Discussion with Key Opinion Leaders on Educating Patients About Diabetes and the Use of Insulin

Transcription

1 Transcript Details This is a transcript of an educational program accessible on the ReachMD network. Details about the program and additional media formats for the program are accessible by visiting: insulin/7608/ ReachMD info@reachmd.com (866) Discussion with Key Opinion Leaders on Educating Patients About Diabetes and the Use of Insulin ReachMD Announcer Open: You re listening to ReachMD. Welcome to this week s medical industry feature, a discussion with key opinion leaders on educating patients about diabetes and the use of insulin, sponsored by Sanofi Diabetes. The following program is for health care professionals only. In this discussion, host Dr. Barry Mennen welcomes several US diabetes experts about the challenges in treating patients with diabetes, particularly when dealing with insulin, the importance of education; and, then we will discuss a therapeutic option for diabetes in adults using insulin. Dr. Barry Mennen is joined by the following diabetes experts: Dr. Sumon Agarwala, clinical endocrinologist in Plymouth Meeting, Pennsylvania; and, Director of Program Development at Einstein Healthcare. Dr. John Anderson, internist at the Frist Clinic in Nashville, Tennessee and former President of the American Diabetes Association. Dr. Helen Baron. Dr. Baron is a clinical endocrinologist and an Assistant Professor of Clinical 2018 ReachMD Page 1 of 10

2 Medicine in the Division of Endocrinology, Diabetes and Metabolism at the Keck School of Medicine at the University of Southern California in Los Angeles, California. Dr. Charles Shaefer, Board Certified in Internal Medicine and Critical Care Medicine from Augusta, Georgia Dr. Tim Reid, family physician and the Medical Director at the Mercy Diabetes Center in Janesville, Wisconsin And, Dr. Carol Wysham, clinical endocrinologist practicing at the Rockwood Clinic in Spokane, Washington and a Clinical Associate Professor of Medicine at the University of Washington. Dr. Mennen (ReachMD Host): There are many challenges in treating patients with diabetes, specifically when dealing with insulin. How do clinicians properly educate their patients? We will be answering this question and much more. This is Dr. Barry Mennen for ReachMD. Doctors, welcome to ReachMD. Let s first discuss your main challenge in managing patients with diabetes? Dr. Anderson, let s begin with you. Dr. Anderson: You know, Barry, that's a pretty broad question because we have a lot of patients with diabetes and they all have different needs. I think one of my greatest challenges in some of my patients is achieving their glycemic goals. Patients require multiple medications; some patients have trouble with the medicines themselves; so treatment is usually layering a number of medications together in order to come up with a treatment approach that will help them achieve their glycemic goals. Another unmet need is figuring out how do you get patients to participate in the management of theirdisease, understand that they own it, and maintain permanent lifestyle changes that can be beneficial for them. Dr. Mennen: Melissa, as a certified diabetes educator, how about your thoughts onthis? M. Magwire: Actually, the two things I hear about that jump out the quickest to me are time and education. And fortunately, the way I practice, time is not really an issue, but with some ofthe practitioners I work with, the time issue is what I hear about over and over again. What I think it really all comes back down to is not only educating the patient but educating the healthcare provider as well. There needs to be a shift in their approach to not really trying to bite off the entire diabetes problem in a single 7-minute visit but really looking at new ways of how to care for their diabetic patients, how to manage their medications in those short visits, and really looking at how to take a stepwise approach and partnering with the patient ReachMD Page 2 of 10

3 Dr. Mennen: Melissa, thank you. Dr. Anderson, what challenges do you encounter with insulin dose adjustment or titration? Dr. Anderson: Barry, patients are used to being prescribed a dose of a medication, so, "Here's your dose. Take this." And if you change the dose, it's a new prescription, "Take this." Insulin, however, is not that concrete. We can use weight-based calculations to estimate with the patient approximately howmuch they're going to need, but it's the first time in their lives that they have had a medication that they are going to have to increase to get to a target blood sugar value. So it's kind of a new concept forpatients in that it requires a little more time on the front end. And, give them a titration algorithm. Write it down for them, and then find a way to communicatewith them every 4 or 5 days, once a week, but again not just seeing them back in 3 months. Dr. Mennen: Melissa, your thoughts? If you had to select one limitation as the reason that patients don't titrate the insulin dose or that your ability to effectively adjust it is compromised, what would you say is that singularlimitation? M. Magwire: I really think that it's because the necessary goal oriented conversations aren't happening. If you educate patients, then their ability to stay on treatment may be higher. One of the issues is that there is still such a myth and stigma surrounding insulin. And, physicians are really not talking to their patients and saying, "Hey, look, this is how your body works, your body is not making insulin. I'm going to replace it, and here's what we want your sugars to be, and this is how this particular insulin works and why you're going to take it at this particular time of day." There's such a hang-up on possible patient objections to why we tend to shy away from talking about the big picture, and those types of conversations really need to happen. Dr. Mennen: Dr. Busch, would you like to chime in? Dr. Busch: I would say that the one limitation countrywide is that caregivers are all very busy; whether it's an MD, NP, PA, they're limited in how to make themselves available to their patients and howmuch time they have. Additionally, there are many patients who don't want to communicate their logs electronically, who don't have fax machines, and so how do they communicate their log sheets to the caregiver? So if you're going over titration, how do you verify that the patient is doing the right thing? I try to do it at the office, give my cell phone number, be accessible to it, but a lot of my fellow clinicians don't do that. And my fellow physicians think I should have a CAT scan and a psych evaluation 2018 ReachMD Page 3 of 10

