Medscape review supports effectiveness and safety of new non-drug blood pressure treatment
Peer-reviewed article highlights seven clinical trials of device-guided breathing with RESPeRATE
Fort Lee, N.J. -- August 10, 2006--InterCure, Ltd., today announced the publication of a peer-reviewed clinical overview of seven clinical trials evaluating the efficacy of device-guided breathing. The study's authors conclude that RESPeRATE, an FDA-cleared over-the-counter therapeutic device, is an effective non-pharmacologic treatment option for treating hypertension with no side effects.
The article, published in the General Medicine Journal (http://www.medscape.com/viewarticle/539099) of Medscape (NASDAQ:WBMD), is authored by William J. Elliott, MD, PhD, professor of Preventive Medicine, Internal Medicine and Pharmacology at Rush Medical College, Ill., and Joseph L. Izzo, Jr., MD, professor of medicine and vice chair of Medical Research at the University of Buffalo, N.Y.
The article confirms the body of evidence from seven published clinical studies concluding that routine use of RESPeRATE, either alone or as an adjunctive treatment with lifestyle modifications or prescription drugs, significantly lowered blood pressure with no adverse side effects. The study also reviews the physiological mechanism of action of device-guided breathing.
A summary of the results of the seven studies shows an average all-day reduction of 14/8 mm Hg within four to six weeks of commencement of 15-minute-daily treatments with RESPeRATE. The reduction in blood pressure was consistent between studies, whether measurements were taken in the home, 24-hour ambulatory setting or physician's office. Larger blood pressure reductions were seen in older individuals and those with higher baseline readings, regardless of whether they were also being treated with prescription antihypertensive medications.
The authors summarize the patient populations for whom device-guided breathing appears to be beneficial: (1) prehypertensives and white-coat or labile hypertensives who might benefit from reducing stress and sympathetic activity; (2) patients with isolated systolic hypertension; and (3) patients with resistant hypertension (uncontrolled blood pressure despite use of a diuretic and at least two other medications at maximum approved doses).
"When I was first introduced to RESPeRATE, I was skeptical, but after seven trials, the body of data speaks for itself. I have seen first-hand that as long as patients use the device regularly, blood pressure is reduced, with no side effects," says Dr. William Elliott, Rush Medical Center. "Controlling hypertension requires a comprehensive approach, and device-guided breathing provides an additional effective therapeutic modality to offer our patients."
More than 65 million Americans have high blood pressure, and even with traditional treatment methods of diet, exercise and medication, 70 percent of that population is either unable to reach their lower blood pressure goals or can't tolerate the side effects of medications. Left untreated, high blood pressure may lead to heart attack, stroke and kidney or heart failure.
RESPeRATE® is FDA-cleared for over-the-counter sale and is the only medical device on the market clinically proven to lower blood pressure through paced breathing therapy. The device uses the body's natural tendency to follow external rhythms, interactively guiding the user to effortlessly reduce breathing rate to a "therapeutic zone" of less than 10 breaths per minute. The breathing exercises with RESPeRATE relax the constricted muscles surrounding the small blood vessels, allowing the blood to flow more freely and yielding a significant and lasting reduction of blood pressure within weeks.
About InterCure, Ltd.
InterCure, a medical device company, has become a leader in the growing Personal Therapeutic Device category. Its broadly patented "device-guided breathing" technology platform enables a systematic reduction in sympathetic outflow of the autonomous nervous system. InterCure is successfully selling the world's 1st hypertension treatment device, RESPeRATE. With multiple published clinical trials, regulatory approvals in most key markets (FDA over-the-counter ("OTC") clearance, CE mark, Chinese SDA, and others) and a renowned scientific advisory board, RESPeRATE is rapidly becoming a part of the standard of care for the treatment of hypertension. (www.intercure.com, www.resperate.com)
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