Study Compares Heart Risks for 2 Hormonal Regimens

WEDNESDAY, Oct. 2 (HealthDay News) -- An estrogen drug used by women to relieve hot flashes and other menopausal symptoms is tied to an increased risk for certain types of heart troubles, while another estrogen drug appears to be safer, a new study says.

Researchers compared the cardiovascular safety of the two commonly used pills: Premarin, a so-called "conjugated equine estrogen" and a generic version of estradiol.

Premarin is made from the urine of pregnant mares while estradiol is a "natural" or "bioequivalent" estrogen, according to background information in the study, which was funded by the U.S. National Heart, Lung, and Blood Institute.

Although these estrogen pills "are effective for managing menopause symptoms, not enough is known about the cardiovascular safety of different oral hormone therapy products relative to each other," lead author Nicholas Smith, an affiliate investigator at the Group Health Research Institute, said in a Group Health news release.

The researchers tracked outcomes for 384 postmenopausal women, aged 30 to 79, who were using hormone therapy pills. The women included 68 who had experienced blood clots in the legs and in the lungs, 67 who had a heart attack, as well as 48 who had an ischemic stroke, which occurs due to blocked blood flow to the brain. The other 201 women acted as a control group.

Compared to women who took estradiol, those who took Premarin had a higher risk of blood clots. The women taking Premarin also had a somewhat higher risk of heart attack. There was no difference in ischemic stroke risk, according to the study published online this week in the journal JAMA Internal Medicine.

Smith and his colleagues said that further studies are needed to confirm these findings.

"If confirmed, the results would provide valuable information to women and their health care professionals when making safety decisions regarding available (hormone therapy) options for menopausal symptom management," the researchers concluded.

One other expert agreed that this "small" study is not the final word on this issue.

"Clearly, further studies need to be done, as for many women HRT is part of the treatment for quality of life, and knowing the safest treatment option is crucial," said Dr. Suzanne Steinbaum, director for women and heart disease at Lenox Hill Hospital, in New York City.

-- Robert Preidt
Copyright © 2013 HealthDay. All rights reserved. SOURCES: Suzanne Steinbaum, M.D., director, women and heart disease, Lenox Hill Hospital, New York City; Group Health Research Institute, JAMA Internal Medicine, news releases, Sept. 30, 2013

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BMD Correlates with Number of HIV Regimens (CME/CE)

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Published: Jul 3, 2013 | Updated: Jul 3, 2013

By Ed Susman, Contributing Writer, MedPage TodayReviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco and Dorothy Caputo, MA, BSN, RN, Nurse PlannerNote that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.The number of HIV treatment regimens a patient undergoes appears to correlate with loss of bone mineral density.Note that the study did not find that current use of or cumulative exposure to antiretrovirals, antiretroviral class, or specific antiretroviral agents independently predicted lower bone mineral density.

KUALA LUMPUR -- The number of HIV treatment regimens a patient undergoes appears to correlate with loss of bone mineral density (BMD), researchers reported here at the International Aids Society Conference on HIV Pathogenesis, Treatment, and Prevention.

In the multivariate analysis involving 210 patients with HIV infection, the parameter estimate for BMD loss at the femoral neck was -0.011 g/cm2 for each regimen a patient had taken (95% CI minus 0.022-minus 0.0003, P=0.05), reported Aoife Cotter, MD, a fellow in infectious diseases at University College Dublin.

"Unexpectedly, we did not find that current use of or cumulative exposure to antiretrovirals, antiretroviral class, or specific antiretroviral agents independently predicted lower bone mineral density," Cotter told MedPage Today at her poster presentation.

In addition to the multivariate analysis finding of lower BMD at the femoral neck, Cotter and colleagues also noted that the lumbar spine BMD loss was also associated with the number of HIV regimens. At the lumbar spine there was a loss of 0.015 g/cm2 (P=0.03), she reported.

Cotter reviewed data in the prospective HIV UPBEAT (Understanding the Pathology of Bone Disease in HIV-infected Subjects) which enrolled HIV-positive and HIV-negative participants from similar demographic backgrounds. The median age of the HIV-infected patients was 39, mean BMI was 26 kg/m2, 58.6% were men, 60.5% were Caucasians, 39.5% were of African ethnicity, 34.8% were current smokers.

Cotter said the researchers considered that the number of HIV regimens might be a surrogate measure for time with HIV infection, but in performing the multivariate analysis they did not find a correlation that was statistically significant.

"We suggest that these findings are consistent with data demonstrating greater reductions in bone mineral density associated with antiretroviral-induced HIV suppression occurring with multiple antiretroviral regimens," she said.

In the multivariate analysis, the researchers did not see a significant difference in bone mineral density loss when comparing injecting drug users with non-injecting drug users with HIV infection (P=0.54); with baseline CD4-positive T-cell counts- (P=0.21); with nadir CD4 cell counts (P=0.09); duration since HIV diagnosis (P=0.86); cumulative antiretroviral exposure (P=0.40); cumulative nucleoside reverse transcriptase inhibitor exposure (P=0.41); cumulative tenofovir exposure (P=0.34); cumulative non-nucleoside reverse transcriptase inhibitor exposure (P=0.63), or cumulative protease inhibitor exposure (P=0.11).

In commenting on the study, Ian Woolley, MBBS, professor of medicine at Monash University in Melbourne, Australia, told MedPage Today, "The number of HIV regimens may be a surrogate for lack of adherence by these patients."

He added, "There are usually two reasons why patients change regimens. It is because of resistance or because of toxicity. It is also possible there is a phenotype that is more likely to develop toxicity."

He noted that resistance often arises when patients are not adherent in taking their antiretroviral medications.

Cotter and Woolley had no disclosures.

Primary source: International AIDS Society
Source reference:
Cotter A, et al "Number of different antiretroviral regimens rather than cumulative exposure to antiretrovirals associated with lower bone mineral density in HIV-positive subjects" IAS 2013; Abstract MOPE078.

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