ADA/EASD consensus guidelines and algorithm

**also see memo on palm under "endo"

The ADA/EASD consensus guidelines and algorithm emphasize:1

Achievement and maintenance of normal glycemic goals
Initial therapy with lifestyle intervention and (usually) metformin
Rapid addition of medications, and/or transition to new interventions/regimens as rapidly as possible — when target glycemic goals are not achieved or sustained
Early addition of insulin therapy in patients who do not meet target goals using other medications, or promptly in patients with greater hyperglycemia
Selecting antihyperglycemic interventions
As seen in algorithm below, the ADA/EASD consensus is that metformin therapy should be initiated concurrently with lifestyle intervention at diagnosis in all but the mildest patients with T2 DM (without contraindications). However, given the progressive nature of T2 DM, more than one medication will be necessary for the majority of patients over time.1 The goal is “to achieve and maintain glycemic levels as close to the nondiabetic range as possible and to change interventions at as rapid a pace as titration of medication allows.” 1



Note that the ADA/EASD algorithm above does not include the incretin mimetics, synthetic amylin, or DPP-4 inhibitors, as limited clinical data were available on these relatively new classes of medication at the time of the guideline publication. However, these drugs may be appropriate choices in selected patients.

Per the guidelines, a number of factors influence the selection of antihyperglycemic medications: their effectiveness in lowering glucose, their extraglycemic effects that may reduce long-term complications, safety profiles, tolerability, and cost.1

When adding a second and potentially third antihyperglycemic medication, the physician should consider potential synergy and other interactions of particular combinations. Generally, agents with different mechanisms of action have greater synergy. For example, insulin plus metformin or insulin plus a thiazolidinedione (TZD) are particularly effective in lowering glycemia.1

Initiation and intensification of basal insulin in patients who fail on oral agents1
The ADA/EASD recommends basal insulin either as second-line therapy if metformin fails, or as third-line therapy if metformin plus a second oral agent fails to meet A1C targets. As stated in the guidelines: “Although 3 oral agents can be used in patients who fail to reach target A1C, the initiation and intensification of insulin therapy is preferred based on effectiveness and expense.”1

For patients with T2 DM, initial insulin therapy is aimed at lowering fasting blood glucose, typically with long- or intermediate-acting insulins. Some patients may also require preprandial rapid- or short-acting insulin therapy.1

Current options in basal insulin therapy
Among the currently available basal insulin therapies to choose from are the insulin analogs and NPH insulin:


Insulin analogs: The newer long-acting insulin analogs, such as Lantus® (insulin glargine [rDNA origin]), and Levemir® (insulin detemir [rDNA origin]) are preferred by many physicians and patients due to their lack of pronounced peak and approximate 24-hour duration of action. Both agents were created by recombinant DNA modification of human insulin, and have the advantage of providing a steady, consistent level of basal insulin coverage.2,3 The physio/chemical structure of LANTUS enables slow release of drug, allowing it to be dosed once-daily.2 Levemir can be dosed once- or twice-daily.3 Treatment with a single-dose of long-acting insulin analog can minimize the complexity of insulin therapy, and decrease the risk of hypoglycemia and weight gain seen with NPH insulin.4 It also compares favorably to adding a third oral agent (a TZD) for impact on health-related quality of life.5
NPH insulin: Neutral protamine Hagedorn, or NPH, insulin has an intermediate duration of action and typically requires twice-daily injection to achieve required basal insulin levels over 24 hours. NPH insulin is lower in cost than the analogs.1,6 So, in patients for whom cost is a consideration, physicians may want to prescribe NPH beginning at bedtime (not dinner) to lower fasting blood glucose (FBG). Target FBG levels in T2 DM are generally 100 mg/dL or slightly less.
Both long-acting analogs and bedtime NPH as basal insulin can be added to oral or other diabetes medications. They can also be started as initial antihyperglycemic therapy when patients have greater hyperglycemia (eg, FBG >300 mg/dL and/or A1C >10%; these patients almost always require insulin treatment to control their glucose intolerance).

