Our editors have summarized several key presentations from the American Diabetes Association 70th Scientific Sessions, held this year in Orlando, FL, June 25-29.
Combination Therapies for Type 2 Diabetes from the Get Go — Are We There Yet?
Presented by Bernard Zinman, MD, Director, Leadership Sinai Centre for Diabetes, Mount Sinai Hospital, professor of Medicine, University of Toronto
In this lecture, Zinman focused on the use of metformin/sulfonylurea and metformin/thiazolidinedione (TZD) therapy in patients with type 2 diabetes.
“Why not use combination therapies early on in treatment?” asked Zinman. After all, the early use of combination therapy is well established in other disease states, such as cancer, HIV/AIDS, hypertension, asthma, RA, tuberculosis. “Are we just slow off the mark in diabetes?”
One of the main arguments in favor of early combination therapy for patients with type 2 diabetes is that “the traditional stepwise approach to treatment frequently results in therapeutic inertia,” said Zinman. Patients may respond to diet and exercise early on, but will likely decline. When that happens, the patient will respond initially to the first-line monotherapy that their physician will likely prescribe, but then level off or decline. This stepwise approach to treatment shows a widespread lack of appreciation of the fundamental nature of type 2 diabetes, said Zinman: “It doesn’t get better with time, it gets worse.” So why not pursue glycemic control through early combination therapy, especially when data shows us that by nine years, 75% of patients will be on combination therapy anyway, he argued.
The rationale for early combination therapy is that it would lead to, among other outcomes, a robust lowering of A1c levels; potential for early combination therapy to improve beta cell function (this could very well be the key, but more data is needed); initiation of therapeutic interventions with complementary mechanism of action; and potential to use less than maximal dose in order to get better outcomes. It could also help avoid clinical inertia associated with stepwise approach to therapy.
Zinman said that, given all of these factors, one of the key questions confronting providers is “which combination therapy should you use.” He noted that there are more than a dozen choices currently available, which is confusing for primary care physicians with a non-specialist’s knowledge of diabetes treatments. Primary care physicians like to use sulfonylureas because they produce rapid early improvement in fasting plasma glucose; however, the effect lessens over time.
Metformin/sulfonylureas, with their complementary mechanisms of action, are the most commonly used combination therapy. Sulfonylureas also have the added benefit of being “cheap, cheap, cheap,” said Zinman. However, sulfonylureas are not without their downsides. For example, they are associated with hypoglycemia and lead to a greater degree of loss of beta cell function compared to other therapies. Sulfonylureas also “have a Nike effect” in change over time when it comes to A1c levels, said Zinman. “In other words, they go down and come back up” (producing a Nike-like “swoosh” when graphing A1c levels over time).
One of the key considerations providers must take into account with metformin/ thiazolidinedione or any combination therapy, said Zinman, is the dose-effect relationship. There is quite a bit of evidence showing that half-maximal dosing of combination therapy produces “more than a half-maximal effect, typically with fewer side effects than seen with the maximal dose.” So the question for investigators and providers is whether low-dose combination therapy can be as powerful in preventing diabetes as other therapies (defined as producing at least a 45% diabetes risk reduction). As an example of this dose-effect phenomenon, Zinman cited results of the CAnadian Normoglycemia Outcomes Evaluation (CANOE) trial he co-authored. In study results published in the Lancet, researchers found that low-dose combination therapy with metformin and a TZD “was highly effective in prevention of type 2 diabetes in patients with impaired glucose tolerance, with little effect on the clinically relevant adverse events of these two drugs.”
The Medical Home: Growing Evidence for an American Revolution
Presented by Thomas C. Rosenthal, MD, Professor and Chair, Department of Family Medicine, School of Medicine and Biomedical Sciences, State University of New York at University at Buffalo
Rosenthal discussed the clinical and economic benefits of the patient-centered medical home model of care, a topic that is of particular importance to the hospitalist community, as it works with primary care providers and other healthcare professionals to define hospital medicine’s place in the coordinated team approach to care.
Although “the concept of the patient-centered medical home is sweeping the company” and is an integral part of healthcare reform, said Rosenthal, “there is still a fair amount of confusion” about what it is and what it “looks like.” He said that ideally, it “should look different for each patient according to his or her individual medical need.”
