St. Jude Medical says use of defibrillator with drugs cut shocks in study

By Lisa Kerner

Erie, Pa., - Jan. 10 - St. Jude Medical, Inc. said a trial found that use of its implantable cardioverter defibrillator with drugs cut the number of shocks received by patients.

The results from the Optic (Optimal Pharmacological Therapy in Implantable Cardioverter Defibrillator Patients) clinical study were published in the Jan. 11 edition of The Journal of the American Medical Association (JAMA).

"Effective strategies to reduce ICD [implantable cardioverter defibrillator] shocks are desirable because they can improve patient quality of life and mental well-being," Dr. Eric S. Fain, executive vice president of development and clinical/regulatory affairs for St. Jude Medical's Cardiac Rhythm Management Division said in a news release. "Results of the Optic Study will benefit ICD patients, and the importance of this study is reflected by the prestigious, peer-reviewed journal in which it is published."

A randomized, controlled clinical trial, the OPTIC Study evaluated 412 patients at 39 clinical centers in the U. S., Canada and Europe. Patients received a St. Jude Medical dual-chamber implantable cardioverter defibrillator within 21 days before randomization. Antiarrhythmic drug therapy began immediately after implant.

The study shows that patients with an implantable cardioverter defibrillator reduced their chances of receiving any shock to 10.3% per year when taking the drug amiodarone combined with beta blocker. This is compared with 24.3% for patients on sotalol alone, and 38.5% for patients on beta blocker alone.

In addition, the amiodarone and beta blocker medical regimen reduced the chance of a patient having an inappropriate shock to only 3.3% per year. Amiodarone plus beta blocker reduces shocks by suppressing ventricular tachycardia, sinus tachycardia and supraventricular arrhythmias

Implantable cardioverter defibrillators shock the heart out of potentially fatal arrhythmias, although the high-voltage shocks can be uncomfortable and upsetting to patients.

St. Jude Medical in St. Paul, Minn. has five major focus areas that include cardiac rhythm management, atrial fibrillation, cardiac surgery, cardiology, and neuromodulation.

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