OB-GYN-L Messages for October, 2002: Re: ERT/HRT- personal prescribing trend

Re: ERT/HRT- personal prescribing trend
From: Terrence.Jones@kp.org
Fri Oct 18 21:01:36 2002

Messages sorted by: [ date ][ thread ][ subject ][ author ]
Next message: Joanne Bulley, MD: "Re: ERT/HRT- personal prescribing trend"
Previous message: Mark Perloe: "Re: ERT/HRT- personal prescribing trend"
Maybe in reply to: Zach Newton: "ERT/HRT- personal prescribing trend"
Next in thread: Jay Kulkin: "Re: ERT/HRT- personal prescribing trend"

This is a multipart message in MIME format. --=_alternative 000AABCA88256C57_ Content-Type: text/plain; charset="us-ascii"
Mark, maybe You can help, I've not had time to satisfactorily investigate this. Is it known how the "Baseline Characteristics" distribution of the treatment group changed following the 42% drop-outs? And whether they dropped out before or after an event? Tho censoring event history 6 months after nonadherence increased effect size, it is not clear what was the (corrected?) distribution of risk in the compliant treatment group. In addition, it isn't clear, who in the treatment group had adverse events. Were the DVT's primarily in the 1% of Pts with a hx of DVT? Were the coronary events clustered in the 4% with prior MI or angina? Was there a skewing of adverse events towards the 66.6% age > 60? I'm a bit confused over the phrase "healthy" postmenopausal women, when 10% are current smokers, and overall smoking prevalence was 50%. When 35% are being treated for HTN, 12% for elev chol, and 4% for DM. This all suggests a high prevalence of cytokine sensitive, nitric oxide insensitive, coronary endothelium. How many of the breast cancers occurred in the 102 excess 'age > 30 at first born' group, or the 112 excess positive 'female rel with breast cancer' group? For primary prevention in truly healthy coronary arteries, 5 years seems a bit short to see any effects from HDL elevation? Yet 5 years seems like plenty of time to increase cytokine mediated inflammation to plaque-ridden arteries at a rate of 37 (vs 30 placebo; with a 10% 'drop-in rate?) out of 10,000 women/year - in a group of 8506 women of which 472 had either MI, angina, or stents. I think Dr. Grady already showed us this. The study designers say the outcomes are too hard to be subject to bias. Still, a 60% unblinding rate in the treatment group seems a bit high, particularly when there was a 42% dropout rate. Is there a potential defect in an intention to treat model when half the treatment group drops out? Maybe we should be patient and leave them time for case control analyses of predictors in the adverse outcomes group (for instance, as You've mentioned - CRP). It seems a shame this was not done prior to termination, considering the resources involved. Oh well Zach, there's always WISDOM. Unfortunately (or not!) - by the time their data is available, Tibolone will be released. Would wonder if, by now, there are sufficient numbers, with Livial, to show any data on DVT (fibrinolysis)? Also, any comments on TMG (Trimegestone)? tj
Mark Perloe <mperloe@ivf.com> Sent by: ob-gyn-l@obgyn.net 10/18/2002 05:08 PM Please respond to ob-gyn-l
To: Multiple recipients of list OB-GYN-L <ob-gyn-l@mail.medispecialty.com> cc: Subject: Re: ERT/HRT- personal prescribing trend
Zach, Please read the followup paper in JAMA two weeks later that revisited the WHI data set. In that paper, they noted that if the study group and control groups were controlled for CRP, a known cardiovascular risk factor, there was no longer an increased risk in the estrogen treatment group. This means that perhaps we need to consider CRP, homocysteine, And maybe Factor V Leiden if there is increased stroke risk. Overall, the WHI did show lower mortality. Less colon cancer. And, the issue of breast cancer mortality was not addressed, just the increased of new cases during a brief period of the study. Mark Perloe
At 08:41 PM 10/16/2002 -0500, you wrote:
The noise level in the role of use of ERT/HRT exceeds the specs on commercial grade ear protectors. The signal level has become garbage on the screen.
Take any EBM you like, then place your bet.
One thing rings true: it makes sense to assess and recommend on basis of individual risk/benefit analysis. Actually, that truism is meaningless, as there is no standard for such assessment.
I digress to common sense and some science.
Bad things happen to those who hold bad cards more often then to those who hold good cards. The baggage carried by bad card holders should not burden potential benefit to the good card holders. Life is not fair.
The patient population in the pre,peri,post menopausal age group that I see are on average in generally good health. Heavy duty morbidity is certainly represented, but lightly on a numbers basis.
Big morbidity translates into premature death risk. Other than vasomoter instability, where is there indication for long term ERT/HRT here?
For the vigorously healthy, I passionately recommend ERT/HRT, absent a medical reason or patient objection.
Trend mentioned in subject line is toward increased use of transdermal delivery in the belief that avoidance of first hepatic passage could reduce multiple risk concerns fostered by induction of hepatic enzyme systems with oral route.
Zach Newton Z. B. Newton, III, M.D. Atlanta/Gyn
--=_alternative 000AABCA88256C57_ Content-Type: text/html; charset="us-ascii"
