Substantiation |
Meerwaarde als andere behandeling faalt. Lagere Calcium waarden verbeteren overleving. Echter in Australië is cinecalcet van de mark gehaald ivm geen overlevingsvoordeel. EMA: 'In children, Mimpara was compared with placebo in a study involving 43 children aged 6 to 18 years with serious kidney disease. The main measure of effectiveness was the reduction of PTH levels by 30%. In this study, 55% (12 out of 22) children given Mimpara achieved a 30% reduction of PTH levels, compared with 19% (4 out of 21) children given placebo.' |