AUGUST 2019 

Study finds no link between SGLT-2 inhibitors and fracture risk in patients with type 2 diabetes

Recent research analysis published in the ADA’s Diabetes Care journal examined the association between sodium-glucose cotransporter 2 (SGLT2) inhibitors and the risk of fractures. To address the limitations in previous similar studies, the researchers conducted a population-based cohort study using the U.K. Clinical Practice Research Datalink (CPRD) to assemble a base cohort of all individuals, at least 40 years old, newly treated with antidiabetic drugs between January 1, 1988 and December 31, 2017. The study, which included 73.178 patients with 9,454 SGLT2 inhibitor users and 18,410 DPP-4 inhibitor users found a fracture incidence rate of 12.88 per 1,000 users. In the paper’s conclusion, the researcher wrote: “Overall, our real-world study provides further reassurance on the safety of this new class of drugs on bone health among patients with type 2 diabetes.”
 

FDA Approves New Intranasal Glucagon Spray for Hypoglycemia Treatment

The FDA recently announced the approval of the first glucagon-based treatment for severe hypoglycemia that doesn’t require an injection. The product, to be sold as Baqsimi, is an intranasal powder delivered through a single use dispenser. The approval was based upon two trials in adults and one trial in adolescents wherein the product demonstrated an ability to “adequately increased blood sugar levels" in response to insulin-induced hypoglycemia. In the FDA’s publicly released statement, Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research noted: “There are many products on the market for those who need insulin, but until now, people suffering from a severe hypoglycemic episode had to be treated with a glucagon injection that first had to be mixed in a several-step process. This new way to administer glucagon may simplify the process, which can be critical during an episode, especially since the patient may have lost consciousness or may be having a seizure.” 
 

ACA and AHA Release Updated Guidelines for Prevention of Sudden Cardiac Death

The American Heart Association and the American College of Cardiology have recently released guidelines on the effective prevention of sudden cardiac death in patients with ventricular arrhythmia. The updated guidelines includes a range of changes, the biggest of which is the addition of angiotensin receptor-neprilysin inhibitors, which the synopsis authors note remain controversial. Additional changes include the recommendation of guideline-directed medical therapy for those with reduced EF (<40%) to include beta-blockers, mineralocorticoid recepter antagonists, and angiotensin-converting enzyme inhibitors. Sudden cardiac death currently stands as a major public health concern, accounting for 50% of all cardiovascular death.
 

Coronary Artery Calcium Testing Predicts Death in Patients Under 50

A recent study published in JAMA Network Open found that for adults aged 30-49 years older with risk factors of cardiovascular disease (CVD), high coronary artery calcium (CAC) scores were associated with increased risk for actual CVD and mortality. The cohort study included 22,346 individuals from the CAC Consortium with clinical indications for CAC, 34% of which had prevalent CAC. In the study synopsis, the author’s concluded: “The risk of death from coronary heart disease, cardiovascular disease, or all-cause mortality was significantly higher for those with elevated CAC scores, even after multivariable adjustment.” The researchers suggested that while previously considered to be a superfluous process for younger patients, coronary artery calcium testing may be worthwhile: “"This paper gives credence to the idea that in certain individuals this might be something you want to think about. The radiation dose is pretty similar to a mammogram, so it's a pretty low dose, and the cost now is around a $100, so it's not a super expensive test, and it can provide some meaningful information clinically."
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For over three decades, Dr. George L. Bakris has led at the front line of kidney disease, hypertension and diabetes research, aiding in pivotal discoveries in the diabetes and hypertension therapy. With an acute expertise in the area of kidney disease, Dr. Bakris' research and work has crossed over into a wide range of specialties. While he initially began studying renal hemodynamic effects of contrast agents in analyzing acute kidney injury, he began to observe the intimate crossover between kidney disease and hypertension: "As times and my interests changed, I got more into diabetic kidney disease and the pathophysiology and therapeutics of trying to stop or slow progressive kidney disease. What I realized was that hypertension was an integral part of kidney disease, and it was almost impossible to divorce the two.” Dr. Bakris has published over 400 articles, is the editor of the American Journal of Nephrology, and currently serves on various editorial boards for a number of publication inclduing Cardiology Today, Journal of Human Hypertension, and the Journal of Nephrology.
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Despite their practicality and accessibility, modern insulin pumps may carry previously unknown risks and safety considerations. Recently, the FDA issued a warning calling to attention potential cybersecurity concerns associated with digital insulin pumps which rely on wireless technology. Certain Medtronic MiniMed insulin pumps have been recalled by the manufacturer due to the possible risk of them being hacked. The recalled pumps include Medtronic’s MiniMed 508 insulin pump and the MiniMed Paradigm series. The FDA recommends patients using these models switch insulin pumps to models that are better equipped to protect against potential cybersecurity risks.
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