Reece's Piece's In a Diabetes World

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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Thanks to Taylor Guelda, PCOM PharmD Candidate 2021, for writing this daily piece.

We know that SGLT-2 inhibitors are a proven medication to help treat type 2 diabetes beyond just their glucose lowering benefits. Robust research supports both their benefit in both cardiovascular and kidney disease. Canagliflozin was the first SGLT-2 inhibitor show benefit in patients with CKD in the CREDENCE trial. This trial found canagliflozin dosed at 100 mg once daily in persons with type 2 diabetes and diabetic nephropathy reduces the risk of end-stage kidney disease, worsening serum creatinine, and death from renal or cardiovascular disease when compared to placebo. Empagliflozin was next to show a benefit in CKD through DAPA-CKD study. This study revealed that empagliflozin dosed at 10 mg every day in persons with CKD with and without type 2 diabetes led to less progression of CKD, renal related death, or cardiovascular related death when compared to placebo. Lastly, dapagliflozin is currently being assessed for its role in CKD in persons with and without diabetes with the study EMPA-KIDNEY with expected outcomes available in 2022. These trials leave no doubt that the SGLT-S inhibitors play not only an important role in type 2 diabetes but also in renal and cardiovascular disease.

References:

Perkovic V, et al. “Canagliflozin and renal outcomes in diabetic nephropathy”. The New England Journal of Medicine. 2019. 380(24):2295-2306.

Heerspink, et al. “Dapagliflozin in patients with chronic kidney disease”. The New England Journal of Medicine. 2020. 383(13):1436-1446.

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#SGLT2inhibitor #renal #cardiovascular #benefits

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Thanks to Taylor Guelda, PCOM PharmD Candidate 2021, for writing this daily piece.

At the beginning of December, the FDA released a statement that sitagliptin (Januvia) does not improve glycemic control in pediatric patients. This statement was based on the results of three studies that used Januvia in patients age 10 to 17 with uncontrolled type 2 diabetes. When they compared Januvia to placebo there was not a significant difference in the reduction in HbA1c. Due to the results of the studies, updates have been made to the prescribing information of Januvia and other sitagliptin containing products (Janumet, Janumet XR). These agents are not recommended in pediatric patients with type 2 diabetes. Januvia and related products should only be used in type 2 diabetes patients age 18 years and older. Current FDA approved medications in the management of type 2 diabetes in the pediatric population include: metformin, insulin, and Victoza.

Reference:  New studies show diabetes drug not proven to improve blood sugar control in pediatric patients. [press release]. Silver Spring, MD: US Food and Drug Administration; December 4, 2020.

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#Januvia #diabetes #labelchange

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Thanks to Taylor Guelda, PCOM PharmD Candidate 2021, for writing this daily piece.

Novo Nordisk created a pharmacokinetically novel long-acting insulin. Insulin icodec has a half-life of ~196 hours allowing for a once-weekly dosing strategy. When first hearing of once-weekly insulin I immediately think of how great that will be for adherence. On the flip side, I also think of the risk of hypoglycemia that could be associated with a once-weekly dosed insulin. A recently published study sought to investigate the safety and efficacy of once-weekly insulin icodec as compared with once-daily insulin glargine in insulin naïve patients with type 2 diabetes concurrently taking metformin with or without dipeptidyl peptidase 4 (DPP4) inhibitor. The results stated that the icodec group’s mean HbA1c decreased by 1.33% at week 26 and the glargine group decreased by 1.15% percentage points This was not found to be statistically significant. However, it is important to note the outcomes were not powered to detect significant differences between the groups. As far as safety, the majority of hypoglycemia with icodec was either mild (53.6% icodec vs. 37.7% glargine) or clinically significant without defined severe hypoglycemia. I definitely think more research needs to be done, but it is definitely exciting to see new potential possibilities for patients with diabetes in the pipeline.

Reference:

Rosenstock, J., Bajaj, H., Janež, A., Silver, R., Begtrup, K., Hansen, M., Jia, T. and Goldenberg, R., 2020. Once-Weekly Insulin for Type 2 Diabetes without Previous Insulin Treatment. New England Journal of Medicine, 383(22), pp.2107-2116.

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#weekly #insulin #diabetes

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Currently, there are four SGLT-2 inhibitors on the market: Invokana, Farxiga, Jardiance and Steglatro. A lot of trials have been done surrounding this class of medications in regards to both cardiovascular and renal protection. Steglatro is what I would call the late bloomer of the group. It was the last agent to gain FDA approval as well as being last to report on cardiovascular (CV) (heart related) outcomes. Results from the VERTIS CV trial were recently published in October 2020. The VERTIS CV trial demonstrated that ertugliflozin is noninferior for reducing CV events in patients with T2DM and established ASCVD. Like it’s counterparts, Steglatro also demonstrated benefits for heart failure, although this was not tested statistically. On the other hand, no significant benefit was observed for ertugliflozin in regards to renal protection. The benefits on cardiovascular and renal outcomes don’t seem as strong compared to others in the same class. The trial still serves the purpose of confirming the important role of SGLT-2 inhibitors in treating type 2 diabetes patients with comorbid ASCVD.

