The Journal of Clinical Endocrinology & Metabolism Vol. 92, No. 11 17a
Copyright © 2007 by The Endocrine Society
Endocrinology & Metabolism News, November 2007
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Endocrine Discovery
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Among 1065 patients given yearly infusions of 5 mg zoledronic acid after hip fracture surgery, the incidence of any new clinical fracture was less than in 1062 controls followed for almost 2 years (8.6% vs. 13.9%, –35% risk reduction. P = 0.001), with reductions in both vertebral (1.7% vs. 3.8%, P = 0.02) and nonvertebral fractures (7.6% vs. 10.7%, P = 0.03). Furthermore, mortality was lower in the zoledronic acid group (9.6% vs. 13.3%, –28%, P = 0.01). No cases of mandibular osteonecrosis were observed, and rates of atrial fibrillation and stroke were similar.
(N Engl J Med [electronically published ahead of print September 17, 2007])
In a prospective randomized controlled comparison of amiodarone versus sotalol or placebo for persistent atrial fibrillation in 612 North American men, hypothyroidism developed in 31% of older amiodarone-treated men versus only 7% of controls; hyperthyroidism, mostly subclinical, occurred in 5% of amiodarone treated patients vs. 2% of controls (P = 0.07).
(Am J Med [Oct. 2007] 120:880)[CrossRef]
In a prospective study of women with Type 1 (330) and Type 2 (870) diabetes, rates of pregnancy loss were similar (2.6 vs. 3.7%), but causes of pregnancy loss differed: in type 1, major congenital anomalies or prematurity were the major causes, whereas in type 2, stillbirth or chorioamnionitis predominated.
(Diabetes Care [Oct. 2007] 30:2603)[CrossRef]
Intake of omega-3 fatty acids after age 1 year was associated with reduced risk of islet autoimmunity in a longitudinal study of 1770 children at high genetic risk for the development of Type 1 diabetes followed for about 5 years.
(JAMA [Sept. 26, 2007] 298:1420)[CrossRef]
In statin-treated patients, HDL cholesterol level predicted risk of major cardiovascular events, even among those with LDL cholesterol below 70 mg per deciliter in a post hoc analysis of data from the Treating to New Targets study. This relationship was also observed among patients with LDL cholesterol levels below 70 mg/dL.
(N Engl J Med [September 27, 2007] 357:1301)[CrossRef]
Two new meta-analyses examined the risk of cardiovascular events with the thiazoledinediones pioglitazone and rosiglitazone, respectively. For pioglitazone, 19 trials with 16390 patients ranging from 4 to 42 months, MI, stroke, or death occurred in 4.4% of pioglitazone-treated patients and 5.7% of controls (hazard ratio, 0.8; 95% [CI 0.7–0.9]). However, heart failure occurred more often in pioglitazone-treated patients (2.3% vs.1.8%; HR, 1.4 [95% CI, 1.1–1.8]).
(JAMA [September 12, 2007] 298:1180).[CrossRef]
For rosiglitazone, 4 randomized controlled trials with 14291 patients followed for 1 to 4 years, increased MI (RR, 1.4 [95% CI 1.1–1.9]) and heart failure risks (RR, 2.1 [95% CI 1.5–2.9) were observed, but with no increased cardiovascular mortality (RR, 0.9 [95% CI 0.6–1.3]).
(JAMA [September 12, 2007] 298:1189)[CrossRef]
When breath of children with diabetes was analyzed by gas chromatography and mass spectrometry for 100 exhaled compounds as potential indicators of blood glucose, methyl nitrate levels correlated best with changes in glycemia.
(Proc Natl Acad Sci USA [Oct. 2, 2007] 104:15613)[CrossRef]
Approximately 10 years after participating in a randomized trial comparing pravastatin with placebo in hypercholesterolemic men with no myocardial infarction (MI) history, the combined incidences of coronary heart disease death and nonfatal MI infarction remained lower in the earlier pravastatin-treated group, 8.6% vs. 10.3% (P = 0.02). Five years after the end of the trial, 38.7% of the original statin group and 35.2% of the placebo group were being treated with a statin.
(N Engl J Med [Oct. 11, 2007] 357:1477)[CrossRef]
The cholesterol metabolite 27-hydroxycholesterol, which is elevated in hypercholesterolemic individuals and present in atherosclerotic lesions, is a competitive antagonist of estrogen receptor-mediated nitric oxide production by vascular cells and inhibits estrogen-induced vasorelaxation in rat aorta. This suggests that 27-hydroxycholesterol may contribute to loss of estrogen protection from vascular disease.
(Nat Med [Oct. 2007] 13:1185)[CrossRef]
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Endocrine Practice
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FDA will require manufacturers of levothyroxine sodium products to narrow their potency specifications to 95% to 105% throughout their labeled shelf lives. However, requirements for bioequivalence between levothyroxine formulations have not been tightened (for more information, see: http://www.fda.gov/cder/drug/infopage/levothyroxine/default.htm).
Drug labeling for olanzapine (Zyprexa) and olanzapine plus fluoxetine (Symbyax) will include stronger warnings about associated risks of hyperlipidemia, hyperglycemia, and weight gain. These will recommend monitoring of treated patients’ glucose and lipid levels.
(For more information, see: http://www.mdconsult.com/das/news/body/79970335-2/drug/0/188893/1.html
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FDA has required that labeling for exenatide (Byetta®) alert healthcare professionals to signs and symptoms of acute pancreatitis and advise them to discontinue the drug if pancreatitis is suspected (For more information, see: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Byetta
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Endocrine Policy
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Almost 90 million Americans—more than one out of three people under 65—lacked medical insurance at some point during 2006–2007, according to a Families USA report based on U.S. Census Bureau data. (For more information, go to: http://familiesusa.org/assets/pdfs/wrong-direction.pdf)
The Food and Drug Amendments Act of 2007 (H.R. 3580), which expands requirements for reporting clinical trials and their results in clinical trials registry databases, was signed into law September 27. The new requirements include expansion of the types of trials that must be registered to include clinical trials (other than preliminary studies) of all drugs, devices, and biologics; reporting of results on efficacy for registered trials; and reporting of additional results for approved and unapproved drugs and devices. (For more information, see: http://www.fda.gov/oc/initiatives/advance/fdaaa.html)
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Endocrinologists
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Karel Pacak, of the NIH, delivered the Peter Heimann Lecture, "PET technology in endocrine oncology." The Heimann Lecture is the highest award given by the International Association of Endocrine Surgeons.
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Milestones in Endocrinology
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One hundred years ago, O.F. Chalk described partial dislocation of the mandible from macroglossia due to acromegaly in Transactions of the Pathological Society of London. .
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In the Journal 25 Years Ago
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A pilot newborn screening for congenital adrenal hyperplasia in Alaska. Pang S, Murphey W, Levine L, Spence D, Leon A, LaFranchi S, Surve AS, New MI.
(J Clin Endocrinol Metab [September 1982] 55:413)
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"Our pilot screening program for CAH in the Alaskan newborn population demonstrates the feasibility of an effective newborn screening program for CAH."
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Footnotes
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Readers are encouraged to suggest items for Endocrinology and Metabolism News by E-mail (sherman{at}endo-society.org). Submissions will be considered based on their significance and timeliness.
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