scholarly journals Interprofessional medication adherence programme for patients with diabetic kidney disease: a mixed randomized controlled and qualitative trial protocol (PANDIA-IRIS) (Preprint)

2020 ◽  
Author(s):  
Carole Bandiera ◽  
Jennifer Dotta-Celio ◽  
Isabella Locatelli ◽  
Dina Nobre ◽  
Grégoire Wuerzner ◽  
...  

BACKGROUND Despite effective treatments, more than 30% of diabetic patients will present with diabetic kidney disease (DKD) at some point. Patients with DKD are among the most complex as their care is multifactorial and involves different groups of health care providers. Suboptimal adherence to polypharmacy is frequent and contributes to poor outcomes. As self-management is one of the keys to clinical success, structured medication adherence programmes are crucial. The PANDIA-IRIS (« patients diabétiques et insuffisants rénaux: un programme interdisciplinaire de soutien à l’adhésion thérapeutique ») study is based on a routine medication adherence programme led by pharmacists. OBJECTIVE The aim of this study is to define the impact of the duration of this medication adherence programme on long-term adherence and the clinical outcomes in DKD patients. METHODS The monocentric adherence programme consists of short, repeated motivational interviews focused on patients’ medication behaviour combined with the use of electronic monitors (EM) that record each daily opening. In total, 72 patients are randomized 1:1 in two parallel arms; the adherence programme will last 6 months in the first arm versus 12 months in the second. After the intervention phases, patients continue using their EM for a total of 24 months, but without receiving feedback. EM and pill counts are used to assess medication adherence. Persistence and implementation will be described using Kaplan-Meier curves and generalized estimating equation (GEE) multimodelling respectively. The evolution of the ADVANCE and UKPDS clinical scores based on medication adherence will be analysed with GEE models. Patients’ satisfaction with the study will be assessed through qualitative interviews, which will be transcribed verbatim, coded and analysed for main themes. RESULTS The study was approved by the local ethics committee (Vaud, Switzerland) in November 2015. Since then, two amendments to the protocol have been approved in June 2017 and October 2019. Patients’ recruitment began in April 2016 and ended in October 2020. In total, 73 patients have been included. Data collection is ongoing, and data analysis is planned for 2022. CONCLUSIONS The PANDIA-IRIS study will provide crucial information about the impact of the medication adherence programme on adherence and clinical outcomes of patients with diabetic kidney disease. Monitoring medication adherence during the post-intervention phase is innovative and will shed light on the duration of the intervention on medication adherence. CLINICALTRIAL The study has been registered at clinicaltrials.gov (n°NCT04190251_PANDIA IRIS).

10.2196/25966 ◽  
2021 ◽  
Vol 10 (3) ◽  
pp. e25966
Author(s):  
Carole Bandiera ◽  
Jennifer Dotta-Celio ◽  
Isabella Locatelli ◽  
Dina Nobre ◽  
Grégoire Wuerzner ◽  
...  

Background Despite effective treatments, more than 30% of patients with diabetes will present with diabetic kidney disease (DKD) at some point. Patients with DKD are among the most complex as their care is multifactorial and involves different groups of health care providers. Suboptimal adherence to polypharmacy is frequent and contributes to poor outcomes. As self-management is one of the keys to clinical success, structured medication adherence programs are crucial. The PANDIA-IRIS (patients diabétiques et insuffisants rénaux: un programme interdisciplinaire de soutien à l’adhésion thérapeutique) study is based on a routine medication adherence program led by pharmacists. Objective The aim of this study is to define the impact of the duration of this medication adherence program on long-term adherence and clinical outcomes in patients with DKD. Methods This monocentric adherence program consists of short, repeated motivational interviews focused on patients’ medication behaviors combined with the use of electronic monitors containing patients’ medications. When patients open the electronic monitor cap to take their medication, the date and hour at each opening are registered. In total, 73 patients are randomized as 1:1 in 2 parallel groups; the adherence program will last 6 months in the first group versus 12 months in the second group. After the intervention phases, patients continue using their electronic monitors for a total of 24 months but without receiving feedback. Electronic monitors and pill counts are used to assess medication adherence. Persistence and implementation will be described using Kaplan-Meier curves and generalized estimating equation multimodeling, respectively. Longitudinal adherence will be presented as the product of persistence and implementation and modelized by generalized estimating equation multimodeling. The evolution of the ADVANCE (Action in Diabetes and Vascular disease: Preterax and Diamicron Modified-Release Controlled Evaluation) and UKPDS (United Kingdom Prospective Diabetes Study) clinical scores based on medication adherence will be analyzed with generalized estimating equation multimodeling. Patients’ satisfaction with this study will be assessed through qualitative interviews, which will be transcribed verbatim, coded, and analyzed for the main themes. Results This study was approved by the local ethics committee (Vaud, Switzerland) in November 2015. Since then, 2 amendments to the protocol have been approved in June 2017 and October 2019. Patients’ recruitment began in April 2016 and ended in October 2020. This study was introduced to all consecutive eligible patients (n=275). Among them, 73 accepted to participate (26.5%) and 202 (73.5%) refused. Data collection is ongoing and data analysis is planned for 2022. Conclusions The PANDIA-IRIS study will provide crucial information about the impact of the medication adherence program on the adherence and clinical outcomes of patients with DKD. Monitoring medication adherence during the postintervention phase is innovative and will shed light on the duration of the intervention on medication adherence. Trial Registration Clinicaltrials.gov NCT04190251_PANDIA IRIS; https://clinicaltrials.gov/ct2/show/NCT04190251 International Registered Report Identifier (IRRID) DERR1-10.2196/25966


