QTC

The Cardiac Risk of Chloroquine in Unapproved Indications

Friday, March 27, 2020 - 1:57am

Recently, the unapproved use of the antimalarial drug, chloroquine, has been touted as a treatment for COVID-19 with some reported deaths with its use in afflicted patients.

Key Points: 
  • Recently, the unapproved use of the antimalarial drug, chloroquine, has been touted as a treatment for COVID-19 with some reported deaths with its use in afflicted patients.
  • Because the QT interval is influenced by heart rate, it is most often given as the corrected QT interval or QTc.
  • Even therapeutic doses of chloroquine in healthy patients are associated with prolongation of QTc1, although this is generally well tolerated.
  • This is why chloroquine has specific warnings in its labeling to inform of the potential danger in patients with underlying risk factors (cardiac disease, hypokalemia, hypomagnesemia, bradycardia)3.

New FDA Guidance Allows Use of KardiaMobile 6L to Measure QTc in COVID-19 Patients

Monday, March 23, 2020 - 1:00pm

The QTc is a heart rate corrected interval that reflects the integrity of the heart's electrical recharging system.

Key Points: 
  • The QTc is a heart rate corrected interval that reflects the integrity of the heart's electrical recharging system.
  • "We are thankful to the FDA for issuing timely guidance to help expand the availability of our device to assist in the treatment of COVID-19 during this global health emergency."
  • The FDA-cleared KardiaMobile 6L device is the most clinically validated personal ECG solution in the world.
  • Mayo Clinic will use any revenue it receives to support its not-for-profit mission in patient care, education and research.

Trevena Reports Third Quarter 2019 Results and Topline Data From Multi-Dose Healthy Volunteer QT Study

Monday, November 4, 2019 - 12:00pm

The goal of the study was to collect the additional QT interval data requested by FDA for the resubmission of the NDA for oliceridine.

Key Points: 
  • The goal of the study was to collect the additional QT interval data requested by FDA for the resubmission of the NDA for oliceridine.
  • The primary endpoint was the placebo-corrected change from baseline in the individual rate-corrected QT interval (QTcI) measured hourly at each of the 24 time points in the study.
  • There were no individual outliers with a rate-corrected change from baseline >60 msec or an absolute QT interval >500 msec.
  • Trevena, Inc. is a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with CNS disorders.

Leidos Completes Acquisition of IMX Medical Management Services

Thursday, August 15, 2019 - 9:45pm

RESTON, Va., Aug. 15, 2019 /PRNewswire/ --Leidos (NYSE:LDOS), a FORTUNE 500 science and technology leader, announced today it has completed the acquisition of IMX Medical Management Services (IMX) and its affiliated businesses.

Key Points: 
  • RESTON, Va., Aug. 15, 2019 /PRNewswire/ --Leidos (NYSE:LDOS), a FORTUNE 500 science and technology leader, announced today it has completed the acquisition of IMX Medical Management Services (IMX) and its affiliated businesses.
  • Headquartered in Malvern, Pa., IMX provides independent medical evaluations, medical record reviews, and medical and vocational case management for insurance carriers, employers, law firms, third party administrators, and state and local government.
  • Nearly 200 IMX staff members will join QTC Management, Inc. (QTC) led by QTC President Grant Kim.
  • QTC is a wholly owned Leidos subsidiary providing more than 3,000 independent medical examinations and medical record reviews per day for key federal customers across all 50 states.

The Potential Role of the J-Tpeak Interval in Proarrhythmic Cardiac Safety: Current State of the Science | ACCP/CSRC Position Paper

Tuesday, April 2, 2019 - 1:30pm

Dr. Michael J. Fossler, Jr emphasized, "This important paper demonstrates the potential value of the J-Tpeak interval, which may be a more discerning marker of pro-arrhythmic potential than the QTc interval.

Key Points: 
  • Dr. Michael J. Fossler, Jr emphasized, "This important paper demonstrates the potential value of the J-Tpeak interval, which may be a more discerning marker of pro-arrhythmic potential than the QTc interval.
  • Very soon, new drug developers may be able to use this technique to develop safer pharmaceuticals for patients.
  • To date, QT interval prolongation has been considered to be an imperfect but nonetheless informative proarrhythmic liability biomarker.
  • More recently, attention has focused on another ECG interval, the heart rate-corrected J-Tpeak interval, hoping that it may prove to be a more discerning biomarker of true proarrhythmic liability.