The American College of Physicians (ACP) has issued a guideline that provides three clinical recommendations(www.annals.org) regarding the comparative effectiveness and safety of type 2 diabetes medications.
The guideline, which specifically addresses the pharmacologic management of patients with type 2 diabetes using agents from any of 11 unique classes of drugs available to treat hyperglycemia in these patients, recommends that clinicians
- add oral pharmacologic therapy for patients with type 2 diabetes in whom lifestyle modifications fail to adequately improve hyperglycemia;
- prescribe monotherapy with metformin for initial pharmacologic therapy to treat most patients; and
- add a second agent to manage patients with persistent hyperglycemia when lifestyle modifications and metformin fail to control hyperglycemia.
The guideline was based on a systematic review of literature published on the topic from 1966 through April 2010. The review was conducted by the Johns Hopkins Evidence-based Practice Center in Baltimore, one of 14 practice centers included in the Agency for Healthcare Research and Quality's Effective Health Care Program.
The evidence review focused on the following key questions:
- The American College of Physicians (ACP) has issued a guideline recommending oral pharmacologic therapy -- typically, with metformin -- for patients with type 2 diabetes when lifestyle modifications fail to improve hyperglycemia.
- If metformin fails to produce the desired result, the guideline recommends adding a second agent.
- In adults 18 or older with type 2 diabetes, what is the comparative effectiveness of these treatment options for the intermediate outcomes of glycemic control, weight or lipids?
- In adults 18 or older with type 2 diabetes, what is the comparative effectiveness of these treatment options in terms of the following long-term clinical outcomes: all-cause mortality, cardiovascular mortality, cardiovascular and cerebrovascular morbidity, retinopathy, nephropathy, and neuropathy?
- In adults 18 or older with type 2 diabetes, what is the comparative safety of these treatment options in terms of the following adverse events and side effects: hypoglycemia, liver injury, congestive heart failure, severe lactic acidosis, cancer, severe allergic reactions, hip and nonhip fractures, pancreatitis, cholecystitis, macular edema or decreased vision, and gastrointestinal side effects?
- Do safety and effectiveness of these treatment options differ across subgroups of adults with type 2 diabetes, in particular for adults 65 or older, in terms of mortality, hypoglycemia, and cardiovascular and cerebrovascular outcomes?
According to family physician John Boltri M.D., of Detroit, Mich., the AAFP's liaison to the National Diabetes Education Program of the National Institute of Diabetes and Digestive and Kidney Diseases, the guideline includes a number of positive elements, such as its use of strength-of-evidence ratings and inclusion of a table that clearly summarizes that rating system.
Using this system, all three recommendations were graded as "strong" -- that is, benefits of the intervention clearly outweigh risks and burden -- and were based on high-quality evidence.
The AAFP is expected to review the guideline for possible endorsement.