8 research outputs found
Monitoring Risk Factors and Improving Adherence to Therapy in Patients With Chronic Kidney Disease (Smit-CKD Project): Pilot Observational Study
Background: Chronic kidney disease is a major public health issue, with about 13% of the general adult population and 30%
of the elderly affected. Patients in the last stage of this disease have an almost uniquely high risk of death and cardiovascular
events, with reduced adherence to therapy representing an additional risk factor for cardiovascular morbidity and mortality.
Considering the increased penetration of mobile phones, a mobile app could educate patients to autonomously monitor cardiorenal
risk factors.
Objective: With this background in mind, we developed an integrated system of a server and app with the aim of improving
self-monitoring of cardiovascular and renal risk factors and adherence to therapy.
Methods: The software infrastructure for both the Smit-CKD server and Smit-CKD app was developed using standard
web-oriented development methodologies preferring open source tools when available. To make the Smit-CKD app suitable for
Android and iOS, platforms that allow the development of a multiplatform app starting from a single source code were used. The
integrated system was field tested with the help of 22 participants. User satisfaction and adherence to therapy were measured by
questionnaires specifically designed for this study; regular use of the app was measured using the daily reports available on the
platform.
Results: The Smit-CKD app allows the monitoring of cardiorenal risk factors, such as blood pressure, weight, and blood glucose.
Collected data are transmitted in real time to the referring general practitioner. In addition, special reminders improve adherence
to the medication regimen. Via the Smit-CKD server, general practitioners can monitor the clinical status of their patients and
their adherence to therapy. During the test phase, 73% (16/22) of subjects entered all the required data regularly and sent feedback
on drug intake. After 6 months of use, the percentage of regular intake of medications rose from 64% (14/22) to 82% (18/22).
Analysis of the evaluation questionnaires showed that both the app and server components were well accepted by the users.
Conclusions: Our study demonstrated that a simple mobile app, created to self-monitor modifiable cardiorenal risk factors and
adherence to therapy, is well tolerated by patients affected by chronic kidney disease. Further studies are required to clarify if
the use of this integrated system will have long-term effects on therapy adherence and if self-monitoring of risk factors will
improve clinical outcomes in this population
Absence of Interactions between Denosumab and Warfarin in Women with Osteoporosis
The monoclonal antibody denosumab reduces bone resorption. Warfarin is an oral anticoagulant used in the prevention and treatment of thrombosis. To date, there have been no studies on the interaction between warfarin and denosumab. The aim of the present study was to assess the maintenance of the Prothrombin Time International Normalized Ratio (INR) in the therapeutic range (TTR) in women under treatment with warfarin and denosumab, in order to evaluate the pharmacological interference of denosumab. No variations of the median TTR were found after undergoing treatment with denosumab: this shows that the intake of denosumab does not require additional checks in anticoagulated patients
Nocturnal hypoxemia, night-day arterial pressure changes and left ventricular geometry in dialysis patients
Nocturnal hypoxemia, night-day arterial pressure changes and left ventricular geometry in dialysis patients. It is well established that nocturnal hypoxemia in sleep apnea causes an inversion of the circadian arterial pressure rhythm and triggers nocturnal hypertension. Since sleep apnea is very frequent in dialysis patients, we hypothesized that nocturnal hypoxemia may be a factor that contributes to alter the 24-hour arterial pressure profile in these patients. To test the hypothesis 32 dialysis patients underwent 24-hour blood pressure (BP) monitoring and continuous monitoring of arterial O2 saturation during the night-time. Hemodialysis patients were studied during the non-dialysis day. All patients underwent an echocardiographic study. Thirteen patients had no episode of nocturnal hypoxemia (group I), 7 had at least one episode overnight but less than 2 episodes/hr (group II) and 12 had ≥ 2 episodes/hr (group III). The average daytime systolic pressure was similar in the three groups. However, the average nocturnal systolic pressure fell in the first group (-2.5 ± 4.2%) and rose in the second (+2.0 ± 3.6%) and in the third (+3.9 ± 2.2%) group (one way ANOVA, P < 0.005). The relative wall thickness of the left ventricle (RWT) was significantly (P < 0.05) higher in group III than in group I, and in the aggregate (N = 32) there was an inverse relationship between average nocturnal SaO2 and RWT (r=-0.43, P = 0.015). The proportion of patients with concentric remodeling or concentric hypertrophy was higher (P = 0.05) in the group with a more severe degree of nocturnal hypoxemia (group III, 8 of 12) than in the other two groups (group I, 3 of 13; group II, 2 of 7). Nocturnal hypoxemia is associated with the “non-dipping” arterial pressure profile in dialysis patients. Disturbed respiratory control during the night may represent an important cardiovascular risk factor in dialysis patients
Correction: Etelcalcetide in Patients on Hemodialysis with Severe Secondary Hyperparathyroidism. Multicenter Study in “Real Life”. J. Clin. Med. 2019, 8, 1066
The authors wish to make the following corrections to the previous publication [...
