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Title: Modafinil Appears Safe Treatment for Sleep Disorders Despite Short-Term Blood Pressure or Heart Rate Elevations in Some Patients: Presented at CHEST

"Modafinil Appears Safe Treatment for Sleep Disorders Despite Short-Term Blood Pressure or Heart Rate Elevations in Some Patients: Presented at CHEST"

By Bonnie Darves SEATTLE, WA -- October 28, 2004 -- Modafinil, a drug frequently prescribed to treat narcolepsy, obstructive sleep apnea (OSA), and other related sleepiness disorders can be safely used without concerns about possible adverse effects on heart rate and blood pressure, a new study has found. Modafinil is now being widely used to promote daytime wakefulness but may produce short-term blood pressure or heart rate elevations in some patients. However, the effects are neither longstanding nor health-threatening, said the study's chief author, Jonathan Sackner-Bernstein, MD, cardiologist, North Shore University Hospital, in Manhasset, New York. Dr. Sackner-Bernstein presented his study's findings here at Chest 2004, the 70th annual scientific assembly of the American College of Chest Physicians. The researchers undertook a meta-analysis of 7 placebo-controlled studies of modafinil involving 1501 patients. The retrospective calculations were designed to detect a change of 5 mm Hg or 5 bpm or greater. "The results are actually quite reassuring. We found no difference in blood pressure or heart rate between the drug and placebo, that extended to 4 weeks after treatment," Dr. Sackner-Bernstein said. "We conclude that the safety profile of modafinil in this group of patients is really quite favorable from a cardiology perspective." Physicians treating excessive sleepiness should be more concerned about the other potentially dangerous effects of the condition than about the drugs used to treat it, Dr. Sackner-Bernstein said. Besides the obvious physical safety risks, there is an emerging recognition that people with excessive sleepiness related to shift work or other factors face cardiovascular health risks that have been poorly addressed. "To me the most important part of this is putting it in the context of what has been published about the implications of sleepiness. What tends to fall off the list is that … people who do shift work [at night] are at higher risk for myocardial infarction and cardiac death," he said. "We view this data as forming the first layer of a foundation for a trial looking at whether treatment of sleep disorders can favorably affect cardiovascular risk factors." [Presentation title: Cardiovascular Profile of Modafinil. No abstract number.]

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