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"Randomized trial of estrogen plus
progestin for secondary prevention of coronary heart disease in postmenopausal
women," by Stephen Hulley and 6
others, for the Heart and Estrogen/progestin Replacement Study (HERS) Research
Group," JAMA-Journal of the American Medical Association,
280(7):605-13, 19 August 1998.
[Main authors' affiliations: University of
California, San Francisco; Johns Hopkins University, Baltimore, MD; Wake
Forest University, Winston-Salem, NC: Wyeth Ayerst Res., Radnor, PA]
Abstract: "Context--Observational
studies have found lower rates of coronary heart disease (CHD) in
postmenopausal women who take estrogen than in women who do not, but this
potential benefit has not been confirmed in clinical trials. Objective--To
determine if estrogen plus progestin therapy alters the risk for CHD events in
postmenopausal women with established coronary disease. Design--Randomized,
blinded, placebo-controlled secondary prevention trial. Setting--Outpatient
and community settings at 20 US clinical centers. Participants--A
total of 2,763 women with coronary disease, younger than 80 years, and
postmenopausal with an intact uterus. Mean age was 66.7 years. Intervention--Either
0.625 mg of conjugated equine estrogen plus 2.5 mg of medroxyprogesterone
acetate in 1 table daily (n = 1380). Follow-up averaged 4.1 years; 82% of
those assigned to hormone treatment were taking it at the end of 1 year, and
75% at the end of 3 years. Main Outcome Measures--The primary
outcome was the occurrence of non-fatal myocardial infarction (MI) or CHD
death. Secondary cardiovascular outcomes included coronary revascularization,
unstable angina, congestive heart failure, resuscitated cardiac arrest, stroke
or transient ischemic attack, and peripheral arterial disease. All-cause
mortality was also considered. Results--Overall, there were no
significant differences between groups in the primary outcome or in any of the
secondary cardiovascular outcomes: 172 women in the hormone group and 176
women in the placebo group had MI or CHD death (relative hazard [RH], 0.99;
95% confidence interval [CI], 0.80-1.22). The lack of an overall effect
occurred despite a net 11% lower low-density lipoprotein cholesterol level and
10% higher high-density lipoprotein cholesterol level in the hormone group
compared with the placebo group (each P<.001). Within the overall null
effect, there was a statistically significant time trend, with more CHD events
in the hormone group compared with the placebo group in year 1 and fewer in
years 4 and 5. More women in the hormone group than in the placebo group
experienced venous thromboembolic events (34 vs 12; RH, 2.89; 95% CI,
1.50-5.58) and gallbladder disease (84 vs 62; RH, 1.38; 95% CI, 1.00-1.92).
There were no significant differences in several other end points for which
power was limited, including fracture, cancer, and total mortality (131 vs 123
deaths; RH, 1.08; 95% CI, 0.84-1.38). Conclusions--During an
average follow-up of 4.1 years, treatment with oral conjugated equine plus
medroxyprogesterone acetate did not reduce the overall rate of CHD events in
postmenopausal women with established coronary disease. The treatment did
increase the rate of thromboembolic events and gallbladder disease. Based on
the finding of no overall benefit and a pattern of early increase in risk of
CHD events, we do not recommend starting this treatment for the purpose of
secondary prevention of CHD. However, given the favorable pattern of CHD
events after several years of therapy, it could be appropriate for women
already receiving this treatment to continue."
This 1998 report from JAMA-Journal of the
American Medical Association was cited 43 times in current
journal articles indexed in the ISI database during July-August 2000. As
during the previous, May-June count, this paper attracted more citations than
any other paper in medicine, aside from reviews, published in the last two
years. Prior to the most recent bimonthly count, citations to the paper have
accrued as follows:
May-June 2000: 51 citations
March-April 2000: 42
January-February 2000: 43
November-December 1999: 33
September-October 1999: 51
July-August 1999: 51
May-June 1999: 23
March-April 1999: 25
January-February 1999: 15
November-December 1998: 10
September-October 1998: 1
Total citations to date: 388
SOURCE: Hot
Papers Database (Available from the ISI
Research Services Group in a CD-ROM version containing data on
hundreds of highly cited papers published during the last two years.
User interface permits searching by author, organization, journal,
field, and more. Total citations, as well as citations accrued during
successive bimonthly periods, can be assessed and graphed. Database is
combined with subscription to the ISI newsletter Science
Watch®; updated discs containing the
most recent bimonthly data are mailed with each new issue, six times a
year.)
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