This document provides an overview of drug rediscovery using the example of 6-thioguanine (6-TG) for inflammatory bowel disease (IBD). It discusses the current standard therapies for IBD, their limitations including side effects. 6-TG, which was previously only used for leukemia, shows promise as an alternative for patients who cannot tolerate standard thiopurines. Studies demonstrate the efficacy of 6-TG for IBD with response rates over 70% and less toxicity than other thiopurines. Low-dose 6-TG may avoid nodular regenerative hyperplasia seen at higher doses. Regulatory hurdles include the need for new clinical trials and difficulties with re-registration and distribution compared to redis
Pharmacology for Physiotherapy Book By Padmaja Udaykumar Second Edition.Khalid Ghaznavi
Pharmacology for Physiotherapy Book
By Padmaja Udaykumar Second Edition.
This consists of a complete book version. I hope this will be helpful for you.
This document discusses managing opioid-induced bowel dysfunction. It describes the physiology behind constipation, measures for assessing treatment impact, and risks of undertreatment. New treatment modalities like Relistor, Amitizia, Entereg, and Linzess are outlined with their mechanisms of action, dosing, side effects, efficacy, and outcomes. Universal precautions for prescribing opioids include diagnosis, goals, monitoring, education, and documentation. Established medications like bulking agents, laxatives, and cathartics are also reviewed with cautions.
Pragmatic Open-Label Randomized Trial of Pre-Exposure Prophylaxis: the PROUD ...Office of HIV Planning
Kathleen Brady of the Philadelphia Department of Public Health shared slides about the PROUD study, originally presented at the 2015 Conference on Retroviruses and Opportunistic Infections (CROI), at the March 2015 meeting of the Philadelphia HIV Prevention Planning Group (HPG).
Personalized medicine involves the prescription of specific therapeutics best suited for an individual based on their genetic or proteomic profile. This talk discusses current approaches in drug discovery/development, the role of genetics in drug metabolism, and lawful/ethical issues surrounding the deployment of new health technology. I highlight some bioinformatic roles in the drug discovery process, and discuss the use of semantic web technologies for data integration and knowledge discovery..
1) The document discusses treatment options for opioid-induced constipation, including non-pharmacologic options like diet and exercise as well as pharmacologic options like methylnaltrexone and naloxegol.
2) Two randomized controlled trials are summarized that evaluated the efficacy and safety of naloxegol and methylnaltrexone for treating opioid-induced constipation. Both drugs were found to be effective compared to placebo with predominantly gastrointestinal side effects.
3) A placebo-controlled crossover study of methylnaltrexone is described that reproduced the efficacy findings from a prior randomized trial, with significant improvements in constipation measures seen after crossover to active treatment compared to placebo.
Personalised medicines -pharmacogentics and pharmacogenomicsAlakesh Bharali
This seminar basically introduces and explains the learner about what is personalised medicines, what is the need for it, how personalised medicines work. For this, the concept of pharmacogenetics and pharmacogenomics are considered. After going through the presentation, the learner will be able to understand about the concept of pharmacogentics and pharmacogenomics. Certain examples of personalised medicines are included in this seminar.Although personalised medicines are specific and helpful, ins spite of having lots of advantages , it also have some disadvantages which are also specified in this seminar.Although , we speak about personalised medicines, we never saw personalised medicines in our local market. So here is an approach given that , when will we see personalised medicines at the local pharmacy. Again, certain marketed products are also listed in the seminar.Also, the future of personalised medicines is depeicted in the seminar. How medicines will be in a an around 2050 is shown in the seminar. After going through the seminar, the learner would be able to understand about personalised medicines and all its aspects in detail.
Personalized medicine involves the prescription of specific therapeutics best suited for an individual based on their genetic or proteomic profile. This talk discusses current approaches in drug discovery/development, the role of genetics in drug metabolism, and lawful/ethical issues surrounding the deployment of new health technology.
Arv active-toxcity-monitoring-gaberone-training-workshop-on-managmentprempanigrahi
This document outlines key aspects of monitoring and managing adverse drug reactions related to antiretroviral therapies. It discusses WHO recommendations for antiretroviral drugs, defines important terms like adverse drug reactions and treatment limiting toxicities, and describes the major toxicities associated with different antiretroviral regimens as well as approaches for clinical management. It also covers recommendations for routine and active toxicity monitoring.
Pharmacology for Physiotherapy Book By Padmaja Udaykumar Second Edition.Khalid Ghaznavi
Pharmacology for Physiotherapy Book
By Padmaja Udaykumar Second Edition.
This consists of a complete book version. I hope this will be helpful for you.
This document discusses managing opioid-induced bowel dysfunction. It describes the physiology behind constipation, measures for assessing treatment impact, and risks of undertreatment. New treatment modalities like Relistor, Amitizia, Entereg, and Linzess are outlined with their mechanisms of action, dosing, side effects, efficacy, and outcomes. Universal precautions for prescribing opioids include diagnosis, goals, monitoring, education, and documentation. Established medications like bulking agents, laxatives, and cathartics are also reviewed with cautions.
