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Advancing Brilaroxazine Research in Schizophrenia with Larry Ereshefsky, PharmD

Brilaroxazine at 50 mg and 15 shows promise in significantly reducing symptoms of 

, investigator Larry Ereshefsky, PharmD, the chief scientific officer at CenExcel Research and Follow the Molecule discussed the 

, and next steps for brilaroxazine research.

Reviva Pharmaceuticals assessed brilaroxazine, a serotonin-dopamine system modulator, in the phase 3 RECOVER trial led by Laxminarayan Bhag, PhD. Brilaroxazine targets D2/3/4 and 5-HT1A/2A receptors as a partial agonist and 5-HT2B/7 receptors as an antagonist. The drug controls inflammatory cytokines, which may serve as a disease driver.

Participants on brilaroxazine 50 mg achieved a 10.1-point reduction compared to placebo in the PANSS score (-23.9 vs -13.8

 < .001), as well as had improvements in positive, negative, and negative marder symptoms; PANSS social cognition, excitement or agitation, PSP, and CGI-S. Participants on brilaroxazine 15 mg had improvements on all endpoints compared to placebo.

Ereshefsky suggests brilaroxazine may not just be effective for treating symptoms of schizophrenia—he said the drug is “likely to be useful” in other psychiatric conditions, such as bipolar disorder and ADHD.

“Mechanistically, something is quite different here,” he said.

More than that, brilaroxazine may treat conditions in areas other than the psychiatric field. Since brilaroxazine controls areas of neuroinflammation and damage caused by inflammatory processes, the drug can potentially treat individuals with brain disease. Ereshefsky said because of brilaroxazine’s mechanism, investigators would like to assess brilaroxazine for pulmonary diseases, fibrosis, arterial hypertension, and psoriasis.

Ereshefsky explained the team needs to explore the link between brilaroxazine and weight gain. The phase 3 trial showed there were a weak association between brilaroxazine and weight gain, unlike the phase 2 trial, thus assessing this in a long-term study is important.

Ereshefsky said he is looking forward to working on the second phase 3 trial, and although he hopes the results will replicate RECOVER, clinical trials are always a challenge.

“You can't bet 100% on anything in psychiatry working, but this, I think, is a solid drug,” Ereshefsky said. “And it's going to be an important addition to the armamentarium, so I'm hoping to see this drug get to patients in the real world soon.”

There were no reported disclosures for Ereshefsky.

Derman, C. Phase 3 Data on Brilaroxazine for Schizophrenia with Larry Ereshefsky, PharmD. 

https://www.hcplive.com/view/phase-3-data-on-brilaroxazine-for-schizophrenia-with-larry-ereshefsky-pharmd

Derman, C. Larry Ereshefsky, PharmD: Brilaroxazine Improves Schizophrenia Symptoms. 

https://www.hcplive.com/view/larry-ereshefsky-pharmd-brilaroxazine-improves-schizophrenia-symptoms

Videos

In an interview, Larry Ereshefsky, PharmD, discussed other conditions brilaroxazine could potentially treat other than schizophrenia due to its mechanism.

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Abigail Brooks is an assistant editor for 

She joined MJH Life Sciences in August 2023 shortly after graduating from Monmouth University where she earned her BA in Communication with a concentration in Public Relations/Journalism and later an MA in Interactive Digital Media. She enjoys traveling, running, and reading books. She can be reached at abrooks@mjhlifesciences.com.

A new tool for predicting patients’ risk of kidney failure and all-cause death may offer a promising alternative to the current benchmark risk prediction model for 

, consistently outperforming the kidney failure risk equation in external testing.

The predictive algorithm and digital dashboard, known as KDpredict, was designed to simultaneously predict kidney failure and death over 1-5 year time horizons and support holistic decision-making for patients with moderate to severe CKD while addressing shortcomings of the kidney failure risk equation.

“We’ve been able to show that KDpredict is consistently more accurate in predicting the risks of kidney failure and death in adults with moderate-to-severe chronic kidney disease than the risk prediction model currently in use,” Pietro Ravani, MD, PhD, professor and clinician scientist in the department of medicine and institute of public health at the University of Calgary, said in a press release.

Acknowledging the shortcomings of the current kidney failure risk equation, investigators sought to build a tool to provide risk predictions for both kidney failure, accounting for the competing risk of death, and all-cause death in adults with newly documented moderate to severe CKD. Of note, the study proposes a strategy for prediction modeling to adapt to local settings rather than a one-size-fits-all model.

The multinational, longitudinal, population-based cohort study included individuals with newly recorded chronic kidney disease stage G3b-G4, defined as estimated glomerular filtration rate (eGFR) 15-44 mL/min/1.73 m2. Population-based health data were linked to form 3 cohorts in Alberta, Denmark, and Scotland, with the Alberta data used to train KDpredict and tested against data from Denmark and Scotland.

The super learner algorithm selected the best-performing regression models or machine learning algorithms based on their ability to predict kidney failure and mortality with minimized cross-validated prediction error based on the Brier score. Prespecified learners, including age, sex, eGFR, albuminuria, presence of diabetes, and cardiovascular disease, were ranked and combined in an ensemble or the learner with the lowest cross-validated prediction error was selected.

The index of prediction accuracy, a measure of calibration and discrimination calculated from the Brier score, was used to compare KDpredict with the kidney failure risk equation. Outcomes included all-cause death and kidney failure, defined as maintenance kidney replacement treatment or eGFR of 10 mL/min/1.73 m2 sustained for more than 90 days, whichever came first.

In total, 67,942 patients from Canada, 17,528 patients from Denmark, and 7740 patients from Scotland were included. Among the cohort, the median age was 77-80 years and the median eGFR was 39 mL/min/1.73 m2.

Median follow-up times were 5-6 years in all cohorts. Kidney failure rates ranged from 0.8-1.1 per 100 person-years and death rates ranged from 10-12 per 100 person-years. Investigators noted KDpredict was more accurate than the kidney failure risk equation in predicting kidney failure risk. Specifically, the 5-year index of prediction accuracy was 27.8% (95% CI, 25.2% to 30.6%) for KDpredict versus 18.1% (95% CI, 15.7% to 20.4%) for the kidney failure risk equation in Denmark and 30.5% (95% CI, 27.8% to 33.5%) for KDpredict versus 14.2% (95% CI, 12.0% to 16.5%) for the kidney failure risk equation in Scotland.

In hypothetical clinical scenarios, investigators pointed out predictions from the kidney failure risk equation and KDpredict differed substantially, potentially leading to diverging treatment decisions. In one example, an 80-year-old man with an eGFR of 30 mL/min/1.73 m2 and an albumin-to-creatinine ratio of 100 mg/g would receive a 5-year kidney failure risk prediction of 10% from the kidney failure risk equation but would receive a 5-year risk prediction of 2% for kidney failure and 57% for mortality from KDpredict.

Investigators also noted individual risk predictions from KDpredict were accurate for both outcomes with 4 or 6 variables. Additionally, models retrained using older data provided accurate predictions when tested in temporally distinct, more recent data.

Investigators highlighted several potential limitations to these findings, some of which include the use of data from 3 countries with predominantly White populations, the use of albuminuria measurements limited to albumin-to-creatinine ratio or protein-to-creatinine ratio in the external testing cohorts, the static nature of the prediction tool, and the need for testing in a randomized trial to validate its usefulness.

“KDpredict is unique in its ability to provide accurate predictions of risk for both clinical outcomes in adults with this severity of CKD at the point of first onset, when a timely discussion should occur,” investigators concluded.

 “By presenting risk predictions of both kidney failure and death, KDpredict supports patient-centered care and holistic decision making.”

Liu P, Sawhney S, Heide-Jørgensen U, et al. Predicting the risks of kidney failure and death in adults with moderate to severe chronic kidney disease: multinational, longitudinal, population based, cohort study. 

University of Calgary. UCalgary researchers can predict kidney failure more accurately. EurekAlert! April 23, 2024. Accessed April 26, 2024. 

https://www.eurekalert.org/news-releases/1042246

Articles

KDpredict uses age, sex, eGFR, and albuminuria to calculate 1-5 year risk of kidney failure and death in chronic kidney disease, outperforming the kidney failure risk equation.

Nephrology

The HCPLive nephrology page is a resource for medical news and expert insights on kidney disease. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments in nephrology, and more.

