OWH/COE Extramural Research Projects
In FY 2000, FDA OWH initiated its collaboration with the COE by funding research on the use, safety and efficacy of botanicals used by women. Six research projects were conducted:
- Phytoestrogens: Drug interaction potential in women. (Gail Anderson, Ph.D., University of Washington)
- Effect of dietary soy and calcium supplementation on lipid levels, brachial artery function, biochemical markers of bone turnover, inflammatory markers of atherosclerosis and menopausal symptoms in postmenopausal women. (Francine K. Welty, M.D., Ph.D., Beth Israel Deaconess Medical Center and Harvard University)
- The effects of St. Johns Wort on the efficacy of oral contraception. (Stephen D. Hall, Ph.D., Indiana University)
- Pattern of botanical dietary supplement usage in menopausal women. (Gail B. Mahady, Ph.D., University of Illinois at Chicago)
- Review of herbal weight loss product experiences and adverse events. (Sara L. Warber, M.D., University of Michigan)
- Use and interaction of dietary supplements in the SEA Trial. (Mara Vitolins, Dr. P.H., Wake Forest University)
In FY 2001, OWH -- in partnership with the DHHS Office on Women's Health - awarded two contracts to develop study protocols and conduct studies to examine the pharmacokinetics and pharmacodynamics of prescription medications used by pregnant women. The contracts are for conducting research on two drugs - labetalol and atenolol -- used by pregnant women to treat high blood pressure.
The awards were made to the University of Illinois at Chicago to determine the appropriate doses and effects of labetolol for treating hypertension in pregnant women and the University of Washington for similar studies of atenolol in pregnant women. FDA funded the research because pregnant women with hypertension commonly use both drugs, even though little clinical data is currently available on this patient population.
The results of the studies will enable the FDA to identify the doses that will provide the greatest benefit and least risk for mothers and their babies. The studies will evaluate the medications already being used by the pregnant women in the study.
- Labetalol and hypertension in Pregnancy: Pharmacokinetics and Pharmacodynamics. Jennifer Hardman and James H. Fisher, University of Illinois at Chicago
- Pharmacokinetics and Pharmacodynamics of Atenolol in Pregnancy, Mary R. Hebert, University of Washington
Of the 11.1 million people in the United States with a diagnosis of diabetes receiving medical care, 18 % have poor control and 34% have inadequate control. They consequently have increased risk of long-term complications, including retinopathy, nephropathy, neuropathy and cardiovascular disease. Improved control has been shown to reduce microvascular complications. Therefore, it is essential for many diabetics to closely monitor their blood glucose several times per day in order to make adjustments in their therapy.
Most diabetics utilize lancet devices to obtain capillary blood samples from their fingertips multiple times a day for self-monitoring of blood glucose (SMBG) using portable electronic measurement devices and adjust their therapy based on the results. The repeated use of lancets on the fingertips can be uncomfortable and a deterrent to testing with adequate frequency. Recently, a new generation of SMBG devices has been developed that allow the use of far smaller volumes of blood, making it is possible to use blood samples from sites other than the fingertip - such as the forearm or thigh. These alternate sites are also less densely innervated with pain receptors than the fingertips, and sampling is less painful for patients.
So far in the evaluation of alternate site blood glucose (ASBG) testing, it has been noted that, under certain circumstances, such testing appears to be less accurate than fingertip blood glucose (FTBG) testing -- which more closely correlates with arterial blood glucose concentration. Since it is not clear whether using ASBG readings instead of FTBG readings will have a positive impact, a negative impact or no impact on long-term control, OWH has funded a research study to assess the impact of ASBG versus FTBG on long-term glycemic control. The study, entitled Self-Monitoring of Blood Glucose with Fingertip Sampling vs. Alternative Site Sampling: Effect on Long-Term Glycemic Control, is being conducted by Dr. Caroline Apovian at Boston University School of Medicine.