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click             here for RealAudio/Video version

 "I'm       Robert Rivard, Professor and Chair of the Department of Obstetrics and       Gynecology at the University of Cincinnati College of Medicine. I'm here       today with Dr. Bruce Ettinger, who is principle investigator - a senior       investigator - at Kaiser Permanante in Oakland, California. We're here to       talk about hormone replacement therapy and customizing therapy. Dr.       Ettinger, you've had an interest in low dose estrogen therapy for many       years."
       
       

       "Absolutely, that's one of my favorite topics. We started in this       field about fifteen years ago with some bone studies, and it's interesting       to see how many others have come along in the last several years showing       that low dose estrogen is adequate to prevent bone loss at the time of       menopause and does a pretty good job of relieving menopausal       symptoms."
       
       

 "Now       you're also a proponent of, if you will, cyclic therapy - but you have       taken a look in the past and are giving a progesterone at less frequent       intervals than once each month."
       
       

 "Yes,       but I like to call this long cycle therapy. We did a study and published       that a few years ago in Obstetrics       and Gynecology, looking       at every three-month cycling using standard hormone replacement therapy       and showed that that was safe - about a 1% hyperplasia rate at the end of       one year and another 1% at the end of a second year. We're now about       halfway through a very interesting study using both a low dose and a       longer cycle that, I think, will be really revolutionary. What we've done       is switched women from standard dose monthly cyclic HRT .625 with       conjugated estrogens and cyclic monthly MPA to a low dose, half strength       every six-month progesterone cycle. We're using an esterified estrogen       Estratab .3 and we've actually gotten all the women into the study, 138       women, to switch from the standard dose monthly to the half strength every       six-month - and you have some very interesting preliminary data. We really       were interested in two aspects, one - would this be acceptable to women?       Would there be a problem with symptoms when they made the switch, and       would the bleeding pattern be acceptable? And we're very pleased to see       that in both regards we're doing quite well. These 138 women had been on       HRT for an average of nine years so they were pretty satisfied with their       standard monthly HRT. Yet they were able to make the switch, and only 10%       of them had any increase in vasomotor symptoms - so 90% of women had       adequate control of hot flashes and night sweats, etc. and were happy to       be on this. In fact, in addition to the good control of vasomotor       symptoms, overall there was a reduction in both psychological and somatic       symptom scores so women had less breast tenderness, less headache, less       irritability, and less mood disturbance when they switched from standard       dose to the low dose. From the point of view of bleeding, we looked at two       things - one was the breakthrough bleeding that would occur during the six       months of unopposed low dose estrogen, and we found just 9% of the women       had any breakthrough bleeding. In fact, it was very close to the 6%       breakthrough bleeding rate that these women had had previously on their       monthly regiment. So breakthrough bleeding didn't appear to be a problem.       What was a big surprise for us was that 60% of these women did not have       significant withdrawal bleeding when they took their Medroxyprogesterone       after six months. We gave them MPA 10 mg a day, for fourteen days - we       wanted to be very conservative and give a very adequate amount of       progesterone. Even after that much progesterone the bleeding, if there was       any, was quite light so only 4% of the cohort had heavy periods compared       to 28% that had reported heavy periods on their monthly standard dose of       HRT. So 60% - no bleeding, very low incidence of heavy bleeding,       relatively shorter cycles, and shorter duration of bleeding. So all of       that, I think, says that this regiment is going to be very acceptable for       women who want safety with this approach.
       
       

 " What       about the long term data for women who want safety with this       approach?"
       
       

 "Now       that's a very important question. Our study is designed for one year, and       we have done endometrial biopsies in all of these 138 women at baseline so       we know that they do not have any endometrial hyperplasia to begin with.       We will be repeating their biopsies as they close out their second cycle.       Those first biopsies are going to be done in the next few weeks, and over       the next six months we'll complete the study, so by early 2000 we should       have all of the endometrial safety data. We're hoping that we can come up       with the same low incidence of endometrial hyperplasia that we found in       our previous study with every three-month cycling. We have good reason to       believe that that will be the case. You know the esterified estrogen study       that was published in the Archives       of Internal Medicine -       two year, unopposed, .3 mg had less than 2% hyperplasia rate, a rate that       was actually similar to the placebo in that study. Of course .625 mg and       higher doses have had higher rates but this was a remarkably low incidence       of endometrial hyperplasia with .3 mg unopposed, and here we're giving       very good opposition every six months. So we hope to get in that same       range of about 1% or less hyperplasia."
       
