Shifting Currents in Hyperkalemia Management 2015 in Review

Slides:

Advertisements

Similar presentations

A daily dose of 400 mg efavirenz (EFV) is non-inferior to the standard 600 mg dose: week 48 data from the ENCORE1 study, a randomised, double-blind, placebo.

Advertisements

CBER Isolagen Therapy (IT) BLA FDA Clinical Review Agnes Lim, MD Yao-Yao Zhu, MD, PhD DCEPT/OCTGT/CBER, FDA October 9, 2009 Advisory Committee Meeting.

Highlights of the Day II: SARCOMA “The not so Old and the New” Presented By Dennis Priebat at 2014 ASCO Annual Meeting.

Randomized Comparison of Ibrutinib Versus Ofatumumab in Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma: Results From the.

Mosby items and derived items © 2007 by Mosby, Inc., an affiliate of Elsevier Inc. Chapter 3 Adverse Reactions.

Question 1 (Hgb Target, Hemodialysis) Vote: yes/no. Based on the available data, primarily derived from the Normal Hematocrit study, should the ESA product.

Locatelli F et al. Proc ASH 2013;Abstract 4378.

SNDA Letrozole (Femara®) Indication: First-line therapy in post- menopausal women with advanced breast cancer. Prior approval: Second-line therapy.

DIVISION OF REPRODUCTIVE AND UROLOGIC PRODUCTS Clinical Trial Design Issues Phill Price MD.

Flow of Patients Through the Trial Nissen SE, et al. JAMA 2008;299:

Clinical Trials - PHASE II. Introduction  Important part of drug discovery process  Why important??  Therapeutic exploratory trial  First time in.

Patients’ Assignments,Values at Screening, and Baseline Efficacy and Safety Values - PartI JP Després, N Engl J Med 2005; 353:

Manufacturer: Relypsa Inc. FDA Approval Date: October 21, 2015

Drug Development Process Stages involved in Regulating Drugs

PATIROMER: A NEW POTASSIUM BINDING RESIN.

Copyright © 2015 by the American Osteopathic Association.

Statin Myopathy (AHA/ACC/NHLBI)

Novel Regimens and Considerations in Radionuclide Therapy for mCRPC

Prior Trials of RAAS Inhibitors

Intervista a Angelo Delmonte

Burden of Atrial Fibrillation The Percentage of Strokes Attributable to AF Increases With Age.

Emerging Concepts in Heart Failure

Current State of Hyperkalemia Management

Introduction: Alarming Statistics Causes of Death in Prevalent Dialysis Patients,

PCP Perspectives Pathophysiologic Principles in the Management of Hyperkalemia.

Hyperkalemia in the Hospital: Collaboration to Improve Transitions of Care.

Patient Presentation. Patient Presentation PRIMO Study Incidence of Muscle Adverse Effects.

New Therapies for Hyperkalemia Across the Continuum of Care

At The Cutting Edge of Developments in the Management of Hyperkalemia

Updates Abound in Hyperkalemia Management

Patient disposition for the double-blind study period.

A New Era for NOACs:.

The Safety and Efficacy of Full vs

Metastatic Renal Cell Carcinoma

Up to Date on Which NOAC for Which Patient

PCP Perspectives Clinical Considerations in Hyperkalemia

Phase 3 Treatment Naïve HIV Coinfection

Clinical Application of New CV Outcomes Data

Krop I et al. SABCS 2009;Abstract 5090.

Bergh J et al. SABCS 2009;Abstract 23.

Expert Perspectives on Hyperkalemia for the Specialist

Ombitasvir + Paritaprevir + Ritonavir +/- Ribavirin in HCV GT4 PEARL-I

Efficacy and Safety of Edoxaban in Patients With AF and HF

Exploring Emerging Treatments for Hyperkalemia

At The Cutting Edge of Developments in the Management of Hyperkalemia

Expert Insights on Complex Clinical Cases of Edema

Deborah J. Clegg, PhD, Michael Cody, MD, Biff F. Palmer, MD

Novel Approaches in T1D Management

Using Heart Rate as a Biomarker in Clinical Practice.

Multidisciplinary Management of Hyperkalemia:

Hyperkalemia in the Hospital

Phase 2b Treatment Naïve and Treatment Experienced

Case #1 Case #1 (cont) Case #1 (cont)

Efficacy and Safety of Elbasvir/Grazoprevir in Treatment-Naïve patients with Chronic HCV GT 1, GT 4 and GT 6 Infection (C-CORAL): A Phase III Randomized.

BAT for HFrEF Trial design: Patients with chronic systolic HF were randomized in a 1:1 fashion to either baroreceptor activation therapy (BAT) or control.

Shifting Currents in Hyperkalemia Management 2015 in Review

Statins, Obesity, and Hyperlipidemia

HARMONIZE Trial design: Patients with hyperkalemia (K ≥5.1 mEq/L) were randomized in a 1:1:1:1.7 fashion to receive sodium zirconium cyclosilicate (ZS)

Maximizing Organ Protection in Patients With CKD and Comorbidities on RAAS Therapy.

Assessing the Burden of Hyperkalemia

Breaking Down the Data in Hyperkalemia

Flow of Patients Through the Trial

Flow of Patients Through Trial

Assessing the Burden of Hyperkalemia

Real-World Evidence.

Clinical Comparisons.

Key Data on Improving Outcomes in HF Patients

Case-Based Look at Hyperkalemia Identification, Diagnosis, and Management.

Areas of Special Interest in PsO

Presentation transcript:

Shifting Currents in Hyperkalemia Management 2015 in Review

Program Goals

Hyperkalemia Is a Clinical Challenge

ZS-9 Mechanism of Action

OPAL-HK Phase 3 Pivotal Study Design

OPAL-HK Results Changes in Serum K+

OPAL-HK Pre-specified Analysis of Hyperkalemic Patients With HF

AMETHYST-DN Change in K+ from Baseline to Week 4

PEARL-HF Safety and Efficacy of Patiromer in HF Patients

PEARL-HF Study Findings

Patiromer Adverse Events*

Two Phase, Dose-Ranging Trial of ZS-9 Study Design

Two Phase, Dose-Ranging Trial of ZS-9 Findings

HARMONIZE Study Design

HARMONIZE Study Population Baseline Characteristics

HARMONIZE Open Label Phase (48 h) Results

HARMONIZE Randomized Withdrawal Phase