BD Ultra-Fine™ Insulin Syringes and Pen Needles: Quality, Comfort and Convenience
MYTH: Taking injections of insulin and other diabetes medications will be painful.

REALITY: Many patients have no idea just how small and thin an insulin needle actually is, and are pleasantly surprised when they finally see and use one for the first time. Also, many are benefiting from the increasing range and availability of insulin pens, since they find it easier and more convenient to dial and administer their dose with this delivery device. Both the insulin analogs and NPH insulin are available in pens.

BD Ultra-Fine Insulin Syringes and Pen Needles are an excellent choice for patients on, or transitioning to, insulin therapy:

No insulin syringe needle is shorter or thinner than BD Ultra-Fine
BD pen needles are universally compatible with all makes of diabetes pens and dosers in the US
BD pen needles come in a variety of lengths, including the shortest pen needle available (5mm) to meet the needs of all patients
BD Getting Started™ Take Home Kits are available to help your patients effectively transition to injection therapy
For more information on BD Ultra-Fine injection products and how to access complimentary BD Getting Started™ kits for your medical practice, visit www.bddiabetes.com/us/

REFERENCES
1. Nathan DM, Buse JB, Davidson MB, et al. Management of Hyperglycemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy. A consensus statement from the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care. 2006;29:1963-1972.
2. Lantus [prescribing information]. February 2006. Bridgewater, NJ, sanofi-aventis, U.S., LLC.
3. Levemir [prescribing information]. 2005. Princeton, NJ, NovoNordisk, Inc.
4. Bethel MA, Feinglos MN. Basal insulin therapy in type 2 diabetes. J Am Board Fam Med. 2005;18:199-204.
5. Vinik AI, Zhang Q: Adding Insulin glargine versus rosiglitazone: health-related quality-of-life impact in type 2 diabetes. Diabetes Care. 2007;30(4):795-800.
6. Goldman-Levine JD. Insulin detemir (Levemir) for diabetes mellitus. STEPS: New drug reviews. Am Fam Physician. 2006;74(2). Available at: http://www.aafp.org/afp/20060715/steps.html.

Strep throat guidelines

Primary care clinicians often fail to follow guidelines when treating patients with sore throats

When doctors see patients with sore throats (pharyngitis), a chief concern is to diagnose or rule out strep throat (caused by the bacterium group A B-hemolytic streptococci). Yet in two-thirds of sore throat visits, primary care clinicians do not follow any available clinical guideline. During these visits, doctors frequently give a strep test to or prescribe antibiotics for patients who are at low risk of strep throat, or for whom tests and antibiotics are not recommended, note researchers at Brigham and Women's Hospital in Boston.

To measure the rate of physician adherence to 3 guidelines, the researchers retrospectively analyzed visits to Boston area primary care clinics by 2,097 adults diagnosed with pharyngitis. The three guidelines included the American College of Physicians (ACP) empirical strategy, the ACP test strategy, and the Infectious Diseases Society of America (IDSA) strategy. Primary care clinicians followed the ACP empirical strategy in 12 percent of visits, the ACP test strategy in 30 percent of visits, and the IDSA strategy in 30 percent of visits. Physicians followed none of these strategies in 66 percent of visits.

The ACP recommends evaluation of adults with pharyngitis using the four-point Centor criteria: fever, absence of cough, tender and swollen anterior lymph nodes, and exudate (pus) on the tonsils. The ACP recommends two potential treatment strategies: empirical antibiotic treatment of patients who meet three of the four Centor criteria (ACP empirical strategy), or testing patients with two or three criteria using a rapid strep test and prescribing antibiotics to patients with a positive test or with four criteria (ACP test strategy). The IDSA guideline agrees with the ACP guideline that adults with zero or one Centor criteria, who are at low risk for strep throat, should neither be tested nor treated with antibiotics. However, the IDSA recommends microbiologic confirmation for all adults with pharyngitis prior to antibiotic prescribing. The study was supported in part by the Agency for Healthcare Research and Quality (HS14420 and HS14563).