Chronic Kidney Disease

Digital Algorithm Outperforms Current Prediction Model for Kidney Failure, Death Risk in CKD

Lana Pine is the editor of HCPLive Rheumatology. She is an experienced editor and technical writer with a demonstrated history of working in the banking and publishing industries. In her free time, she enjoys cooking, yoga, listening to podcasts, and drawing. She can be reached via email at LPine@mjhlifesciences.com.

 care was linked to a higher uptake of and adherence to urate lowering therapy (ULT) compared with usual care, according to a study published in 

“Currently, gout management, particularly ULT, is often suboptimal,” wrote a team of investigators led by Claus Rasmussen, MD, associated with the Department of Rheumatology, North Denmark Regional Hospital in Hjorring, Denmark. “Nurses successfully manage various diseases including gout. As gout prevalence is rising, and rheumatologists and general practitioners face shortages, a new approach is imperative.”

Despite the established recommendations for ULT, less than half of patients are prescribed ULT and treatment adherence is generally poor. Further, the doses are often fixed without titration, which hinders a patient’s ability to obtain target plasma urate (p-urate) concentrations.

In the real-life prospective cohort study, investigators assessed the effectiveness of a nurse-led care program that used a treat-to-target strategy for the management of gout over a span of 2 years.

Patients with clinically confirmed gout diagnosed between June 2017 and June 2021 who were treated at the Clinic of Rheumatology in the North Denmark Regional Hospital were recruited into the study. The nurse-led management program provided a structured treatment plan including consultations, patient leaflets, laboratory monitoring, and telephone contacts. Patients were required to have had ≥ 1 visit or telephone call with the nurse-led clinic and nurses were given specialized training in gout management, with a focus on overcoming established barriers to treatment.

At the 1-year mark, patients were cared for in general practice for the remainder of the trial. The primary endpoint was obtaining target p-urate levels, defined as < .36 mmol/L, at 2 years. Other endpoints were treatment adherence and the achievement of target p-urate levels among specific subgroups. These results were compared with patients diagnosed with gout in the same clinic but receiving usual care.

A total of 114 patients with gout were recruited into the nurse-led group and 172 patients received usual care.

Among the nurse-led cohort, 82% (n = 92/112) achieved target p-urate levels and 98% continued treatment with ULT. Results were comparable among patient subgroups. Most (90%, n = 101/112) patients received allopurinol treatment with an average daily dosage of 308 mg. Conversely, only 44% (n = 63/144) of patients in the usual care group obtained target p-urate with insufficient doses of allopurinol (67%, n = 97/144), with a mean daily dosage of 235 mg. Additionally, fewer patients (73%) in this group continued ULT. The nurse-led care averaged 2 visits and 3 telephone calls over a 336-day period.

The overall mortality rate at the end of 2 years was 15%, with 4% (n = 4/114) in the nurse-led group compared with 23% (n = 39/172) in the usual care group (95% confidence interval [CI] .1547 [.04 — .43], 

Investigators mentioned limitations including selection bias and a lack of alternative comparison groups. However, by examining and comparing the nurse-led and usual care groups, they were able to obtain valuable insights regarding treatment efficacy and could better understand potential trends and associations that may impact future research and clinical practice.

“Our study demonstrates that a low-cost nurse-led gout clinic, primarily based on telephone interventions for 1 year, can be highly successful in achieving a clinically relevant reduction in p-urate levels,” investigators concluded. “This reduction significantly decreases the risk of disease progression, complications and potentially even mortality rates.”

Rasmussen C, Larsen JW, Christensen HM, et al. Optimising gout treatment: insights from a nurse-led cohort study. 

. 2024;10(2):e004179. Published 2024 Apr 24. doi:10.1136/rmdopen-2024-004179

Bavanendrakumar M, Robinson PC. Management of patients with gout and achievement of target serum Urate levels at a tertiary rheumatology service in Australia. Intern Med J 2020;50:337–41. doi:10.1111/imj.14445

Among the nurse-led cohort, 83% of patients with gout achieved target p-urate levels and 98% continued treatment with urate lowering therapy.

Gout

On the HCPLive gout page, resources on the topics of medical news and expert insight into gouty arthritis can be found. Content includes articles, interviews, videos, podcasts, and breaking news on gout, and more.

