'Unique' NICE Guidelines Have Clinician and Patient in Mind

Jay H. Shubrook, DO: Hi. I'm Jay Shubrook, a family physician and professor at Touro University, California. We're here at the 78th American Diabetes Association Scientific Sessions in Orlando, Florida. We're going to continue our discussion about guidelines for diabetes around the world.

Today I'm happy to have with me Dr John Wilding, who is a professor at the University of Liverpool in the United Kingdom. We're going to talk a little bit about the National Institute for Health and Care Excellence (NICE) Guidelines.

Thanks for coming. Tell me about the NICE Guidelines.

NICE Guidelines

John P.H. Wilding, DM, FRCP: The NICE Guidelines are quite interesting and unique in the way they are produced. First, there is a very rigorous review process which looks at all of the evidence, including a cost-effectiveness element and a clinical element. The guideline review committees usually consist of experts in the field, experts in guideline development, and, very importantly, patients with the condition of interest—in this case, type 2 diabetes.

Shubrook: That is interesting—the NICE Guidelines evaluate cost-effectiveness, include patient involvement, and have rigorous review. Who follows the NICE Guidelines? Who are they speaking to?

Wilding: The NICE Guidelines are there to support clinical decision-making for people caring for patients with diabetes in the United Kingdom. That would obviously include physicians who are specialists in diabetes, primary care practitioners (who do the majority of diabetes care in the United Kingdom), and other clinicians, like nurse practitioners, who also help with care of people with diabetes.

Shubrook: Is it something that patients would access, too?

Wilding: Yes. Patients can access guidelines that are available in a simplified form. You can download them from the website and produce them as a paper form as well.

NICE Approach to A1c

Shubrook: That is great that patients have easy access. One of the things that is controversial with the diabetes guidelines here in the United States is the A1c goal. How does NICE approach the A1c goal for patients?

Wilding: NICE starts with an A1c goal of 6.5% for patients who are newly diagnosed and on monotherapy. That would be the target early in the course of the disease, which I believe is completely appropriate. They then use slightly different goals as escalation targets. If the A1c rises above 7%, the first point of escalation, you can then add a second drug. But once you reach the third and fourth stages of escalation, the point at which you should escalate therapy actually rises to 7.5%.

I would emphasize that those are guideline levels and, of course, you have to adjust as appropriate for the patient. If you have a patient who is perhaps very keen, very interested in looking after their disease, perhaps a younger person, you might keep that lower target even at higher levels of escalation. Conversely, if you have an elderly frail patient, you might be more relaxed with your approach to glucose control.

Shubrook: Like other guidelines, there is room for individualization specific to your patient.

Wilding: That is correct.

Shubrook: What is the guidance regarding stopping of medication? Could you talk about that?

Discontinuing Therapy

Wilding: Yes. Another thing that NICE has done, which is part of the cost-effectiveness analysis, is suggest that drugs like GLP-1 receptor agonists have a place in the treatment of people with type 2 diabetes, perhaps focusing on those who are more obese.

It also suggests that after 6 months of therapy, if the patient is not losing weight (3% is the target) and not dropping A1c by at least 1%, then you should review whether it's appropriate to continue that therapy. It suggests actually stopping the drug if it's not effective at that point. Again, in clinical practice there is a little bit of leeway around that. For example, if a patient had an A1c drop of 1.2% but had lost only 2% of weight, I think most people would accept that they had not quite met the weight loss target of 3% but were pretty close, and since they had a bigger A1c reduction, it would be okay [to continue]. I think most people would review the guidelines sensibly rather than necessarily interpreting them to the letter. They are there to guide us, not to instruct us.

Shubrook: Particularly when we look at the cost of diabetes medications, just adding more medicine, especially if you are not getting efficacy, probably is not a wise investment.

Wilding: Yes, absolutely. It is there to ensure that we are using medicines wisely, especially those that are most expensive.

Two Most Important Takeaways

Shubrook: What are the two most important factors from the NICE Guidelines for diabetes?

Wilding: The first and most important factor is that you are going to get a guideline that is largely based in practical, real-world clinical medicine. I think it is strongly based on evidence. Of course, you can always improve guidelines and they are reviewed on a regular basis. You could argue that they should be reviewed more often. One point that perhaps is missing from the NICE Guidelines at present is any guidance that includes the evidence that is already there on the cardiovascular outcome trials. That is something they will be looking at probably in the next 12-18 months. You could perhaps argue that there is some inertia in the guidelines that is actually preventing us from using the best evidence at the moment.

Shubrook: What we have heard today is that the NICE Guidelines provide a good evidence base for diabetes treatment. There is a focus on an A1c approach to the intensity of treatment as well as stopping rules to make sure that we are not adding unnecessary medicines in diabetes. Thank you so much for being here today.

Wilding: Thanks, Jay.

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