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Ben Schwartz is Associate Editor, Contemporary OB/GYN.
Researchers note that the number of women who annually visit an ob/gyn has steadily declined since 2000. Plus: MAb may reduce risk of fracture in women with osteoporosis. Also, a study shows that postmenopausal hormone therapy is not associated with risk of all-cause, cardiovascular, or total cancer mortality.
Results of a study published online in Obstetrics & Gynecology show that the number of women who annually visit an ob/gyn has steadily declined since 2000. Using National Health Interview Survey data from 2000 to 2015, the researchers identified the percentage of US women who visited an ob/gyn and also the percentage of women who visited a primary care physician within the past 12 months. The data were adjusted for sociodemographic and health factors.
When looking at visitation trends among ob/gyns, there was no significant change from 2000-2003 or from 2007-2011, but from 2003-2007, the adjusted percentage of visitations declined from 45.0% to 41.2% and during 2011-2015, visitations declined from 41.8%-38.4% (P < .001 for trends). The number of patients who saw both an ob/gyn and primary care physician in the preceding 12 months also declined; the adjusted percentage of these patients was 32.4% in 2000, peaked at 35.2% in 2003, and by 2015 had fallen to 29.8%. The authors found that the adjusted percentage of women who visited a primary care physician remained steady without significant change from 2000-2015, ranging from 70.1% in 2007 to 74.2% in 2003 (P > .05 for trend).
The authors believe this trend suggests that the decline in ob/gyn visits was not simply a substitution of physician types since the numbers of women seeing a primary care physician did not increase. However, the data do not identify the reason why ob/gyn visits have decreased. The study’s authors posit that longer-acting contraceptive methods may be one possibility for the decline. Another possibility could be due to the change in recommendations for Pap smear frequency. One more possibility raised is the increased usage of nurse practitioners and physician assistants who may be able to provide women the same services that formerly were only available from ob/gyns.
MAb may reduce risk of fracture in women with osteoporosis
A monoclonal antibody (MAb) that improves bone formation has been shown to reduce risk of bone fracture in women with osteoporosis, according to research published in the New England Journal of Medicine. Romosozumab binds to and inhibits sclerostin, creating a dual effect of increasing bone formation and decreasing bone resorption. Sclerostin is a protein that prohibits bone formation. Romosozumab has not yet been approved by the Food and Drug Administration.
A phase 3, multicenter, international, randomized, double-blind trial involved 3654 ambulatory postmenopausal patients aged 55-90 who either had a T score of -2.5 or less and at least one moderate or severe vertebral fractures; or a T score of -2.0 or less and two or more moderate or severe vertebral fractures. The patients were randomly split into two groups with one group receiving romosozumab by injection and the other receiving weekly doses of alendronate, a drug commonly used as first-line therapy for osteoporosis. After 12 months of receiving their assigned therapy, both groups received alendronate for an additional 12 months.
In the romosozumab group, new vertebral fractures were observed in 127 of 2046 participants (6.2%), while the alendronate group had 243 fractures among their 2047 participants (11.9%). Rates of non-vertebral fracture were also lower among the romosozumab group with 8.7% of participants experiencing a fracture while 10.6% of the alendronate group experienced a fracture. Hip fracture rates were also lower in the romosozumab group with 41 patients (2%) compared to 66 patients (3.2%) in the alendronate group. Bone mineral density gains in the romosozumab group were also higher than in the alendronate group; 13.7% to 5% gains at the lumbar spine, 6.2% to 2.8% at the total hip, and 4.9% to 1.7% at the femoral neck.
The incidences of adverse effects were similar overall between the two groups but the romosozumab group did have serious cardiovascular events at a more frequent rate than the alendronate group. The authors note that, while there was no histologic or radiographic evidence of development or exacerbation of vascular mineralization in long-term studies in rats and monkeys, sclerostin is expressed in the aorta and sclerostin inhibition could promote vascular calcification. Alendronate, conversely, has been associated with reduced cardiovascular risk in some studies. Ultimately, the authors admit that while romosozumab shows promise in lowering risk of fracture in patients with osteoporosis, further evaluation is necessary to determine the cause of the cardiovascular events.
Menopausal hormone therapy and mortality
Eighteen-year follow-up of more than 27,000 women in the Women’ Health Initiative (WHI) trial shows that postmenopausal hormone therapy is not associated with risk of all-cause, cardiovascular, or total cancer mortality. Published in JAMA, the findings reveal no significant difference in hazard ratios (HRs) for all-cause mortality in participants taking conjugated equine estrogen (CEE) plus medroxyprogesterone acetate (MPA) versus placebo for 5 to 7 years.
For the analysis, the authors looked at total and cause-specific cumulative mortality during the intervention and extended post-intervention follow-up of the two WHI trials. In WHI, 27,347 postmenopausal women aged 50 to 79 were randomized to 0.625 mg/d CEE plus MPA or placebo for 5.6 years, or CEE alone or placebo for 7.2 years. During the cumulative 18-year follow-up, 7,489 deaths occurred.
For the overall pooled cohort, in the hormone therapy group, all-cause mortality was 27.1% versus 27.6% in the placebo group. For CEE plus MPA, the HR was 1.02 and with CEE alone, it was 0.94. The HRs with hormone therapy were 1.00 for cardiovascular mortality, 1.03 for total cancer mortality, and 0.95 for other causes.
The authors also assessed 10-year age groups comparing women aged 50 to 59 to women aged 70 to 79 in the pooled cohort and found a ratio of nominal HR for all-cause mortality of 0.61 during the intervention phase and 0.87 during cumulative 18-year follow-up, without significant heterogeneity between trials.
The researchers noted that results are not generalizable to hormone preparations other than those used in WHI. Mortality follow-up, they said, was available for more than 98% of the participants and was determined by regular surveillance of the study cohort through the National Death Index. As a result, many of the concerns about post-intervention follow-up associated with previous WHI reports were obviated in this study.