Medicines for older people: assessment and transparency at the European Medicines Agency regarding cardiovascular and antithrombotic medicinal products
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To describe whether for the cardiovascular and antithrombotic medicines approved in the period 2006-2016 (a) the pivotal trial was designed with an upper ageexclusion criterion, (b) the age distribution of the participants in the registration trials reflected expected use, (c) post-authorisation studies were planned, and d) the age distribution of participants was clearly presented in the approval documents.
The data provided to EMA in support of centralized marketing authorisations of were analysed.
Two out of 19 protocols excluded patients over 80 and 85 years old. In the heart failure, atrial fibrillation and antithrombotic drug registration trials, the proportion of patients aged 65–74 years was 33–50%, and 13–20% over 75 years. For antithrombotic drugs, it was 25–35% for the 65–74 age, and around 15% for the 75+ age. For statins and antihypertensives, it was 20–40% for the 65–74 age and 3–6% for 75+ age. Post-authorisation studies were planned in two cases. An improvement on the transparency of public data is apparent, although information is not always presented clearly and uniformly.
There is more publicly available information since 2006, but data on older patients with frailty and multimorbidity are generally scant. To address this, CHMP Geriatric Expert Group has currently published a Reflection paper on physical frailty to support subgroup categorisation of older patients beyond age with the aim of ensuring that clinical trial populations are representative of the users of the medicine.
KeywordsOlder people European Medicines Agency Marketing authorization Pharmacovigilance Transparency
Compliance with ethical standards
The views expressed in this article are the personal views of the author(s) and may not be understood or quoted as being made on behalf of or reflecting the position of the European Medicines Agency or one of its committees or working parties.
Conflict of interest
The authors declare that they have no conflict of interest. Andreia Padrão was working at the European Medicines Agency when the study was carried out.
This article does not contain any studies with human participants or animals performed by any of the authors.
For this type of study formal consent is not required.
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