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A Pharmacist’s Perspective: Stuart T. Haines, PharmD, FCCP, FASHP, FAPhA

Patient Education and Monitoring Recommendations for the Use of GLP-1’s

Unlike most diseases, diabetes requires extensive patient self-management….

Educating patients with type 2 diabetes mellitus (T2DM) about self-management skills is essential to improving health outcomes.1 To achieve the greatest benefit and efficiently use resources, self-management education should be specific and relevant to each patient’s needs. Beginning at the time of diagnosis, individualizing patient education is accomplished through an assessment process that identifies the needs, concerns, and capabilities of the patient, including barriers to learning. Since the patient’s educational needs will change over time, this assessment process should be done at regular intervals, ideally with each visit….

An education program that includes behavioral and psychological strategies that are both culturally sensitive and age-appropriate should be developed.1 Because T2DM is often asymptomatic in its early stages, patients often feel that lifestyle recommendations and treatments have a negative impact on their quality of life. For these reasons, having an honest discussion about the benefits and risks of various treatment options and involving the patient in the therapeutic decision-making process can improve treatment adherence. It is equally important to ask patients to establish short-term goals and priorities and to congratulate themselves when they have met their goals.

Establishing glycemic goals at the outset is important for patient self-management and acceptance of treatment modifications when necessary. To guide management, the American Diabetes Association (ADA) recommends self-monitoring of blood glucose (SMBG) based on the particular needs and goals of the patient. The ADA, however, acknowledges that the optimal timing and frequency of SMBG for patients with T2DM on non-insulin therapy is unclear2.

The use of GLP-1 receptor agonists changes the dynamics of glucose control and monitoring and getting your patients on these medications can be very beneficial if done properly.

Question:

How is treatment with a GLP-1 receptor agonist initiated?

Both liraglutide and exenatide are started at a low dose, which is increased over a period of a few weeks to reduce the likelihood and severity of nausea.

Liraglutide. In clinical trials, liraglutide was started at 0.6 mg once daily for 1 week, then increased to 1.2 mg once daffy for 1 week, and finally increased to 1.8 mg once daily as tolerated. This regimen is under review by the FDA and has been approved by the European authorities.6 The 1.2 mg dose appears to be the minimum effective dose. Based on FPG and/or PPG levels, the dose is generally increased to the maximum dose of 1.8 mg once daily as tolerated. In clinical trials, liraglutide was administered once daily at approximately the same time each day without regard to meals6-10.

Exenatide. Start at 5 mcg twice a day for 1 month, then increase to 10 mcg twice a day. The 5 mcg twice-daily dose is the minimum effective dose. Based on fasting plasma glucose (FPG) and/or PPG levels, the dose is generally increased to the maximum dose of 10 mcg twice a day as tolerated.5 Exenatide is administered twice daily within 60 minutes before the 2 main meals of the day (generally breakfast and dinner) and at least 6 hours apart.5

Question:
 
How are GLP-1s administered?

GLP-1 receptor agonists are administered subcutaneously in the abdominal fat, upper thigh, or arm. Although many patients will readily agree to administer an injectable medication that will help them lose weight, some patients will express reluctance or fear. It’s important to explore the patient’s feelings.

Many patients have had a previous negative experience with an injectable medication or vaccination given intramuscularly and requiring a large-gauge needle. Many assume that all injections are painful. Some patients believe that injectable therapies are only used as a last resort and are reserved for patients who have a severe or fatal illness. Many patients lack the self-confidence to administer injectable medications, worry about making errors, or believe that it requires years of training. Many patients associate injectable medication with drug dependency and addiction.

Case Study

At a follow-up visit 5 weeks after initiating treatment with exenatide (29 weeks after diagnosis), ML’s physician notes that her blood glucose levels and body weight have improved and her leg swelling has resolved. ML reports no symptoms of hypoglycemia, but states that she experienced mild nausea for a few days after increasing her dose to 10 mcg twice a day. The report from the certified diabetes educator to whom the physician referred ML notes that ML has improved her eating habits but skips lunch 1 or 2 times a week.

Question:

What if the patient doesn’t eat as planned or forgets to take the dose?

If a patient takes exenatide but the meal is delayed more than 1 hour after the injection, the patient has a small risk of experiencing hypoglycemia.13,14 Consequently, it is prudent to advise the patient to be vigilant for symptoms of hypoglycemia if he or she does not eat when planned and to avoid driving or performing other dangerous tasks until after eating.

On the other hand, if the patient eats and realizes he or she forgot to take exenatide before that meal, that dose should be skipped and the next dose should be taken at the scheduled time. The patient should be advised not to double the dose, because this will increase the risk for GI side effects and will not lower blood glucose any better than a standard dose.5,14

 


For the latest on GLP-1 Agonist Therapy, check out our special topics page with all our GLP-1-related News Articles, Special Features, Tools for Your Practice, Homerun Slides, and much more.

