Managing Type 2 Diabetes: New American Diabetes Association Position Statement

Information sourced from Journal Watch:

New Position Statement for Managing Type 2 Diabetes

A one-size-fits-all approach is rejected.

The American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) have published a new position statement entitled, "Management of Hyperglycemia in Type 2 Diabetes: A Patient-Centered Approach." The document outlines basic elements of lifestyle modification, oral agents, noninsulin injectable agents, and insulin, and provides management tips that even experienced clinicians might find helpful. Two aspects of the report are particularly noteworthy:

• Acknowledging "mounting concerns about . . . potential adverse effects [of drug therapies] and new uncertainties regarding the benefits of intensive glycemic control on macrovascular complications," the authors emphasize a patient-centered approach with individualized targets for glycemic control. For example, they recommend more-stringent control (e.g., glycosylated hemoglobin [HbA_1c] target, <7%) for motivated patients with new-onset diabetes and long life expectancies, and less-stringent control (e.g., HbA_1c goal, 8% or even higher) for less-motivated patients with longstanding diabetes, limited life expectancies, and high risk for adverse outcomes from hypoglycemia.
• Because the authors reject a one-size-fits-all approach, they make this important statement: "Utilizing the percentage of diabetic patients who are achieving an HbA_1c <7% as a quality indicator, as promulgated by various health care organizations, is inconsistent with the emphasis on individualization of treatment goals."

Comment: Many clinicians talk about getting their patients with type 2 diabetes "to goal," as if a single, evidence-based target was applicable to every patient. Others talk about being "dinged" by real or imagined organizations if their patients' HbA_1c levels are not in a certain range. In contrast, this position statement supports a more-reasoned approach that involves shared decision making and flexible goals. In a worthwhile accompanying editorial, the author describes the process that resulted in this position statement. One note: Nine of the 10 authors of the statement each have financial ties to numerous pharmaceutical companies.

— Allan S. Brett, MD

Published in Journal Watch General Medicine July 24, 2012

CITATION(S):

Inzucchi SE et al. Management of hyperglycemia in type 2 diabetes: A patient-centered approach. Position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care 2012 Jun; 35:1364. [Free full-text PDF | PubMed® abstract]

Cefalu WT. American Diabetes Association–European Association for the Study of Diabetes position statement: Due diligence was conducted. Diabetes Care 2012 Jun; 35:1201. [Free full-text PDF | PubMed® abstract]

Copyright © 2012. Massachusetts Medical Society. All rights reserved.

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Journal Watch: When Metformin Fails, Which Second-Line Type 2 Diabetes Therapy Is Superior?

Information sourced from Journal Watch:

What Therapy Is Best for Diabetes After Metformin Fails?

In three trials, researchers assess options for second-line diabetes therapy.

Metformin is accepted widely as first-line treatment for patients with type 2 diabetes, but no clear guidelines exist on how to proceed when metformin monotherapy fails. In three new industry-supported studies, researchers compared available second-line treatments.

In an open-label study, 1029 adults with glycosylated hemoglobin (HbA_1c) levels between 6.5% and 9.0% while taking metformin were randomized to add either the glucagon-type peptide-receptor agonist exenatide (Byetta; 5–10 µg subcutaneously twice daily) or the sulfonylurea glimepiride (titrated to maximum tolerated daily dose). During 4 years of follow-up, significantly fewer exenatide recipients than glimepiride recipients (41% vs. 54%) reached the primary endpoint of treatment failure (HbA_1c level >9% after 3 months of treatment, or HbA_1c level >7% at two consecutive readings after 6 months of treatment). Significantly more patients in the exenatide group than in the glimepiride group reached a target HbA_1c level of <7% (44% vs. 31%). Patients who received exenatide lost a mean of 3.3 kg, whereas those who received glimepiride gained a mean of 1.2 kg — a significant difference. Hypoglycemia occurred significantly more often in patients taking glimepiride.

In another open-label trial, researchers randomized 515 adults with HbA_1c levels between 7% and 11% while taking metformin to add either once-daily insulin glargine (Lantus; titrated to a fasting glucose level of 72–99 mg/dL) or the dipeptidyl peptidase-4 (DPP-4) inhibitor sitagliptin (Januvia; 100 mg once daily). After 24 weeks, patients who received insulin glargine had a significantly greater reduction in mean HbA_1c level than did those who received sitagliptin (–1.7% vs. –1.1%), and more patients who received insulin glargine reached the HbA_1c target of 7% (68% vs. 42%). Mean body weight increased slightly in the insulin glargine group and decreased slightly in the sitagliptin group, and significantly more hypoglycemic events occurred in the insulin glargine group (4.2 vs. 0.5 per patient-year).