Pragmatic Open-Label Randomized Trial of Pre-Exposure Prophylaxis: the PROUD ...Office of HIV Planning
Kathleen Brady of the Philadelphia Department of Public Health shared slides about the PROUD study, originally presented at the 2015 Conference on Retroviruses and Opportunistic Infections (CROI), at the March 2015 meeting of the Philadelphia HIV Prevention Planning Group (HPG).
Personalized medicine involves the prescription of specific therapeutics best suited for an individual based on their genetic or proteomic profile. This talk discusses current approaches in drug discovery/development, the role of genetics in drug metabolism, and lawful/ethical issues surrounding the deployment of new health technology. I highlight some bioinformatic roles in the drug discovery process, and discuss the use of semantic web technologies for data integration and knowledge discovery..
1) The document discusses treatment options for opioid-induced constipation, including non-pharmacologic options like diet and exercise as well as pharmacologic options like methylnaltrexone and naloxegol.
2) Two randomized controlled trials are summarized that evaluated the efficacy and safety of naloxegol and methylnaltrexone for treating opioid-induced constipation. Both drugs were found to be effective compared to placebo with predominantly gastrointestinal side effects.
3) A placebo-controlled crossover study of methylnaltrexone is described that reproduced the efficacy findings from a prior randomized trial, with significant improvements in constipation measures seen after crossover to active treatment compared to placebo.
Personalised medicines -pharmacogentics and pharmacogenomicsAlakesh Bharali
This seminar basically introduces and explains the learner about what is personalised medicines, what is the need for it, how personalised medicines work. For this, the concept of pharmacogenetics and pharmacogenomics are considered. After going through the presentation, the learner will be able to understand about the concept of pharmacogentics and pharmacogenomics. Certain examples of personalised medicines are included in this seminar.Although personalised medicines are specific and helpful, ins spite of having lots of advantages , it also have some disadvantages which are also specified in this seminar.Although , we speak about personalised medicines, we never saw personalised medicines in our local market. So here is an approach given that , when will we see personalised medicines at the local pharmacy. Again, certain marketed products are also listed in the seminar.Also, the future of personalised medicines is depeicted in the seminar. How medicines will be in a an around 2050 is shown in the seminar. After going through the seminar, the learner would be able to understand about personalised medicines and all its aspects in detail.
Personalized medicine involves the prescription of specific therapeutics best suited for an individual based on their genetic or proteomic profile. This talk discusses current approaches in drug discovery/development, the role of genetics in drug metabolism, and lawful/ethical issues surrounding the deployment of new health technology.
Arv active-toxcity-monitoring-gaberone-training-workshop-on-managmentprempanigrahi
This document outlines key aspects of monitoring and managing adverse drug reactions related to antiretroviral therapies. It discusses WHO recommendations for antiretroviral drugs, defines important terms like adverse drug reactions and treatment limiting toxicities, and describes the major toxicities associated with different antiretroviral regimens as well as approaches for clinical management. It also covers recommendations for routine and active toxicity monitoring.
38 use of drugs in children with impaired renal functionDang Thanh Tuan
The document discusses several key issues regarding drug dosing in pediatric patients with impaired renal function:
1) Most drug studies are performed on adults and two-thirds of drugs are excreted by the kidneys, so dosing children with renal impairment requires careful consideration.
2) Factors like a child's absorption, distribution, and developmental physiology must be accounted for in dosing, as well as the drug's pharmacokinetic properties and metabolism.
3) Guidelines provide recommendations for adjusting drug dosages based on a child's renal function and monitoring drug levels, but balancing specificity and generalizability remains challenging.
bevacizumab chemotherapy treatment of metastastic colorectal cancer metasta...Мандухай Г.
Bevacizumab is one of the chemotherapy for metastatic colorectal cancer. It is effective with Irinotecan, fluorouracil,, and Leucovorin for metastatic colorectal cancer.
This document discusses the emerging field of personalized or tailored medicine. It begins with an introduction to personalized medicine, defining it as tailoring medical treatments to an individual's characteristics. The document then covers the history and driving factors behind personalized medicine. It discusses the goals and benefits of personalized medicine, as well as some limitations. Potential applications discussed include pharmacogenetics, pharmacometabonomics, and cancer management. Several examples of personalized cancer treatments and diagnostics are provided. The document emphasizes that a one-size-fits-all approach to medicine is often ineffective and can cause harm, whereas personalized medicine aims to provide each patient with the right treatment.
This document summarizes a study on polypharmacy among patients in South India. The study defined polypharmacy as using 2-4 drugs as minor polypharmacy and 5 or more drugs as major polypharmacy. It found that 59.82% of patients had major polypharmacy, occurring most in cardiovascular diseases. Polypharmacy was more prevalent in males and in ages 19-60 years. Hospital stays were longer for major polypharmacy. The study suggests simplifying treatment regimens by eliminating unnecessary drugs and dosages to reduce problems from polypharmacy.
