Physician's Weekly Article - Conference Highlights: The 2009 ADA Scientific Sessions

       The American Diabetes Association held its 2009 annual meeting from June 5 to 9 in New Orleans. The features below highlight some of the news emerging from the meeting. For more information on these items and other research that was presented, go to www.diabetes.org.

      A New Way to Diagnose Diabetes?

      The Particulars: Currently, the fasting plasma glucose and the oral glucose tolerance tests are used to diagnose diabetes. An international expert committee assembled by the American Diabetes Association, International Diabetes Federation, and European Association for the Study of Diabetes assessed the potential for using the A1C assay to diagnose diabetes.

      Data Breakdown: In reviewing data examining A1C levels and long-term complications, an A1C value of 6.5% or greater is recommended for use in the diagnosis of diabetes. Investigators reported that this cut-point should not be construed as an absolute dividing line between normal glycemia and diabetes. However, an A1C level of 6.5% is sufficiently sensitive and specific to identify people with diabetes.

      Take Home Pearl: The A1C assay is recommended for use when diagnosing diabetes because values vary less than in other tests.

      Long-Term Data on Rosiglitazone & CV Outcomes

      The Particulars: Rosiglitazone is an insulin sensitizer used for glucose-lowering alone or in combination with metformin and/or a sulfonylurea. The RECORD (Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes) study was designed to evaluate the long-term impact of rosiglitazone on cardiovascular (CV) outcomes and blood glucose control as compared with metformin and sulfonylureas.

      Data Breakdown: On the composite outcomes of cardiovascular death, stroke, and heart attack, results slightly favored rosiglitazone over metformin and sulfonylureas. At the end of the study, rosiglitazone was shown to be superior in controlling blood glucose levels when compared with metformin and sulfonylureas. After 5 years, patients in the rosiglitazone group had A1C levels 0.29% lower than people on sulfonylureas and 0.26% lower than those on metformin.

      Take Home Pearl: When used in appropriately selected patients, rosiglitazone appears to carry no overall increase in CV risk with regard to major morbidity or mortality.

      Evaluating Treatment Approaches & Mortality

      The Particulars: The BARI 2D (Bypass Angioplasty Revascularization Investigation in Type 2 Diabetes) study compared intensive medical treatment with prompt coronary revascularization by either bypass surgery or angioplasty to intensive medical treatment alone. The study also assessed whether controlling diabetes with drugs to improve insulin sensitization had an advantage for heart health or survival.

      Data Breakdown: After an average follow up of 5 years, no differences in mortality rates or in cardiovascular events were observed between types of early coronary revascularization when compared with medical therapy alone. However, among the subgroup of participants who were pre-identified as candidates for coronary bypass surgery, the group receiving prompt surgery had significantly fewer heart attacks or strokes when compared with those who initially received intensive medical therapy alone.

      Take Home Pearl: Prompt revascularization does not appear to hold any advantage over intensive medical therapy alone with regard to total mortality.

      Combo Therapy Effective Against Diabetes, Hypertension

      The Particulars: A double-blind study of 1,423 patients with hypertension was conducted in which patients were randomized to treatment with telmisartan and amlodipine combination therapy or with telmisartan and amlodipine as monotherapy. Of the study population, 16.2% had diabetes.

      Data Breakdown: The combination of telmisartan and amlodipine produced clinically relevant blood pressure (BP) reductions and was equally effective in hypertensive patients with and without diabetes. With telmisartan plus amlodipine, up to 30.4% of hypertensive patients with diabetes achieved recommended BP targets. Telmisartan 80 mg plus amlodipine 10 mg produced the largest BP decreases and highest BP control rates. The telmisartan/amlodipine combinations were more effective than telmisartan and amlodipine as monotherapies.

      Take Home Pearl: Combining telmisartan and amlodipine appears to be effective in reducing BP and achieving clinically relevant BP control within recommended targets in patients with type 2 diabetes.

      Extended-Release Drug Promising for DPN

      The Particulars: Pure mu-opioids have been used for the management of pain in patients with diabetic neuropathic pain (DPN) but have been associated with gastrointestinal and central nervous system adverse effects. Researchers assessed the investigational extended-release (ER) formulation of tapentadol in patients with moderate to severe pain due to chronic DPN.

      Data Breakdown: Tapentadol ER 100 mg to 250 mg twice daily was safe and effective for the management of chronic neuropathic pain in patients with DPN. Patients receiving tapentadol ER maintained improvements observed in the open-label phase. Placebo-treated patients significantly worsened from the start of the double-blind phase. Tapentadol ER was associated with a relatively low rate of study discontinuations due to treatment-emergent adverse events.

      Take Home Pearl: Patients who respond initially to the ER formulation of tapentadol for the treatment of DPN appear to experience ongoing benefits throughout 12 additional weeks of treatment.

      Improving BP in Diabetes

      The Particulars: Exenatide is a glucagon-like peptide-1 receptor agonist intended to improve glucose control in adults with type 2 diabetes. Investigators examined 6-month blood pressure (BP) outcomes with exenatide using 7-year data from a national EMR database. All patients in the study started exenatide during or after 2005 and had one or more additional exenatide orders after their index date. They also had prior orders for metformin, a sulphonylurea, and/or a thiazolidinedione.

      Data Breakdown: About 44% and 43% of patients receiving exenatide achieved systolic and diastolic BP targets, respectively, at 6 months. Among patients who were not at systolic and diastolic BP targets at baseline and received exenatide, 22% achieved BP goals. BP outcomes did not differ between patients treated with antihypertensive agents and those who were not treated.

      Take Home Pearl: Exenatide appears to lead to clinically meaningful BP improvements in patients with type 2 diabetes irrespective of background antihypertensive medications.