WHO Guidelines Support Lower-Cost Medications for Diabetes

09/05/18

By Will Boggs MD

NEW YORK (Reuters Health) - New guidelines from the World Health Organization (WHO) support the use of lower-cost second- and third-line medications for type 2 diabetes and the use of human insulin for blood glucose control in nonpregnant adults with diabetes.

"The purported benefits of the newer diabetes medicines reviewed in these guidelines are modest at best and based on weak evidence, particularly for important long-term outcomes," said Dr. Gojka Roglic from the WHO, in Geneva, Switzerland.

"The financial burden of these newer and more expensive medicines to the individual and/or health system is substantial," she told Reuters Health by email.

A core function of WHO is to provide guidance for a broad range of public-health problems that is intended for a global audience but focuses on low- and middle-income countries, where technical expertise and financial resources are often lacking.

This approach seeks to ensure the widest possible access to services and medicines at the population level and to achieve a balance between implementing the best-established standard of care and what is feasible on a large scale in resource-limited settings.

Dr. Roglic and Dr. Susan L. Norris, also at the WHO, updated earlier WHO recommendations by reviewing newer second- and third-line medicines that are most frequently marketed in low- and middle-income countries. Their guideline, online September 4 in the Annals of Internal Medicine, includes five recommendations.

First, patients with type 2 diabetes who do not achieve glycemic control with metformin alone or who have contraindications to metformin should be treated with a sulfonylurea.

Second, patients with type 2 diabetes who do not achieve glycemic control with metformin and/or a sulfonylurea should be treated with human insulin.

Third, where insulin is unsuitable, a dipeptidyl peptidase-4 (DPP-4) inhibitor, a sodium-glucose cotransporter-2 (SGLT-2) inhibitor, or a thiazolidinedione (TZD) may be added.

Fourth, human insulin should be used to manage blood glucose in adults with type 1 diabetes and in adults with type 2 diabetes for whom insulin is indicated.

Finally, long-acting insulin analogues may be used to manage blood glucose in adults with type 1 or type 2 diabetes who have frequent severe hypoglycemia with human insulin.

Dr. Roglic explained that these recommendations "are more relevant in low-income settings, because the consequences of high expenditure are more serious in low-income settings. However, even in some high-income settings, there are people who have no financial protection and could be pushed into catastrophic personal expenditure with overenthusiastic interpretation of the potential benefits of newer medicines."

"The individual or health system healthcare expenditure on these newer diabetes medicines is in large disproportion with what we know about their health benefits," she said. "Patients and policymakers should be aware of what health impact can be expected with their use."

Dr. Amir Qaseem from the American College of Physicians (ACP), in Philadelphia, who co-authored a linked editorial, told Reuters Health by email, "I think we need to look at the value of any intervention, value being assessment of the best available evidence for benefits, harms, and costs together. (The) 'limited resources' concept exists and applies to all countries, as there is always a maximum budget for any healthcare system with individuals within such a system with their own top limits for spending on health care. Considering the unsustainable rising costs in our own system, we need start seriously thinking about how to make appropriate decisions to provide high-value care and improve the quality of care of Americans."

"When pharmacologic treatment is needed, metformin is the first-line medication," he said. "For a second-line agent, ACP recommends that physicians should discuss benefits, adverse effects, and costs with the patient when deciding between a sulfonylurea, a thiazolidinedione, an SGLT-2 inhibitor, or a DPP-4 inhibitor."

"Newer medications for treating diabetes are considerably more expensive and consideration of costs is important," he said. "Hence, we recommended shared decision making with a patient."

"WHO gave sulfonylureas a priority because of lower costs but acknowledges the risk of hypoglycemia associated with it," Dr. Qaseem said. "Thiazolidinediones, SGLT-2 inhibitors, and DPP-4 inhibitors have generally similar efficacy in terms of their ability to lower blood glucose, but their long-term safety is not as well known. We need more research to compare the time-tested medications with these newer agents to see the benefits, harms, side effects such as hypoglycemia and weight gain, costs, and feasibility for patients."

He added, "Nonpharmacologic therapy, such as diet, exercise, lifestyle modifications, and weight loss, is an important component to manage diabetes."

Dr. Nanny N. M. Soetedjo from Universitas Padjadjaran, in Bandung, Indonesia, who recently reviewed treatment of patients with diabetes in Indonesia, Peru, Romania and South Africa, told Reuters Health by email, "The problem, in my opinion, in low- and middle-income countries (LMIC) is how to have good monitoring and cheaper systems for monitoring blood glucose, especially HbA1c, kidney function, and risk for cardiovascular disease. My article said that, in fact, in 4 LMIC countries 33.3% of diabetic patients had HbA1c >10%, and from those groups only 54.8% received insulin, with the lowest rate in my country, Indonesia (31.7%)."

"So I think we have to develop not only guidelines for treatment, but also guidelines for how and when to monitor diabetic patients in LMIC countries," she said.

SOURCE: https://bit.ly/2wHPCDB and https://bit.ly/2PEznyJ

Ann Intern Med 2018.

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