Cyclosporine/ketoconazole reduces treatment costs for nephrotic syndrome

Abstract

Cyclosporine A (CyA) is an effective agent for the treatment of glucocorticoid-dependent idiopathic nephrotic syndrome (GCDNS), but costs are prohibitive in resource-poor societies. The objectives of this study were to evaluate the efficacy and safety of reducing the dose of CyA by co-administering ketoconazole. A prospective study targeting children 2-18 years of age with GCDNS in remission with CyA monotherapy was conducted. CyA dose was reduced by 50% and ketoconazole was added at 25% of the recommended therapeutic dose, and the drug levels and therapeutic and adverse effects (AE) were monitored. Continued combined therapy after completion of the 4-week trial period was offered. Ten patients (median age 9.5 years, range 3.0-16.0 years) were enrolled in the study. At week 4, the CyA dose was 2.2 ± 0.7 mg/kg/day compared with 5.6 ± 0.9 mg/kg/day at enrolment (P < 0.0001). No AE were noted. All patients continued ketoconazole treatment for at least 3 months. CyA drug cost savings were 61%, and approximately 60% with ketoconazole cost included. The combination of an expensive immunosuppressive drug with a cheap metabolic inhibitor reduced the treatment costs by> 50% without increased adverse events or drug monitoring needs. This intervention demonstrates how access of patients with limited resources to needed drugs can be improved by interference with physiological drug elimination.

Management of focal segmental glomerulosclerosis in resource-limited regions

“…Successful strategies that have been used to decrease costs include adding an inexpensive drug like ketoconazole to inhibit the metabolism of cyclosporine. This has been shown to reduce the cost of treatment by more than 50% without increasing adverse events or the need for drug monitoring [19,20]. Guidelines have suggested the use of CP as an alternative to CNI as the first line in SRNS [8,13]; however, previous reports as well as the current study show lower rates of response compared to CNI [10,21,22].…”

The Expression Pattern and Regulatory Mechanism of the G0/G1 Switch Gene 2 (G0S2) in the Pathogenesis and Treatment of AChR Myasthenia Gravis (MG)

“…Immunosuppressors are the main treatment for MG, especially for those who suffered severe adverse effects of glucocorticoid. Previous studies provided evidence that CYA is effective as a monotherapy or in combination with glucocorticoid in MG [ 35 ]. However, cyclosporine A also showed serious side effects.…”

Drug- not carrier-dependent haematological and biochemical changes in a repeated dose study of cyclosporine encapsulated polyester nano- and micro-particles: Size does not matter

“…In addition, CsA alone or in combination with other immunosuppressant drugs is found to have benefit in diverse clinical conditions such as rheumatoid arthritis, psoriasis, traumatic brain injury or glucocorticoid-dependent idiopathic nephrotic syndrome (Gremese et al, 2004;Sullivan et al, 2011;Colombo et al, 2013;Iyengar et al, 2013;Mrowietz 2013). The side effects, however, of CsA such as nephrotoxicity and hypertension often outweigh its benefit.…”