Reece's Piece's In a Diabetes World

We currently have glucagon like peptide 1 agonists (i.e. Ozempic, Trulicity, Victoza) available for treatment of type 2 diabetes. Tirzepatide, a once weekly glucose-dependent insulinotropic polypeptide and glucagon like peptide 1 agonist, is currently in phase III clinical trials (name of trials are SURPASS-3 and SURPASS-5). The results of A1c reduction by 2.37 percent and body weight by 12.9 kg (28.4 lbs) are very promising. Both studies were well designed with SURPASS- 3 comparing tirzepatide (5 mg, 10 mg, 15 mg) with insulin degludec in adults with type 2 diabetes not at glycemic goals on metformin +/- SGLT-2 inhibitor over 52 weeks. SURPASS-5 compared safety and efficacy of tizepatide (5 mg, 10 mg, 15 mg) with placebo with both as an add on to insulin glargine +/- metformin in adults with type 2 diabetes. In both SURPASS-3 and SURPASS-5, the primary and secondary endpoints were met. It is worth noting that the most common adverse effects of tirzepatide were GI related not surprising considering its mechanism of action. Please click below for more details regarding SURPASS-3 and SURPASS-5.

https://investor.lilly.com/news-releases/news-release-details/tirzepatide-significantly-reduced-a1c-and-body-weight-people

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#tirzepatide #novel #A1c #weight #diabetes

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Contributor: Ja’Davia Schafer, M.S., PCOM Georgia D.O. Candidate Class of 2023

RM with type 2 diabetes, arthritis and heart condition recently inquired about whether a fish oil supplement would be beneficial for her. She is currently taking insulin degludec, empagliflozin and semaglutide for her diabetes as well as rosuvastatin for her cholesterol.  Would a fish oil supplement or prescription product be appropriate for RM?

According to the 2010 Dietary Guidelines reported by the National Center for Complementary and Integrative Health (NCCIH),  it was recommended that individuals consume a variety of 8 ounces of fish or more per week due to the variety of nutrients provided (1). Many individuals supplement this with a dosage of 250–500 mg over-the-counter fish oil pills per day (2). This is the recommended dosage for the average healthy adult in the United States, however, they should not serve as a full replacement of whole foods. 

These translucent yellow supplements contain Polyunsaturated fatty acids (PUFA). One key subgroup of PUFA is omega-3 fats including, Eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), which is found primarily in fish and fish oils (3). Extensive research studies have shown that diets high in EPA and DHA have significantly lowered the risk of heart  and other inflammatory diseases (4). Diets high in PUFA and monounsaturated, such as the Mediterranian diet, have shown to reduce the instances of coronary artery disease, ischemic strokes, and lowering cholesterol (5, 6). Individuals with pre-existing heart conditions also benefit from taking OTC fish oil supplements, however, these patients have better outcomes from taking prescription medications such as statins (HMG CoA reductase inhibitor that reduces the production of cholesterol) or prescription omega-3 PUFA formalations (7). (an FDA approved ethyl esters of omega-3 fatty acids that contain a higher amount of DHA and EPA). The FDA approved prescription omega-3 PUFA formulations are indicated for treatment of triglyceride levels of 500 mg/dL or greater. 

•      LovazaⓇ (omega-3 acid ethyl ester of EPA/DHA)
•      EpanovaⓇ (omega-3 carboxylic acid of EPA/DHA)
•      VascepaⓇ (ethyl ester of EPA only)

The amount of EPA/DHA per capsule is 1 gram in the prescription omega-3 PUFA formulations and less than 300 mg per capsule OTC fish oil supplements (8).  For prescription formulations,  the total daily dose is 2 – 4 grams. Typically an OTC fish oil supplement can be purchased for less than $10 (Look for the buy one get one FREE deals.) while the prescription fish oil products will be at least $40 without insurance coverage.  In terms of side effects, some people may notice a “fishy” taste, dyspepsia (with LovazaⓇ) or increased risk of bleeding event (VascepaⓇ) (so be cautious if you have a history of bleeding event). 

Questions you should ask during your provider visit regarding fish oil:

1. Can I take a fish oil supplement or prescription product  considering all of my current health conditions? 
2. Can I take a fish oil supplement or prescription product with my other medication? 
3. Do I need to separate when I take fish oil from my other medications?
4. Would a fish oil supplement or prescription product be better for me?
5. Can I take these supplements while pregnant? 
6. What are some signs that I may be deficient in omega 3 fatty acids? 

Back to RM, after collaborating in the decision making process, a prescription fish oil product was selected.  RM followed up in a week sharing that she has tolerated it without any side effects. 

References:
1. 7 Things to Know About Omega-3 Fatty Acids. National Center for Integrative Health.  

https://www.nccih.nih.gov/health/tips/things-to-know-about-omega-fatty-acids#pdf. Accessed on February 20, 2021. 

