Reece's Piece's In a Diabetes World

Currently, dapagliflozin (Farxiga) is best known for its indication for treating type 2 diabetes, reducing hospitalization for heart failure (even in persons without diabetes) and delaying progression of chronic kidney disease in type 2 diabetes. Well, it is not alone. FDA recently approved finerenone (Kerendia) for delaying progression of diabetes related chronic kidney disease in persons with type 2 diabetes. Additionally, it has been approved for reducing cardiovascular (heart) death, non-fatal heart attacks and hospitalization for heart failure so bottom line it helps with protecting heart and kidneys. This medication works by blocking mineralocorticoid receptor activation in kidney which decreases fibrosis and inflammation. It is a once daily medication available in 10 mg and 20 mg. Please keep in mind that it will take time for insurance plans to add this new medication to their drug formulary (list of preferred medications that they cover under their health plan). To learn more, please click on link below.

https://www.medpagetoday.com/nephrology/diabetes/93515

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#diabetes #kidneydisease

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I am beyond thrilled that Medicare has removed the requirement of testing glucose four times daily for Medicare beneficiaries to qualify for CGM. This requirement has been a burden for many and created a barrier for access to CGM. Medicare will continue at this time to require Medicare beneficiaries to be on a basal bolus insulin regimen to qualify for CGM. Additionally, a c-peptide and fasting glucose level is often required prior to approval of CGM. Please click on link below to learn more from my dear colleague, Kate Thomas with ADCES, regarding this important update in Medicare requirements for CGM.

https://www.diabeteseducator.org/news/perspectives/aade-blog-details/adces-perspectives-on-diabetes-care/2021/06/14/medicare-updates-cgm-benefit

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#Medicare #CGM

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I am beyond excited about the FDA approval of semaglutide 2.4 mg for weight loss. This medication has been absolutely amazing in reducing glucose and cardiovascular (heart related) risk (for stroke and heart attack) in persons with diabetes in many persons with diabetes that I know personally. In my experience, I have seen first hand off label use for weight loss in persons without diabetes. Four trials, Semaglutide in Treatment Effect in People with Obesity (STEP), (STEP 1 – 4) compared semaglutide 2.4 mg versus placebo (no drug), and the results proved the effectiveness of semaglutide 2.4 mg in reducing weight in persons without diabetes. Please click below for additional information.

https://www.medscape.com/viewarticle/952441?src=wnl_newsalrt_210604_MSCPEDIT&uac=293412PG&impID=3421015&faf=1

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#semaglutide #weightloss #FDA

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Dapagliflozin is a game changer as this medication addresses renal and cardiovascular protection even in folks without diabetes. In this most recent study (Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure [DAPA-HF], the safety and efficacy of dapagliflozin 10 mg vs placebo in a randomized, double-blind, placebo-controlled trial of patients heart failure (HFrEF) was evaluated with primary outcome of the composite of an episode of worsening HR or cardiovascular death. The association found in this study is promising. To learn more, please click below.

Butt JH, Docherty KF, Petrie MC, et al. Efficacy and safety of dapagliflozin in men and women with heart failure with reduced ejection fraction: a prespecified analysis of the Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure trial. JAMA Cardiol. Published online March 31, 2021. doi:10.1001/jamacardio.2021.0379

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#dapagliflozin #heartfailure #benefits

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Diabetes technology is exploding new innovations coming fast. The recent FDA approval of Bigfoot Biomedical’s smart insulin cap which allows for on demand insulin dose recommendation. The system is made up of a smart pen cap (compatible with all U.S. brands of rapid and long acting disposable insulin pens), mobile app and integration with Freestyle Libre 2 continuous glucose monitor sensor. What an innovation! To learn more, please click below.

https://www.ajmc.com/view/fda-clears-bigfoot-biomedical-s-smart-insulin-pen-caps

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#technology #diabetes #innovation

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A novel medication, imeglimin, for type 2 diabetes has shown promising results in lowering hemoglobin A1c and fasting glucose. Its mechanism of action addresses excessive release of glucose from liver, decreased uptake of glucose by muscle tissue and increase death of beta cells. It has been in development for a few years. The most recent study, TIMES 1, assessed the safety, efficacy (how well does imeglimin work in lowering hemoglobin A1c) and tolerability (can persons taking the drug tolerate the drug) of imeglimin 1000 mg taken twice daily in persons not at goal hemoglobin with diet and exercise. The study results were promising in imeglimin’s ability to lower hemoglobin A1c. To learn more, please click on link below.