 Mark, maybe You can help, I've not had time to satisfactorily investigate this. Is it known how the "Baseline Characteristics" distribution of the treatment group  changed following the 42% drop-outs? And whether they dropped out before or after an event? Tho censoring event history 6 months after nonadherence increased effect size, it is not clear what was the (corrected?) distribution of risk in the compliant treatment group. In addition, it isn't clear, who in the treatment group had adverse events. Were the DVT's primarily in the 1% of Pts with a hx of DVT? Were the coronary events clustered in the 4% with prior MI or angina? Was there a skewing of adverse events towards the 66.6% age > 60? I'm a bit confused over the phrase "healthy" postmenopausal women, when 10% are current smokers, and overall smoking prevalence was 50%. When 35% are being treated for HTN, 12% for elev chol, and 4% for DM. This all suggests! a high prevalence of cytokine sensitive, nitric oxide insensitive, coronary endothelium. How many of the breast cancers occurred in the 102 excess 'age > 30 at first born' group, or the 112 excess positive 'female rel with breast cancer' group? For primary prevention in truly healthy coronary arteries, 5 years seems a bit short to see any effects from HDL elevation? Yet 5 years seems like plenty of time to increase cytokine mediated inflammation to plaque-ridden arteries at a rate of 37 (vs 30 placebo; with a 10% 'drop-in rate?) out of 10,000 women/year - in a group of 8506 women of which 472 had either MI, angina, or stents. I think Dr. Grady already showed us this. The study designers say the outcomes are too hard to be subject to bias. Still, a 60% unblinding rate in the treatment group seems a bit high, particularly when there was a 42% dropout rate. Is there a potential defect in an intention to treat model when half the treatment group drops out?  Maybe we shoul! d be patient and leave them time for case control analyses of predictors in the adverse outcomes group (for instance, as You've mentioned - CRP). It seems a shame this was not done prior to termination, considering the resources involved. Oh well Zach, there's always WISDOM. Unfortunately (or not!) - by the time their data is available, Tibolone will be released. Would wonder if, by now,  there are sufficient numbers, with Livial, to show any data on DVT (fibrinolysis)? Also, any comments on TMG (Trimegestone)?   tj   <table width0%> <tr valign=top> <td> <td>Mark Perloe <mperloe@ivf.com> Sent by: ob-gyn-l@obgyn.net 10/18/2002 05:08 PM Please respond to ob-gyn-l <td>                To:        Multiple recipients of list OB-GYN-L <ob-gyn-l@mail.medispecialty.com>         cc:                 Subject:        Re: ERT/HRT- personal prescribing trend</table> Zach, Please read the followup paper in JAMA two weeks later that revisited the WHI data set. In that paper, they noted that if the study group and control groups were controlled for CRP, a known cardiovascular risk factor, there was no longer an increased risk in the estrogen treatment group. This means that perhaps we need to consider CRP, homocysteine,  And maybe Factor V Leiden if there is increased stroke risk. Overall, the WHI did show lower mortality. Less colon cancer. And, the issue of breast cancer mortality was not addressed, just the increased of new cases during a brief period of the study. Mark Perloe At 08:41 PM 10/16/2002 -0500, you wrote: The noise level in the role of use of ERT/HRT exceeds the specs on commercial grade ear protectors. The signal level has become garbage on the screen. Take any EBM you like, then place your bet. One thing rings true: it makes sense to assess and recommend on basis of individual risk/benefit analysis. Actually, that truism is meaningless, as there is no standard for such assessment. I digress to common sense and some science. Bad things happen to those who hold bad cards more often then to those who hold good cards. The baggage carried by bad card holders should not burden potential benefit to the good card holders. Life is not fair. The patient population in the pre,peri,post menopausal age group that I see are on average in generally good health. Heavy duty morbidity is certainly represented, but lightly on a numbers basis. Big morbidity translates into premature death risk. Other than vasomoter instability, where is there indication for long term ERT/HRT here? For the vigorously healthy, I passionately recommend ERT/HRT, absent a medical reason or patient objection. Trend mentioned in subject line is toward increased use of transdermal delivery in the belief that avoidance of first hepatic passage could reduce multiple risk concerns fostered by induction of hepatic enzyme systems with oral route. Zach Newton Z. B. Newton, III, M.D. Atlanta/Gyn 

Next message: Joanne Bulley, MD: "Re: ERT/HRT- personal prescribing trend"
Previous message: Mark Perloe: "Re: ERT/HRT- personal prescribing trend"
Maybe in reply to: Zach Newton: "ERT/HRT- personal prescribing trend"
Next in thread: Jay Kulkin: "Re: ERT/HRT- personal prescribing trend"

Return to Mail a New Message to the Forum: ob-gyn-l@obgyn.net
Forum Administrator: geffrey.klein@obgyn.net
Report Technical Problems: webmaster@obgyn.net
Last Updated: Wed Dec 2 04:54:14 2009

The American Medical Association is no longer designating CME hours for AMA Category II CME credit. However, physicians themselves may self designate learning activities as Category II CME credit hours if they feel it is of sufficient educational merit and meets the formal definitions of continuing medical education. OBGYN.net believes these interaction in this forum meets these criteria. For further information see the AMA web site.

use when must restrict search to only the ob-gyn-l forum...
Enter search keywords:
	Returns per screen: Require all keywords: