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Cardiac Toxicity in Chronic Fatigue Syndrome: Results from a Randomized 40-Week Multicenter Double-blind Placebo Control Trial of Rintatolimod [Ampligen®] – Source: Journal of Applied Research, vol 10, #3, 2010

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By Bruce C Stouch, et al. • • October 7, 2010

[Note: to read the full text of the article, click HERE]

The sedentary life-style caused by extreme fatigue is a significant risk factor for heart disease, which is a leading cause of death in Chronic Fatigue Syndrome (CFS) patients.

AMP-516, a 40-week double-blind, placebo controlled study in CFS patients to evaluate the effectiveness of rintatolimod (Ampligen®) included repeated QT interval measurements. [Note: The QT interval is the time between the start of the Q wave and end of the T wave in the heart’s electrical cycle (heartbeat) – measured in milliseconds (ms). A prolonged QT interval is thought to be associated with a defect in the heart muscle cell structures called ion channels, which are special pores in the cell membrane that control the passage of ions into and out of the cell as it ‘beats.’]

A 5 [or greater] ms post-treatment mean increase in QT prolongation was observed in the placebo group, while a [less than] 5 ms mean post-treatment increase in QT prolongation was observed in the rintatolimod patients.

A greater proportion of the placebo patients were found to have significant QT prolongation, compared to patients receiving rintatolimod.

The increase in QT in the placebo group was associated with continued use of concomitant medications known to prolong QT: patients randomized to receive rintatolimod were able to significantly reduce their dependence on these same medications. [Note: Drugs not specified, but to review a list of drugs that may have this side effect, click HERE.]

Reducing the risk of cardiac toxicity by reducing fatigue and the use of concomitant medications with serious side effects is an important clinical objective and underscores the seriousness of CFS.

Source: Journal of Applied Research, vol 10, #3, 2010, pp. 80-87. Stouch BC, Strayer D, Carter W. Philadelphia College of Osteopathic Medicine; Hemispherx Biopharma, Inc., Philadelphia, Pennsylvania, USA.

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