چکیده (انگلیسی):

Background:Elderly patients are particularly vulnerable to adverse drug reactions, especially if they are affected by
additional risk factors such as multimorbidity, polypharmacy, impaired renal function and intake of drugs with high
risk potential. Apart from these clinical parameters, drug safety and efficacy can be influenced by pharmacogenetic
factors. Evidence-based recommendations concerning drug-gene-combinations have been issued by international
consortia and in drug labels. However, clinical benefit of providing information on individual patient factors in a
comprehensive risk assessment aiming to reduce the occurrence and severity of adverse drug reactions is not
evident. Purpose of this randomized controlled trial is to compare the effect of a concise individual risk information
leaflet with standard information on risk factors for side effects.
Methods/Design:The trial was designed as a prospective, two-arm, randomized, controlled, multicenter, pragmatic
study. 960 elderly, multimorbid outpatients in general medicine are included if they take at least one high risk and
one other long-term drug (polymedication). As high risk“index drugs” oral anticoagulants and antiplatelets were
chosen because of their specific, objectively assessable side effects. Following randomization, test group patients
receive an individualized risk assessment leaflet evaluating their personal data concerning bleeding- and
thromboembolic-risk-scores, potential drug-drug-interactions, age, renal function and pharmacogenetic factors.
Control group patients obtain a standardized leaflet only containing general information on these criteria.
Follow-up period is 9 months for each patient. Primary endpoint is the occurrence of a thromboembolic/bleeding
event or death. Secondary endpoints are other adverse drug reactions, hospital admissions, specialist referrals and
medication changes due to adverse drug reactions, the patients’ adherence to medication regimen as well as
health related quality of life, mortality and resulting costs.
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* Correspondence:katharina.kaumanns@bfarm-research.de
1
Research Division, Federal Institute for Drugs and Medical Devices,
Kurt-Georg-Kiesinger-Allee 3, 53175 Bonn, Germany
2
Centre for Translational Medicine, University of Bonn, Sigmund-Freud-Str. 25,
53127 Bonn, Germany
Full list of author information is available at the end of the article
© 2016 Stingl et al.Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0
International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and
reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to
the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver
(http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
Stinglet al. BMC Family Practice (2016) 17:49
DOI 10.1186/s12875-016-0447-6
(Continued from previous page)
Discussion:Despite extensive evidence of risk factors for adverse drug reactions, there are few prospective trial
data about an individualized risk assessment including pharmacogenetic information to increase patient safety. By
conducting a health economic analysis, we will evaluate if the application of an individualized drug therapy in daily
routine is cost-effective.
Trial registration:German Clinical Trials Register: DRKS00006256, date of registration 09/01/15.