Pharmacology Watch: Defining Diagnosis and Management of Prediabetes
Defining Diagnosis and Management of Prediabetes
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In This Issue: Guidelines for prediabetes from The American College of Endocrinology; statins for the prevention of dementia? Possible help for women suffering from sexual side effects while on antidepressants; government incentives for electronic prescribing; FDA Actions.
The American College of Endocrinology has issued its Consensus Statement on the diagnosis and management of prediabetes. The guideline was prompted by evidence that complications of diabetes begin early in the progression from normal glucose tolerance to frank diabetes. They define impaired fasting glucose (IFG) as a fasting glucose 100-125 mg/dL, and impaired glucose tolerance (IGT) as 2 hour post glucose load 140-199 mg/dL. (Diagnostic for diabetes are fasting levels ≥126 mg/dl and post challenge ≥ 200 mg/dL). The guideline recommends intensive lifestyle management for pre-diabetes patients, including weight reduction by 5-10%, regular moderate-intensity physical activity for 30-60 minutes daily at least 5 days a week, a diet low in total saturated fat and transfatty acids, adequate dietary fiber along with low sodium intake, and avoidance of excess alcohol. Although they acknowledge that there are no approved pharmacologic therapies for prevention of diabetes there is evidence that both metformin and acarbose may reduce the rate of development of diabetes from prediabetes. There are safety concerns with thiazolidinediones and they must be used with caution. Persons with prediabetes should have the same lipid goals of those with established diabetes, including statin therapy to achieve LDL cholesterol, non-HDL-cholesterol, or apoB treatment goals of 100 mg/dl, 130 mg/dL, and 90 mg/dL respectively. Other lipid-lowering drugs may be used as considered appropriate. Niacin should be used with caution because of its potential to raise blood sugar. Blood pressure control should also be at the same targets as recommended for diabetics including systolic blood pressure <130 and diastolic less than 80 mmHg. ACEI/ARB should be first-line agents, with CCBs as appropriate second line treatment approaches. Thiazides, beta-blockers, or their combinations should be used with caution due to adverse effects on blood sugar. Antiplatelet therapy with aspirin is recommended for all persons with prediabetes who have no contraindications for aspirin. The full guideline can be found online at www.aace.com/meetings.
Statins and Dementia
Do statins help prevent dementia and cognitive impairment? The medical literature has been conflicting on this issue, but now a new study from the University of Michigan raises hope that there is benefit. In a population-based cohort study, 1674 older Mexican Americans who were free of dementia or cognitive impairment at baseline were studied over 5 years. Overall, 27% of the participants took statins during the study. After adjusting for education, smoking status, genetic testing, and history of stroke or diabetes at baseline, persons who had used statins were about half as likely as those who did not to develop dementia or cognitive impairment (HR = 0.52; 95% CI 0.34-0.80). The authors conclude that statin users were less likely to have incident dementia or cognitive impairment without dementia during a 5-year follow-up. They also suggest that these results add to the emerging evidence suggesting a protective effect of statin use on cognitive outcomes (Neurology. 2008; 71: 344-350).
Help for Women on Antidepressants Who Suffer from Sexual Side Effects
Women with antidepressant related sexual side effects improved with sildenafil (Viagra) according to a new study. In the 8-week randomized double-blind placebo-controlled trial, 98 women who were stabilized on a serotonin reuptake inhibitor were randomized to sildenafil or placebo at a flexible dose starting at 50 mg adjustable to 100 mg. before sexual activity. The primary outcome was change in baseline to study end in the Clinical Global Impression sexual function scale. Women treated with sildenafil had significantly improved sexual function scores even factoring in women who discontinued the medication prematurely. Baseline endocrine levels were the same in both groups as were depression scale scores. Headache, flushing, and dyspepsia were the most commonly reported side effects of sildenafil. The authors conclude that sildenafil treatment of sexual dysfunction in women taking serotonin reuptake inhibitors was associated with a reduction in adverse sexual side effects (JAMA. 2008; 300: 395-404). The study was sponsored by Pfizer, the manufacture of sildenafil.
Electronic Prescribing Worth Your While
If you are not already utilizing electronic prescribing, the government may soon make it worth your while by providing incentive payments to physicians and qualified health care professionals who utilize the technology. Beginning in 2009 Medicare will provide incentive payments for electronic prescribers which will include 2% incentive payments in 2009 and 2010; 1% incentive payment in 2011 and 2012, and a 0.5% incentive payment in 2013. On their website, Health and Human Services states that E-prescribing is more efficient, convenient for consumers, improves the quality of care, and lowers administrative costs. They also suggest that widespread E-prescribing would eliminate thousands of medication errors every year. More information can be found at www.HHS.gov/news/facts/eprescribing.html.
FDA Actions
The FDA has ordered safety-related changes to the labeling of erythropoietin products (Procrit, Ecogen, Aranesp) to reflect safety concerns based on recent data. The new labeling states that the drugs are "not indicated for those receiving myelosuppressive therapy when anticipated outcome is cure." Additionally the agency recommended therapy should not be initiated at hemoglobin levels of 10 g/dL and above, and dosage should be withheld if hemoglobin levels exceed a level needed to avoid transfusion. The FDA also encourages health-care professionals to discuss with their patients the risk of erythropoietin therapy including increased risk of vascular events, shortened time to tumor progression recurrence, and shortened survival.
The FDA has approved the first generic divalproex (Depakote delayed-release tablets) for the treatment of seizures and bipolar disorder, and the management of migraine headaches. Both the brand and generic versions of divalproex carry a Boxed Warning regarding the risk of liver damage and pancreatitis. Eight generic companies have received approval to market divalproex including Upsher-Smith laboratories and TEVA Pharmaceuticals.
The FDA has added a Boxed Warning to fluoroquinolone antibiotics regarding the risk of tendinitis and tendon rupture. The risk is higher in patients older than 60, those taking corticosteroids, and patients with kidney, heart, and lung transplants. Patients experiencing pain, swelling, or inflammation of the tendon or tendon rupture should stop taking their fluoroquinolone immediately and contact their health-care professionals. Fluoroquinolones requiring new labeling include ciprofloxacin (Cipro, Proquin), gemifloxacin (Factive), levofloxacin (Levaquin), moxifloxacin (Avelox), norfloxacin (Noroxin) and ofloxacin (Floxin).
This supplement was written by William T. Elliott, MD, FACP, Chair, Formulary Committee, Kaiser Permanente, California Division; Assistant Clinical Professor of Medicine, University of California-San Francisco. In order to reveal any potential bias in this publication, we disclose that Dr. Elliott reports no consultant, stockholder, speaker's bureau, research, or other financial relationships with companies having ties to this field of study. Questions and comments, call: (404) 262-5431. E-mail: [email protected].
In This Issue: Guidelines for prediabetes from The American College of Endocrinology; statins for the prevention of dementia? Possible help for women suffering from sexual side effects while on antidepressants; government incentives for electronic prescribing; FDA Actions.Subscribe Now for Access
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