To highlight the need for a better approach to care in the US (particularly care for acute and chronic disease and illness), Rosenthal cited several well-known facts and statistics:
Clearly, “it’s time to understand that addressing only one medical problem at a time in isolation from others has been a failed strategy for making patients well,” said Rosenthal.
One potential solution to these dilemmas, the patient-centered medical home, focuses on true primary care that is characterized by coordinating preventive, maintenance, and acute health services. It employs an integrated team approach to conduct care management, and relies heavily on the effective use of information technology to supports care decisions, which makes it easier to establish robust registries and harvest data from patient panels. The patient-centered medical home should make use of formal quality management programs and promotes 24-hour patient communication and rapid access.
What would a patient-centered medical home look like in practice? Although there would ideally be great variability and flexibility based on patients’ needs, Rosenthal said that the medical home would deviate from our current “rule-out approach,” which incentivizes physicians “to order every possible test.” This is “a ‘rescue strategy’ that is really only appropriate for very ill patients,” Rosenthal said. The model for the medical home is the “try-out approach,” which is a generalist approach that leads to fewer tests and promotes communication and a provider-patient relationship that engages the patient as partner in the acre process.
The patient-centered medical home would meet patients’ desires for fast access to effective treatment and clear, comprehensive, and reliable healthcare advice and information; respect for their treatment preferences and attention to their physical and emotional needs; greater family involvement; and continuity of care and smooth transitions to specialty care and hospitalization.
A Computerized Intravenous Insulin Controller (CIIC) Shows Significantly Less Hypoglycemia than NICE-SUGAR and Five Paper Protocols for Intensive Control--0.3% vs. 10.6%
Presented by Paul C. Davidson, R. Dennis Steed, Bruce W. Bode, and Harry R. Hebblewhite
What if your facility could safely and effectively achieve tight glycemic control among patients in the intensive care unit (ICU) with little danger of severe hypoglycemia?
According to study results presented at the ADA, this outcome is possible through the use of Glucommander, a computerized algorithm that accurately manages intravenous insulin.
In their poster, Davidson and colleagues reported their findings from a study that compared hypoglycemia rates among patients in hospitals that used Glucommander to manage insulin to the rates seen in patients in the NICE-SUGAR trial (http://hcp.lv/dxlYb9) and in patients who were managed using various “tight-control paper protocols.”
The authors noted that “studies have shown excessive rates of hypoglycemia” in ICU patients (rates from the studies they cited range from 5.2% to 28.6%, with a mean rate of 10.6%), despite efforts at effective blood glucose management, leading the ADA and AACE to issue what the authors labeled as “compromise” guideline revisions that accept blood glucose levels in these patients that “were previously associated with increased complications.”
The Glucommander computerized intravenous insulin controller (CIIC) for insulin dosing enables providers to avoid hypoglycemia by accurately controlling patients’ blood glucose to desired target levels. The Glucommander system alerts staff to measure patients’ blood glucose and can make adjustments to patients’ insulin doses to “prevent excursions outside the target range. When a patient’s blood glucose decreases, the system will phase out insulin while enteral or parenteral nutrition continues and can augment the patient’s carbohydrate intake with a titrated solution of 50% dextrose in water (D50), “correcting the glucose level to mid-target range.”
The authors presented data comparing the number of patients in the NICE-SUGAR trial and the number of patients managed with tight-control paper protocols that had at least one blood glucose reading of less than 40 mg/dl to the number of Glucommander patients who did. In the NICE-SUGAR trial, 6.8% of patients had at least one blood glucose reading of less than 40 mg/dl. In the tight-control paper protocols group, 12.6% of patients had at least one blood glucose reading of less than 40 mg/dl. Only 0.3% of Glucommander patients met these criteria.
These results led the authors to conclude that “It is possible with the Glucommander to implement tight glycemic control in all institutions” and to achieve the ideal 110-140 [mg/dl blood glucose] range cited by the ADA and AACE.” They advise more hospitals to implement this “effective, safe, and more normoglycemic algorithm in an accurate, computer-controlled system.”
Find More Online
Visit www.hcplive.com/ada-hosp for more coverage of the ADA Scientific Sessions, including the following audio podcasts: