Klinische Studien2021-02-24T12:26:58+00:00

Klinische Studien

Aktuelle und zukünftige klinische Forschung mit Persönliches Medizinisches Profil (PMP)

Applying PGx-guided drug therapy in decision making for diabetes and elderly patients

The use of clopidogrel and PPIs either alone or in combination is quite widespread, in particular among the elderly and persons with diabetes. This further supports the emerging need of accessing and accounting for not only DDI (drug-drug-interactions) but also for applying PGx-guided drug therapy in clinical decision making for antiplatelet therapy with clopidogrel having a particular focus on persons with diabetes and the elderly. https://doi.org/10.3390/metabo11020096 Keywords: clopidogrel; proton pump-inhibitors, drug use, pharmacogenomics, polypharmacy, drug-drug interactions, drug-gene interactions, drug-drug-gene interactions, diabetes, elderly, cardiovascular disease.

Personal Medicine for patients with depression and/or anxiety

The literature on pharmacogenomics as a tool to support antidepressant precision is burgeoning. In this prospective, single-blind randomized controlled design, the impact of pharmacogenomics guided versus standard antidepressant was evaluated. Participants were 213 outpatients diagnosed with major depressive disorder and/ or generalized anxiety disorder, randomized to receive pharmacogenomics guided (n = 105) or standard antidepressant treatment (n = 108); participants were blinded to the study. Patient reported outcomes of depression, anxiety, disability, and treatment satisfaction were assessed at months 0, 1, 3, and 6. Hypotheses were investigated using mixed effect models on the full data. All clinical outcomes improved significantly. A randomized controlled trial. Clin Transl Sci. 2021;00:1–10. https://doi.org/10.1111/cts.12986

Approx. half the population over 65 years in Germany can have an elevated risk

Around 9 million of the 17 million individuals aged ≥65 years in Germany potentially have an elevated risk for adverse drug reactions and 4.6 million potentially have a highly elevated risk. Analyses were based on the first 5,000 participants of the Rhineland Study (mean age 55 years; 57% women). Of our participants, 66.0% reported the use of a drug regularly, which increased to 87.4% in participants aged ≥65 years (n=1,301). The use of polypharmacy, potentially inappropriate medication, and pharmacogenomic drugs was 15.9%, 6.4%, and 20.5%, respectively. In participants <65 years, 16.0% (95%CI 14.8;17.3) had at least one risk factor. In participants aged ≥65 years, 54.1% (95%CI 51.4;56.8) had at least one, and 27.4% (95%CI 25.0;29.9) had at least two risk factors. Extrapolating these numbers to the German population implies, that around 9 of the 17 million individuals aged 65 years or older are potentially at an elevated risk for adverse drug reactions, of which 4.6 million are at a potentially highly elevated risk for adverse drug reactions. Conclusion: Our study shows that drug use is common and the individual risk for an adverse drug reaction in our population is high. This suggests room for improvement in general medication use. Please cite this article as doi: 10.1111/bcp.14671 (article accepted for review) Polypharmacy, potentially inappropriate medication, and pharmacogenomics drug exposure in the Rhineland Study. Short running title: Suboptimal drug use and adverse effect risk Folgerdiena M de Vries1, Julia C Stingl2, and Monique M B Breteler1,3 The authors confirm that the PI for this paper is Monique M. B. Breteler. 1. Population Health Sciences, German Center for Neurodegenerative Diseases (DZNE), Bonn, Germany 2. Institute of Clinical Pharmacology University Hospital of RWTH Aachen, Germany. 3. Institute for Medical Biometry, Informatics and Epidemiology (IMBIE), Faculty of Medicine, University of Bonn, Bonn, Germany

A large fraction of elderly Danes are exposed to drugs with “actionable guidelines”

A Danish register study shows that 49 drugs have "actionable guidelines" related to CYP2C6 and CYP2C19 corresponding 14.5% of the total sales in DDD. Pantoprazole, lansoprazole, omeprazole, clopidogrel and metoprolol constituted fifty-eight percent of the consumption in DDD of drugs having "actionable guidelines". The consumption of antidepressant drugs, opioides, and antipsychotic drugs were 441.850 users, 427.765 users and 128.935 users, respectively. Age distribution of consumption of drugs and drug combinations e.g., for sertraline redeemed either alone or in combination with metoprolol and tramadol, are presented in the study. The exploratory register study clearly showed that a large fraction of the Danish population, especially the elderly, are exposed to drugs or drug combinations for which there excist "actionable guidelines" related to CYP2C6 AND CYP2C19. Westergaard et al. J. Pers.Med 2020, 10(3); doi:10.3390/jpm10010003

FDA: pharmacogenomics can play an important role in identifying responders to medication

Pharmacogenomics can play an important role in identifying responders and non-responders to medications, avoiding adverse events, and optimizing drug dose. Drug labeling may contain information on genomic biomarkers and can describe: Drug exposure and clinical response variability Risk for adverse events Genotype-specific dosing Mechanisms of drug action Polymorphic drug target and disposition genes Trial design features https://www.fda.gov/drugs/science-and-research-drugs/table-pharmacogenomic-biomarkers-drug-labeling

The Parker Institute study

Preparation of a clinical studyThe Parker Institute and Genetelligence is in collaboration about a new clinical study with the purpose to investigate safety of pharmacogenetic-guided methotrexate treatment versus standard of care. A pilot study is currently running to perform consept mapping in relevance to PMP before the clinical study can be initiated.Read more about concept mapping by e.g., Trochim and Kane. Concept mapping: an introduction to structured conceptualization in health care. International Journal for Quality in Health Care 2005; Volume 17, Number 3: pp. 187-191.

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