African American patients have not been recorded in many drug safety trials.
Even though African Americans patients are reported to have high rates of type 2 diabetes in the United States, they have not been recorded in many drug safety trials.
Researchers from the William Sansum Diabetes Center in Santa Barbara, California explained in a recent study that the US Food and Drug Administration (FDA) mandated that new glucose lowering drugs have to be examined for cardiovascular safety, as treatment shift from standardized to individualized options. The investigators reviewed the published data from seven cardiovascular outcome trials prompted by the 2008 FDA mandate to determine if there are variations in the potential effects of these drugs on patients of varying racial and ethnic groups. The studies, which the researchers termed “mega trials,” included EXAMINE, EMPA-REG, SAVOR-TIM 53, ELIXA, TECOS, LEADER, and SUSTAIN-6.
Research shows that African Americans make up 12.6% of the US populations and their type 2 diabetes rate of 13.2% is almost twice that of white people (7.6%). The team added that mortality rates of cardiovascular disease are also higher among African Americans, meaning that the new therapies could be particularly beneficial for this population.
In five of the seven published studies that the researchers analyzed, the reported participation of black or African American people was less than 5%. The team also reported that race and ethnic descriptions was inconsistent among the trials. They explained only two of the seven trials collected demographic data as suggested by the US National Institutes of Health.
“As new drugs for type 2 diabetes become available, planners of cardiovascular outcome trials should ensure greater representation of minorities, in view of the potential for race to affect drug efficacy,” the study authors concluded. “Improving representation will require new strategies for enrolling participants from minority populations, especially black or African American individuals, to reflect the burden of type 2 diabetes in the USA.”
The researchers speculated that some of the reasons for this low participation could include challenges related to socioeconomic status, insufficient reliable transportation, poor health literacy, inadequate knowledge about the nature of medical research, and a historic fear of abuse.
Researchers surmised that if African Americans are excluded from future studies, they could be exposed to expensive therapies that may not work or could even cause harm. The article even went on to say that this isn’t a problem that exists only in diabetes research — blood pressure drugs and heart medicine drugs can also affect patients depending on race and ethnicity.
The study, titled “Minority underrepresentation in cardiovascular outcome trials for type 2 diabetes,” was published in The Lancet Diabetes & Endocrinology.