https://care.diabetesjournals.org/content/44/4/952.long

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#imeglimin #diabetes #novel

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Hypoglycemia is serious business. Timely treatment is essential. We now have an additional option for treatment of hypoglycemia. Dasiglucagon (brand name Zegalogue) is a human glucagon analogue that is approved for treatment of severe hypoglycemia in persons with diabetes 6 years of age and older. The three studies assessing efficacy of dasiglucagon included children 6 – 17 years old and adults with type 1 diabetes. On average, the median time to glucose recovery was 10 minutes across the three studies. To learn more about this new option for treatment of hypoglycemia, please click below.

https://www.healio.com/news/endocrinology/20210323/fda-approves-rescue-pen-for-treating-severe-hypoglycemia?utm_source=selligent&utm_medium=email&utm_campaign=topicalert&M_BT=4557970002905

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#dasiglucagon #hypoglycemia #treatment

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Contributor: Quynh Nguyen, PCOM Georgia PharmD Candidate Class of 2022

CB, 50 year old female with 10 year history of type 2 diabetes, recently shared her frustration of struggling to lose weight. While her A1c is below 7%, the scale will not budge. She feels like her diabetes medications are working great in lowering her blood glucose but not so positive impact on her weight. CB is not alone in her frustration as one of the frustrations that I most commonly hear from persons taking insulin is the weight gain.  Often, glucagon like peptide 1 (GLP-1) agonists can be an alternative to insulin as this class of drugs effectively lowers glucose and body weight as well as protects the heart.  Within the GLP-1 agonist class, semaglutide has been shown in clinical trials to have the greatest body weight reduction.  Recently, results from two clinical trials, STEP 1 and 2, have shed additional light on the weight loss benefits of semaglutide.  In both trials, life management (dietary and physical activity), a vital foundation, was combined with semaglutide.  

STEP 1 study used  a combination approach of lifestyle management along with once-weekly 2.4mg of semaglutide for weight loss in obese patients. In this study, a total of 1,961 adults who had a body mass index (BMI) of 30 or higher, or those with a BMI of 27 or greater with at least one weight-related disease (hypertension, liver disease, various cancers) were enrolled in this trial.  Semaglutide was initiated at 0.25mg once weekly for the first four weeks, and then the dose increased every four weeks until the target dose of 2.4mg was reached. All adults in the study received lifestyle counseling (dietary and physical activity management). Data indicates within the first four weeks of initial treatment, those receiving semaglutide had more than a 2% reduction in their body weight, and continued losing weight the remainder of the 68 week trial. Furthermore, about 70% of those receiving semaglutide and lifestyle management were able to lose 10% of their weight, and about 50% were able to lose 15% of their body weight. STEP 1 study showed that in total, the adults on semaglutide treatment lost an average of 33.7 lb  by the end of 68 weeks. Overall, the study provided promising results for those who want to lose weight. An average weight loss of 14.9% was achieved for those receiving semaglutide 2.4 mg and lifestyle management, versus the 2.4%  of those on lifestyle management only. These promising results must be balanced with mild to moderate side effects of nausea, diarrhea, vomiting, and constipation. 

STEP 2  study was similar to STEP 1 in using a combination approach of lifestyle management and semaglutide 2.4 mg once weekly except in persons with type 2 diabetes and BMI of at least 27.  This STEP 2 trial included 1,210 patients with diabetes who had a BMI of at least 27, from all across the globe ranging from North and South Americas, Europe, Middle East, South Africa, and Asia. There were three different groups for this trial: one group receiving the higher dose of semaglutide which was 2.4mg, a second group receiving 1.0mg of semaglutide, and the last group, not receiving any dose of semaglutide.  All three groups received lifestyle modification counseling. The two groups receiving the semaglutide began with 0.25mg weekly dose, and then the dose was increased until the target dose of 2.4 mg was reached.  The semaglutide groups lost an average of 9.6% of their initial starting body weight compared to the 3.4% for those not receiving semaglutide. After 68 weeks, those receiving semaglutide 2.4 mg once weekly had a five-fold higher chance of achieving at least 5% body weight reduction versus those who did not receive semaglutide. Furthermore, about 69% of those on the higher dose (2.4mg) had improvements in their overall health including waist circumference, blood pressure, blood glucose, and physical functioning. Side effects of semaglutide were similar in STEP 1 and 2. Higher dose (2.4 mg) semaglutide provided great weight loss results for those with diabetes and BMI at 27 or higher. 

The results of these trials revealed the effectiveness of using semaglutide 2.4mg weekly for weight loss, in those with and without diabetes who have a BMI at 27 or higher.  As a result of these trials, NovoNordisk has submitted an application to the FDA for weight reduction indication in those with and without diabetes for the 2.4 mg dosage of semaglutide.  So be on the lookout for this as a future option for weight loss for those with or without diabetes.  

Back to CB, she and I discussed her trying semaglutide once weekly in place of her daily sitagliptin.  When she followed up, she was pleasantly surprised to see the scale finally moved in the right direction. 

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#semaglutide #weight loss #diabetes

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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.