Author(s):  
Frank Brosius, III ◽  
David Cherney ◽  
Patrick Gee ◽  
Raymond Harris ◽  
Alan Kliger ◽  
...  

Diabetes and its associated complications pose an immediate threat to humankind. Diabetic kidney disease (DKD) is one of the most devastating complications, increasing the risk of death more than 10-fold over that in the general population [1]. Until very recently, the only drugs proven and recommended to slow progression of DKD were angiotensin-converting enzyme (ACE) inhibitors and angiotensin II type 1 receptor blockers (ARBs), which act by inhibiting the renin-angiotensin system (RAS) [2]. Despite their efficacy as kidney and cardiovascular protective therapies and as antihypertensive agents, RAS inhibitors have been grossly underutilized [3]. Moreover, even when RAS inhibitors are used, patients still have a high residual risk of DKD progression [1, 2]. Finally, the kidney-protective effect of RAS inhibitors has been categorically demonstrated only in patients with macro-albuminuria included in the IDNT and RENAAL trials - not in other individuals [4]. The lack of new therapies to treat DKD over the past two decades has therefore represented a tremendous challenge for patients and health care providers alike. In recent years, a number of powerful new therapies have emerged that promise to transform care of patients with diabetes and kidney disease. The challenge to the community is to ensure rapid implementation of these treatments. This white paper highlights advances in treatment, opportunities for patients, challenges and possible solutions to advance kidney health and introduces the launch of the Diabetic Kidney Disease Collaborative at the American Society of Nephrology, to aid in accomplishing these goals.


2020 ◽  
Vol 9 (4) ◽  
pp. 947 ◽  
Author(s):  
José Luis Górriz ◽  
María José Soler ◽  
Juan F. Navarro-González ◽  
Clara García-Carro ◽  
María Jesús Puchades ◽  
...  

Type 2 diabetes mellitus (T2DM) represents the main cause of chronic kidney disease (CKD) and end-stage renal disease (ESKD), and diabetic kidney disease (DKD) is a major cause of morbidity and mortality in diabetes. Despite advances in the nephroprotective treatment of T2DM, DKD remains the most common complication, driving the need for renal replacement therapies (RRT) worldwide, and its incidence is increasing. Until recently, prevention of DKD progression was based around strict blood pressure (BP) control, using renin–angiotensin system blockers that simultaneously reduce BP and proteinuria, adequate glycemic control and control of cardiovascular risk factors. Glucagon-like peptide-1 receptor agonists (GLP-1RA) are a new class of anti-hyperglycemic drugs shown to improve cardiovascular and renal events in DKD. In this regard, GLP-1RA offer the potential for adequate glycemic control in multiple stages of DKD without an increased risk of hypoglycemia, preventing the onset of macroalbuminuria and slowing the decline of glomerular filtration rate (GFR) in diabetic patients, also bringing additional benefit in weight reduction, cardiovascular and other kidney outcomes. Results from ongoing trials are pending to assess the impact of GLP-1RA treatments on primary kidney endpoints in DKD.


