NPS Pharmaceuticals, Inc. (NASDAQ: NPSP), a biopharmaceutical company pioneering and delivering therapies that transform the lives of patients with rare diseases worldwide, yesterday presented initial findings from PARADOX, which is believed to be the largest and most comprehensive collection of research to date analyzing the burden of illness for hypoparathyroidism. Findings from 374 patients in PARADOX, which NPS conducted in partnership with the Mayo Clinic and the Hypoparathyroidism Association, reveal that patients with hypoparathyroidism experience an average of 16 of the 38 physical, emotional and cognitive symptoms cited, some of which were reported for the first time in this landmark assessment. Ninety-nine percent of patients with this rare, complex endocrine disorder experience multiple symptoms despite taking medications, such as calcium and vitamin D. Further, 69% of patients with hypoparathyroidism experience serious comorbid conditions, including heart arrhythmias and kidney stones. The findings were presented at ENDO 2013, The Endocrine Society’s 95th Annual Meeting in San Francisco, CA.
“PARADOX provides much-needed evidence to elucidate the burden of hypoparathyroidism and the clinical, social and economic impact of this rare endocrine disorder,” said Bart Clarke, MD, Associate Professor of Medicine at the Mayo Clinic in Rochester, MN and lead researcher for PARADOX. “Beyond the quantity, frequency, and pervasive nature of symptoms reported in PARADOX, what should not be overlooked is that these patients continued to be burdened by hypoparathyroidism despite attempts to manage the disorder through calcium and vitamin D supplementation. Hypoparathyroidism is the only classic endocrine disorder without an approved replacement therapy and these data reinforce the need for improved treatment options targeting the underlying cause of the disorder.”
Key findings from this analysis of PARADOX suggest that patients with hypoparathyroidism have a high burden of illness, as 99% continue to experience multiple symptoms despite the use of calcium and vitamin D supplements and other medications. On average, patients reported experiencing a collection of 16 of the 38 symptoms reported in the analysis. The most common physical symptoms reported included fatigue (82%), muscle pain or cramping (78%), paresthesia (76%), tetany (70%), and joint or bone pain (67%), and pain/heaviness/weakness in extremities (53%). Cognitive and emotional symptoms were also prevalent. Brain fog/mental lethargy (72%), inability to focus or concentrate (65%), and memory loss or forgetfulness (61%), and sleep disturbances (57%) were common, while anxiety (59%) and depression (53%) were also reported. The findings also showed that symptoms persist for an average of 13 hours over the course of a day.
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