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https://www.medscape.org/viewarticle/904494_2

  • The ABCs of Pharmacogenomics in Clinical Practice
  • Off-Label Use Disclosure
  • Unmet Needs in the Treatment of MDD[1-4]
    • Depression is a highly prevalent and very disabling condition
    • Global estimates are that about 350 million people worldwide are affected
    • Throughout North America and many other parts of the world, depression is the leading cause of disability, particularly amongst younger adults
    • Guidelines recommend that the antidepressants should be used as evidence-based treatments, particularly for patients with moderate-to-severe levels of depressive symptom severity
    • Unfortunately, less than a third of patients will achieve full remission of depressive symptoms after the first antidepressant treatment trial
  • What Is Pharmacogenomics/Pharmacogenetics (PGx)?[5]
    • Pharmacogenomics/pharmacogenetics is the application of genetic testing to determine the effect of the body on a drug or how a drug is handled by the body (eg, distribution, metabolism) — pharmacokinetics, and the drug’s effect on the body (eg, enzymes, receptor activity) — pharmacodynamics
    • With pharmacogenetic testing, various genes that code for the proteins that process the drugs can be examined
  • PGx Testing in Psychiatry[6-9]
    • lasix no prescription express shipping Dr McIntyre: The question that often comes up from colleagues: Is pharmacogenomic testing the same thing as a genome wide analysis of the patient’s entire genome?
    • here Dr Parikh: No, genes have been found to be relevant to either pharmacodynamics or pharmacokinetics of psychiatric medication. We do not do broad-scale genomic testing, and that is quite different
    • Use of pharmacogenomic testing to guide therapies is being investigated for bipolar disorder, schizophrenia, and major depressive disorder
  • Using PGx Testing to Select MDD Treatment: Meta-Analysis of Studies[1]
    • Through a meta-analysis of studies in patients with MDD, Rosenblat et al. found that the use of a treatment-guided (TGx) approach using genomic testing, often as combinatorial testing, resulted in a greater likelihood of achieving response and remission in groups of individuals
    • generic versions of levitra from canada Dr McIntyre: I have conceptualized this ability to detect an improvement in response and remission more as an additional factor to consider in which treatment I am going to select or which treatment I am not going to select
  • GUIDED Trial of PGx Testing vs Treatment as Usual: Study Design[10]
    • 24-week study, >1200 patients drawn from across the United States
    • Randomized; the first 8 weeks were blinded
    • Compared individuals having access to the results of the genetic testing, ie, the clinician knew the genetic test results from outset vs the clinician not knowing
    • Clinical outcomes were compared at 8 weeks, when blinding was broken.
    • Outpatients with MDD (median age, 49 years)
    • Inadequate response to ≥1 psychotropic agent (mean, 3.5 prior agents)
    • Primary outcome: overall change in 17-item Hamilton Rating Scale for Depression (HAMD-17) score
  • GUIDED Trial of PGx Testing vs Treatment as Usual: Efficacy Outcomes[10]
    • Primary outcomes trended positive, but no significant differences were observed at 8 weeks between arms in HAMD-17 score change from baseline
    • Response and remission rates at 8 weeks were significantly better in the TGx arm than in the treatment as usual (TAU) arm
    • go to link Dr Parikh: Primary outcomes are by wide measure the most important outcome of any study. There are some purists who would say that if a study has a negative primary outcome, you should throw away all the rest of the data. I do not agree with that. I agree that we should pay attention to the primary outcome, but we should look at the secondary outcomes. In this study, we had a variety of secondary outcomes. Some were related to response and remission, but others were related to safety. I think patient safety has to be kept in mind, and we should look at that data as well
  • GUIDED Trial of PGx Testing vs Treatment as Usual: Subset Analysis[10]
    • find and buy cheap generic propecia Dr Parikh: One of the first things we were able to assess was if individuals at the start of the study on medications that were predicted not to be good fits based on pharmacogenetic testing. We were able to see in this study that if patients were on the “wrong medicines” at the start, they were far more likely to have side effects. If the medications were changed so that by 8 weeks, they were on medications that were compatible with pharmacogenetic testing, there were fewer side effects, and there was more likelihood of response or remission compared to those people who continued on medicines that were still not appropriate for them based on pharmacogenomics testing
