BiDil (hydralazine/isosorbide dinitrate) / Azurity Pharma - LARVOL DELTA

Public Controversy and Community Voices: A Culture-Centered Examination of the Federal Drug Administration's Approval of BiDil from the Perspective of African American-Led Organizations. (PubMed, J Racial Ethn Health Disparities) - "These themes illustrate how HYD/ISDN's approval was both a symbol of racial progress and a point of contention, reinforcing debates about racialized medicine, affordability, and systemic bias in clinical research. The study concludes that while HYD/ISDN's promotional messaging helped raise awareness of racial health disparities, true health equity requires structural reforms in drug accessibility, research participation, and culturally centered care."

Journal • Cardiovascular • Congestive Heart Failure • Heart Failure

Is pharmacogenetics being racialized? An investigation into the reinscription of racial beliefs in modern biomedicine. (PubMed, Theor Med Bioeth) - "The heart failure drug BiDil, which was only approved for Black people in 2005, gained particular notoriety...In this paper, these racializations of pharmacogenetics are examined, explaining how they arise and how they are kept alive. Finally, this paper argues for better moderation of race in pharmacogenetic studies."

Biomarker • Journal • Cardiovascular • Congestive Heart Failure • Heart Failure

Comparison chart: Some drugs for HFrEF. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Cardiovascular • Congestive Heart Failure • Heart Failure

Drugs for chronic heart failure. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Cardiovascular • Congestive Heart Failure • Heart Failure

Enhancing Patient-Centricity in Cardiovascular Outcomes: Exploring Endpoint Strategies With Clinical Outcome Assessments (COA) in Approved Drugs for Chronic Heart Failure (ISPOR-EU 2024) - "This work highlights a convergence between HF clinical outcomes (mortality and functional capacity assessment) while in its recent guideline, FDA emphasizes on quality-of-life assessment, as well as the importance of ADL measurement , and supports the use of DHT, which is noteworthy."

Clinical • Clinical data • Cardiomyopathy • Cardiovascular • Congestive Heart Failure • Heart Failure

The Case Against Race-Based Quotas in Pharmaceutical Trials. (PubMed, Am J Law Med) - "It next examines the cautionary tale of BiDil, the first drug authorized by the U.S. Food and Drug Administration (FDA) for use in only Black people...In this way, rejecting these quotas is not in conflict with addressing health disparities; rather, it is beneficial to it. This Article will hopefully serve as a catalyst for future research regarding best practices on how pragmatic; legal; and diversity, equity, and inclusion considerations can synergistically exist."

Journal

"15/ Since the 1990's, the FDA has issued guidance pertaining to race/ethnicity in trials, & has even approved a race-specific drug (BiDil)." (@Willyintheworld)

FDA event

GRAHF-2: Genomic Response Analysis of Heart Failure Therapy in African Americans (clinicaltrials.gov) - P=N/A | N=225 | Completed | Sponsor: University of Pittsburgh | Active, not recruiting ➔ Completed | N=500 ➔ 225 | Trial completion date: Apr 2022 ➔ Sep 2022

Enrollment change • Trial completion • Trial completion date • Cardiovascular • Congestive Heart Failure • Heart Failure

DANHEART (H-HeFT and Met-HeFT) (clinicaltrials.gov) - P4 | N=1500 | Recruiting | Sponsor: Henrik Wiggers | Trial completion date: Sep 2023 ➔ Dec 2026 | Trial primary completion date: Mar 2023 ➔ Dec 2026

Trial completion date • Trial primary completion date • Cardiovascular • Congestive Heart Failure • Diabetes • Heart Failure • Metabolic Disorders

Revisiting Pharmacology Curricula with an Anti-racist Lens. (PubMed, FASEB J) - "Misrepresentation of race appeared in some parts of the pharmacology curriculum in the preclinical years as pharmacology textbooks consistently emphasize race-based biological differences. Revisiting the curriculum with an anti-racist lens helped to mitigate the racial bias and identify an opportunity to highlight the limitation and adverse consequences of using race in research and patient care. Our study revealed that there is an opportunity to integrate a holistic understanding of health disparities in the pharmacology curricula."