4 because I do that. But I like doing it. I like seeing my patients successful in their titration. I find it very rewarding to teach the patient, but you have to audit what they'redoing. Dr. Mennen: Now, Melissa, how do you approach the necessary patient education in your practice? M. Magwire: Well, fortunately, there's a lot of really good patient education material out there right now, and the biggest issue is really making sure that practitioners are comfortable and aware of the education that is available to them. Empowering their support staff, I believe, is really the key. There are so many different pieces of education material in my office. And I think giving providers further education on the tools and how to use them effectively with their patients is really key, and there are some simple tools for this education that just aren't beingused. Dr. Baron: I completely believe in the power of the CDEs, and that's why I consider myself very fortunate to have my own CDE who works in the office adjacent to me, so that patients can avail themselves of these beautiful one-on-one opportunities for greater education in all areas of their disease. Dr. Mennen: Dr. Anderson- you wanted to say something? Dr. Anderson: Yes, I try to spend more time during the visit, particularly if that patient is struggling. You've got to tell them about their medications, how they work. You've got to talk to them about how do you prescribe it, when do you take it, what happens if you miss a dose? You want to reinforcea titration schedule depending on an algorithm you use. You should also discuss the schedules based on their individual goal and should not be changed just based on a singular blood glucose reading. So I take more time to explain what insulin does, how it works. I try to reinforce the titration schedule. I check in with them more frequently, not just, I'll see you back in 3 months and we'll recheck your A1c. Then they have to have their own monitoring schedule when do you monitor? And it's important thatwe know their fasting glucoses if you're titrating basal insulin dose. And investigating the specifics of the patients lives is critical to tailoring their therapy. So again, you've got to be very specific and clear about this with the patient. Dr. Mennen: I think we all agree that a team approach and educating our patients about diabetes care is essential. We ve discussed some key challenges in treating patients. This may be a good time tonow discuss a therapeutic option for diabetes, specifically TOUJEO (insulin glargine injection) 300 Units/mL. TOUJEO is a long-acting human insulin analog indicated to improve glycemic control in adults with 2018 ReachMD Page 4 of 10

5 diabetes mellitus. TOUJEO is not recommended for treating ketoacidosis. We would like our listeners to stay tuned at the end of this pod cast for full important safety information. Dr. Wysham, can you describe the mechanism of TOUJEO precipitate formation? Dr. Wysham: TOUJEO is soluble at a ph of 4, and then when injected in the subcutaneous tissue, because of the difference in ph, the TOUJEO solution is neutralized and forms a precipitate under the skin from which the insulin is absorbed. The low volume of TOUJEO results in a smaller surface area that leads to a slow insulin release. Dr. Mennen: For our listening audience, we want to remind everyone that TOUJEO is contraindicated during episodes of hypoglycemia and in patients hypersensitive to insulin glargine or any of its excipients. So, doctors, have you started any patients on TOUJEO? Dr. Wysham, would you like to start off with your experience? Dr. Wysham: Yes, we've started patients on TOUJEO for a variety of reasons. I remind them to take it once a day at the same time every day. I have a couple of patients that, for them, taking TOUJEO in the morning was the best way for them to remember it. For some other patients, they find that taking it in the evening was the best for them. As with any therapy, you have to individualize it for the patient. Dr. Mennen: And, you Dr. Agarwala? Dr. Agarwala: Yes, I have many patients over the past few months that I've initiated TOUJEO on. I would suggest probably about 50% of these were previously on other basal insulins, and about 50% of them were insulin-naïve patients. Dr. Mennen: And, what characteristics of TOUJEO make it an option you would choose for an adult patient with diabetes? Dr. Agarwala: Well, this really goes back to my own algorithm of how I treat diabetes. I tend to lookat the fasting glucose values, and I look at the hemoglobin A1c. And of course, you've got to takeinto account the post prandials, but I always target the fasting glucoses first. So in that manner, if the A1c is suboptimal, yet the fasting glucose remains elevated despite metformin, then I usually would consider basal insulin therapy. Dr. Mennen: And, at this time, our sponsor would like to share some of the Warning and Precautions 2018 ReachMD Page 5 of 10