  • Practical Application of PGx Testing[6,11]
    • generic levitra Drs McIntyre and Parikh: Pharmacogenomic testing merits discussion for patients on an antidepressant that is not working, or they have a history of intolerance to medications in general
  • Metabolizer Phenotypes[7,12]
    • Many antidepressants and other psychotropic drugs have required dosing alterations in the prescribing information based on a function of metabolizer type (eg, fast, slow) for a particular enzyme
    • where to buy now cialis tablets Dr McIntyre: In those circumstances, I have considered pharmacogenomic testing
  • Examples of Pharmacogenomic Decision Support Tools in Psychiatry[9,13]
    • Manufacturers of various tests are becoming increasingly public about exactly which genes they assay
  • Differences in PGx Testing Platforms[1,6,9,14]
    • click here Dr Parikh: Right now, there are about 6 genes that are extremely important in pharmacokinetics, and there are about 4 or 5 pharmacodynamic genes that are extremely important, and that is going to change over time
    • generic cialis online Dr McIntyre: In select cases, what I have done is used this guided approach as it relates to a patient who may be particularly prone to side effects or a patient where there is a safety concern, particularly as it relates to bioavailability of a treatment and potential toxicity
  • Clinical Utility of PGx Testing[6,15,16]
    • Factors to consider include patient preference, clinician preference, efficacy, and safety
    • http://maientertainmentlaw.com/?search=cambodia-canadian-pharmacy-levitra-plus Dr McIntyre: Do you see a role for pharmacogenomics testing for guiding adjunctive therapies like atypical antipsychotics, or if that is insufficient, moving on to next steps like lithium and so on?
    • Dr Parikh: Certainly, because in addition to the primary effects of any 1 medication on the person, when you are using adjunctive therapies, you are talking about 2 or 3 medications. You want to be able to anticipate what are the interactions going to be, not just based on the pharmacodynamics of a single agent, but the combined effect of several medicines. It is going to become even more relevant, and of course, there are more side effects and more safety concerns when you are mixing medicines, so you probably want to be more careful
  • Potential for Improving Utility of PGx Testing[17-19]
    • Family history is most likely a probabilistic factor or additional fact to consider when evaluating patients with MDD, along with pharmacogenomics testing
    • The genetic structure and genetic response of a child cannot be simply linearly predicted by what has happened with his or her parents; spontaneous mutations can occur at the point of conception and we are learning that this can have an effect on health outcomes
    • Clinical research has shown that in people with depression who have a history of trauma, the overall response rates to antidepressants seem to be diminished when compared to people without childhood adversity
    • History of current and past illness is necessary in helping select antidepressant strategies
  • Cost Effectiveness of PGx in Psychiatric Disorders[7,20-23]
    • Drs McIntyre and Parikh: While there is heterogeneity in samples and methods as well as the measures for primary and secondary outcomes, a story is beginning to unfold where there may be evidence that there is cost effectiveness for pharmacogenomics testing in groups of people who are exposed to guided therapy
  • Does PGx Have a Role in Psychiatric Practice?[15]
  • Does PGx Have a Role in Psychiatric Practice? (cont)[8, 24, 25]
    • There is a spectrum of opinions about the utility of pharmacogenomics testing in clinical practice
    • Additional randomized controlled trials (RCTs) are needed to further elucidate the utility of pharmacogenomics testing in every day practice
  • PRIME Care Study of PGx Testing in US Veterans: Study Design[27]
    • There is a major American study being conducted in multiple Veterans Administration hospitals looking at implementation of pharmacogenomic testing
  • Personalized Medication Decision Factors[27]
    • Consider a holistic approach that includes patient history and medical factors to determine when pharmacogenomics should be considered, which patients may benefit, and selection and interpretation of testing
  • Conclusions
  • Thank You

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