2020 ◽  
Vol 245 (13) ◽  
pp. 1142-1154
Author(s):  
Liliany Souza de Brito Amaral ◽  
Cláudia Silva Souza ◽  
Hernando Nascimento Lima ◽  
Telma de Jesus Soares

Sedentary lifestyle is associated with increased incidence of diabetes mellitus, whereas exercise training improves metabolic control and therefore may contribute to prevention of various chronic complications. Diabetic kidney disease is the most common microvascular complication of diabetes mellitus, and is associated with increased mortality from cardiovascular disease in diabetic patients. The literature highlights oxidative stress, renal inflammation, and activation of the renin-angiotensin-aldosterone system as the main pathophysiological mechanisms underlying tissue damage, extracellular matrix accumulation, and renal function deficit. Unfortunately, although the benefits of exercise training on cardiovascular diseases are well established, their impact on the pathophysiological mechanisms involved in the development and progression of diabetic kidney disease is not well understood. In addition, standardization of experimental models and physical rehabilitation programs in diabetic kidney disease are scarce. In this article, we present a brief review of the pathogenesis and pathophysiological mechanisms of diabetic kidney disease,and bring to light the latest findings in the literature on the impact of exercise training on diabetic kidney disease progression. Impact statement Diabetic kidney disease (DKD) is associated with increased mortality in diabetic patients and has a negative impact on public health. The identification of potential therapies that help the management of DKD can contribute to the improvement of health and quality of life of patients. Thus, this paper is timely and relevant because, in addition to presenting a concise review of the pathogenesis and major pathophysiological mechanisms of DKD, it addresses the most recent findings on the impact of exercise training on this disease. Thus, since non-pharmacological interventions have gained increasing attention in the fight against chronic diseases, this paper appears as an important tool to increase knowledge and stimulate innovative research on the impact of exercise on kidney disease.


Diabetes ◽  
2019 ◽  
Vol 68 (Supplement 1) ◽  
pp. 539-P
Author(s):  
YOSHINORI KAKUTANI ◽  
MASANORI EMOTO ◽  
KATSUHITO MORI ◽  
YUKO YAMAZAKI ◽  
AKINOBU OCHI ◽  
...  

2021 ◽  
Vol 22 (11) ◽  
pp. 5808
Author(s):  
Annalisa Giandalia ◽  
Alfio Edoardo Giuffrida ◽  
Guido Gembillo ◽  
Domenico Cucinotta ◽  
Giovanni Squadrito ◽  
...  

Diabetic kidney disease (DKD) is one of the most serious complications of both type 1 (T1DM) and type 2 diabetes mellitus (T2DM). Current guidelines recommend a personalized approach in order to reduce the burden of DM and its complications. Recognizing sex and gender- differences in medicine is considered one of the first steps toward personalized medicine, but the gender issue in DM has been scarcely explored so far. Gender differences have been reported in the incidence and the prevalence of DKD, in its phenotypes and clinical manifestations, as well as in several risk factors, with a different impact in the two genders. Hormonal factors, especially estrogen loss, play a significant role in explaining these differences. Additionally, the impact of sex chromosomes as well as the influence of gene–sex interactions with several susceptibility genes for DKD have been investigated. In spite of the increasing evidence that sex and gender should be included in the evaluation of DKD, several open issues remain uncovered, including the potentially different effects of newly recommended drugs, such as SGLT2i and GLP1Ras. This narrative review explored current evidence on sex/gender differences in DKD, taking into account hormonal, genetic and clinical factors.


2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
Liliana Garneata ◽  
Carmen-Antonia Mocanu ◽  
Tudor Petrisor Simionescu ◽  
Andreea Elena Mocanu ◽  
Gabriel Mircescu