Nurse-Led Gout Care Linked to Better Medication Adherence 

Connor Iapoce is an associate editor for 

 and joined the MJH Life Sciences team in April 2021. He graduated from The College of New Jersey with a degree in Journalism and Professional Writing. He enjoys listening to records, going to concerts, and playing with his cat Squish. You can reach him at 

Credit: University of Alabama at Birmingham

 in two large clinical cohorts experienced elevated tricuspid regurgitation velocity (TRV), a surrogate marker for pulmonary hypertension, according to new research.

Evidence from the cross-sectional, multi-center study revealed pediatric patients with a history of chronic kidney disease (CKD) and cerebrovascular disease demonstrated a higher prevalence of abnormal TRV, suggesting the need for an echocardiogram in clinical assessment.

“Our findings suggest that adolescent patients may benefit from universal echocardiography performed at steady state if they have been identified with either cerebrovascular disease or albuminuria,” wrote the investigative team, led by Chibuzo Ilonze, MD, division of pediatric hematology and oncology, University of Alabama at Birmingham (UAB).

Determining those at risk for multi-organ disease progression can be crucial for initiating appropriate disease-modifying therapies in young patients with SCD.

 Clinical guidelines in SCD provide screening suggestions for the development of end-organ disease—however, the American Society of Hematology (ASH) and American Thoracic Society (ATS) have differing recommendations for screening echocardiogram for pulmonary hypertension.

The evidence-based ASH guideline suggests against screening echocardiograms in the absence of cardiopulmonary symptoms, abnormal cardiac examination, or history of pulmonary embolism.

 However, both guidelines admit elevated TRV is associated with early mortality in adults, suggesting more evidence is required to support or refute the role of echocardiograms as a screening tool for pediatric patients at risk of pulmonary hypertension.

For this analysis, Ilonze and colleagues sought to measure the associations between multi-organ dysfunction in children with SCD aged 1–21 years across two large sickle cell cohorts from 2012 to 2022.

 The team hypothesized children with SCD, and abnormal surrogate markers of pulmonary hypertension (≥2.5 m/s) would have increased odds of having either cerebrovascular disease or CKD.

Children were recruited from the UAB sickle cell cohort and the Sickle Cell Clinical Research and Intervention Program (SCCRIP) cohort at St. Jude Children’s Research Hospital. A total of 204 patients with SCD received care at the comprehensive sickle cell center at UAB and 166 participants were included for analysis. A total of 1,300 patients were identified in the SCCRIP cohort at St. Jude’s and 325 children completed ≥1 echocardiogram between 2009 - 2019.

These cohorts were combined for 491 children with an echocardiogram performed at a steady state. Together, the prevalence of elevated TRV was 21% (n = 104) in both the UAB and SCCRIP cohorts. The SCCRIP cohort was comparable to the UAB cohort in age, sex, and the prevalence of elevated TRV and persistent albuminuria, but the UAB cohort exhibited a higher statistical prevalence of cerebrovascular disease (55% vs. 42%; 

Among 104 participants with elevated TRV and cerebrovascular disease assessments, 61% had a history of cerebrovascular disease, correlating with higher odds of elevated TRV than those without history. After controlling for age, sex, SCD-modifying therapy, and site, elevated TRV was significantly associated with greater odds of cerebrovascular disease (odds ratio [OR], 1.88; 95% CI, 1.12 - 3.15; 

Among 88 individuals with elevated TRV and multiple albumin–creatinine ratio measurements, 36% demonstrated persistent albuminuria, suggesting higher odds of persistent albuminuria than those without elevated TRV. After controlling for age, sex, SCD-modifying therapy, and site, elevated TRV was associated with higher odds of persistent albuminuria (OR, 1.81; 95% CI, 1.07 - 3.06; 

Ilonze and colleagues indicated these findings provide evidence that children with a history of CKD and cerebrovascular disease exhibit a higher prevalence of abnormal TRV. They noted pediatric sickle cell providers may consider performing echocardiograms in children with these additional comorbidities.

“These data provide additional evidence needed to support future guideline statements for screening echocardiography,” they wrote.

 “Furthermore, we identified that elevated TRV is more prevalent in adolescent patients, which may reflect early signs of accumulated cardiovascular complications in older children.”

Ilonze C, Rai P, Galadanci N, et al. Association of elevated tricuspid regurgitation velocity with cerebrovascular and kidney disease in children with sickle cell disease. Pediatr Blood Cancer. Published online April 21, 2024. doi:10.1002/pbc.31002

DeBaun MR, Kirkham FJ. Central nervous system complications and management in sickle cell disease. 