Reference:

Cannon CP, Pratley R, Dagogo-Jack S, et al., for the VERTIS CV Investigators. Cardiovascular Outcomes with Ertugliflozin in Type 2 Diabetes. N Engl J Med 2020;383:1425-35.

Today’s daily piece is written by Taylor Guelda, PCOM SOP PharmD Candidate Class of 2021.

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#SGLT2inhibitor #diabetes #cardiovascular

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The aim of the SCORED trial was to assess the safety and effectiveness of sotagliflozin in reducing cardiovascular events among patients with type 2 diabetes mellitus and chronic kidney disease. Sotagliflozin is an SGLT2 inhibitor, but also inhibits SGLT1, which primarily exists in the gut and appears to delay glucose absorption. The results of this trial indicate that sotagliflozin has salutary effects on cardiovascular (heart) outcomes among patients with T2DM and CKD. The benefit was primarily in reduction of heart failure events, but there was also a reduction in cardiovascular (heart) death/MI (heart attack)/stroke, primarily due to reduction in MI (heart attack) and stroke. A reduction in renal (kideny) events was not observed, likely due to early cessation of the trial due to loss of funding.

https://www.endocrinologyadvisor.com/home/topics/diabetes/sglt2-inhibitor-sotagliflozin-cardiovascular-heart-failure-events-diabetes-ckd/?utm_source=newsletter&utm_medium=email&utm_campaign=ea-update-hay-20201201&cpn=&hmSubId=lgd8VCc5wdc1&hmEmail=6uDHAmJj0tD-ewCsWh7M6oKmz9R2geZa0&NID=&email_hash=51466cd2e70cdac06bc0cab2420cd276&mpweb=1323-113698-6605859

Today’s daily piece is written by Jipal Patel, PCOM SOP PharmD Candidate Class of 2021.

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#kidney #heart #protection #diabetes

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We currently have great options for automated insulin delivery with the Medtronic, Tandem and Omnipod insulin pumps. Another option for patients is on the horizon as Lilly and Ypsomed collaborate in an automated insulin delivery system. Currrently, Ypsomed has the mylife YpsoPump, an automated insulin delivery device, which is available in Europe. The unique features of this pump are its small size and icon based touch screen. Ypsomed is developing a version of the mylife YpsoPump for the U.S. with plans to submit for FDA approval in 2022. Once FDA approval is given, Lilly with commercialize the insulin pump in the U.S.

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#diabetes #insulin #delivery

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The Kidney Disease: Improving Global Outcomes (KDIGO) organization has released new guidelines for management of diabetes in chronic kidney disease. These guidelines take a multidisciplinary approach. Below are a few medication highlights of the 12 recommendations as well as a link with all of the recommendations.

1. Treatment with an angiotension-converting enzyme inhibitor (ACEI) or angiotension II receptor blocker (ARB) to be initiated in person with diabetes, hypertension and albuminuria, and titrate to highest approved dose that is tolerated.
2. Advising persons with diabetes who use tobacco to quit using tobacco products.
3. Treating persons with type 2 diabetes, CKD and eGFR >/= 30 mL/min/1.73 m2 with metformin.
4. Treating persons with type 2 diabetes, CKD and eGFR >/= 30 mL/min/1.73 m2 with SGLT2-inhibitor.
5. In persons with type 2 diabetes and CKD who have not achieve their goal glycemic targets on metformin and SGLT2-inhibitor or are unable to tolerate these medications, a long acting GLP-1 receptor agonist is recommended.

https://www.acpjournals.org/doi/10.7326/M20-5938

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#diabetes #kidney #medications

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Continuous glucose monitors (CGM) provide vital, timely glucose data for persons with diabetes to keep them safe from the dangers of hypo- and hyperglycemia. One group that unfortunately has had limited access to CGMs are Medicare beneficiaries with requirement that the CGM be approved as a therapeutic CGMs (can use them to make treatment decisions) plus beneficiary having to be on basal bolus insulin regimen and test four times daily. Yikes!! Such limitations which creates frustration. This week a ray of sunlight peaked through the clouds with CMS proposed changes which would increase access to CGMs for Medicare beneficiaries through providing access to all CGMs (not just therapeutic CGMs) as durable medical equipment (DME) and establish payment amounts for these items. Now if only CMS would revise rules to eliminate four times daily testing of glucose, and being on basal bolus insulin regimen requirements. Please click below for details.

https://www.cms.gov/newsroom/press-releases/new-cms-proposals-streamline-medicare-coverage-payment-and-coding-innovative-new-technologies-and

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#CGM #Medicare #technology

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