> apparently with esterified estrogen.

>

> Both reports appear in the October 6, 2004 issue of the Journal of the

> American Medical Association.[112737, 112743]

>

> The main results from WHI, published in July 2002, had shown a 2-fold

> increase in VT risk with estrogen plus progestin.[112749] In this

> analysis, researchers with first author Dr Cushman (University of

> Vermont, Burlington) report final WHI results, including about 0.4 years

> of additional follow up reflecting the close out of the study. They also

> looked more closely at risk factors that might be associated with

> further increased risk to help inform women who may be considering

> hormone use.

>

> The trial included 16 608 postmenopausal women between 50 and 79 years

> of age, randomized to placebo or 0.625 mg/day of conjugated equine

> estrogen (CEE) plus 2.5 mg/day of medroxyprogesterone acetate.

>

> VT occurred in 167 women in the E+P group (3.5 per 1000 person-years),

> compared with 76 taking placebo (1.7 per 1000 person-years), for a

> hazard ratio of 2.6 (95% CI 1.57-2.70).

>

> Compared with women 50 to 59 years of age on placebo, the risk for VT

> associated with treatment increased with increasing age.

>

> Overweight and obesity also increased the risk for VT among women taking

> estrogen plus progestin.

>

> Finally, baseline gene variants related to thrombosis risk were measured

> in the first 147 women who developed VT during the trial, and in 513

> controls. The researchers found that the factor V Leiden mutation

> increased VT risk compared with women in the placebo group without this

> mutation by almost 7-fold (HR 6.69, 95% CI 3.09-14.49). Other genetic

> factors examined did not appear to modify the association between

> hormone therapy and the risk for VT.

>

> Cushman told rheumawire that it's unlikely at this point that older

> women would be considering the use of hormones so the " more clinically

> relevant finding " is the increased risk with obesity and overweight. " If

> you have a woman sitting in front of you, and you want to use hormone

> therapy, she needs to understand that her risk is higher from an

> absolute perspective than a thinner woman who's considering taking

> them, " Cushman said. They calculated that the absolute risk for obese

> women with no other thrombosis risk factors would be " a little more than

> 1%, " she said, " so you wouldn't necessarily withhold treatment, but

> you'd want to make sure they understand the risk, and that they know the

> symptoms [of venous thrombosis] to look for. "

>

> The finding relating to factor V Leiden would probably not be considered

> in this decision unless the patient has a family history of thrombosis,

> because in general this information would not be available, she said.

> They calculated that 800 women would need to be screened for factor V

> Leiden to prevent 1 episode of VT, which is unlikely to be

> cost-effective. " This is an inter-relation that we know exists, but we

> don't know that it would make sense to screen for it based on the

> findings. "

>

> In a separate report in the same issue of JAMA, Dr L

> (PhD, University of Washington, Seattle) and colleagues some of whom

> were also coauthors on the previous paper used data from the Group

> Health ative (GHC), a large health maintenance organization in

> Washington State, to look at what they speculated might be differential

> effects of CEE vs esterified estrogens (EE) on venous thrombosis risk.

>

> Clinical trial evidence indicating an increased risk of VT with hormone

> therapy used CEE, et al write, and so might not be generalizable

> to other estrogen compounds. EEs have received less attention, they

> point out, but all these products continue to be used to treat

> menopause-related vasomotor symptoms.

>

> In October 1999, the GHC pharmacies switched the standard postmenopausal

> therapy from EE to CEE for current and new users of hormone therapy, the

> researchers write. " The formulary change occurred during data collection

> for a case-control study of cardiovascular outcomes that included VT,

> which presented us with the opportunity to examine the association of

> oral EE and CEE with VT risk in perimenopausal and postmenopausal

> women, " et al write.

>

> Between January 1995 and December 2001, 586 incident cases of VT were

> identified, and matched for age, hypertension status and calendar year

> with 2268 controls.

>

> Compared with women not currently using hormones, women currently using

> EE had no increase in VT risk, while those taking CEE did.

>

> When analysis was restricted to estrogen users, current users of CEE had

> a higher risk of VT than those currently using EE (OR 1.78, 95% CI

> 1.11-2.84). Increasing daily doses of CEE was also associated with

> increased risk, and concomitant progestin use again increased risk among

> all estrogen users, compared with estrogen alone (OR 1.60, 95% CI

> 1.13-2.26).

>

> " I think it was the assumption that most estrogens are the same and you

> could exchange them without much problem, " told rheumawire. " Our

> data suggest that may not be the case. "

>

> If these results are replicated, he said, EE might be a better

> alternative for those choosing short-term symptom relief during

> menopause. He cautioned though that EEs have never been studied in large

> trials, so their effects on other endpoints might be more favorable than

> CEE, but they might not. " There's just so much that's not known about

> these drugs, " he said.

>

>

>

> I'll tell you where to go!

>

> Mayo Clinic in Rochester

> http://www.mayoclinic.org/rochester

>

> s Hopkins Medicine

> http://www.hopkinsmedicine.org

>

>

>