 


Liraglutide can be administered at any time of day without regard to meals, but it should be taken at the same time each day. In clinical trials, liraglutide was administered once daily in the morning or the evening with no apparent difference in blood glucose response.7-9 If a patient forgets to eat a meal or a meal is delayed, the patient should be advised to eat as soon as he or she remembers and to watch for symptoms of hypoglycemia. The patient should not drive or perform other dangerous tasks until he or she eats.

Case Study Continued

At her 33-week follow-up visit, ML’s physician congratulates her on achieving the target A1C goal of <7.0%. ML seems pleased but confides that her life has changed quite a bit since she was diagnosed. ML felt fine before diagnosis, and although she follows a routine of taking her medications, eating better, exercising regularly, and monitoring her blood glucose level every day, she just isn’t sure all the effort is worth it. The physician empathizes with ML. He acknowledges that she has made significant changes in her lifestyle behaviors, but that she may be having difficulty with motivation. He reminds ML of the long-term health benefits of controlling her diabetes and engaging in healthy lifestyle behaviors. He also points out that she:

  • Lost 3 kg since diagnosis.
  • No longer needs to monitor her blood glucose daily and recommends that she do so only 2 or 3 times a week and whenever she’s not feeling well.
  • Has had positive changes in blood pressure and lipids that will reduce her risk of heart disease. ML appreciates her physician’s support and reaffirms her commitment to improve her diabetes self-management.
Summary

Ongoing patient education and feedback is critical to successful self-management for patients with T2DM. The patient’s individualized program is based on an ongoing needs assessment, involves an interprofessional approach with a team of qualified health care professionals, and supports the patient by using positive feedback and motivational strategies at each visit.

References
  1. Funnell MM, Brown TL, Childs BP, et al. National standards for diabetes self-management education. Diabetes Care. 2009;32(suppl 1):S87-S94.
  2. American Diabetes Association. Standards of medical care in diabetes–2009. Diabetes Care. 2009;32(suppl 1):S13-S61.
  3. Nathan DM, Buse JB, Davidson MB, et al. Medical management of hyperglycemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy: a consensus statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care. 2009;32:193-203.
  4. Noel RA, Braun DK, Patterson RE, et al. Increased risk of acute pancreatitis and biliary disease observed in patients with type 2 diabetes: a retrospective cohort study. Diabetes Care. 2009;32:834-838.
  5. Byetta [prescribing information]. San Diego, CA: Amylin Pharmaceuticals, inc.; 2008.
  6. Garber A, Henry R, Ramer R, et al. Liraglutide versus glimepiride monotherapy for type 2 diabetes (LEAD-3 Mono): a randomised, 52-week, phase III, double-blind, parallel-treatment trial. Lancet. 2009;373:473-481.
  7. Vilsboll T, Zdravkovic M, Le Thi T, et al. Liraglutide, a long-acting human glucagon-like peptide-1 analog, given as monotherapy significantly improves glycemic control and lowers body weight without risk of hypoglycemia in patients with type 2 diabetes. Diabetes Care. 2007;30:1608-1610.
  8. Madsbad S, Schmitz O, Ranstam J, et al. Improved glycemic control with no weight increase in patients with type 2 diabetes after once-daily treatment with the long-acting glucagon-like peptide 1 analog liraglutide (NN2211): a 12-week, doubleblind, randomized, controlled trial. Diabetes Care. 2004;27:1335-1342.
  9. Harder H, Nielsen L, Tu DT, et al. The effect of liraglutide, a long-acting glucagon-like peptide 1 derivative, on glycemic control, body composition, and 24-h energy expenditure in patients with type 2 diabetes. Diabetes Care. 2004;27:1915-1921.
  10. Degn 103, Juhl CB, Sturis J, et al. One week’s treatment with the long-acting glucagon-like peptide 1 derivative liraglutide (NN2211) markedly improves 24-h glycemia and alpha-and beta-cell function and reduces endogenous glucose release in patients with type 2 diabetes. Diabetes. 2004;53:1187-1194.
  11. Nauck M, Frid A, Hermansen K, et al. Efficacy and safety comparison of liraglutide, glimepiride, and placebo, all in combination with metformin, in type 2 diabetes: the LEAD (liraglutide effect and action in diabetes)-2 study. Diabetes Care. 2009;32:84-90.
  12. DeFronzo RA, Ranter RF, Han J, et al.. Effects of exenatide (exendin-4) on glycemic control and weight over 30 weeks in metformin-treated patients with type 2 diabetes. Diabetes Care. 2005;28:1092-1100.
  13. Linnebjerg H, Kothare PA, Skrivanek Z, et al. Exenatide: effect of injection time on postprandial glucose in patients with type 2 diabetes. Diabet Med. 2006;23:240-245.
  14. Amylin Pharmaceuticals, Inc. Byetta–Meal-time dosing.www.byetta.com/patient/byetta_dosing_faq. jsp?reqNavId=5.4. Accessed April 21, 2009.

Stuart T. Haines, PharmD, FCCP, FASHP, FAPhA, is Professor and Vice Chair for Clinical Services, and Pharmacotherapy Specialist in the Department of Pharmacy Practice & Science, University of Maryland School of Pharmacy.