. 2016;127(7):829-838. doi:10.1182/blood-2015-09-618579

Liem RI, Lanzkron S, D Coates T, et al. American Society of Hematology 2019 guidelines for sickle cell disease: cardiopulmonary and kidney disease [published correction appears in Blood Adv. 2023 Jul 25;7(14):3530]. 

. 2019;3(23):3867-3897. doi:10.1182/bloodadvances.2019000916

Klings ES, Machado RF, Barst RJ, et al. An official American Thoracic Society clinical practice guideline: diagnosis, risk stratification, and management of pulmonary hypertension of sickle cell disease. 

. 2014;189(6):727-740. doi:10.1164/rccm.201401-0065ST

A higher TRV was significantly associated with cerebrovascular disease and persistent albuminuria in children with SCD across two large cohorts.

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Hematology

Tricuspid Regurgitation Velocity Linked to Cerebrovascular, Kidney Disease in SCD

An automatic electronic health record (EHR)-based 

 register was proven to be a feasible and valid option for assessing and improving gout management, according to a study published in 

 During the analysis, investigators also noted a substantial under-reporting and underdiagnosis of the disease since the beginning of the COVID-19 pandemic.

Although guidelines for the management of gout and how to treat acute flares or chronic gouty arthritis are readily available, previous research has shown the disease remains undertreated. For example, a recent study reported only 30% — 50% of patients with gout are prescribed urate lowering therapy and fewer than half of these patients adhere to their medication.

“Despite the high prevalence of this disease, existing gout registers predominantly come from rheumatology settings which do not fully capture the disease’s spectrum,” wrote a team of investigators led by Nils Bürgisser, MD, associated with the Division of Rheumatology at Geneva University Hospitals (HUG) in Switzerland. “One of the barriers to create larger gout registers is their labor-intensive nature, requiring manual data collection by healthcare professionals. Furthermore, administrative datasets, a common source for research studies, often lack relevant clinical information such as laboratory data and specific patient-centered outcomes.”

The EHR collected information from all adult patients aged > 18 years from HUG, a French-speaking tertiary academic hospital, between January 2013 and December 2022. Gout diagnosis was based on 6 criteria: urate-lowering therapy prescription, monosodium urate crystals in joint aspiration, the International Classification of Diseases 10 (ICD 10) gout diagnosis, and gout-related terms in the problem lists, clinical reports, or imaging reports. The team evaluated the positive predictive value (PPV) and negative predictive value (NPV) of the query by the chart reviews.

Among a total of 2,110,902 patients, 10,289 exhibited ≥ 1 criteria for gout. A combination of joint aspiration or diagnostic in the problem list or ≥ 2 other criteria created a subcategory of 5138 patients. Of this register, 92.4% had a PPV (95% confidence interval [CI] 88.5% — 95.0%) and 94.3% had a NPV (95% CI 91.9% — 96.0%). The PPV and NPV were comparable among inpatients and outpatients.

The incidence was 2.9 per 1000 patient-years, which dropped by 30% at the beginning of the COVID-19 pandemic.

Patients with a gout diagnosis were predominantly male (76.5%), overweight (69.5%), had several comorbidities, and had an average age of 71.2 years. The most common comorbidities were hypertension (69.4%) and cardiovascular and ischemic disease (53.0%). Over half (57.4%) were prescribed a urate lowering therapy, 6.7% had either ≥ 2 flares within a year or were hospitalized due to gout, and 32.9% received a consultation from a rheumatologist.

Investigators noted selection bias as a main limitation of the study, which could also hinder generalizability. Additionally, the EHR could not evaluate any patients who consulted with clinicians in private clinics or practices and those who did not ultimately seek medical attention. However, HUG provides free care to the majority of the regional population, including inpatient and outpatient care to more vulnerable patients. Other important limitations were the use of a single hospital for the register, the possibility of misdiagnosis, and the chance that some patients with gout went undiagnosed due to missing information within the EHR.

“The automatic nature of the query makes this register inexpensive and sustainable, facilitating the assessment of the adequacy of gout management, the monitoring of indicators following quality improvement projects, and the detection of gout patients to be included in new studies or trials,” investigators summarized. “Also, the decline of gout diagnoses since 2020, especially evident in inpatient settings, prompts questions about how the pandemic may have affected healthcare access, patient behaviors and diagnostic approaches.”