2. Interim Summary of Conclusions and Dietary Recommendations on Total Fat & Fatty Acids. The Joint FAO/WHO Expert Consultation on Fats and Fatty Acids in Human Nutrition. Nov 2008. https://www.who.int/nutrition/topics/FFA_summary_rec_conclusion.pdf?ua=1. Accessed on February 20, 2021. 

3. PM Kris-Etherton, Denise Shaffer Taylor, Shaomei Yu-Poth, Peter Huth, Kristin Moriarty, Valerie Fishell, Rebecca L Hargrove, Guixiang Zhao, Terry D Etherton. Polyunsaturated fatty acids in the food chain in the United States. The American Journal of Clinical Nutrition, Volume 71, Issue 1, January 2000, Pages 179S–188S, https://doi.org/10.1093/ajcn/71.1.179S

4. H Gerster. Can adults adequately convert alpha-linolenic acid (18:3n-3) to eicosapentaenoic acid (20:5n-3) and docosahexaenoic acid (22:6n-3). Int J Vitam Nutr Res. 1998;68(3):159-73.

5. Why the Mediterranean Diet is Good for your Heart. Harvard Women’s Health Watch. https://www.health.harvard.edu/heart-health/why-the-mediterranean-diet-is-so-good-for-your-heart. Accessed on February 20, 2021. 

6. Miguel A. Martínez-González, Alfredo Gea, Miguel Ruiz-Canela. The Mediterranean Diet and Cardiovascular Health. Circulation Research. 2019;124:779–798. https://doi.org/10.1161/CIRCRESAHA.118.313348

7.L DeDea. When to take statins; Lovaza versus OTC Fish Oil Supplements. Journal of the American Academy of PAs. 2001;24(5):23. 

8.  MS Kelly, C Beavers, JD Bucheit, et al. Pharmacologic approaches for the management of patients with moderately elevated triglycerides (150 – 499 mg/dL). J Clin Lipidol, 2017;11:872-879.

Sotagliflozin, a drug that works in the kidneys to increase amount of glucose released into urine for elimination, is currently pending FDA approval for treatment of type 2 diabetes. Data from clinical trial for sotagliflozin revealed possible reduction in hospitalization or urgent visits for heart failure and cardiovascular (heart) related death in persons with diabetes and chronic kidney disease. The concern with this study is lack of power so further studies are needed. To learn more, please click below.

Bhatt DL, Szarek M, Pitt B, et al; SCORED Investigators. Sotagliflozin in patients with diabetes and chronic kidney disease. N Engl J Med. 2021;384:129-139. doi:10.1056/NEJMoa203018

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#sotagliflozin #heart #benefit

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I am super excited about this study of once weekly semaglutide (you may recognize the injectable brand of Ozempic) plus lifestyle interventions (changes to eating habits and moving more) in persons without diabetes and with body mass index of 30 or greater for weight loss. Semaglutide works in the satiety center (which controls hunger) in the brain to decrease hunger which works great in combination with changing eating habits and moving more. The results of the study are promising. I hope that semaglutide will be approved for weight loss in persons without diabetes, and this study is a step towards making this approval happen in the future.

https://www.nejm.org/doi/full/10.1056/NEJMoa2032183

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#semaglutide #weight #loss #medicine

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We have been taught to store insulin in refrigerator (35.6 – 46.4 degrees Fahrenheit) at least until first use of the vial or pen then at at 77 degrees for up to two – four weeks (varies depending on product). A study by researchers from Doctors Without Borders and the University of Geneva has shown that refrigeration might not be necessary. In this study, they test insulin in more real world conditions with temps ranging from 77 to 98.6 degrees Fahrenheit for four weeks. Interestingly in the study the insulin only lost no more than 1% potency (current regulations allow for up to 5% potency). These findings particularly helpful for places of fewer resources where access to refrigeration is limited.

https://consumer.healthday.com/b-2-4-insulin-may-not-need-refrigeration-freeing-up-its-use-in-poorer-nations-2650234326.html

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#insulin #storage #diabetes

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Novo Nordisk has submitted to the FDA for approval of higher dose (2 mg) Ozempic which is currently available in 0.5 mg and 1 mg once weekly injectable doses. The potential for additional lowering of hemoglobin A1c and weight loss with higher dose. Recently, Trulicity (also an injectable once weekly GLP-1 agonist) was FDA approved for higher dosing (3 mg and 4.5 mg). I look forward to the FDA approving the 2 mg dose of Ozempic as this provides more options for persons with type 2 diabetes to have greater decrease in glucose and weight loss.

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#FDA #diabetes #medication

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WE are in a new year! Thank goodness 2021 is here. 

