Clinical Benefits of an Adherence Monitoring Program in the Management of Secondary Hyperparathyroidism with Cinacalcet: Results of a Prospective Randomized Controlled Study

Abstract

Background/Aims. One of the causes of uncontrolled secondary hyperparathyroidism (sHPT) is patient's poor drug adherence. We evaluated the clinical benefits of an integrated care approach on the control of sHPT by cinacalcet. Methods. Prospective, randomized, controlled, multicenter, open-label study. Fifty hemodialysis patients on a stable dose of cinacalcet were randomized to an integrated care approach (IC) or usual care approach (UC). In the IC group, cinacalcet adherence was monitored using an electronic system. Results were discussed with the patients in motivational interviews, and drug prescription adapted accordingly. In the UC group, drug adherence was monitored, but results were not available. Results. At six months, 84% of patients in the IC group achieved recommended iPTH targets versus 55% in the UC group (P = 0.04). The mean cinacalcet taking adherence improved by 10.8% in the IC group and declined by 5.3% in the UC group (P = 0.02). Concomitantly, the mean dose of cinacalcet was reduced by 7.2 mg/day in the IC group and increased by 6.4 mg/day in the UC group (P = 0.03). Conclusions. The use of a drug adherence monitoring program in the management of sHPT in hemodialysis patients receiving cinacalcet improves drug adherence and iPTH control and allows a reduction in the dose of cinacalcet.

Strategies to improve dietary, fluid, dialysis or medication adherence in patients with end stage kidney disease on dialysis: A systematic review and meta-analysis of randomized intervention trials

“…Four studies [8, 11, 24, 51] indicated that they were partly or fully supported by pharmaceutical sponsors, whereas 20 studies were funded by public organisations, including universities. No information on funding source was provided in twelve studies.…”

“…The lack of standardized methods to measure adherence in these domains, contributes to the reported variations in the rate of non-adherence, and the difficulty of precisely estimating the effectiveness of interventions to improve adherence [3, 5]. Methods of measuring adherence vary across studies and include indirect measures, such as self-reported adherence [6, 7]; direct measures such as pill counts or electronic medication event monitoring system (MEMS) [8], and attendance in dialysis sessions [9]; as well as surrogate measures such as inter-dialytic weight gain [10, 11] or biochemical parameters, which include phosphate and potassium levels [12, 13].…”

Adesão de portadores de doença renal crônica em hemodiálise ao tratamento estabelecido

“…The study showed that, after six months of follow-up, 84% of the patients submitted to the IC group achieved satisfactory parathormone levels, compared to 55% of the patients in the habitual care group. (11) At a conservative treatment outpatient clinic in the city of Rio de Janeiro, the need was noticed to advance in the patient approach strategies to improve their treatment adherence. A collective strategy was adopted, which consisted of a waiting room debate mediated by health professionals; and an individual strategy consisting of a CKD monitoring card inspired by the child monitoring care, making it easier to visualize the progression of the disease, in addition to other aspects of treatment.…”

Clinical Pharmacokinetics and Pharmacodynamics of Etelcalcetide, a Novel Calcimimetic for Treatment of Secondary Hyperparathyroidism in Patients With Chronic Kidney Disease on Hemodialysis

“…Cinacalcet is also a substrate and inhibitor of cytochrome P450 (CYP) isoenzymes and requires careful management of concomitant medications to avoid drug–drug interactions . Furthermore, high pill burden in CKD dialysis can increase the challenges of compliance with self‐administered drugs . There is a need for a calcimimetic given by a more convenient route of administration for patient adherence, without drug–drug interaction potential, and one that can sustain PTH‐lowering effects to enable less frequent dosing.…”