Bürgisser N, Mongin D, Mehouachi S, et al. Development and validation of a self-updating gout register from electronic health records data. 

. 2024;10(2):e004120. Published 2024 Apr 24. doi:10.1136/rmdopen-2024-004120

Dehlin M, Jacobsson L, Roddy E. Global epidemiology of gout: prevalence, incidence, treatment patterns and risk factors. Nat Rev Rheumatol 2020;16:380–90. doi:10.1038/s41584-020-0441-1

The incidence of gout was 2.9 per 1000 patient-years, which dropped by 30% at the beginning of the COVID-19 pandemic. 

EHR-Based Gout Register May Improve Disease Management

Dermatologists Drs Tina Bhutani and Scott Boswell and patient Kanya Oul share resources and tools available to cope with generalized pustular psoriasis (GPP).

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Physician assistants TJ Chao and Kristine Kucera share their knowledge on which patients make good candidates for TYK2 inhibitors.

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Good Candidates for TYK2 Inhibitors

Coping With and Support for Generalized Pustular Psoriasis (GPP)

A patient and 2 dermatologists discuss the impact of generalized pustular psoriasis (GPP) on patient’s quality of life.

Impact of Generalized Pustular Psoriasis (GPP) on the Quality of Life

Tim Smith joined the MJH Life Sciences team as an assistant editor for HCPLive in August 2022. He graduated from UC Berkeley with a degree in political science, working in multimedia journalism as a staff writer prior to joining MJH. In his spare time, he enjoys reading, watching TV, listening to podcasts, and rock climbing. You can contact him at 

This discussion with Ohuabunwa was held at the ACP conference and covered inpatient geriatrics assessment tips for internal medicine physicians.


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Ugochi Ohuabunwa, MD: Tips for Inpatient Geriatric Management, Frailty Assessment

Larry Ereshefsky, PharmD, discussed the effects of brilaroxazine on inflammatory cytokines and neuroinflammation and how this can impact future schizophrenia treatment.

Larry Ereshefsky, PharmD: Brilaroxazine Improves Schizophrenia Symptoms

Areas with socioeconomic disadvantage often face concentrated poverty, poor walkability, and few healthcare facilities, creating challenges in eye care follow-up.

Diabetic Macular Edema

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Race, Neighborhood Influence Lapses in Diabetic Retinopathy Care 

Using a cut-off value of 7.1 kPA for liver stiffness, results of the transient elastography yielded 100% sensitivity and 68% specificity among this patient population. 

Psoriatic Arthritis

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Transient Elastography Deemed Reliable Method to Detect Liver Fibrosis in Patients with PsO Treated with MTX

Patrick Campbell is the managing editor of HCPLive. Formerly the editorial lead of Endocrinology Network, Practical Cardiology, and Rheumatology Network, Patrick has spent years spearheading coverage surrounding cardiometabolic health and rheumatic disease for MJH Life Sciences. He now helps to lead coverage in each of these respective areas for HCPLive. Before joining MJH Life Sciences in 2019, he spent time as a beat reporter with the Pocono Record in Stroudsburg, PA, and Star News Group in Manasquan, NJ. He also touts experience in multimedia, having spent time as a multimedia specialist with NJ Advance Media and multimedia coordinator at the Pocono Record. Follow him on Twitter @RealPatCampbell or reach him via email at PCampbell@mjhlifesciences.com.

Matthew Nudy, MD, discusses a trio of meta-analyses examining the effects of intensive blood pressure control on various targets. 

Hypertension

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Matthew Nudy, MD: Balancing the Benefits and Risk of Intensive Blood Pressure Control

Strategies designed to promote medication adherence were found in only 1 out of 3 websites. 

Latest News

Advancing Brilaroxazine Research in Schizophrenia with Larry Ereshefsky, PharmD

Digital Algorithm Outperforms Current Prediction Model for Kidney Failure, Death Risk in CKD

Nurse-Led Gout Care Linked to Better Medication Adherence

Tricuspid Regurgitation Velocity Linked to Cerebrovascular, Kidney Disease in SCD

EHR-Based Gout Register May Improve Disease Management