Experts On One Accord: Studies Not as Advanced as Hoped (Continued)

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One takeaway from the ACCORD trial was that aggressive cardiovascular disease prevention over short time periods is probably not appropriate in older patients with long duration of type 2 diabetes who are at high risk for heart disease. The study is not clear on aggressive blood glucose control over a longer time frame or for patients with a shorter duration of type 2 diabetes and lower risk for heart disease, but most doctors we know emphasize the importance of tight control in reducing microvascular risk. They say it is important to note, as stated, that ACCORD trial participants aren’t representative of the general diabetic population: the patients were older, very ill, had high baseline A1c values, rapid A1c drop, and gained a lot of further weight (unlike in ADVANCE, perhaps because therapy was pursued so intensely), and were treated with multiple medications (>60% were on three to four orals and insulin). Unfortunately, given the unusual patient population, it is hard to differentiate between the patient group and the treatment strategy.

The ADVANCE Trial
Another big study at the ADA conference was ADVANCE. Much like the ACCORD trial, the ADVANCE trial focused on the effects of intensive glucose control on major macrovascular (e.g. heart disease and stroke) and microvascular (eye, kidney, or nerve disease) outcomes in 11,140 type 2 diabetes patients, including the effects of lowering blood pressure on these major outcomes. Participants in the intensive treatment arm also received more frequent visits, greater emphasis on lifestyle management, and glucose control through the use of sulfonylurea (gliclazide modified release) and other oral drugs and insulin, as needed.

Over the five-year study period, intensive glucose control did not reduce overall mortality and macrovascular complications, including heart attacks, strokes, or cardiovascular death. However, researchers found that intensive blood pressure control significantly reduced outcomes including retinopathy and nephropathy, by about 14%, which is equivalent to approximately one less event for every 52 people in the study. Blood pressure was lowered below current guidelines using a fixed combination of a long-acting ACE inhibitors and other oral blood pressure medications. The study also noted a reduction in microalbuminuria (leakage of small amounts of albumin protein by the kidney – an early sign of kidney damage) by 30%.

The results of the ADVANCE trial suggest that it would be beneficial to explore the effects of intensive blood pressure control (which in their study was shown to produce more pronounced benefits). Although the study did not observe any macrovascular benefits, which we wouldn’t necessarily expect after only five years, further studies and long-term follow-up of patients may eventually show significant benefits of intensive glucose control on macrovascular outcomes. It may well be that cardiovascular benefit would have been shown over a longer number of years, but that will never be known. We advocate longer studies in populations that resemble more closely the average patient – we look forward, as always, to learning more and in the meantime we advocate, on behalf of all our medical advisors, tight glycemic control while watching out for hypoglycemia.

Kelly Close is editor in chief of diaTribe (www.diaTribe.us), a free online newsletter for patients looking for more information on products and research.

NOTE: The information is not intended to be a replacement or substitute for consultation with a qualified medical professional or for professional medical advice related to diabetes or another medical condition. Please contact your physician or medical professional with any questions and concerns about your medical condition.

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