6 from the Important Safety Information for TOUJEO. TOUJEO contains the same active ingredient, insulin glargine, as LANTUS. The concentration of insulin glargine in TOUJEO is 300 units per ml. Insulin pens and needles must never be shared between patients. Do NOT reuse needles. So, Dr. Shaefer, what are your thoughts on which characteristics of TOUJEO make it an option foryou? Dr. Shaefer: The long duration of action of TOUJEO is really key. There are no typical patients with diabetes, and at some point every patient with diabetes is going to need insulin. One of the biggest problems we have in primary care is we wait too long to intensify treatment. It doesn't work to use insulin as a warning, for example, saying, "If you don't lose that weight, I'm going to start you on insulin." You don't want to make the patient feel like they're being punished when they start on insulin. It's all about understanding disease progression and making sure you're trying to be yourpatient's advocate for their next therapy. Dr. Mennen: And, when you are starting or converting patients to TOUJEO, how do you dose the patients? Dr. Wysham: Well, based upon the information provided in the package insert the recommended starting dose of TOUJEO in insulin-naïve patients with Type 1 diabetes is approximately 1/3 to 1/2 of the total daily dose. The remainder of the total daily dose should be given as short-acting insulin and divided between each daily meal. As a general rule, 0.2 to 0.4 units of insulin per kilogram of body weight can be used to calculate the initial total daily dosing of insulin-naïve patients with Type 1 diabetes. The maximum glucose-lowering effect of a dose of TOUJEO may take 5 days to fully manifest, and the first TOUJEO dose may be insufficient to cover metabolic needs in the first 24 hours of use. Dr. Mennen: And, just to note, this applies to insulin-naive patients with Type 1 Diabetes. For our listening audience, we would like to remind everyone to monitor blood glucose in all patients treated with insulin per the warnings and precautions of the Important Safety Information for Toujeo. Modify insulin regimens cautiously and only under medical supervision. Changes in insulin strength, manufacturer, type, or method of administration may result in the need fora change in insulin dose or an adjustment in concomitant oral antidiabetic treatment. Changes ininsulin regimen may result in hyperglycemia or hypoglycemia. Okay Dr. Wysham, back toyou ReachMD Page 6 of 10

7 Dr. Wysham: The recommended starting dose of TOUJEO in insulin naïve patients with Type 2 diabetes is 0.2 units per kilogram of body weight once-daily. The dosage of other anti-diabetic drugs may need to be adjusted when starting TOUJEO to minimize the risk of hypoglycemia. To minimize the risk of hypoglycemia when changing patients from a once-daily long-acting or intermediate acting insulin product to TOUJEO, the starting dose of TOUJEO can be the same as the once daily long-acting dose. For patients controlled on LANTUS (insulin glargine, 100 units per ml) expect that a higher daily dose of TOUJEO will be needed. To minimize the risk of hypoglycemia when changing patients from twicedaily NPH insulin to once-daily TOUJEO, the recommended starting TOUJEO dose is 80% of the total daily NPH dose. To minimize the risk of hyperglycemia when changing patients to TOUJEO, monitor glucose frequently in the first weeks of therapy, titrate the dose of TOUJEO per instructions and the dose of other glucose-lowering therapies per standard of care. Dr. Mennen: And, for our listening audience, per the Warnings and Precautions of the Important Safety Information for Toujeo, Unit for unit, patients started on, or changed to, TOUJEO required a higher dose than patients controlled with Lantus. When changing from another basal insulin to TOUJEO, patients experienced higher average fasting plasma glucose levels in the first few weeks of therapy until titrated to their individualized fasting plasma glucose targets. Higher doses were required in titrateto-target studies to achieve glucose control similar to Lantus So, Dr. Reid, When you convert your patients to TOUJEO from another basal insulin, how do you approach that conversation with your patients about putting them on another drug? 6 Dr. Reid: Well, first of all, when working with patients on insulin, it's honestly all about therelationship. You want a situation where the patient trusts what you're telling them. You could say, "I actually havea product I'd like you to try, and based on what I understand from the label, I think it may be agood option." It's just one of those things I think if the patient has confidence in your relationship youhave built with them managing their disease, they're open to options to help manage their blood sugar levels. When changing patients to TOUJEO, I always counsel them to monitor blood glucose frequently, especially in the first weeks of therapy, to minimize the risk of hypoglycemia. If they come back and they're doing okay, it's not only our relationship doing well, but they also develop a relationship with the product at that point and say, "Hey, it's actually working for me. I want to continue it." Of course, as we all know, individual results can vary. Dr. Mennen: Before we end our discussion, I will like to mention that hypoglycemia is the most common 2018 ReachMD Page 7 of 10