Journal

Cardiologists' Perspectives on BiDil and the Use of Race in Drug Prescribing. (PubMed, J Racial Ethn Health Disparities) - "The survey provides useful findings that, when viewed within the context of ongoing debates about race-based medicine, show little progress toward appropriately utilizing BiDil to maximize health outcomes, yet, might inform the development of practical and effective guidelines concerning the use of race in medicine."

Journal • Cardiovascular

GRAHF-2: Genomic Response Analysis of Heart Failure Therapy in African Americans (clinicaltrials.gov) - P=N/A; N=500; Active, not recruiting; Sponsor: University of Pittsburgh; Trial completion date: Aug 2021 ➔ Apr 2022

Trial completion date • Cardiovascular • Congestive Heart Failure • Heart Failure

GRAHF-2: Genomic Response Analysis of Heart Failure Therapy in African Americans (clinicaltrials.gov) - P=N/A; N=500; Active, not recruiting; Sponsor: University of Pittsburgh; Trial primary completion date: Apr 2021 ➔ Dec 2020

Trial primary completion date • Cardiovascular • Congestive Heart Failure • Heart Failure

Comparison chart: Some drugs for HFrEF. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Cardiovascular • Congestive Heart Failure • Heart Failure

Drugs for chronic heart failure. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Cardiovascular • Congestive Heart Failure • Heart Failure

Is there evidence for the racialization of pharmaceutical regulation? Systematic comparison of new drugs approved over five years in the USA and the EU. (PubMed, Soc Sci Med) - "The most emblematic example is the heart drug BiDil, approved by the US Food and Drug Administration in 2005 for "self-identified blacks." Previous social science research has explored this "racialization of pharmaceutical regulation" in the USA, and discussed its implications for the "pharmaceuticalization of race" in terms of reinforcing certain taxonomic schemes and conceptualizations...Our analysis also noted variability and inconsistency in the racial/ethnic taxonomy used in labels. We discuss implications for the racialization of pharmaceutical regulation and the pharmaceuticalization of race in the USA and EU."

Journal

Comparison table: Some drugs for HFrEF. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Cardiovascular • Congestive Heart Failure • Heart Failure

Vericiguat (Verquvo) for heart failure. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Cardiovascular • Congestive Heart Failure • Heart Failure

[VIRTUAL] Efficacy and safety of sacubitril/valsartan in African American patients with heart failure with reduced ejection fraction (ASHP 2020) - "Eligible patients were allocated into four groups based on being prescribed one of the following therapeutic regimens at discharge in addition to standard of care: 1) sacubitril/valsartan, 2) an ACE inhibitor (ACEi) or angiotensin receptor blocker (ARB), 3) sacubitril/valsartan with hydralazine/isosorbide dinitrate (H-ISDN), or 4) ACEi or ARB with H-ISDN. The primary outcome measure was a composite of CV mortality and HF hospitalization. Secondary outcomes includes CV mortality, HF hospitalization, all-cause mortality, new atrial fibrillation, renal function decline, change in EF, and change in NYHA classification."

Clinical • Atrial Fibrillation • Cardiovascular • Congestive Heart Failure • Heart Failure

[VIRTUAL] Change the management of patients with heart failure mirrored analysis at a texas community hospital (ASHP 2020) - "Only one patient was on isosorbide dinitrate/hydralazine. Based on the ACC/AHA Heart Failure guidelines, many HFrEF patients at HMW were not on optimized GDMT at the time of discharge. Fifty-nine HFrEF patients were found to be missing at least one heart failure medication that has been proven to decrease morbidity and mortality. An attempt to optimize GDMT (defined as increase/initiation of GDMT) was performed in forty nine patients during admission."

