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At the heart of the matter

Diabetes is one of the most serious chronic diseases affecting the developed world. Its spread is global and its consequences severe. It is a condition that American physician Dr Lawrence Blonde knows only too well.

“The International Diabetes Federation has estimated that as of 2014, there are some 387 million people with diabetes in the world, a prevalence of 8.3 per cent. It is expected that by the year 2035, there will be an additional 205 million people with diabetes” he tells the Medical Independent (MI). “About half of those with diabetes are undiagnosed and don’t yet know that they have the disease.”

Global problem

 In Ireland, it is believed that there are about 225,000 people with the condition, with 90 per cent of them living with type 2 diabetes. This number is also expected to rise to more than a quarter of a million by 2030.

“It is a global problem and in a recent issue of Diabetes Care, there is a paper on the economic burden of the disease in the US,” explains Dr Blonde. “When they added those with prediabetes, undiagnosed diabetes and gestational diabetes to those with diagnosed diabetes, the total cost exceeded $322 billion (€257.5 billion) in 2012.”

The economic burden of the disease is undoubtedly enormous but the personal costs are incalculable. Dr Blonde is familiar with both.

He is presently the Director of the Ochsner Diabetes Clinical Research Unit, at the Ochsner Medical Centre in New Orleans, LA.

He is also a former Chair of the Steering Committee of the US’s National Diabetes Education Programme (NDEP). The NDEP is sponsored by the US Department of Health and Human Services’ National Institutes of Health and the Centres for Disease Control and Prevention. It also includes over 200 partners working together to improve the treatment and outcomes for people with diabetes, promote early diagnosis and prevent or delay the onset of type 2 diabetes.

While he stresses that the cornerstone of treatment for those with type 2 diabetes remains lifestyle intervention, most patients will need pharmacological intervention at some point. He believes that canagliflozin, an oral, once-daily medication belonging to a new class of medications (sodium glucose co-transporter 2 inhibitors), can be a valuable component of pharmacotherapy for many patients with type 2 diabetes.

Newest drug class

 “This newest class of drug is associated with good glycaemic efficacy,” he explains, “and although not approved for blood pressure reduction or weight loss, change in weight and systolic blood pressure were pre-specified end points in the clinical trials of SGLT2 inhibitors. In studies of canagliflozin, significant weight loss and reduction in systolic blood pressure, in addition to improvements in glycaemic control, were noted.

“Depending on how you count, there are at least 11 classes of antihyperglycaemic agents. I think clinicians can look at the characteristics of these medicines and the characteristics of their patients and try and match them up to select the most appropriate medications for individual patients,” he adds. “And if we do that, we’re likely to get better efficacy, safety and tolerability and therefore, hopefully, better control of diabetes and better outcomes. There is a move towards individualising treatment and having multiple classes of agents that address the different components of the pathophysiological mechanism of action of diabetes will be quite helpful.”

I think clinicians can look at the characteristics of these medicines and the characteristics of their patients and try and match them up to select the most appropriate medications for individual patients

According to Janssen — the maker of Invokana, an SGLT2 inhibitor which came on the market in Ireland last month — the efficacy of canagliflozin was supported by a comprehensive global Phase III clinical programme. The programme enrolled more than 10,300 patients in nine studies.

The trial was one of the largest late-stage development programmes for an investigational pharmacological product for the treatment of type 2 diabetes submitted to health authorities to date.

Efficacy

 “It assessed the efficacy and tolerability of canagliflozin across the spectrum of adult type 2 diabetes management, in patients who needed further glucose control as a single agent, in combination with metformin, and in combination with other glucose-lowering agents, including insulin,” the statement from the company read.

“These Phase III studies have directly compared canagliflozin to current standard treatments. Two head-to-head data studies compared canagliflozin to sitagliptin, a DPP4 inhibitor, and another study compared canagliflozin to a sulphonylurea, glimepiride. In all three comparator studies, canagliflozin 300mg provided greater and sustained reductions in HbA1C compared to those on placebo or an active comparator with the additional effect of significant weight reduction.

“The Phase III programme also included three large studies in special populations: older patients with type 2 diabetes; patients with type 2 diabetes who had moderate renal impairment; and patients with type 2 diabetes who were considered to be at high risk for cardiovascular disease.”

Changing behaviours

 One of the biggest issues surrounding diseases like diabetes is changing lifestyle. This can take time and effort to see results. Dr Blonde notes that the NDEP “has multiple resources on their webpage, which can be very useful. One is ‘Diabetes HealthSense,’ developed by a group of behaviour-change experts to assist patients with, and at risk of, diabetes in adhering to their healthcare professionals’ recommendations for lifestyle interventions (medical nutrition therapy and appropriately-prescribed physical activity), as well as taking any prescribed medications. The NDEP has also just published a document called Guiding Principles for the Care of People with or at Risk for Diabetes. Rather than adding a new guideline to the list of already-published diabetes guidelines, the NDEP worked with other medical organisations to identify where there was general agreement across existing guidelines.”

These areas include identifying people with undiagnosed diabetes, pre-diabetes, and managing the latter to prevent or delay the onset of the disease; detecting and monitoring diabetes microvascular complications; and considering the needs of special populations, such as women of child-bearing age, older adults, and high-risk racial and ethnic groups.

“The NDEP has focused on developing education programmes addressing the needs of these special populations. For example, resources are available in many different languages,” Dr Blonde tells this newspaper.

We should be hopeful too, Dr Blonde adds, as progress is being made, albeit slowly.

“In the US there may now be some levelling-off in the rise in the incidence of obesity and type 2 diabetes. However, prevalence isn’t decreasing because people with diabetes are living longer and there is a growth of minority groups especially susceptible to the condition. Nevertheless, the decrease in the rise of the incidence is encouraging.

“I’m older than most people,” he jokes, “and I still remember when two-thirds of my professors smoked. Today, less than 20 per cent of American adults smoke. I think that there is evidence that over a long period of time, public health messages can really work.”

Websites

For further information please visit the National Diabetes Education Programme: www.ndep.nih.gov or

Diabetes HealthSense: http://ndep.nih.gov/resources/diabetes-healthsense/index.aspx.

Guiding Principles for the Care of People with or at Risk for Diabetes: www.ndep.nih.gov/hcp-businesses-and-schools/guiding-principles/ .

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