Practice Update: Diabetes

ADA 2017 11

estimated premeal insulin dose. Blood glucose levels were measured four times daily. Incorporating glucagon and insulin into automated dosing during and after exercise reduced exercise-induced hypoglycemia from 6.3 t to 1.0% vs insulin-only usage. The dual-hormone closed-loop systemwas also more effective than both the predictive low-glu- cose-suspend dosing system and current-care therapy. Results across all 4 days from a subset of the 20 adult subjects from 17 visits showed that time spent in hypoglycemia (<70 mg/ dL) was 1.0% for the dual-hormone system; 3.4% for single-hor- mone; 1.2% for the predictive low-glucose-suspend system; and 2.1% for current care. Participants undergoing current care, however, prevented exer- cise-induced hypoglycemia by keeping their blood sugar levels significantly higher leading up to the start of exercise. Mean glucose level after exercise was significantly lower for single- than with dual-hormone, 67 ± 6 and 100 ± 9 mg/dL, respectively. Dr Jacobs concluded, “Our findings showed that fully automated insulin and glucagon delivery, combined with wearable physical activity sensors that detected exercise, controlled glucose levels effectively, reduced exercise-induced hypoglycemia, and were used safely in a home environment. The results suggested that a dual-hormone closed-loop system with automated detection of aerobic exercise can be used as a tool to adjust insulin and glucagon dosing during and after exercise.” He added, “We plan to explore migrating our system from a smartphone platform to a smart watch, where exercise can be detected more easily. These exercise-enabled automated dosing systems may soon be able to help people with type 1 diabetes exercise safely without fear of hypoglycemia.” www.practiceupdate.com/c/54688 significantly, and allowing patients and their families to get a good night’s sleep. Hybrid closed-loop systems do a great job improving glucose control overnight, lowering the risk of hypoglycemia

The PCSK9 Inhibitor Alirocumab Reduces Non-HDL Cholesterol in Patients with Type 2 Diabetes and Mixed Dyslipidaemia The PCSK9 inhibitor alirocumab has been shown to reduce non-HDL cholesterol in patients with type 2 diabetes and mixed dyslipidaemia. This outcome of the randomized, open-label, parallel group ODYSSEY DM – DYSLIPIDEMIA Study was reported at the American Diabetes Association’s 77th Scientific Sessions, from June 9–13. R obert R. Henry, MD, of the University of California, Veterans Administration Medical Center, San Diego, said, “Cardiovas- cular disease is a significant cause of morbidity and mortality in patients with type 2 diabetes. Mixed dyslipidemia is present commonly in these patients and further increases their cardio- vascular risk.” Dr Henry and colleagues evaluated alirocumab vs standard care (either no additional lipid-lowering therapy or ezetimibe, fenofi- brates, omega-3 fatty acids, or nicotinic acid) in patients with type 2 diabetes and mixed dyslipidemia who were at high cardiovascular risk (established atherosclerotic cardiovascular disease or at least one other cardiovascular risk factor) with non-HDL- C inadequately controlled with the maximum tolerated dosage of statin therapy. Mixed dyslipidemia was defined as elevations in non-HDL cho- lesterol and triglyceride levels, often accompanied by low levels of HDL cholesterol. The study enrolled 413 patients with type 2 diabetes from 110 centers from the US, Europe, South America, the Middle East, Australia, and the UK. The trial consisted of a 24-week treatment period, and a safety follow-up period of 8weeks. Patients were randomized to either 75 mg of alirocumab (adminis- tered via an autoinjector every 2 weeks for 24 weeks); or standard care in a 2:1 ratio. Patients randomized to alirocumab, but who did not achieve adequate reduction in non-HDL-cholesterol after 12 weeks of follow-up were titrated to 150 mg in a blinded manner. The primary endpoint was the difference between treatment arms in percentage change of non-HDL-C from baseline to week 24. After 24 weeks of treatment, alirocumab reduced the non-HDL-C significantly, by 32.5% vs usual care. Non-HDL-C is considered a better predictor of cardiovascular risk than LDL-C levels, par- ticularly in patients with type 2 diabetes with mixed dyslipidemia. Additionally, patients who received alirocumab improved in other lipid parameters vs those who received usual care. Themajority of patients in the alirocumab group reached the recom- mended lipid levels with the 75 mg dose. The number of adverse events was similar between the two treatment arms. Further, aliro- cumab was well tolerated and did not affect glucose control. Dr Henry concluded, “The ODYSSEY-DM-DYSLIPIDEMIA Study was the first trial to compare a PCSK9 inhibitor vs usual care in patients with type 2 diabetes with lipid disturbances. The results will help cli- nicians manage mixed dyslipidemia, a persistent clinical challenge

PracticeUpdate Editorial team.

in patients with type 2 diabetes.” www.practiceupdate.com/c/54541

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VOL. 1 • NO. 2 • 2017