Clinical studies2020-09-08T16:44:12+00:00

Clinical studies

Current and future clinical research involving the Personal Medicine Profile (PMP)

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.

Adverse drug reactions are a major health concern worldwide

There are multiple causes of adverse drug reactions, some of which are preventable. Pharmacogenomics accounts for app. 80% variability in drug efficacy and safety. Over 400 genes are clinically relevant in drug metabolism, and app. 200 pharmagenes are associated with adverse drug reactions. The condition of extensive metabolizer in the european (caucasian) population is lower than 20%, and about 60% of patients are exposed to potential adverse drug reactions. Expert opinion: The regulatory Agencies should make recommendations to the pharmaceutical industry in favor of the introduction of pharmacogenomics in drug development and the inclusion of pharmacogenomic information on drug labels, with specific warnings for the population at risk. Expert Review of Clinical Pharmacology 2019, vol 12, No. 5, 407-442, Taylor & Francis Group.

Nearly 30% of children could benefit from study finds

Improving drug safety with genomics Manzi teamed up with Dianbo Liu, PhD, Karen Olson, PhD, and Kenneth Mandl, MD, MPH, in the Computational Health Informatics Program (CHIP) at Boston Children’s. Together, they analyzed pharmacy claims from more than 2 million people nationwide, including more than 400,000 children. “As our understanding of the impact of pharmacogenomics on safe medication use has grown, we wanted to understand how many patients this knowledge could benefit,” says Manzi. “With the expertise of CHIP and this large claims database, we could begin to answer this question.” A surprising 63 percent of adults and 29 percent of children were prescribed medications whose effects could differ based on their genetics. Ten percent of people studied were prescribed more than one such medication at a time for at least 30 days. Many of the medications were extremely common, like ibuprofen and codeine. Knowing a patient’s genetics could prompt a medical provider to choose a different drug, change the dosing regimen, or provide closer monitoring to make sure the drug is working and not causing harm, says Manzi.

Clinical study, personalized medication

Personal medicine in long term care. Prescribing safe and effective medications for older patients with multiple chronic diseases is a big challenge. Nursing home residents are treated with multiple medications and are at higher risk of adverse events due to polypharmacy and age-related factors. A study by Dorfman et al. 2020 included 90 nursing home residents. The study demonstrated that with pharmacogenetic testing, 114 distinct drug therapy problems were identified. Out of the 114 drug therapy problems, 29 were classified as serious. The pharmacogenetic analysis revealed that 64% of the participants were treated with antidepressants and 35% of these had altered CYP2C19 and CYP2D6 metabolism. Read more by Dorfman et al. 2020. Individualized Medication Management in Ontario Long-Term Care Clinical Impact on Management of Depression, Pain and Dementia. JAMDA 21 (2020) 823-829.

Mental health disorders account for 6.2% of healthcare spendings in the USA

Pharmacogenetic-guided psychiatric intervention associated with increased adherence to treatment and cost savings. Depression and other psychiatric illnesses have substantial costs in human and financial terms, accounting for 4 of the top 10 causes of disability worldwide. In USA it is extimated that mental health disorders account for 6.2% of the nation´s healthcare spendings. A major driver of depression costs is treatment-resistant depression (TRD), defined as failure to reach symptomatic remission despite at least 2 adequate treatment trails. An estimated two-thirds of patients with depression will not respond to first-line treatment resistant. These individuals pose a striking cost burden, approximately 40% higher, compared with patients without TRD.  Data show the utility of pharmacogenetic testing in everyday psychiatric clinical practice, as it can lead to improved patient adherence and decreased healthcare costs. Fagerness et al. Pharmacgenetic-guided Psychiatric Intervention Associated with Increased Adherence and Cost Savinge. Am J Manag Care. 2014; 20(5):e 146-e156

The ICANPIC study

Personal medicine at community pharmacies in Canada The objective of the study was to evaluate the feasibility of implementing personalized medication services into community pharmacy practice and to assess the number of drug therapy problems identified as a result of pharmacogenomic screening. The study was carried out in two community pharmacies in Toronto, Canada One hundred patients taking a mean of 4.9 chronic medications were enrolled in the study. Pharmacists cited the most common reasons for pharmacogenomic  (PGx) testing as ineffective therapy (43.0%), to address an adverse reaction (32.6%), and to guide initiation of therapy (10.4%).  An average of 1.3 drug therapy problems directly related to the PGx testing were identified per patient. Pharmacist recommendations included change in therapy (60.3%), dose adjustment (13.2%), discontinuation of a drug (4.4%), and increased monitoring (22.1%). Read more by Papastergiou et al. 2017. The Innovative Canadian Pharmacogenomic Screening Initiative in Community Pharmacy (ICANPIC) study. Journal of the American Pharmacists Association 57 (2017) 624-629.

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