JDC Gems

6. Drug/Device Updates

Smart Insulin Pen Cleared for Kids

      The Smart Insulin pen developed by Companion Medical had received clearance from FDA for its use in children of all ages (ages seven and older, otherwise under the supervision of an adult). The Bluetooth-enabled smart insulin pen was previously available only for adults. The InPen is the first and only FDA-cleared SmartPen™ that includes technology to:

  • Calculate and recommend optimal dosing;
  • Track history and timing of doses;
  • Monitor insulin temperature;
  • Display last dose and insulin-on-board; and
  • Track and report to the health care provider.
  •     The goal of this reusable pen is to make insulin injections safer with its features such as automatic capture of mealtime doses and keeping track of insulin on board. InPen comes with an app that helps people with diabetes easily track insulin doses and glucose levels. The app includes a bolus calculator which can help prevent insulin “stacking.” The app also creates an easily accessible report combining your glucose and insulin data – this tool is helpful for working with your healthcare team. InPen is also cleared in the U.S. for use with Lilly Humalog® or Novo Nordisk Novolog® rapid acting insulin. The InPen app is cleared for Apple iOS with an Android version planned for late 2016.

    Read More Link 1 | Link 2

    Bempedoic acid reassures lowering of LDL-cholesterol

          Clinical trials on the oral once daily ATP citrate lyase (ACL) inhibitor, Bempedoic acid reinforce the potential of the drug to lower the synthesis of cholesterol in the liver and thereby reducing the circulating LDL cholesterol. It is intended for patients with diabetes, prediabetes or normoglycemia, hypercholesterolaemia and/or at high risk of atherosclerotic cardiovascular disease (ASCVD) who need additional LDL-C lowering despite maximally-tolerated statin therapy.

          For the study, 3623 patients who were part of phase III clinical trials and on stable lipid lowering therapy were selected. They were assigned 180mg Bempedoic acid and placebo once per day for 12 to 52 weeks. The studies on the drug were grouped for analysis based on the enrollment criteria such as 52 weeks for patients with atherosclerotic cardiovascular disease/heterozygous familial hypercholesterolemia, or 12 or 24 weeks in patients who were statin intolerant.

    The observations obtained were for patients with atherosclerotic CVD or heterozygous familial hypercholesterolemia found that Bempedoic acid significantly lowered LDL compared with placebo in patients regardless of they had diabetes (18.6% vs. 0.6%; mean difference, 19.2%; 95% CI, 22.2 to 16.2), had prediabetes (16.4% vs. 2.1%; mean difference, 18.5%; 95% CI, 20.9 to 16.1) or were normoglycemic (14% vs. 3.2%; mean difference, 17.2%; 95% CI, 21.4 to 13). Similar observation was also seen in studies with patients who were statin intolerant and had diabetes (20.9% vs. 1.9%; mean difference, 18.9%; 95% CI, 24.7 to 13.1), had prediabetes (25% vs. 4.7; mean difference, 29.7%; 95% CI, 34.6 to 24.7) or were normoglycemic (25.2% vs. 1.6%; mean difference, 23.6%; 95% CI, 29.7 to 17.4).

    The research provides a new ray of hope to patients especially regarding the efficacy and safety of the drug l for patients needing to lower their bad cholesterol.

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