Docs Debate Clinical Inertia vs Overtreatment in Diabetes Care

Liam Davenport

March 15, 2017

MANCHESTER, UK — "Clinical inertia" in treating diabetes patients, resulting either from delayed treatment initiation or failure to escalate therapy, is responsible for a significant proportion of patients not achieving their targets. On the other hand, some diabetes patients — particularly the elderly — need to be protected from overtreatment.

Arguing the toss between these two, apparently contrasting, views were two experts from the University of Leicester, United Kingdom, who debated which of the two represents the greatest medical risk at the recent Diabetes UK Professional Conference 2017.

Kamlesh Khunti, MD, PhD, head of department and professor of primary care, diabetes, and vascular medicine, jousted with Melanie Davies, MD, PhD, CBE, professor of diabetes medicine.

Less Than 50% of UK Diabetes Patients Achieve Target HbA1c

Dr Khunti started his argument for "clinical inertia" by noting that there is "excellent trial evidence showing that reducing HbA1c leads to better outcomes in the short term for microvascular benefits and, in the longer term, for macrovascular benefits, and this is for both type 1 and type 2 diabetes."

He added that guidelines also "tell us that we should be individualizing therapy," with control more or less tight depending on the given patient, with factors such as patient attitude, the risk of hypoglycemia, their age, and the presence of comorbidities and/or vascular complications to be taken into account.

Defining tight control as an HbA1c of 6.5% and less tight control as 8.0%, he noted, "Despite this evidence base, despite the guidelines, we don't seem to be achieving these targets," with only around 50% of UK patients achieving an HbA1c of less than 7.0%.

Moreover, a recent study in eight European countries indicated that the United Kingdom was performing the worst in terms of achieving HbA1c targets, at a mean of 40% (Diabetes Care. 2013;36:2628-2638). "So we're not doing too well, looking at these data."

Dr Khunti said that this therapeutic or clinical inertia was thought to be primarily associated with starting insulin in type 2 diabetes and sometimes treatment intensification but is instead "a problem throughout the paradigm in terms of treatments."

A Problem Throughout the Treatment Paradigm

He noted that the 2015 ADA/EASD position statement on treatment of type 2 diabetes indicates that therapy should be escalated every 3 months if patients are not achieving their target HbA1c (Diabetes Care. 2015;38:140-149).

However, a study of more than 40,000 type 2 diabetes patients initiating basal insulin in five European countries and in the United States, just published (Diabetes Obes Metab. 2017; DOI:10.1111/dom.12927), reveals that only 8.1% of UK patients reached their target at 3 months, and that failure at this point was associated with a fivefold increased risk of not achieving the target at 24 months, he explained.

So such clinical inertia can result in patients remaining poorly controlled for long periods of time, with potentially serious consequences.

For example, Paul et al demonstrated that patients with type 2 diabetes and an HbA1c of ≥7% who did not receive treatment intensification within a year experienced an increased risk of myocardial infarction, stroke, heart failure, and combined cardiovascular end points after 5 years (Cardiovasc Diabetol. 2015; DOI:10.1186/s12933-015-0260-x), Dr Khunti said.

Moreover, "We wait far too long to intensify once people are on insulin.…We know from treat-to-target trials…that we can get to these targets much more quickly, and we should be getting to these targets much, much earlier."

He acknowledged, however, that there is some evidence for overtreatment but that it is limited to a smaller group of typically elderly patients.

Studies have also shown that there is significant excess mortality in older patients with diabetes that is unexplained by comorbidity and polypharmacy. However, it has also been demonstrated that an HbA1c of more than 8.0% is associated with an increased risk of all-cause and cause-specific mortality in diabetes patients aged 65 years or older, he stressed.

"If someone's young, you should be going for tight control, whether or not they have…risk factors. Once you get to middle age, maybe you want to loosen the target in people who have these factors….When you're elderly, quality of life is more important, and maybe you're going for a looser target."

Is More Treatment Always Better?

