Cinacalcet – Clinical and Laboratory Effectiveness, Concomitant Treatment Patterns and Treatment Cost: Could We Do Better and How?

Abstract

Background: The cost and effectiveness patterns in the treatment of secondary hyperparathyroidism (SHPT) in dialysis patients in the Czech Republic are unknown. Methods: 52 dialysis patients from 17 centers were followed up in a multicenter prospective study of laboratory and clinical (hospitalization rate, clinical complaints questionnaire) responses to 12-month cinacalcet treatment. Treatment patterns and cost (including phosphate binders, vitamin D, and cinacalcet) were evaluated. Results: The mean s-Ca dropped significantly from 2.36 ± 0.24 to 2.21 ± 0.20 mmol/l, s-P from 2.45 ± 0.54 to 2.01 ± 0.53 mmol/l, Ca×P from 5.79 ± 1.25 to 4.42 ± 1.13 mmol²/l², and iPTH dropped from 919.0 ± 465.6 to 372.1 ± 294.6 pg/ml. The mean cinacalcet dose reached 44.1 ± 23.0 mg/day after 12 months. Itching intensity decreased significantly. No change in hospitalization rate was observed. The direct cost of daily SHPT treatment rose significantly from EUR 8.77 ± 9.59 to 20.62 ± 9.22. Conclusions: Cinacalcet decreased elevated s-Ca, s-P, Ca×P, and iPTH, alleviated itching, and significantly raised the SHPT treatment cost. A minority of patients reached K/DOQI targets, especially due to poor phosphate control caused by insufficient phosphate binder treatment, cinacalcet underdosing, and advanced SHPT.

Evaluating Real-World Use of Cinacalcet and Biochemical Response to Therapy in US Hemodialysis Patients

“…After its approval, uptake of cinacalcet by the nephrology community was rapid [11]. However, there is a paucity of data evaluating real-world use and effectiveness of cinacalcet; existing reports provide only descriptive characterizations in mostly small patient samples [12,13,14]. Factors that predict cinacalcet initiation as well as dose titrations and discontinuation among patients who initiate therapy are largely unknown.…”

“…While cinacalcet has been shown in clinical trials to reduce PTH, serum calcium, and phosphorus concentrations in end-stage renal disease (ESRD) patients with SHPT [15,16,17], little available data show the degree of laboratory changes that occur under usual clinical care [12,13,14], the presumed mechanism by which some or all clinical benefit is mediated. Notable among these studies was the pan-European ECHO study (n = 1,865), which detailed achievement of biochemical targets in patients initiated on cinacalcet [14].…”

“…Notable among these studies was the pan-European ECHO study (n = 1,865), which detailed achievement of biochemical targets in patients initiated on cinacalcet [14]. Two other small (n < 75) non-US observational studies also described biochemical change; one of these reported predictors of reduced response, which included high baseline PTH and higher sevelamer doses [12,13]. Understanding the association between biochemical effects of therapy and clinical benefit is important.…”

The Efficacy of Cinacalcet in the Treatment of Hyperparathyroidism in Turkish Hemodialysis Patient Population

“…In many observational and randomized controlled trials, cinacalcet has been shown to be effective in reducing serum PTH, Ca, P and Ca x P levels (8)(9)(10)(11)(12)(13)(14)(15)(16)(17)(18). However, there are some studies suggesting that cinacalcet treatment is less effective than it seems for reducing PTH levels and also has a high cost (19). We observed that effectiveness and compliance of cinacalcet was low during the follow-up period in our patients and we recognized that there is no data on this subject in the other centers of our country.…”

Changes of Serum Total and Free Testosterone Concentrations in Male Chronic Hemodialysis Patients with Secondary Hyperparathyroidism in Response to Cinacalcet Treatment

“…Cinacalcet was introduced in the year 2004 and has been proven to be effective in the treatment of secondary hyperparathyroidism [15,16] and other morbidities e.g. calciphylaxis [17].…”