31 Jan IV Etelcalcetide (Parsibiv®) Can Treat Elevated PTH in Dialysis Patients More Effectively Than Oral Medication
MedicalResearch.com Interview with:
Dr. Geoffrey Block
Geoffrey A. Block, MD
Director of Research at Denver Nephrology
Denver, Colorado
MedicalResearch.com: What is the background for this study?
Response: Secondary hyperparathyroidism is a chronic and progressive disorder characterized by elevations in parathyroid hormone (PTH). It is seen in most patients with advanced chronic kidney disease and has been associated with a number of important adverse health effects such as bone pain, fracture, premature cardiovascular disease, abnormal heart enlargement, pathologic calcium accumulation in blood vessels and tissues and premature death.
Currently there are several classes of drugs used to treat high PTH but each are associated with challenging side effects which limit their effectiveness. Active vitamin D compounds are effective in lowering PTH but do so at the expense of causing elevations in other minerals such as calcium and phosphorus which are felt to be harmful.
An oral drug known as cinacalcet (Sensipar®) is in the class of medicine known as ‘calcimimetics’ and reduces PTH and simultaneously reduces calcium and phosphorus however it must be taken daily due to its short half-life and is commonly associated with nausea when first initiated or the dose is increased. Clinical trials with cinacalcet are suggestive though not conclusive of a beneficial effect on improving cardiovascular events and prolonging life.
MedicalResearch.com: What are the main findings?
Response: Etelcalcetide (Parsibiv®) is in the same class of medicine as cinacalcet but was developed to be given intravenously and due to its metabolic profile can be administered only three times per week to patients on hemodialysis who have high PTH. In these 2 manuscripts we report the results of 3 randomized clinical trials which demonstrate that etelcalcetide was more effective than either placebo or cinacalcet in reducing PTH and in simultaneously reducing calcium and phosphorus in patients already receiving standard therapy. In addition, etelcalcetide had a significant effect to lower blood markers of abnormal bone turnover (common in patients with high PTH) and to lower a hormone known as FGF23, high levels of which are felt to be harmful to the heart.
Etelcalcetide, as expected, was associated with reductions in blood calcium levels and while symptoms related to this finding were uncommon, close attention and monitoring of blood calcium is mandatory when using etelcalcetide. In the placebo controlled randomized trials (approximately 500 patients), etelcalcetide was associated with nausea in 9-12% of patients while in the trial using cinacalcet (approximately 370 patients)as a comparison this side effect was seen in 18% of etelcalcetide treated patients and 22% of cinacalcet treated patients, a finding which was no different between the two groups.
MedicalResearch.com: What should readers take away from your report?
Response: Etelcalcetide is a new intravenously administered medicine for the treatment of high PTH in patients on hemodialysis which has been shown to be more effective than standard therapy and more effective than cinacalcet in head to head trials.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: Previous randomized controlled trials with cinacalcet strongly suggest, but are not conclusive, that this class of medicine is associated with important cardiovascular benefit and may extend life. It will be essential to assess whether etelcalcetide, by overcoming many of the disadvantages of cinacalcet, is able to show conclusive evidence of benefit to improve patient outcomes.
MedicalResearch.com: Is there anything else you would like to add?
Response: I’d like to disclose that both the senior author, Dr. Glenn Chertow, and I have received consulting and advisory fees from Amgen for helping lead the Global Development program for this new medicine.
MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.
Citations:
Note: Content is Not intended as medical advice. Please consult your health care provider regarding your specific medical condition and questions.
More Medical Research Interviews on MedicalResearch.com
[wysija_form id=”5″]
Last Updated on January 31, 2017 by Marie Benz MD FAAD