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Exclusion of older patients prevalent among trials testing HF treatments
Cherubini A. Arch Intern Med. 2011;171:550-556.
Gurwitz J. Arch Intern Med. 2011;171:557-558.
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More than one-quarter of clinical trials that investigated treatment for HF excluded patients with an upper age limit, despite recommendations issued by national and international regulatory agencies against the practice.
The new study appearing in the Archives of Internal Medicine also found that upper age restrictions were significantly more common in the European Union than the United States.
To generate these data, Antonio Cherubini, MD, PhD, and colleagues scrutinized ongoing clinical trials regarding HF registered in the WHO database. Trials were excluded if they were observational in design; did not have HF as the main target condition; did not propose any treatment; involved children; or were registered twice. The final analysis included 251 trials.
Overall, 64 trials (25.5%) excluded patients by what researchers termed an “arbitrary upper age limit,” which varied between 65 and 95 years of age (median age, 80 years). They also found that 109 trials (43.4%) had poorly justified exclusion criteria that may negatively affect inclusion of older individuals in HF trials.
Compared with the trials conducted in the United States, those performed in the European Union more often excluded older patients (32.3% vs. 16.2%; P=.007). Upper age restrictions were also more common in trials sponsored by public institutions vs. private entities (35.6% vs. 13.9%; P=.02).
“Despite the recommendations offered by the Helsinki Declaration of the World Medical Association and by several national and international regulatory agencies … and the best efforts of physicians caring for older patients, the exclusion of older individuals in clinical trials regarding HF continues to be widespread in pharmacologic and nonpharmacologic trials currently ongoing,” Cherubini and colleagues wrote. “To improve care of elderly patients, more older individuals need to be included in clinical trials investigating conditions of relevance to members of this fast-growing age group.”
In an accompanying editorial, Jerry H. Gurwitz, MD, and Robert J. Goldberg, PhD, with the Meyers Primary Care Institute, Worcester, Mass., said the guidelines have been ineffective in enhancing the participation of older individuals in clinical trials. As a way to improve the evidence base to guide the care of older patients with CVD, they proposed a multifaceted approach. The four initial steps include:
- Eliminating arbitrary age-based exclusions in CV clinical trials.
- Requiring strong justification for exclusion criteria that could adversely affect the inclusion of older individuals, including those criteria relating to comorbidity, medication use, and functional and cognitive impairment.
- Encouraging the design and conduct of randomized controlled trials specific to older individuals through targeted funding.
- Reporting and publicizing trends in the inclusion of elderly patients in CV clinical trials to assess progress in improving the generalizability of research findings to this high-risk population.
Disclosure: Drs. Gurwitz and Goldberg reported no relevant financial disclosures.
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