By Craig McIntosh
Staff writer
Low female participation in cardiovascular drug trials is holding back efforts to improve the diagnosis and treatment of cardiovascular disease, the leading cause of death among men and women worldwide, health experts say.
One in every three women die from cardiovascular disease, which affects the heart, brain and blood vessels, and the warning signs for female patients differ from those for men. Yet a systematic study of cardiovascular clinical trials between 2010 and 2017 found the overall percentage of women enrolled was just over 38 percent.
Participation was particularly low (just 26 percent) in trials where the average subject was 61 to 65 years old, despite the largest share of trials taking place in this age group.
‘As clinical trials provide evidence for more accurate diagnosis, treatment, and prevention, the low representation of women in trials means women around the globe are less likely to be diagnosed appropriately, receive preventive care or be treated aggressively for cardiovascular disease,’ said Xurui Jin, a master’s student in Duke Kunshan’s global health program and the paper’s lead author. ‘Our study is a loud reminder for physicians to be sensitive to sex differences in disease diagnosis, manifestation, treatment and prognosis.’
Jin and his research colleagues, including at Singapore’s National Health Centre, published their findings in Circulation, an American Heart Association journal.
The team analyzed 740 cardiovascular trials with 862,652 participants registered on ClincalTrials.gov and extracted information on disease type, sponsor type, country, trial size, intervention type and the demographic characteristics.
The results showed that, relative to their prevalence in the disease population, women are well represented in pulmonary hypertension and hypertension trials but largely still missing from stroke, arrhythmia, coronary heart disease and acute coronary syndrome trials, with the lowest participation in heart failure trials.
Reasons for the low representation include inadequate information for women available through consumer channels and from study investigators on the opportunities to participate in trials, a misperception among women on the risks and benefits involved in trials, and logistical issues such as transportation and childcare.
‘Women need to understand and be comfortable with the process and with the overall experience. Cultural background or biases, investigator communication and written materials can all influence patient comfort,’ said Lijing L. Yan, professor of global health and head of non-communicable disease research at Duke Kunshan’s Global Health Research Center, who was corresponding author.
There has been significant increases in the recruitment of women into stroke and heart failure trials in recent years. However, the research team recommended tailored, multifactorial approaches to build on this trend in target areas.
‘The hearts of men and women are wired differently,’ Jin said. ‘Important studies have highlighted sex differences in pathophysiology, clinical presentation and outcomes. Instead of dismissing these differences, let’s embrace them.’
He said adequate representation of women in clinical trials would allow physicians to tailor sex-specific preventative and therapeutic options based on evidence.
‘All of us have female figures in our lives whom we celebrate,’ Yan added. ‘It’s our responsibility to ensure their heart health is cared for.’