Dr Davies began her case by outlining that the fourth (quaternary) level of prevention and care — to identify patients at risk of overmedicalization, to protect them from invasive medical interference, and to provide ethically acceptable and safe procedures — "is very important, because there is a big assumption that all the progress we make in terms of technology, in terms of society, is constant and always for the better."

"Actually, quaternary prevention challenges this, in that we can have positive iatrogenia," ie, even using medicine properly, that "has the potential to overmedicalize and can cause personal damage [and] unnecessary risk to patients, and it can, and I think importantly…waste resources," she noted.

Protecting the person with diabetes from overmedicalization is an important aspect of diabetes care, she stressed, as they are already living a "medically invaded" life.

But she continued: "I don't disagree with Kamlesh that we have problem…of a gap in terms of how patients are doing. I just have a disagreement with him about what the problem is, and I'm not sure the problem is just as simple as 'we're not writing enough prescriptions for patients.' "

In the elderly, Dr Davies pointed to a recent editorial discussing the fact that general practitioners in the United Kingdom receive financial incentives to have type 2 diabetes patients meet HbA1c targets and that this is a performance indicator (Br J Gen Pract. 2015;65:334-335). GPs could thus inadvertently harm these patients, it concluded. Instead, overtreatment in the elderly should be avoided by concentrating on established risk factors, said the author, who also suggested that there should be a greater focus on younger patients in these times of limited resources.

Dr Davies also pointed out that, in the older type 2 diabetes population, the symptoms may be different from those in younger patients, there is less awareness of hypoglycemia, and the patients have more comorbidities.

Furthermore, there is a bidirectional relationship between hypoglycemia and cognitive decline, making the combination of hypoglycemic unawareness and cognitive dysfunction "critical factors in the treatment of older adults."

She went on to note that almost a quarter of all emergency admissions to the hospital in the United States are associated with treatment with either insulins or oral hypoglycemic agents, while separate data have indicated that 52% of patients with type 2 diabetes and comorbid dementia are tightly controlled, with an HbA1c of <7%, thus placing them at high risk of hypoglycemia.

Moreover, Lipksa et al showed that tight control is being achieved in older US patients regardless of health status, suggesting that at least some are being overtreated (JAMA Intern Med. 2015;175:356-362).

Overtesting , Nonadherence, and Education All Need to Be Addressed

Dr Davies also referred to a retrospective analysis of a US national administrative claims database by McCoy et al, which showed that, across age ranges, excessive HbA1c testing, defined as five or more times per year, was associated with a significant 35% increase in the risk of treatment intensification, while frequent testing (three to four tests per year) was linked to a small but significant 8% decrease in the likelihood of treatment deintensification (BMJ. 2015;351:h6138).

Consequently, it was concluded that excessive testing is ineffective and inefficient, contributing to a waste of healthcare recourses and increasing patient burden.

And this is set against a background of nonadherence reaching "epic proportions" in chronic diseases, she noted, with 30% of patients stopping their medications before their first supply runs out, 25% taking less than the recommended dose, and 33% not filling out their prescriptions. In the United Kingdom, 33% of patients report insulin nonadherence, she observed.

"Nonadherence to the glucose-lowering therapies that we already prescribe is the norm; most patients won't take their medication, and that we really have to understand and address."

Also, the majority of patients don't have access to or are not even offered structural self-management support.

Concluding, Dr Davies said that "protecting the person with diabetes from overmedicalization is an important and, I would say, crucial aspect of diabetes care, and we're focusing on the wrong problem if we just think prescribing more drugs is going to heal things."

Dr Khunti declared that he had consulted for, received research support from, and was on speakers' bureaus for numerous companies, including AstraZeneca, Boehringer Ingelheim, Janssen, Lilly, Novo Nordisk and Sanofi. Dr Davies reported no relevant financial relationships.

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Diabetes UK Professional Conference 2017. March 8, 2017; Manchester, United Kingdom. Debate



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