JUN 2019 

Weight Loss With Metformin Maintained at 15 Years

A post-hoc analysis of the Diabetes Prevention Program (DPP) trial found that metformin may help maintain long-term weight loss in those at risk for type 2 diabetes. The analysis observed that among participants who lost 5% of body weight after a year on trial, mean weight loss from 6 to 15 years was 6.2% for those on metformin versus 2.8% for the placebo group and 3.7% for the diet and exercise group. However, overall 62.6% of patients undergoing the intensive lifestyle intervention (ILS) lost at least 5% of their body weight compared to much lower to all other groups. The researcher explained that “Although the benefits of metformin on blood glucose and insulin sensitivity are known, the benefits of metformin on weight loss are not quite as well understood.”
 

BAROnova Announces FDA Approval of the TransPyloric Shuttle® (TPS®) Device

BAROnova, a medical device company centered on the development of non-surgical solutions for the treatment of obesity, recently announced that the U.S. Food and Drug Administration (FDA) has approved a non-surgical weight loss solution for adults suffering from obesity with a body mass index of 30 to 40 kg/m2. The TransPyloric Shuttle (TPS) is approved for up to 12 months of treatment, while patients complete lifestyle modification counseling to further develop and maintain healthy habits. Approval for the TPS is derived from data from the randomized, double-blind, and sham-controlled ENDObesity®II study.
 

FDA Grants Approval to Personal ECG Device to Detect Bradycardia and Tachycardia

For the first time, the FDA has granted approval to a personal device to detect and show ECG results for Bradycardia and Tachycardia. AliveCor, the company which developed the device, now maintains the only ECG device in with FDA clearance to detect the three most common heart arrhythmias as it was previously approved to detect Atrial Fibrilliation (AFib). In a public statement, Dr. Jacqueline Shreibati, CMO of AliveCor noted: "While we have traditionally focused on the patient empowerment that comes from increased awareness of atrial fibrillation, we are excited to give all of our users more actionable insights into their heart health."
 

Canagliflozin: Renoprotective in T2D, Chronic Kidney Disease

Findings published in the New England Journal of Medicine demonstrated that the SGLT-2 inhibitor canagliflozin showed a significant renal benefit in the phase III CREDENCE trial. Patients with type 2 diabetes and albuminuria on 100 mg of once daily oral canagliflozin experienced a 30% reduced risk for a composite outcome of end-stage kidney disease, doubling of serum creatinine, or renal or cardio vascular death (HR 0.70, 95% CI 0.59-0.82, P=0.00001) compared with placebo (event rates of 43.2 and 61.2 per 1,000 patient-years). The researchers, from The George Institute for Global Health in Sydney, explained: “The observed benefits were obtained on a background of renin-angiotensin system blockade, the only approved renoprotective medications in type 2 diabetes, a factor that highlights the clinical significance of the findings."
 

New Research Further Identify Bempedoic Acid as a Lipid-Lowering Agent

New findings suggest that bempedoic acid can significantly lower low-density lipoprotein (LDL) cholesterol when added to maximally tolerated statins in high-cardiovascular-risk patients. Through the CLEAR Wisdom study, patients treated with the investigational oral agent had a 15.1% reduction in the primary end point of LDL cholesterol at 12 weeks compared with a 2.4% increase of placebo (17.4% placebo corrected difference P < .001). The study also showed oral bempedoic acid also significantly reduced non-HDL cholesterol, total cholesterol, apolipoprotein B, and creative C-reactive protein levels. In a statement to Medscape Cardiology, Valentine Fuster, MD, Mount Sinai Icahn School of Medicine, New York City, remarked that the findings may serve as an "opening door to a new pharmacological strategy.”
 

New Trial for Obeticholic Demonstrates Efficacy for NASH

In a phase 3, 18-month REGENERATE trial, results demonstrate that obeticholic acid improves liver fibrosis, scarring, and other difficulties of nonalcoholic steatohepatitis (NASH). Of the 931 participants, 308 received obeticholic acid 25 mg daily, 312 received obeticholic acid 10 mg daily, and 311 received a placebo. While the end point of the NASH resolution was not met, a larger number of patients in the 25 mg group than in the placebo group saw improvements in hepatocellular ballooning (35.1% vs 23.2; P = .0011) and in lobular inflammation (44.2% vs 35.7%; P = .0322). One clinician, Zobair Younossi, MD, from Virginia Commonwealth University stated: “This is a watershed moment. It’s the first trial that shows efficacy for NASH.” However, while the results were statistically significant, they did not meet the mandated threshold of .0001 for US FDA approval.  
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Mark your calendar: the 14th Annual Cardiometabolic Health Congress is right around the corner!
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