Clinical • Cardiovascular • Congestive Heart Failure • Heart Failure • Nephrology • Renal Disease

[VIRTUAL] Impact on guideline-directed medical therapy (GDMT) of a telehealth pharmacist-managed heart failure (HF) medication titration clinic (ASHP 2020) - "Clinical guidelines recommend titrating HF medications (ACEI/ARB/ARNI, beta-blocker, MRA, and hydralazine/isosorbide dinitrate) to target doses as this has been shown to decrease morbidity, mortality, and hospital readmissions in patients with heart failure with reduced ejection fraction (HFrEF). Patients will be evaluated either in person or via telehealth every 2 weeks until target dose or maximum tolerated dose is reached for GDMT. The data will be evaluated to determine the impact of the pharmacist in terms of time to target doses and/or 50% of target dose, number of patients who reached target doses and/or 50% of target dose, number of visits, compliance/no show to the appointment, change in EF on echocardiogram upon completion of titration, hospital admissions, and morbidity/mortality."

Cardiovascular • Congestive Heart Failure • Heart Failure

Nitrates in combination with hydralazine in cardiorenal syndrome: a randomized controlled proof-of-concept study. (PubMed, ESC Heart Fail) - "Our pilot study does not support the addition of H-ISDN on top of standard medical therapy to improve exercise capacity in patients with CRS."

Clinical • Combination therapy • Journal • Atrial Fibrillation • Cardiovascular • Congestive Heart Failure • Diabetes • Heart Failure • Hypertension • Hypotension • Metabolic Disorders • Nephrology • Renal Disease

The DANish randomized, double-blind, placebo controlled trial in patients with chronic HEART failure (DANHEART): A 2 x 2 factorial trial of hydralazine-isosorbide dinitrate in patients with chronic heart failure (H-HeFT) and metformin in patients with chronic heart failure and diabetes or prediabetes (met-HeFT). (PubMed, Am Heart J) - "The H-HeFT and Met-HeFT studies will yield new knowledge about the potential benefit and safety of two commonly prescribed drugs with limited randomized data in patients with HFrEF."

Clinical • Journal • Cardiovascular • Congestive Heart Failure • Heart Failure • Metabolic Disorders • Myocardial Infarction

[VIRTUAL] 04. Beyond Socioeconomic & Access To Care: The Clinical Imperative for Understanding Racial Heart Failure Differences and Disparities (Joint Session ABC) (HFSA 2020) - "Present the unique determinants and outcomes of HF in AA women, including PPCM, Adriamycin induced CMP Describe the unique genetic and biologic determinants of HF in African Americans, including DCM, amyloid, and the new data that documents the limited utilization of genetic screening in patients of color. Explain the poor underutilization of hydralazine-isosorbide dinitrate, and how this drug fits into the rapidly expanding landscape of novel therapies for HF (including ARNI, SGLT2i)"

Clinical • Cardiovascular • Congestive Heart Failure • Heart Failure

[VIRTUAL] Congestive Heart Failure Readmission And Guideline Based Therapy Rates Improvement At Safety Net Hospital Heart Health Center (HFSA 2020) - "Introduction: The 2017 HFSA co-sponsored guidelines on heart failure (HF) focus on developing strategies to lower readmission rates and increase adherence to guideline directed medical therapy (GDMT), specifically beta blockers (BB), ACE inhibitors and Angiotensin II receptor blockers (ACEi/ARB), spironolactone, Bidil or combined hydralazine/isosorbide dinitrate (Hydral/ISDN), and ARB with neprilysin inhibitor (ARNI). Among HF patients at a public safety net medical center at high risk for readmission, hospitalization under a primary cardiology care team in an integrated inpatient-outpatient HF service was associated with improvement in readmission outcomes and GMT adherence. This study has important implications for strategies for safety net hospitals and medical centers serving broader populations."

Clinical • Cardiovascular • Congestive Heart Failure • Heart Failure