Each January many people have changes to their health insurance whether it’s a new health plan, changes in the amounts of deductibles, copays, and/or new drug formulary.  Since the start of the year, I have worked with several individuals with diabetes to help make their diabetes medications more affordable that experienced changes to their health insurance plans.  Even for the most well versed in health insurance, all of these changes can be overwhelming and confusing.  Here are some very practical money saving tips to consider before you head to the pharmacy to pick up your prescriptions this month: 

-Make sure that your pharmacy has your updated health insurance information

-Inquire as to whether you have lower prescription copays by getting 90 day supply as opposed to 30 day supply

-Inquire as to whether your health insurance plan has lower copay for using mail order pharmacy (I cringe typing this sentence as I am a firm believer in patient choice of their preferred pharmacy) 

-Look up your preferred drug formulary for your health insurance (****warning this change even if your overall health insurance plan did not change), and learn the preferred brand name and generic medications for the class of drugs that you have been taking 

-Always ask if cash price is less than your copay particularly for generic medications

-Check price on GoodRx as it may be lower than your insurance copay particularly for generic medications 

-For brand name drugs, check the pharmaceutical manufacturer website for copay or savings cards

-If you can not afford your medications, please talk with your pharmacist and your medical provider’s office. Please DO NOT simply go without the medication until your next telehealth or office visit.  

Brand name drug	A drug under a trademark name or specific name and is protected by a patent. For example, Lantus, Levemir (Reference: www.healthcare.gov)
Generic drug	a medication that is approved to be the same as a brand name drug specifically with regards to dosage form, strength, safety, route of administration and quality.  (Reference: www.fda.gov)
Drug formulary	a list of medications (brand and generic) covered by your health plan. Often drug formularies have tiers with least expense medications (generics) as tier 1 and most expensive as tier 3 or4).  (Reference: Goodrx.com)

I hope that this blog has provided you with tips that will prevent you from the experience of rationing or simply not getting your medications because of cost. 

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#avoiding #medication #cost #shock

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So person with diabetes presents to the emergency room due to significantly elevated glucose after rationing insulin due to recent job loss. Unfortunately this scenario happens way too often these days. It breaks my heart. I have a passion for helping people with financial resources so they can afford their medications. A resource that I use on a weekly basis is NovoCare Immediate Supply. I have provided the link below – if you are a person with Medicare Part D, please call 1-800-910-0454 to enroll. While this is not a long term solution by any ways, it can provide short term help with accessing insulin. Basically, it provides a month supply of NovoNordisk insulin (i.e. Novolog, Fiasp, Levemir, Tresiba) (pens and/or vials) at no cost. Persons with diabetes or healthcare professionals can click on the link to enroll and get the copay card. Once you have the card, simply take to the pharmacy – make sure you have a prescription for insulin.

https://www.novocare.com/insulin/immediate-supply.html

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#insulin #access #rationing

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As the new year starts, many people experience changes in their drug formulary (list of preferred medications for your health plan) whether they have a Medicare Part D plan or employer based health plan. Often, the change goes unnoticed until person goes to pharmacy to pick up a refill and finds out their copay has increased significantly. Please do not blame the pharmacist or pharmacy – they are only the messenger. So how can you prevent this from happening to you? Become a student seeking to understand your health plan and what is covered in terms of health services and medications. Access and review your drug formulary to check to see if your current medications are covered — check online at your health insurance plan’s website or call your health insurance plan. If your current medication(s) are no longer covered, look for alternatives. Your pharmacist or a pharmacy intern (a student who is enrolled in a school/college of pharmacy who is working at the pharmacy) can help you as you seek to understand your drug formulary and look for alternatives. Some physicians offices have ambulatory care pharmacists (like myself) (pharmacists who work in the physicians office with a focus on non-medication dispensing activities) who can also help you. Please use these tips to avoid surprises when you go to the pharmacy to pick a refill this January — also, please remember to not blame the pharmacist or pharmacy as your insurance determines the copay.

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#diabetes #medications #copays

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FDA approved the first generic glucagon injection kit (manufactured by Amaphastar Pharmaceuticals) which is therapeutically equivalent to Eli Lilly’s branded Glucagon injection kit. The generic injection kit is approved to treatment severe hypoglycemia (typically defined as blood glucose < 54 mg/dL) and as a diagnostic test (in gastrointestinal (aka stomach related) radiologic imaging). It is similar to Lilly’s branded glucagon kit in that it involves a multistep mixing process. The advantage the generic has over the branded injection kit is a lower cost although the mixing is still cumbersome (when considering its use for severe hypoglycemia). The newer products (which are not available generically) have the advantage of ease of use with either the intranasal (Baqsimi) or prefilled pen or syringe (Gvoke HypoPen and Gvoke PFS) which personally I would prefer in an emergency of severe hypoglycemia. Please click below to learn more.

https://www.medscape.com/viewarticle/943385?nlid=138895_3901&src=wnl_newsalrt_201230_MSCPEDIT&uac=293412PG&impID=2804095&faf=1

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#generic #glucagon #FDA #approval

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