Last week, Indianapolis-based drug maker Eli Lilly announced data from a study showing that, by combining the two different types of diabetes drugs, Jardiance and Trulicity, more patients may be able to reach target blood sugar levels than by using one drug alone.
And, since Lilly already sells each of these drugs: Trulicity as part of the GLP-1 class and Jardiance as an SGLT2, many expect the company will seek approval of such a combination drug from the FDA to give them an edge in an already crowded diabetes market.
However, doing so could raise safety questions. Namely, both GLP-1s and SGLTs have been linked to their own unique and severe side effects already. Additionally, no data has been published so far on the long-term effects of such a potent combination.
Lilly Funded Study Supports Combining Company’s Top-Selling Drugs
The study, entitled AWARD-10, was funded entirely by Eli Lilly and published in the February 23, 2018 edition of The Lancet Diabetes & Endocrinology. Researchers followed 424 patients taking the company’s SGLT2 drug Jardiance for type 2 diabetes over 24 weeks.
They then supplemented some of the patients’ treatment with once-per-week injections of the company’s GLP-1 drug Trulicity. What they discovered was that more patients with the add-on Trulicity treatment reached safe blood sugar levels than those who didn’t get it.
It should also be noted that those receiving both drugs had higher rates of nausea, vomiting and diarrhea. However, doctors said the already-existing risks of Trulicity weren’t increased by the combination with Jardiance.
It’s these already-present risks of both GLP-1 and SGLT2 drugs that have some worried. SGLT2 drugs like Jardiance have been linked to a toxic blood condition called ketoacidosis, while GLP-1 drugs have been repeatedly associated with pancreatitis and pancreatic cancer.
And, the combination of these could produce more dangerous long-term effects that a short 24-week study might not reveal.
SGLT2 Drugs Jardiance, Invokana & Farxiga Linked to Ketoacidosis
SGLT2 drugs like Jardiance, Invokana and Farxiga are part of a class of diabetes drugs known as gliflozins. They were first approved by the FDA for sale in the United States in 2013 and have grown to become some of the most-often prescribed treatments for type 2 diabetes.
SGLT2s work by blocking a certain protein that allows the kidneys to reabsorb blood sugar, thereby flushing out excess glucose.
However, the FDA warned in May 2015 that these drugs were linked to higher rates of the dangerous blood condition ketoacidosis, which is when too much acid accumulates in the bloodstream.
More recently, some SGLT2 drugs have also been linked to higher rates of foot, toe and lower leg amputations.
GLP-1 Drugs Linked to Pancreatic Cancer
GLP-1 medications are part of a larger class of diabetes drugs known as incretin mimetics. Some of the more popular brand names of GLP-1s include Victoza, Trulicity, Lyxumia and Byetta/Bydureon. These drugs first gained FDA approval in 2005 and still account for most diabetes treatments.
GLP-1s work by promoting the release of a different protein that encourages the body to release more sugar-fighting insulin.
Unfortunately, however, incretins have also been the subject of much debate over safety. The FDA first warned of pancreatitis risks with incretins in 2006. More importantly, studies in 2011 and 2017 revealed that patients taking incretins have higher rates of pancreatic cancer.
The Unknown Danger of Combining Diabetes Drugs
One thing is known for sure: both SGLT2 and GLP-1 drugs were released to the market and prescribed to millions of patients before the most severe risks were identified or disclosed by the manufacturers.
Both SGLT2s and incretins have been named in thousands of lawsuits filed by patients over ketoacidosis, amputation, pancreatitis or pancreatic cancer side effects. At present, several class action type courts around the country are awaiting the start of the next trials and companies are facing billions of dollars in liability to those injured.
Therefore, it is recommended that, should a combination drug emerge that joins SGLT2s and GLP-1s together, patients should proceed with caution before switching treatment until the true long-term risks are known.
DrugNews is your source for the latest in diabetes drug research, warnings and litigation news.
Ludvik, B. et al. Dulaglutide as add-on therapy to SGLT2 inhibitors in patients with inadequately controlled type 2 diabetes (AWARD-10): a 24-week, randomised, double-blind, placebo-controlled trial. The Lancet Diabetes and Endocrinology. (Febraury 23, 2018). Retrieved from http://www.thelancet.com/journals/landia/article/PIIS2213-8587(18)30023-8/fulltext
Helfand, C. As diabetes heats up, Lilly looks for Trulicity edge with positive SGLT2 combo data. FiercePharma. (February 27, 2018). Retrieved from https://www.fiercepharma.com/pharma/lilly-looks-for-trulicity-edge-positive-sglt2-combo-data
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