       

 "How       about protection of bone and cardiovascular effects?"
       
       

 "I       think, of the best bone data that's out, in terms of the quality of the       studies on esterified estrogens is the study that was published in the       archives - Genant, was the first author in December 1997, had about       one-hundred women in each arm of the study - one-hundred on placebo,       one-hundred on .3 mg, one-hundred on .625 mg, and one-hundred on 1.25 mg.       It was very convincing that the .3 mg was adequate to protect against bone       loss over this two-year period. All of the women received calcium in that       study, and I think that's an important element that total calcium intake       of 1200 mg a day helps the estrogen to work better. I understand now that       esterified estrogen testing approved the .3 mg dose by the FDA for       prevention of osteoporosis. Of course, there are several other estrogens       in the low dose category that are also being approved or considered for       osteoporosis prevention. So I think it's just a matter of time until we       are using half strength estrogens for prevention of osteoporosis in a much       more wide spread fashion. Currently only 13% of women in northern       California Kaiser are using half strength estrogen, it goes up to about       18-19% for women over age 65 but it's still a minority of women that are       taking advantage of the benefits of low dose estrogen. I really think the       benefits are the convenience, the lack of side effects, and probably in       the long run - a safer regiment for women to be on. Now you did ask about       cardiovascular disease, and that's a tough one because there aren't that       many women who have been on .3 mg for a very long period of time. We don't       have rock solid data on this, and we know that the half strength estrogen       has a smaller effect on HDL than LDL cholesterol but the nurse's health       study produced some very interesting data a few years ago in the New       England Journal of Medicine.       They showed that compared to women who weren't using hormone therapy at       all, that those on .3 mg or the equivalent of a half strength estrogen,       had about the same degree of cardio protection - around 45-46% reduction       in MI rates as those on .625 mg and that women who use higher doses have       less cardio protection. That's really interesting, and I think it makes us       rethink about the mechanism - the way that estrogen is working to reduce       heart disease may not be all that HDL-LDL dependant. There are a lot of       other factors - the beta receptors that were now discovered in the       endothelium that are very sensitive to small amounts of estrogen and other       mechanisms whereby, a small amount of estrogen could protect against heart       disease without having a big effect on HDL and LDL."
       
       

 "So who       is the ideal candidate for this kind of therapy to your way of       thinking?"
       
       

 "In       my practice, I typically give standard dose estrogen to women who are very       symptomatic at menopause, and who are having a lot of hot flashes and       sweats. I will typically use a monthly cyclic regiment for them because       the continuous combined is terrible for breakthrough bleeding and       irregular bleeding at that time - right at the menopause transition. But       if a woman is on HRT and she likes the way she feels, and she wants to       continue it for the long term benefits, then I typically transition after       a couple of years to a half strength estrogen. I think the choice right       now is half strength estrogen with long cycle either the three-month cycle       or if our six-month cycle works out or a low dose half strength with       continuous combined. I know there are some studies ongoing looking at       continuous combined half strength estrogen and the hope there is that we       can get by with half as much progesterone. I think in a year or so we'll       see those studies. So there are a lot of new options, and physicians are       going to have to learn the new ways of using low dose estrogen."
       
       

 "Bruce,       I want to thank you for sharing your data with us. I'm sure we're all       going to be looking forward to the completion of the study and the final       presentation and publication of these results. Thank you again, Dr. Bruce       Ettinger, from the Kaiser Clinic."
       
       

"Long-Cycle,       Low-Dosage HRT Using Esterified Estrogens, (Estratab)"

ACOG

From ACOG - Philadelphia, Pennsylvania - May, 1999

Customizing Hormone Replacement Therapy

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