Etelcalcetide in Patients on Hemodialysis with Severe Secondary Hyperparathyroidism. Multicenter Study in “Real Life”
Abstract: Etelcalcetide is a new calcimimetic indicated for the treatment of secondary
hyperparathyroidism (SHPT) in dialysis patients. Etelcalcetide ecacy in SHPT has been ascertained
only in randomized controlled trials. This multicenter study was carried out in “real world” setting that
is dierent from randomized controlled trials (RCTs) to (1) evaluate the eectiveness of etelcalcetide in
SHPT, (2) to assess calcium, phosphorus, alkaline phosphatase changes, (3) to register gastrointestinal
side eects. Data were collected from twenty-three dialysis units with n = 1190 patients on the
charge. From this cohort, n = 168 (14%) patients were on treatment with etelcalcetide, and they were
evaluated for statistics. A median weekly dose of etelcalcetide was 15 mg (7.5–45 mg). Patients were
either naĂŻve (33%) or switched from cinacalcet to obtain better control of SHPT with reduced side
eects or pills burden. Serum parathyroid hormone (PTH) declined over time from a median value
of 636 pg/mL to 357 pg/mL. The median time for responders (intact PTH (iPTH) range: two to nine
times the upper normal limit) was 53 days; the percentage of responders increased (from baseline
27% to 63%) being similar in switched-patients and naĂŻve-patients. Few patients had symptomatic
hypocalcemia requiring etelcalcetide withdrawal (four cases (3%) at 30-day control, two cases (2%)
at 60-day, one case (1%) at 90-day control). Side eects with etelcalcetide were lower (3–4%) than
that registered during cinacalcet treatment (53%). Etelcalcetide is a new therapeutic option for SHPT
with low side eects and pills burden. Etelcalcetide may improve adherence to therapy, avoiding
unremitting SHP. It remains to be assessed whether etelcalcetide may reduce parathyroidectomy,
vascular calcification, or mortality. Being etelcalcetide very potent in suppressing PTH levels, even in
severe SHPT, future studies should evaluate the potential risk of more adynamic bone disease during
long-term therapy
Home Pulse Pressure Predicts Death and Cardiovascular Events in Peritoneal Dialysis Patients
Increased arterial hypertension represents a prevalent condition in peritoneal dialysis patients that is often related to volume expansion. Pulse pressure is a robust predictor of mortality in dialysis patients, but its association with mortality is unknown in peritoneal patients. We investigated the relationship between home pulse pressure and survival in 140 PD patients. During a mean follow-up of 35 months, 62 patients died, and 66 experienced the combined event death/CV events. In a crude COX regression analysis, a five-unit increase in HPP was associated with a 17% increase in the hazard ratio of mortality (HR: 1.17, 95% CI 1.08–1.26 p p = 0.001). Similar results were obtained considering the combined event death–CV events as an outcome. Home pulse pressure represents, in part, arterial stiffness, and it is strongly related to all-cause mortality in peritoneal patients. In these high cardiovascular risk populations, it is important to maintain optimal blood pressure control, but it is fundamental to consider all the other cardiovascular risk indicators, such as pulse pressure. Home pulse pressure measurement is easy and feasible and can add important information for the identification and management of high-risk patients
What can we learn from a statistically inconclusive trial? Consensus conference on the EVOLVE study results
The link between serum parathyroid hormone (iPTH) and cardiovascular (CVS) mortality has not been fully elucidated. The EVOLVE Study was designed to test whether a drug such as cinacalcet, aimed at lowering iPTH, could reduce the astonishingly high cardiovascular risk in patients on maintenance dialysis (CKD-5D). Accordingly, the primary outcome of the study was the combined endpoint of time to death or hospitalization due to CVS factors or from any cause. Time to bone fracture and parathyroidectomy were regarded as secondary endpoints. At study completion, the Intention-To-Treat analysis documented a non- significant 7% (Hazard Ratio: 0.93; 95% Confidence interval: 0.85-1.02; P = 0.11) reduction of the primary composite endpoint. However, the intention to treat analysis does not take into account adherence to drug regimens or control for factors that may potentially jeopardize the conduction of the study. In particular, in spite of a careful pre-planned study sample calculation, the final power of the EVOLVE study was 54% instead of the assumed 90%, greatly reducing the reliability of study results. Furthermore, the pre-planned multivariable adjustment of the primary endpoint suggests a nominally significant reduction of the risk of the primary composite endpoint when age is entered into the statistical model. The sensitivity analysis further corroborates this result. The Lag Time Censoring Analysis (LTCA) evidenced a nominally significant 15% risk reduction of the composite endpoint among patients allocated to cinacalcet if the patients follow-up was terminated 6 months after the study drug discontinuation, as pre-planned in the protocol. It is interesting that the LTCA suggests that the effect of cinacalcet weakened over time and became insignificant after about 1 year from drug discontinuation. Although authors could not detect any effect of cinacalcet on bone fracture associated with cinacalcet use, the secondary analyses of the EVOLVE trial suggest a nominally significant 60-70% risk reduction of parathyroidectomy and a reassuring safety profile of prolonged exposure to cinacalcet. In summary, the EVOLVE study adds to the list of inconclusive randomized clinical trials in Nephrology. However, the preplanned exploratory and sensitivity analyses suggest that when imbalances of patients characteristics at study entry (i.e. age) or study drug discontinuation are considered, a 'nominally' significant risk reduction in CVS and parathyroidectomy associated with cinacalcet treatment is noted