Cinacalcet, a drug commonly given to patients with end stage kidney disease to help keep phosphorus and parathyroid blood levels within a target range, has few patient level clinical benefits and several adverse effects, suggesting that it should no longer be routinely prescribed, according to a study by international researchers published in this week's PLOS Medicine.
Cinacalcet, sold by Amgen under the name Seinspar in North America, has become the largest single drug cost for patients on dialysis in the United States, with an annual expenditure of at least $260 million. In the UK, prescribing costs for this drug increased by up to 33% from 2010 to 2011, with no improvement in the survival of these dialysis patients.
In an analysis led by Giovanni Strippoli, an academic at the University of Sydney in Australia and a senior medical and research executive at renal provider Diaverum (a provider of renal services), the researchers examined the clinical effects of cinacalcet in almost 7500 patients by combining the findings from previous randomized controlled trials. They found that compared to placebo or no treatment, cinacalcet had little or no effect on the risk of death by any cause in people in the final stage of chronic kidney disease and unclear effects on death by any cause in people in the less severe stages of disease. Cinacalcet also had uncertain effects on cardiovascular mortality and fracture prevention in patients with late stage disease. All these are the primary reasons why its use has been long suggested and why large-scale studies have been performed, the researchers said.
Now performed, these studies shown no survival advantage and the authors also found that cinacalcet had significant side effects such as increased risk of hypocalcemia, nausea, vomiting and diarrhea but reduced the risk of hypercalcemia and prevented the need for surgical parathyroidectomy in people with end-stage disease.
Overall, they concluded that on average, routinely treating 1,000 people with cinacalcet for one year has no effect on death, but might prevent three people from experiencing surgical parathyroidectomy and leads to approximately 60 and 150 people experiencing hypocalcemia and nausea, respectively.
"Cinacalcet therapy provides small reductions in the risk of surgical parathyroidectomy but has little or no effect on all-cause mortality and uncertain effects on cardiovascular death for people with chronic kidney disease and is commonly associated with nausea and vomiting," the authors said. "Routine use of cinacalcet therapy in people with chronic kidney disease does not appear warranted, and benefits may be limited to preventing parathyroidectomy in the small number of patients for whom surgery is contraindicated."