______________________________________________

More details are in "Evaluation and treatment of pharyngitis in primary care practice," Jeffrey A. Linder, M.D., M.P.H., Joseph C. Chan, B.S., and David W. Bates, M.D., M.Sc., in the July 10, 2006, Archives of Internal Medicine 166, pp. 1374-1379. [Medline® abstract]

Research Activities Newsletter. April 2007, No. 320. AHRQ Publication No. 07-0027. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/research/apr07/

The above message comes from "AHRQ", who is solely responsible for its conten

Guideline: Mammography optional in women 40-49

Clinical Question: Should screening mammography be used in women between the ages of 40 years and 49 years?

Bottom Line: In a break from other authorities, this evidence-based guideline from the American College of Physicians (ACP) makes no absolute recommendation for or against the screening of women between the ages of 40 years and 49 years. Instead, it recommends routine, periodic risk assessment, as well as discussions with individuals regarding the benefits and harms of screening mammography.(LOE = 1a)

Reference: Armstrong K, Moye E, Williams S, Berlin JA, Reynolds EE. Screening mammography in women 40 to 49 years of age: a systematic review for the American College of Physicians. Ann Intern Med 2007;146:516-526. [Free full-text Annals article online] [Medline® abstract]

Study Design: Practice guideline
Funding: Foundation
Setting: Various (guideline)

Synopsis

Here's an underappreciated fact: More women between the ages of 40 and 49 years die from heart disease (6800) than from breast cancer (5000) each year. To develop this guideline, the ACP researchers analyzed the latest meta-analyses on this topic and considered an additional study that was subsequently published. The main findings: There are 7% to 23% fewer deaths due to breast cancer over an average of 14 years with screening starting at age 40; an overall mortality reduction hasn't been shown; screening increases rates of mastectomy; rates of ductal carcinoma in situ diagnosis skyrocket 7-fold with increased screening, representing 25% of the diagnoses of "cancer" in this age group; and, 20% to 56% of women will have a false-positive diagnosis when tested yearly for 10 years. In addition to recommending more research, the authors made 3 recommendations:

(1) The decision of whether to order a screening mammography should be made on an individual basis, taking into account the benefits, harms, risk profile, and patient preferences.

(2) Clinicians should update a woman's risk profile every 1 to 2 years. Risk factors for all women include a family history of breast cancer, earlier menarche, later age at time of first birth, and a history of breast biopsy. In addition, women aged 40 to 49 years with certain risk factors are at higher risk than the average 50-year-old woman, including 2 first-degree relatives with breast cancer and 2 previous breast biopsies. The Gail Risk Model Calculator (available in InfoRetriever) can be used to determine an individual woman's risk.

(3) Clinicians should discuss the potential benefits and harm of screening mammography with their patients. The most recent meta-analysis found a reduction in breast cancer-related mortality by 15%, although the confidence interval was wide (as little as 1% risk reduction and as much as 27% risk reduction). A more recent randomized trial, which was not included in the meta-analysis, found no statistically significant reduction in risk of breast cancer mortality. Potential harms include false-positive results, which are as high as 20% to 56% over the course of 10 mammograms, as well as the anxiety associated with the false-positives. Other theoretical risks include discomfort with the procedure. The authors found no evidence of increased radiation-induced cancer or overdiagnosis due to screening.

Written by Cung Pham, MD

Copyright © 2007 by Wiley Subscription Services, Inc. All rights reserved. www.infopoems.com

