Drug products: Renagel, Renagel®, Renvela, Sevelamer 2care4, Sevelamer carbonate Winthrop, Sevelamer Ebb, Sevelamer Mylan, Sevelamer Sandoz, Sevelamer Teva
ATC code: V03AE02
Substances: sevelamer, sevelamer carbonate, sevelamer hydrochloride
Analysis of clinically relevant differences in effect is lacking and does not motivate differentiation in dosing or treatment. Cardiovascular safety seems to be similar in men and women.
The incidence of end-stage renal disease (ESRD) is lower among women than men . Serum phosphorus levels in women with and without chronic kidney disease were demonstrated to be significantly higher than in men . There are sex-related differences in phosphorus homeostasis theoretically impacting the needs of treatment differently in men and women . For example, estrogen was shown to increase phosphorus excretion and estrogen replacement therapy in postmenopausal women is associated with lower phosphorus levels .
Data from the Dialysis Outcomes and Practice Patterns Study have demonstrated that use of phosphate binders is an independent predictor of improved survival among women on hemodialysis .
Oral administration of sevelamer did not lead to systemic absorption in any of 20 healthy subjects (5 women and 5 men 19-40 years, 5 men and 5 women >65 years) . No studies with a clinically relevant sex analysis regarding the dosing of sevelamer have been found.
No published studies with a clinically relevant sex analysis regarding the effects of sevelamer have been found.
There was no difference in proportion of men and women with adverse experiences in analysis of data for the pooled safety population of 384 patients in controlled and uncontrolled clinical trials of sevelamer .A case-control study in patients on hemodialysis treated with sevelamer (in total 152 men and women, approximately 2/3 women) suggests higher rates of first hospitalization in men .Subgroup analysis of an observational cohort study (1184 men, 1455 women) of patients ≥65 years of age and requiring hemodialysis (in total 2639 men and women) report similar cardiovascular safety of sevelamer in men and women .
There is no human data available on the effects of sevelamer on fertility in women and men. Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan).
Use of sevelamer in women with diabetes type II and diabetic kidney disease has been reported to lead to reduction of HbA1c. This effect was not observed in the overall population .
Higher levels of iPTH (intact parathyroid hormone) is seen in women . Reduction in iPTH levels was a primary efficacy objective in the clinical studies reported in NDA review for sevelamer , however no differences in men and women were discussed.
Date of litterature search: 2019-05-23
Reviewed by: Mia von Euler
Approved by: Karin Schenck-Gustafsson