8 adverse reaction of insulin therapy, including TOUJEO, and may be life-threatening. Well, Ilike to thank our guests for joining us today and sharing their insights on the use of insulin indiabetes management, importance of patient education, understanding titration and utilizing patient resources; and finally use of TOUJEO in the management of diabetes mellitus. ReachMD Announcer Important Safety Information and Close: And, now here s Important Safety Information for TOUJEO (insulin glargine injection) 300 Units/mL Contraindications: TOUJEO is contraindicated during episodes of hypoglycemia and in patients hypersensitive toinsulin glargine or any of its excipients. Warnings and Precautions: TOUJEO contains the same active ingredient, insulin glargine, as Lantus. The concentration ofinsulin glargine in TOUJEO is 300 units per ml. Insulin pens and needles must never be shared between patients. Do NOT reuseneedles. Monitor blood glucose in all patients treated with insulin. Modify insulin regimens cautiously and only under medical supervision. Changes in insulin strength, manufacturer, type, or method of administration may result in the need for a change in insulin dose or an adjustment in concomitantoral antidiabetic treatment. Changes in insulin regimen may result in hyperglycemia or hypoglycemia. Unit for unit, patients started on, or changed to, TOUJEO required a higher dose than patients controlled with Lantus. When changing from another basal insulin to TOUJEO, patients experienced higher average fasting plasma glucose levels in the first few weeks of therapy until titrated to their individualized fasting plasma glucose targets. Higher doses were required in titrate-to-target studies to achieve glucose control similar to Lantus. Hypoglycemia is the most common adverse reaction of insulin therapy, including TOUJEO, and may be life-threatening. Medication errors such as accidental mix-ups between basal insulin products and other insulins, particularly rapid-acting insulins, have been reported. Patients should be instructed to always verify the insulin label before each injection. 7 Do not dilute or mix TOUJEO with any other insulin or solution. If mixed or diluted, the solutionmay 2018 ReachMD Page 8 of 10

9 become cloudy, and the onset of action/time to peak effect may be altered in an unpredictable manner. Do not administer TOUJEO via an insulin pump or intravenously because severe hypoglycemia can occur. Severe life-threatening, generalized allergy, including anaphylaxis, can occur. Discontinue TOUJEO, monitor and treat if indicated. A reduction in the TOUJEO dose may be required in patients with renal or hepatic impairment. As with all insulins, TOUJEO use can lead to life-threatening hypokalemia. Untreated hypokalemia may cause respiratory paralysis, ventricular arrhythmia, and death. Closely monitor potassium levels in patients at risk of hypokalemia and treat if indicated. Fluid retention, which may lead to or exacerbate heart failure, can occur with concomitant useof thiazolidinediones (TZDs) with insulin. These patients should be observed for signs and symptoms of heart failure. If heart failure occurs, dosage reduction or discontinuation of TZD must be considered. Drug Interactions Certain drugs may affect glucose metabolism, requiring insulin dose adjustment and close monitoring of blood glucose. The signs of hypoglycemia may be reduced in patients taking anti- adrenergic drugs (e.g., beta-blockers, clonidine, guanethidine, and reserpine). Adverse reactions Adverse reactions commonly associated with TOUJEO include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, rash, edema and weightgain. Important Safety Information for TOUJEO SoloStar Toujeo SoloStar is a disposable prefilled insulin pen. To help ensure an accurate dose each time, patients should follow all steps in the Instruction Leaflet accompanying the pen; otherwise they may not get the correct amount of insulin, which may affect their blood glucose levels. Do not withdraw Toujeo from the SoloStar disposable prefilled pen with a syringe. Click the link on this webpage for full prescribing information for TOUJEO or visit You have been listening to ReachMD. The preceding program was sponsored by Sanofi Diabetes. To 2018 ReachMD Page 9 of 10

10 download this podcast, visit reachmd.com/toujeo. That s reachmd.com/toujeo. Thank you for listening. US.GLT ReachMD Page 10 of 10