Stroke Clinical Trial
Official title:
Risk of Intracranial Hemorrhage in Users of Oral Antithrombotic Drugs: a Nationwide Study
The true incidence and risks of intracranial hemorrhage (ICH) in patients on various
antithrombotic treatments remain unknown. Here a nationwide study is conducted to investigate
the risk for and incidence rates of ICH in users and non-users of various oral antithrombotic
drugs in Norway between 2008 through 2014.
Hopefully, this study will contribute to a more responsible prescription pattern of
antithrombotic medications.
The most serious adverse effect of antithrombotic therapy is bleeding. Combinations of
antithrombotic agents are now frequently used (e.g. after use of drug eluting stents or after
ischemic stroke), and this may lead to an increased frequency of significant bleeding
complications. Among hemorrhagic complications of antithrombotic drugs, intracranial
hemorrhage (ICH) may have particularly devastating consequences with high morbidity,
disability and even mortality rates. Intracerebral hemorrhage (hemorrhagic stroke) is
generally associated with a higher risk for death and incurs greater loss of health over a
lifetime than ischemic stroke.
This makes antithrombotic therapy a double-edged sword. Although a certain risk for bleeding
may be acceptable in the context of even greater protection against ischemic events, it is
important to quantify the magnitude of bleeding risk. So far the efficacy and safety profile
of antithrombotic agents are generally assessed in randomized controlled trials (RCT).
However, extrapolating the results from randomized clinical trials to the general patient
population in this context is challenging. Patients who participate in clinical trials are
frequently highly selected and therefore somewhat unrepresentative. In addition, their
numbers are limited and the treatment period is often much shorter than in routine management
of a chronic disease or condition. Finally, patients in clinical trials are often monitored
more closely than in routine practice.
The incidence of intracranial hemorrhage due to antithrombotic therapy could theoretically be
monitored by post-marketing surveillance by including spontaneously reported events.
Unfortunately, it seems this does not provide more reliable estimates. A recent study from
Finland has shown that bleeding complications due to oral anticoagulation with Warfarin are
underreported in daily clinical practice. Further, it has been shown that reporting rates of
side effects following medical therapy tend to decrease over time indicating that it is more
likely that adverse events to a newer drug are reported than to a drug that has been
available for many years. This is why population-based large-scale pharmaco-epidemiological
studies are needed, in which cohorts of patients exposed to antithrombotic medications are
monitored to determine a valid and reliable risk of the treatment.
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