Wednesday, July 11, 2007

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.

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