The following represent additions to UpToDate since the last version that were considered by the authors and editors to be of particular interest. The new material described below represents a small subset of the updating that has been performed, since approximately 40 percent of the topic reviews are updated during each four-month cycle.
DIABETES
Lipids — The Action to Control Cardiovascular Risk in Diabetes lipid (ACCORD Lipid) trial evaluated the use of fenofibrate as an adjunct to simvastatin in patients with type 2 diabetes [1]. After a mean follow-up of 4.7 years, there was no significant difference in the primary composite outcome of first occurrence of a major cardiovascular event in patients receiving fenofibrate compared to placebo. (See "Clinical trials of cholesterol lowering in patients with coronary heart disease or coronary risk equivalents", section on 'ACCORD Lipid trial'.)
Hypertension — The Action to Control Cardiovascular Risk in Diabetes blood pressure trial (ACCORD BP) evaluated goal blood pressure in patients with type 2 diabetes at high risk for cardiovascular events [2]. After a mean follow-up of 4.7 years, there was no significant difference in the annual rate of the primary composite outcome of nonfatal myocardial infarction, nonfatal stroke or death from cardiovascular causes between the intensive (goal systolic pressure pressure less than 120 mmHg) versus standard (goal systolic pressure pressure less than 140 mmHg) therapy groups. (See "Treatment of hypertension in patients with diabetes mellitus", section on 'ACCORD BP trial'.)
Prevention — The Nateglinide and Valsartan in Impaired Glucose Tolerance Outcomes Research (NAVIGATOR) trial evaluated the use of nateglinide and/or valsartan in approximately 9300 patients with impaired glucose tolerance and one or more risk factors for cardiovascular disease [3,4]. All patients also participated in a lifestyle modification program. After a median follow-up of five years, there was no difference in the incidence of diabetes or any cardiovascular outcome between the nateglinide and placebo groups [3]. (See "Prediction and prevention of type 2 diabetes mellitus", section on 'Nateglinide'.)
There was a modest but statistically significant decrease in the incidence of diabetes in the valsartan group [4]. The data suggest a relatively weak effect of valsartan compared with lifestyle intervention or other effective medications for the prevention of diabetes. (See "Prediction and prevention of type 2 diabetes mellitus", section on 'Inhibition of angiotensin II'.)
OSTEOPOROSIS
Denosumab — The US Food and Drug Administration (FDA) and the European Commission (EC) approved denosumab for the treatment of postmenopausal women with osteoporosis at high risk for fracture (history of osteoporotic fracture, multiple risk factors for fracture) or patients who have failed or are intolerant of other available osteoporosis therapies [5,6]. Denosumab inhibits the formation, function, and survival of osteoclasts. It decreases bone resorption, increases bone mineral density (BMD), and reduces the risk of fracture. (See "Denosumab for osteoporosis".)
Vitamin D — A randomized trial of high-dose vitamin D (500,000 units) administered once yearly versus placebo in women age 70 years and older found an increase in the risk of falls and fracture in the vitamin D group [7]. (See "Calcium and vitamin D supplementation in osteoporosis", section on 'Calcium versus vitamin D'.)
Teriparatide
- In a randomized trial of teriparatide versus placebo in 102 postmenopausal women with distal radial fractures, teriparatide did not significantly accelerate fracture healing [8]. (See "Parathyroid hormone therapy for osteoporosis", section on 'Fracture healing'.)
- A phase 2 clinical trial compared transdermal teriparatide to a placebo patch or teriparatide injection in 165 postmenopausal women with osteoporosis [9]. After six months, the mean change in lumbar spine BMD was similar in the teriparatide groups and significantly greater than placebo. (See "Parathyroid hormone therapy for osteoporosis", section on 'Transdermal administration'.)
REPRODUCTION
New CDC medical eligibility tables for contraceptive use — The United States Centers for Disease Control (CDC) modified the World Health Organization (WHO) tables for medical eligibility criteria for contraceptive use [10]. Selected WHO recommendations were adapted for US clinicians and patients, the number of medical conditions was expanded and recommendations added, and contraceptive methods not available in the US were removed. These changes are described in the table (table 1). (See "Overview of contraception", section on 'CDC modifications to WHO tables'.)
Treatment of recurrent pregnancy loss — A large randomized trial found that neither aspirin alone nor aspirin plus heparin improved the live-birth rate of women with unexplained recurrent pregnancy loss (RPL) [11]. In this trial, 364 women with unexplained RPL after a thorough evaluation were randomly assigned to receive daily aspirin (80 mg), aspirin plus nadroparin (2850 international units), or placebo during pregnancy. The live-birth rates for combination therapy, aspirin alone, and placebo were not significantly different: 69, 62, and 67 percent, respectively. (See "Management of couples with recurrent pregnancy loss", section on 'Aspirin with or without heparin'.)