In the third trial, researchers randomized 1551 patients with HbA_1c levels between 6.5% and 10.0% who were taking metformin alone to the DPP-4 inhibitor linagliptin (Tradjenta; 5 mg daily) or to glimepiride (1–4 mg daily, titrated to fasting plasma glucose ≤110 mg/dL). After 2 years, average HbA_1c level was –0.16% in the linagliptin group and –0.36% in the glimepiride group. Thirty percent of patients taking linagliptin and 35% of those taking glimepiride reached HbA_1c levels <7%. Average body weight decreased slightly with linagliptin and rose slightly with glimepiride; hypoglycemic events occurred in 7% of patients taking linagliptin and in 36% of those taking glimepiride.

Comment: The choice of diabetes therapies is complex, involving patient acceptance, efficacy, and safety. These trials were limited to surrogate endpoints, and all were industry-sponsored (by the makers of exenatide, insulin glargine, and linagliptin, respectively); also, the insulin glargine–sitagliptin trial was very brief. Nevertheless, these trials highlight some of the strengths and weaknesses of the various options for second-line diabetes therapy; the long-term effects of these therapies on glucose metabolism and clinical endpoints remain to be elucidated.

— Bruce Soloway, MD

Published in Journal Watch General Medicine July 10, 2012

CITATION(S):

Gallwitz B et al. Exenatide twice daily versus glimepiride for prevention of glycaemic deterioration in patients with type 2 diabetes with metformin failure (EUREXA): An open-label, randomised controlled trial. Lancet 2012 Jun 16; 379:2270. [Medline® Abstract]

Aschner P et al. Insulin glargine versus sitagliptin in insulin-naive patients with type 2 diabetes mellitus uncontrolled on metformin (EASIE): A multicentre, randomised open-label trial. Lancet 2012 Jun 16; 379:2262. [Medline® Abstract]

Gallwitz B et al. 2-year efficacy and safety of linagliptin compared with glimepiride in patients with type 2 diabetes inadequately controlled on metformin: A randomised, double-blind, non-inferiority trial. Lancet 2012 Jun 27; [e-pub ahead of print]. [Medline® Abstract]

Copyright © 2012. Massachusetts Medical Society. All rights reserved.

The above message comes from "Journal Watch", who is solely responsible for its content.

Do Probiotics Protect Against Antibiotic-Associated Diarrhea? Systematic Review and Meta-analysis

Probiotik efektif untuk mencegah diare akibat pemberian antibiotik

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Information sourced from BMJ:
BMJ 2012;344:e3359
Research News

All you need to read in the other general journals

Probiotics protect against diarrhoea associated with antibiotics
JAMA 2012;307:1959-69 [PubMed® abstract]

More evidence that probiotics can help prevent diarrhoea associated with antibiotics has emerged from a meta-analysis of randomised trials. The authors found 82 trials after a systematic search but only 63 reported how many people took the probiotics, how many took the control treatment, and how many developed diarrhoea. Across these 63 trials, probiotics were associated with a 42% reduction in the risk of diarrhoea (relative risk 0.58, 95% CI 0.50 to 0.68; number needed to treat 13, 10.3 to 19.1).

Most trials tested probiotic preparations containing lactobacilli, alone or in mixed cultures. The effect looked consistent in multiple different analyses, including two confined to high quality trials and another that looked specifically at adults taking antibiotics for Helicobacter pylori infections (the most commonly reported indication). The authors are confident their results are as robust as they can be given the generally poor quality of the evidence base.

Most trials were underpowered and badly reported. It is still hard to know the precise mix of micro-organisms that is likely to work best and the characteristics of patients most likely to benefit. Details of the antibiotics being taken were missing from many trials, as were reliable assessments of side effects. Still, we have enough encouraging evidence to justify further research to fine tune these results, say the authors. Diarrhoea associated with antibiotics is common and can be life threatening.

© 2012 BMJ Publishing Group Ltd