Treatment failure, Non-responders, and Non-adherence


Dr. Doron Schneider: Hi, I'm Dr. Doron Schneider. I'm a general internist at Abington Health Center right outside of Philadelphia. There I am the chief quality and safety officer for the health system and deputy program director for internal medicine. And with me I have Dr. Jack Leahy. Jack …
Dr. Jack Leahy: Great. I'm Jack Leahy. I'm the endocrine chief at the University of Vermont here in Burlington. I'm very interested in diabetes pathogenesis, but also clinical care.
Dr. Doron Schneider: Thanks, Jack, and so we are hoping in the next period of time to provide some reflections on current diabetes care especially in light of the new guidelines that are out from the ADA/EASD, and really fit them into the evolving landscape of diabetes care. With healthcare reform, Affordable Care Act, the landscape is rapidly shifting, and this is an attempt on our part to really provide some reflections about that. Often what I see in primary care is rather than reflecting on the lack of response we continue to move to add additional therapy, thus increasing complexity, costs, side effects, etc., and I wonder if you have an approach to looking at withdrawing medications that may not be working for folks in providing any wisdom to the primary care community regarding this concept of non-responding. And then a second follow-up question is really the fact that when you're a non-responder the other part of the differential diagnosis is that you may not be adhering to the medication and not taking it and if you don't really adhering, you're not going to respond. So any words of wisdom of how you deal with folks whose A1C just is not moving? Their blood sugar and self-monitoring data suggests that it is not efficacious and how you handle that situation.
Dr. Jack Leahy: So this is a spectacular question and I think you should really look at the diabetes specialty community. One of the really active conversations now that's growing is as people look at studies of insulin therapy, of GLP-1 drugs, of really any of the traditional oral agents you will find sub groups of people. Some people respond very well to that therapy and other people don't respond well to that therapy—just as true for insulin as it is for these other agents. There's a lot of confusion out there and questioning, well is there a biology, or are there some other underlying issues that we could identify and figure out what's the best therapy? We're not there yet, but that's clearly an interest and may be fruitful for the future. So in terms of your question, actually it's something I don't routinely have a clear sort of guideline in my practice what I do. You have to realize that I'm a referral endocrinologist so people are sent to me by definition are typically on multiple diabetes agents and failing.  And more and more people are sent to me on insulin programs and multi-shot insulin programs along with other agents and failing. So part of my discussion with them is to try to understand why, and certainly part of the reason why is because people don't take the medicine the way they're prescribed or even sometimes the way the primary care doctor thinks they do. Certainly, a huge part of the conversation with me for people who are on insulin programs that seemingly are reasonably good doses and reasonably good programs, but still A1Cs are 9, 10, 11, I do a lot of discussion with people about—I have this little game I play—over a seven-day week, how many injections of your glargine Lantus might you forget to take as opposed to an open-ended question, such as do you really take your insulin kind of thing. Then I try and map out what they're taking. Sometimes there are people who are not taking their medicine, and then we have long discussions about that and find an adjustment. But also there are people who are on medicines where they just don't seem to work for them. And then it becomes an individual choice as to whether it's taken away or not. I think it's almost like blood pressure where we don't often sort of take drugs away. We stack drugs on top of each other. So if someone comes to see me and if they're on say, three oral agents, and I'm adding basal insulin, I don't often take things away. I mean if they're on metformin, I like it with basal insulin. If they're on a sulfonylurea well they'll probably stay on it until we see if the basal insulin is going to work for them. The agent of discussion would be the TZD, and that's mostly because we're afraid of those drugs and in combination with insulin maybe there's going to be more weight gain or some edema. You know, maybe that's one agent I might think of taking away, but it's hard to do it. If someone's on these three drugs and their A1C is 9, you take one away and you think, oh my God, it's going to get worse. So I'm a little embarrassed to say I do not have any formal system that when I'm adding an agent I necessarily am taking away agents that I think may be ineffective. I think that's just sort of evolves for different patients and how it happens to evolve.
Dr. Doron Schneider: You're really describing the art of medicine, where that art meets science and there is not a lot of guidance out in the worldscientific guidanceabout that issue of the non-responder and how to optimally deal with that. The issue of addressing non-adherence is a critical one. There are multiple data sets that suggest that for these medications that are being used to treat chronic illness that don't have symptoms—high blood pressure, being a great example, that the rate of adherence is extremely low—osteoporosis drugs, etc. And we need to be aware of that and have that very high in our differential diagnosis of the non-responder and develop systems of care to screen for patients as they present for routine office visits for non-adherence. I do like your approach, which is one that normalizes that for patients, that recognizes that they are human and may have omitted doses and asking them in a nonjudgmental way as you do is a very reasonable strategy that we need to be thinking through as we develop more robust systems in the primary care world. Non-adherence is a very critical problem.
Dr. Jack Leahy: You know, just sort of one comment related to that: Specialists in particular live in this world of thinking about their own illness. So, you come to see me and I'm thinking about your one or two or three diabetes agents and how I'm going to adjust things. Primary care doctors live in a world where these patients are on lipid drugs and blood pressure drugs and drugs because their joints hurt and they're depressed and, you know, you look at these long lists of medicines—people on 8, 10, 12, 15 agents and then, you know, who can do that? I think if you saw a patient who took all of their medicine absolutely in a bulletproof way, you'd be amazed and a bit skeptical. So this multiple medicines and non-compliance is really an extraordinarily complicated issue.
Dr. Doron Schneider: Right, and one that we have yet to solve.  So, having said that I'd like to thank Dr. Jack Leahy for his reflections on this recent ADA/EASD position statement.  We look forward to the feedback of the readers and the listeners of Beta Cells in Diabetes. We'd like to hear you comments, suggestions, thoughts and reflections on what you've heard. Please submit those to betacellsanddiabetes.org. Thank you.