Abstract Background and Aims Dietary protein restriction is rediscussed as mainstay approach in advanced Chronic Kidney Disease (CKD), both in diabetics and non-diabetics to defer renal replacement therapy (RRT), mainly by better metabolic control; improvements in mineral bone disorders (MBD) were also suggested, but less studied in Diabetic Kidney Disease (DKD). An unicentric prospective interventional trial aimed to assess the effects of ketoanalogue-supplemented low protein diet (sLPD) on proteinuria and CKD progression (data already presented). The parameters of MBD were also evaluated. Method Adult diabetic patients (452) with stable CKD stage 4+, proteinuria>3g/g creatininuria and SGA A were enrolled in a run-in phase (3 mo), with LPD (0.6g/kg dry ideal bw). Those who proved adherent (92, 64% males, median age 55.7 yrs, 65% on insulin) received sLPD (Ketosteril®, 1 tablet/10kg) for 12mo. Monitoring and treatment followed the Best Practice Guidelines. The primary endpoint was proteinuria during intervention as compared to pre-enrolment. Serum levels of calcium, phosphates and iPTH were considered to assess MBD. Nutrition, inflammation (SGA, BMI, serum albumin, CRP) and compliance were safety parameters. Results In patients with advanced DKD and severe proteinuria, sLPD was associated with a 69 (63; 82) % reduction in proteinuria (data presented). Significant amelioration in MBD was noted: serum levels of calcium and phosphates were significantly ameliorated at the end of the study as compared to enrolment - 4.3 (4.2-4.9) vs 3.2 (3.1-3.5) mg/dL and 5.4 (4.9-6.1) vs 8.2 (7.8-8.9) mg/dL, respectively. Serum iPTH significantly decreased: 185 (168-212) vs 375 (354-585) pg/mL. The need for calcium supplementation decreased: 6.5 (6.0-6.7) vs 7.0 (6.8-7.3) g/day. Vitamin D was required by only 35% vs 65% of patients. Nutritional status was preserved and dietary compliance was very good throughout the study. Conclusion In patients with advanced DKD ketoanalogue supplemented low protein diet seems to be effective and safe as part of MBD management.


2021 ◽  
Vol 8 (2) ◽  
pp. 112-119
Author(s):  
Juju Raj Shrestha ◽  
Kashyap Dahal ◽  
Anil Baral ◽  
Rajani Hada

Introduction: Non diabetic kidney disease (NDKD), a treatable condition, is common in diabetic patients with atypical clinical presentations. Present study aimed to find out histopathological diagnosis of kidney disease in type 2 Diabetes mellitus with such presentations. Method: This was a hospital based cross sectional study conducted in Nephrology department, Bir hospital, Nepal from Aug 2019 to January 2021. Total 29 diabetic patients with atypical presentations, rapid rise of proteinuria alone (n=5), with microscopic hematuria (n=6), with impaired renal function (n=8) and rapid rise of creatinine with (n=8) or without (n=2) microscopic hematuria were included. The baseline information was recorded and kidney biopsy was performed. Result: The mean age of patients was 52.6±10.4 y and 22(75.9%) were male. Diabetic retinopathy (DR) was absent in 24(82.8%) patients. Presence of NDKD alone was in 6(20.7%) and superimposed on diabetic kidney disease (DKD) in 10(34.5%) with total NDKD in 16(55.2%) and isolated DKD in 13(44.8%) patients. Non diabetic kidney disease were glomerulonephritis 12(75%) with membranous nephropathy 4(25%) and IgA nephropathy 4(25%) patients. The significant difference between NDKD and isolated DKD was only the duration of diabetes < 5 y in 8(61.5%) of isolated DKD and ≥5 y in 13(81.2%) patients with NDKD (p=0.018). Diabetic retinopathy was absent in 6(100%) patients with isolated NDKD, 8(80%) of class III and 5(62.5%) of class IV DKD. Conclusion: Glomerulonephritis is the commonest NDKD in type 2 DM with atypical presentation and advance DKD (Class III & IV) is present even in absence of diabetic retinopathy and short duration of diabetes.


Molecules ◽  
2019 ◽  
Vol 24 (15) ◽  
pp. 2857 ◽  
Author(s):  
Sun ◽  
Wu ◽  
Cao ◽  
Zhu ◽  
Liu ◽  
...  

Diabetic kidney disease develops in approximately 40% of diabetic patients and is a major cause of chronic kidney diseases (CKD) and end stage kidney disease (ESKD) worldwide. Hydrogen sulfide (H2S), the third gasotransmitter after nitric oxide (NO) and carbon monoxide (CO), is synthesized in nearly all organs, including the kidney. Though studies on H2S regulation of renal physiology and pathophysiology are still in its infancy, emerging evidence shows that H2S production by renal cells is reduced under disease states and H2S donors ameliorate kidney injury. Specifically, aberrant H2S level is implicated in various renal pathological conditions including diabetic nephropathy. This review presents the roles of H2S in diabetic renal disease and the underlying mechanisms for the protective effects of H2S against diabetic renal damage. H2S may serve as fundamental strategies to treat diabetic kidney disease. These H2S treatment modalities include precursors for H2S synthesis, H2S donors, and natural plant-derived compounds. Despite accumulating evidence from experimental studies suggests the potential role of the H2S signaling pathway in the treatment of diabetic nephropathy, these results need further clinical translation. Expanding understanding of H2S in the kidney may be vital to translate H2S to be a novel therapy for diabetic renal disease.


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