Sphincterotomy vs. Nitroglycerin for Chronic Anal Fissure: Long-Term Follow-Up

Cure rate was higher and patients were more satisfied with sphincterotomy.
Chronic anal fissure usually is treated with nitroglycerin ointment, botulinum toxin (Botox) injection, or lateral internal sphincterotomy. All three treatments decrease anal sphincter pressure and improve anal blood flow. Lateral internal sphincterotomy has the highest cure rate but has been associated with postoperative incontinence in retrospective studies.
Now, researchers report 6-year follow-up results from a randomized controlled trial in which 82 patients received thrice-daily nitroglycerin ointment (0.25%) or underwent lateral internal sphincterotomy. Participants were enrolled from February 1997 through October 1998. Sixty-two percent of patients (27 in the nitroglycerin arm and 24 in the sphincterotomy arm) responded to a telephone survey in 2004 about treatment outcomes.
Recurrent fissure symptoms were less likely to have occurred in the sphincterotomy arm than in the nitroglycerin arm (0% vs. 41%; P=0.0004), and sphincterotomy patients were less likely to have required additional surgical treatment (0% vs. 59%; P<0.0001). The sphincterotomy patients were more likely to say that they were "moderately" or "very" satisfied with treatment (100% vs. 56%; P=0.04) and that they would use the same therapy again (92% vs. 63%; P=0.02). Fecal incontinence scores were similar in the two groups.
Comment: Provided that a surgeon who is skilled in lateral internal sphincterotomy is available, few downsides to this procedure exist. Initial use of topical nitroglycerin or Botox injection still is reasonable, but, given these data, repeated courses of medical therapy probably are not the best choice for patients with recurrent or persistent chronic fissure.
— Douglas K. Rex, MD
Published in Journal Watch Gastroenterology June 29, 2007
Citation(s):
Brown CJ et al. Lateral internal sphincterotomy is superior to topical nitroglycerin for healing chronic anal fissure and does not compromise long-term fecal continence: Six-year follow-up of a multicenter, randomized, controlled trial. Dis Colon Rectum 2007 Apr; 50:442-8.

Estrogen Therapy Associated with Lower Levels of Coronary-Artery Calcification

Physicians First Watch June 21, 2007

Estrogen therapy in younger postmenopausal women is associated with less coronary-artery calcification, reports a study in the New England Journal of Medicine.

Researchers studied some 1000 women from the Women's Health Initiative who were aged 50 to 59 at randomization, had previously undergone hysterectomy, and received conjugated equine estrogens or placebo for a mean of 7.4 years. Some 1.3 years after the trial was stopped (because of alarm over the number of cardiovascular events across all age ranges) and thus 8.7 years after randomization, the women underwent CT of the heart.

The mean calcium score was 83.1 for women on estrogens and 123.1 for those on placebo — a statistically significant difference.

The authors write that their results provide support "for the hypothesis that estrogen therapy may have cardioprotective effects in younger women." However, editorialists emphasize — as the authors do — that estrogens should not be used to prevent CVD

ACIP Recommendations on Varicella Immunization

The CDC's Advisory Committee on Immunization Practices has issued its recommendations for preventing varicella.

The recommendations, published as a supplement to MMWR, include the following highlights:

• Children should receive two doses of the vaccine, one between 12 and 15 months of age, and the other between the ages of 4 and 6.

• Healthy adults and adolescents without evidence of immunity should receive two doses, 4 to 8 weeks apart.

• A second dose is recommended for all those who have received only a single previous dose.

Full recommendations are available on the CDC's website.

Lowering Blood Pressure Improves Diastolic Function, Regardless of Regimen

Reductions in blood pressure lead to improved diastolic function — regardless of the antihypertensive drugs used — reports a study in Lancet.

Researchers sought to determine whether the angiotensin-receptor blocker valsartan would be more effective than other antihypertensives at improving diastolic function. They randomized nearly 400 patients with hypertension and evidence of diastolic dysfunction to receive either the ARB or placebo. The patients also received other classes of antihypertensive agents to lower blood pressure to below 135/80 mm Hg.

After 38 weeks, tissue Doppler imaging showed improved diastolic function in both valsartan and placebo recipients, but there was no significant difference between the groups.

Authors of an accompanying commentary note that valsartan might have an advantage in patients with more advanced left ventricular remodeling. Nevertheless, they add, "the good news is that lowering blood pressure improves diastolic function, irrespective of the antihypertensive regimen used."