Abimbola Farinde, PharmD

The incidence of diabetes in the United States continues to rise, climbing to 9.3% of the U.S. population or approximately 29.1 million Americans in 2012.

 If this trend continues to escalate, estimates predict up to 52% of American adults will be living with diabetes by 2020.

The recent United States Food and Drug Administration approvals of Tresiba (insulin degludec injection) and Ryzodeg 70/30 (insulin degludec/insulin aspart injection) appear to offer additional or alternative options for both providers and patients when it comes to the effective and long-term management of diabetes. Tresiba is a long-acting insulin analog that is injected subcutaneously once daily, whereas Ryzodeg can be administered either once or twice daily.

The use of long-acting insulins to better manage diabetes symptoms and achieve improved glycemic control is not a novel therapeutic approach for treatment of diabetes, but the use of Tresiba for both type 1 and type 2 diabetes is a characteristic that draws the attention of both providers and patients. The landscape for diabetes management has widened with the approval of these two diabetic drugs, but their efficacy has not been shown to be superior to that of other long-acting insulin products on the market. Rather, it has been reported that the reduction in HbA1C for Tresiba was comparable to that of other insulin agents. The observed benefits of Tresiba and Ryzodeg have been described as being similar to current agents on the market, and even Tresiba was found to offer no additional benefit over existing insulins, according to reports made by the German Institute for Quality and Efficiency Healthcare in 2014.

Ultimately, with increased awareness, the outcomes of postmarketing evaluations, and additional trials, these two agents have the potential to overtake agents that are currently being prescribed by most providers and used by most patients to manage their diabetes on a daily basis. At this point in time it is too soon to predict the impact that Tresiba and Ryzodeg will have on the diabetes market. Only time will tell if they have the power to change prescribing habits or fail to have a significant impact both on the market and in clinical practice.

1. Centers for Disease Control. National diabetes statistics report, 2014. Accessed 23 Oct 2015 at 

http://www.cdc.gov/diabetes/pubs/statsreport14/national-diabetes-report-web.pdf

2. Diabetes Advocacy Alliance. Diabetes facts and figures – the future. Accessed 23 Oct 2015 at 

http://www.diabetesadvocacyalliance.org/html/resources_diabetes_facts_future.html

3. Institute for Quality and Efficiency in Health Care. Insulin degludec (Tresiba) for diabetes mellitus. Accessed 23 Oct 2015 at 

http://www.informedhealthonline.org/insulin-degludec-tresiba-for-diabetes-mellitus.2736.en.html

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Two new drugs have hit the diabetes market, including a drug to treat both types 1 and 2, but do they have the power to change prescribing habits?

New Diabetes Drug Approvals

According to a recent announcement and warning made by the United States Food and Drug Administration (FDA) in September 2015, the type 2 diabetes medications that fall in the class of sodium-glucose cotransporter-2 (SGLT2) inhibitors have been reported to lead to ketoacidosis, a condition where the body produces high amounts of ketones. Ketoacidosis is a condition that can require hospitalization and can progress to a life-threatening issue (coma and death) if not appropriately addressed in a timely manner. The FDA reported about 20 cases of ketosis that occurred between March 2013 and June 2014 in patients treated with SGLT2 inhibitors. The patients required a visit to the emergency room or were hospitalized as a result of ketoacidosis. Even after these cases, additional adverse events continued to be reported for diabetic ketoacidosis and ketoacidosis in patients who were treated with SGLT2 inhibitors. In the wake of the announcement, healthcare professionals and patients are instructed to pay very close attention to any presenting signs or symptoms of ketoacidosis. For healthcare professionals with patients who are on these drugs, an evaluation for the presence of acidosis should be performed and the SGLT2 inhibitor should be discontinued if suspected acidosis is confirmed in any given patient. The FDA also urges healthcare professionals and patients to continue to report side effects that involve the use of SGLT2 inhibitors to their MedWatch program.

Examples of SGLT2 inhibitors include canagliflozin (Invokana), dapagliflozin (Farxiga), and empagliflozin (Jardiance), and combination drugs of canagliflozin and metformin (Invokamet) and empagliflozin and linagliptin (Glyxambi).

Besides the concern related to SGLT2 inhibitors leading to ketoacidosis, the FDA also strengthened its warning for canagliflozin and the increased risk of fractures. New information related to decreased bone mineral density now accompanies the dispensing of the drug. Other potential concerns related to SGLT2 include potential increased risk of kidney failure, heart attacks, strokes, or other cardiovascular issues. These issues continue to be investigated and managed appropriately on a case-by-case basis until a formal statement is made to the general public. To date the FDA has not released a formal statement on how the drugs will be regulated.

The SGLT2 inhibitors are still considered to be safe and effective drugs, but close monitoring and a case-by-case assessment should be performed by each patient and prescriber to determine the need for continuation or discontinuation of therapy. As it currently stands, an official statement that indicates how prescribers should proceed with the use of SLGT2 is pending but in the meantime, an evaluation should always be performed.

Our blogger provides her assessment of recent FDA warnings on SGLT2 inhibitors.

Author | Abimbola Farinde, PharmD

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New Diabetes Drug Approvals

FDA Warnings about SGLT2 Inhibitors