Recommendations for FH address need for diversity, inclusion in FH clinical trials
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Racial/ethnic disparities are prevalent in today’s familial hypercholesterolemia research, and care and equitable representation is urgently needed, according to a perspective published in Circulation: Cardiovascular Quality and Outcomes.
The authors provided examples of this inequity and provided recommendations for the next steps for improving care in familial hypercholesterolemia (FH).
“In addition to recommendations for increasing representation of diverse patients in cardiovascular and hypercholesterolemia trials, a gap remains for those affected by FH, particularly nonwhite individuals who have been historically excluded from and exploited throughout biomedical research,” Reed Mszar, MPH, postgraduate associate in the department of chronic disease epidemiology at the Yale School of Public Health, and colleagues wrote. “Increasing a diverse representation of patients confers an array of equitable advancements in research and clinical practice, including the discovery of novel mechanisms for high LDL-C to aid in the development of personalized therapies.”
For this clinical perspective, Mszar and colleagues evaluated prior research in racial/ethnic disparities in the prevalence and treatment of FH; assessed diversity in FH clinical trials; and reported their recommendations to help mitigate inequities.
Evidence of inequity
According to a study that utilized 13 years of pooled data from National Health and Nutrition Examination Surveys to evaluate the incidence of FH using Dutch Lipid Clinic criteria, researchers estimated the prevalence to be 0.4%, or 1 in 250, of U.S. adults aged at least 20 years.
Among white individuals, a probable or definite diagnosis of FH was estimated at 0.4% (1 in 249), whereas among Black individuals, the estimate was 0.47% (1 in 211), 0.24% (1 in 414) among Mexican Americans and 0.29% (1 in 343) among other races/ethnicities.
In an analysis of 3,167 patients with FH enrolled in the CASCADE-FH study, researchers observed that Black (OR = 0.49; 95% CI, 0.32-0.74) and Asian (OR = 0.47; 95% CI, 0.24-0.94) patients with FH were less likely to achieve an LDL level below 100 mg/dL or a 50% or greater reduction in pretreatment LDL compared with non-Hispanic white patients. However, just 4.9% of CASCADE-FH participants identified as Hispanic, 8.2% identified as Black and 2.9% identified as Asian, Mszar and colleagues wrote.
“The authors of this particularly notable study suggest several potential mechanisms for the observed differences in LDL-C goal achievement, including variations in access to specialty lipid clinics, differences in socioeconomic status and comorbidity profiles, and inconsistent perceptions regarding LDL-C lowering goals,” Mszar and colleagues wrote.
Within a pediatric FH statin trial cohort, researchers observed that 92% of the children enrolled were white, “thus highlighting that current family history-based screening strategies may further increase disparities in nonwhite children,” the researchers wrote.
Another study demonstrated that a higher proportion of non-Hispanic Black individuals experienced unexplained autosomal dominant hypercholesterolemia compared with non-Hispanic white and Hispanic individuals, and the low frequency of LDLR mutations within this population may suggest an alternate mechanism for the expression of the FH phenotype among Black adults.
Moreover, in an analysis of approximately 160,000 patients who were prescribed a PCSK9 inhibitor, researchers found that historically underrepresented groups, women, individuals with less education and those with lower family incomes were less likely to have their prescription for a PCSK9 inhibitor approved by a payer compared with white men. Researchers also noted these individuals were less likely to fill their prescription.
As Healio previously reported, high-risk patients prescribed a PCSK9 inhibitor who rejected the therapy or abandoned their prescriptions experienced worse outcomes compared with those whose prescriptions were paid for and picked up.
Recommendations to mitigate inequity
The researchers offered the following recommendations to address the racial/ethnic gaps in access to FH research and care:
- Encourage registry-based research and funding that values diversity and inclusion.
- Build trust with those with FH through transparency and mutual respect for patients and their families.
- Improve diversity among research staff, health care providers and trainees.
- Ensure safety and support for patients with FH and while listening to barriers and concerns.
- Address implicit bias and racism in health care and clinical research through education.
“Current and future FH studies and registries should prioritize the meaningful evaluation of racial/ethnic differences in diagnosis, screening, treatment, and outcomes for individuals and families affected by FH,” the authors wrote. “Building trust with diverse members of the community, prioritizing funding sources and research initiatives dedicated to equity and inclusion, recognizing implicit bias and structural racism at the individual and institutional level, ensuring participant safety through transparency and a personal commitment to fostering diversity among clinical and research staff, and actively listening to the concerns of all participants and barriers to their registry or trial enrollment all represent key next steps in better understanding the burden experienced by underrepresented and underserved individuals with FH and working collectively to reconcile current disparities in research and care.”
References:
- Ahmad Z, et al. Circ Genom Precis Med. 2012;doi:10.1161/CIRCGENETICS.112.963587.
- Amrock SM, et al. Atherosclerosis. 2017;doi:10.1016/j.atherosclerosis.2017.10.006.
- De Ferranti SD, et al. Circulation. 2016;doi:10.1161/circulationaha.115.018791.
- Ethnicity and Disease prior archives. https://www.ethndis.org/edonline/index.php/ethndis/pages/view/priorarchives. Accessed Feb. 5, 2021.
- Myers KD, et al. Circ Cardiovasc Qual Outcomes. 2019;doi:10.1161/CIRCOUTCOMES.118.005404.
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