Estrogen-progestin contraception — A possible mortality benefit was reported in the Royal College of General Practitioners' prospective cohort study of over 46,000 women followed for up to 39 years [12]. Ever users of oral estrogen-progestin contraceptives (OCs) had a significantly lower rate of death from any cause, as well as disease-specific mortality related to cancer, cardiovascular disease, and coronary heart disease. The estimated absolute reduction in all cause mortality for ever users of OCs was 52 per 100,000 woman years. (See "Risks and side effects associated with estrogen-progestin contraceptives".)
Route of estrogen and stroke risk — In a population-based case-control study, postmenopausal women using low-dose transdermal estrogen therapy (≤ 50 mcg patch) were not at increased risk for stroke compared to nonusers [13]. However, postmenopausal women taking higher doses of transdermal estrogen (>50 mcg patch) or any dose of oral estrogen therapy had a higher rate of stroke than nonusers (rate ratios 1.89 and 1.28, respectively). (See "Postmenopausal hormone therapy and cardiovascular risk".)
THYROID
Treatment guidelines for thyroid nodules — The American Thyroid Association has published Revised Clinical Guidelines for the management of thyroid nodules and differentiated thyroid cancer [14]. The American Thyroid Association guidelines recommend FNA biopsy as the procedure of choice for evaluating thyroid nodules and selecting candidates for surgery. (See "Diagnostic approach to and treatment of thyroid nodules".)
Medullary thyroid cancer — Preliminary results from an open-label phase II study of sorafenib in patients with metastatic medullary thyroid cancer (MTC) showed a partial response in one patient with sporadic MTC and a median progression-free survival of nearly 18 months [15]. (See "Chemotherapy and immunotherapy for medullary thyroid cancer", section on 'Sorafenib'.)
OBESITY
Orlistat — Severe liver injury has been reported rarely with the use of orlistat [16]. A US Food and Drug Administration review identified 13 reports of severe liver injury, 12 of which occurred outside of the United States. Over the ten year period of the review, an estimated 40 million people worldwide used orlistat. A causal relationship has not been established. (See "Drug therapy of obesity", section on 'Orlistat'.)
REFERENCES
- Ginsberg, HN, Elam, MB, Lovato, LC, et al. Effects of combination lipid therapy in type 2 diabetes mellitus. N Engl J Med 2010; 362:1563.
- Cushman, WC, Evans, GW, Byington, RP, et al. Effects of intensive blood-pressure control in type 2 diabetes mellitus. N Engl J Med 2010; 362:1575.
- Holman, RR, Haffner, SM, McMurray, JJ, et al. Effect of nateglinide on the incidence of diabetes and cardiovascular events. N Engl J Med 2010; 362:1463.
- McMurray, JJ, Holman, RR, Haffner, SM, et al. Effect of valsartan on the incidence of diabetes and cardiovascular events. N Engl J Med 2010; 362:1477.
- www.pi.amgen.com/united_states/prolia/prolia_pi.pdf. Accessed June 1, 2010.
- ttp://ec.europa.eu/enterprise/sectors/pharmaceuticals/documents/community-register/html/newproc.htm. Accessed June 7, 2010.
- Sanders, KM, Stuart, AL, Williamson, EJ, et al. Annual high-dose oral vitamin D and falls and fractures in older women: a randomized controlled trial. JAMA 2010; 303:1815.
- Aspenberg, P, Genant, HK, Johansson, T, et al. Teriparatide for acceleration of fracture repair in humans: A prospective, randomized, double-blind study of 102 postmenopausal women with distal radial fractures. J Bone Miner Res 2010; 25:404.
- Cosman, F, Lane, NE, Bolognese, MA, et al. Effect of transdermal teriparatide administration on bone mineral density in postmenopausal women. J Clin Endocrinol Metab 2010; 95:151.
- U.S. Medical Eligibility Criteria for Contraceptive Use, 2010 - Adapted from the World Health Organization Medical Eligibility Criteria for Contraceptive Use, 4th edition. Available at www.cdc.gov/mmwr/preview/mmwrhtml/rr59e0528a1.htm (Accessed May 28, 2010).
- Kaandorp, SP, Goddijn, M, van der, Post JA, et al. Aspirin plus heparin or aspirin alone in women with recurrent miscarriage. N Engl J Med 2010; 362:1586.
- Hannaford, PC, Iversen, L, Macfarlane, TV, et al. Mortality among contraceptive pill users: cohort evidence from Royal College of General Practitioners' Oral Contraception Study. BMJ 2010; 340:c927.
- Renoux, C, Dell'aniello, S, Garbe, E, Suissa, S. Transdermal and oral hormone replacement therapy and the risk of stroke: a nested case-control study. BMJ 2010; 340:c2519.
- Cooper, DS, Doherty, GM, Haugen, BR, et al. Revised American Thyroid Association management guidelines for patients witht thyroid nodules and differentiated thyroid cancer. Thyroid 2009; 19:1167.
- Lam, ET, Ringel, MD, Kloos, RT, et al. Phase II Clinical Trial of Sorafenib in Metastatic Medullary Thyroid Cancer. J Clin Oncol 2010; 28:2323.
- http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm213038.htm Accessed June 2, 2010.
