lisinopril - Losartan

Treatment of early cardiac systolic dysfunction in Duchenne muscular dystrophy with lisinopril or Losartan: a prospective, randomized, blinded, crossover trial

Dr Spurney
Children's National Medical Center, USA

Saturday 6th February 2010

Professor Jerry R. Mendell was the lead reviewer and guided the meeting discussions and the generation of the TACT recommendations report to the applicant.

In summary, TACT recommended that additional valuable studies performed by the applicant in the mdx mouse on the effects of Losartan on skeletal and cardiac function should be published in order to provide a clear rationale for the proposed clinical trial and clarify ongoing questions in the field about the potential role of Losartan in the treatment of DMD. The trial design as proposed combined cardiac and strength assessments and TACT felt this could be improved in some respects, with a key point of clarification being whether the study objectives relate to cardiomyopathy (as suggested by the comparison with the lisinopril) or the muscle effects of Losartan.  Finally, TACT noted that regulatory input would be important when considering the use of these drugs in children.

“The TACT process was extremely beneficial. It was timely, fair and well organized. The TACT committee provided experts from multiple fields and each provided unique insight on the proposal. We received a breadth of comments that will strengthen our proposal. In its entirety, the TACT review likely will save us over a year's time in moving our clinical protocol forward. I highly recommend the TACT committee.”

Dr Spurney

12 Apr 2017