Boston, Mass. -- A clinical trial studying the use of Verapamil (a drug currently in use for cardiovascular disease and cluster headache) in alleviating chronic rhinosinusitis (CRS) with nasal polyps revealed significant improvement in the symptoms of this subset of patients. It is the first study of its kind to explore treatment for CRS by inhibiting P-glycoprotein, a protein pump within the nasal lining that Mass. Eye and Ear researchers previously identified as a mechanism for these severe cases of CRS marked by the presence of nasal polyps. The clinical trial results, published online today in the Journal of Allergy and Clinical Immunology: In Practice, suggest that Verapamil represents a promising novel therapy for the treatment of CRS with nasal polyps.
"Recently, we became aware that some of the inflammation in CRS with nasal polyps is generated by the nasal lining itself, when a particular protein pump (P-glycoprotein) is overexpressed and leads to the hyper-secretion of inflammatory cytokines," said senior author Benjamin S. Bleier, M.D., a sinus surgeon at Mass. Eye and Ear and an assistant professor of otolaryngology at Harvard Medical School. "Verapamil is a first-generation inhibitor that is well-established in blocking P-glycoprotein. In some patients with CRS with nasal polyps, we saw dramatic improvement in their symptom scores."
One of the more prevalent chronic illnesses in the United States, CRS has been known to cause significant quality of life detriments to affected patients, who often cannot breathe or sleep easily due to obstructed nasal and sinus passages. The presence of nasal polyps represents a particularly severe presentation of the disease. Current treatment strategies (most often long-term steroid use) are plagued by difficult side effects and fail to target an underlying source of the disease.
Motivated by their previous finding of the presence of P-glycoprotein overexpression in the nasal lining of patients with CRS with nasal polyps, the study authors conducted a randomized, double-blind, placebo-controlled clinical trial studying the use of low-dose Verapamil in 18 patients with CRS with nasal polyps. An analysis of these patients demonstrated improved outcomes for those in the Verapamil group in relation to those in the placebo group. However, the researchers also observed that the treatment effect was significantly limited among patients with higher body mass indices. Future studies are being planned to determine if a higher dose of Verapamil may be needed to be therapeutic for some patients.
"Chronic rhinosinusitis with nasal polyps is among our most challenging diagnoses to treat, because these patients essentially have chronic, lifelong inflammation that needs chronic, lifelong treatment," said Dr. Bleier. "We observed no significant side effects at the doses we used, and we are very encouraged by the results of this first step toward a more targeted therapy for our patients."
Authors on the JACI In Practice report include Dr. Bleier, first author Marcel M. Miyake, M.D., of Mass. Eye and Ear/Harvard Medical School and Santa Casa de Sao Paulo School of Medical Sciences, Angela Nocera, Patricia Levesque, Rong Guo, Christine A. Finn, Pharm.D., Jeremy Goldfarb, M.D., Stacey Gray, M.D., Eric Holbrook, M.D., and Nicolas Busaba, M.D., of Mass. Eye and Ear/Harvard Medical School and Jose Eduardo L. Dolci, M.D., of Santa Casa de Sao Paulo School of Medical Sciences.
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Mass. Eye and Ear clinicians and scientists are driven by a mission to find cures for blindness, deafness and diseases of the head and neck. Now united with Schepens Eye Research Institute, Mass. Eye and Ear is the world's largest vision and hearing research center, developing new treatments and cures through discovery and innovation. Mass. Eye and Ear is a Harvard Medical School teaching hospital and trains future medical leaders in ophthalmology and otolaryngology, through residency as well as clinical and research fellowships. Internationally acclaimed since its founding in 1824, Mass. Eye and Ear employs full-time, board-certified physicians who offer high-quality and affordable specialty care that ranges from the routine to the very complex. In the 2016--2017 "Best Hospitals Survey," U.S. News & World Report ranked Mass. Eye and Ear #1 in the nation for ear, nose and throat care and #1 in the Northeast for eye care. For more information about life-changing care and research, or to learn how you can help, please visit MassEyeAndEar.org.