This document discusses pharmacokinetics and important drug interactions for treating HIV. It describes the four components of pharmacokinetics - absorption, distribution, metabolism and excretion - and explains how the liver's cytochrome P450 system plays a key role in drug metabolism. It provides examples of cytochrome P450 inducers and inhibitors and how they can affect substrate drugs. Specifically, it notes that the antibiotic rifampin is a strong inducer that significantly decreases levels of protease inhibitors, NNRTIs, methadone and antifungals by inducing cytochrome P450. Managing interactions is important for successful HIV treatment.
This document summarizes a systematic review that analyzed randomized controlled drug trials for fibromyalgia syndrome (FMS) and painful diabetic peripheral neuropathy (DPN) to determine the impact of nocebo effects on adverse events reported. The review found that nocebo effects substantially accounted for adverse events in the drug groups for both conditions. Specifically, nocebo effects accounted for 72.0% of dropouts due to adverse events in the FMS drug groups and 44.9% in the DPN drug groups. The review calls for standards to better assess and report adverse events in clinical trials to more accurately determine the risks and benefits of drug therapies.
Ocrelizumab is a humanized monoclonal antibody that selectively targets CD20-positive B cells. Two phase III trials, OPERA I and OPERA II, compared ocrelizumab to interferon beta-1a in patients with relapsing-remitting multiple sclerosis. The studies found that ocrelizumab significantly reduced annualized relapse rates, disability progression, and MRI activity compared to interferon beta-1a over 96 weeks with an acceptable safety profile. Ocrelizumab was generally well-tolerated with a higher rate of infusion-related reactions but lower rates of serious adverse events and infections compared to interferon beta-1a. The trials provide support for the role of B
2015 10-06 Building Bridges Biomarker symposium FIMM Helsinki, Alain van GoolAlain van Gool
A unique honour and opportunity to give a 1.5 hour lecture to young biomarker scientists to introduce biomarkers and their importance in translational medicine and personalized healthcare.
Advances in induction in Acute Lymphocytic Leukemiaspa718
This document summarizes key findings from recent studies on improving induction therapy for acute lymphocytic leukemia (ALL). It describes trials showing that intensified chemotherapy regimens based on pediatric protocols improved outcomes for young adults compared to historical regimens. A trial incorporating the targeted therapy ponatinib into frontline therapy for Philadelphia chromosome-positive ALL achieved high rates of complete response and molecular response. Combining the epigenetic agents decitabine and vorinostat with chemotherapy showed tolerability and clinical benefit for relapsed/refractory ALL. Overall, the document discusses advances demonstrating that pediatric-inspired and targeted regimens are feasible and effective for certain adult ALL patients.
This document summarizes research on improving adherence to oral chemotherapy through nursing interventions. It describes barriers to adherence such as side effects and costs. It then outlines several studies that tested nursing interventions like education using tools like MOATT, follow-up calls, and oral chemotherapy clinics. These interventions showed improvements in medication knowledge and adherence and reduced side effects and health care costs. The document advocates for standardizing oral chemotherapy education and monitoring to help patients better manage treatment at home.
Pharmacogenetics is the study of how genetic factors influence individual responses to drugs. Variations in genes involved in drug metabolism and response can help explain differences in drug efficacy and toxicity between individuals. Understanding these genetic factors may allow doctors to personalize drug selection and dosing for each patient, improving outcomes by decreasing adverse reactions and increasing efficacy. However, concerns remain regarding the reliability of pharmacogenetic tests, healthcare providers' preparedness to apply this information, and potential issues around discrimination and privacy with a personalized medicine approach.
This document discusses bridging system biology research to personalized healthcare. It summarizes:
1) System biology considers genetics, metabolism, mental state, and environment to yield personalized profiles for personalized healthcare solutions using lifestyle, food, and/or pharmaceutical interventions.
2) Personalized healthcare involves stratifying patients using multilevel diagnosis, respecting patient treatment preferences, and involving care communities.
3) Applying novel technologies in clinical care requires a balance of research/technology push to add useful biomarkers with considerations of daily practice needs and costs.
Pharmacogenetics and pharmacogenomics is an upcoming branch in therapeutics. Various pharmacogenomic tests are currently available to aid in actual clinical practice. It has shown to have promising results in personalized medicine It is my attempt to compile the basic concepts from various books, articles, and online journals. Please feel free to comment.
This document summarizes the results of the DECISION trial, a phase 3 randomized controlled trial evaluating the effectiveness of sorafenib in patients with radioactive iodine-refractory differentiated thyroid cancer. The trial found that treatment with sorafenib resulted in a significant improvement in median progression-free survival compared to placebo (10.8 months vs 5.8 months). Sorafenib also increased disease control rates and prolonged time to progression. The most common adverse events were consistent with the known safety profile of sorafenib.
This document discusses the use of pharmacogenomics for personalized medicine. It defines key terms like pharmacogenomics and pharmacogenetics. It describes how genetic variations can be identified and linked to differences in drug response and phenotypes. Specific examples are given of actionable genotypes for warfarin and codeine metabolism. Challenges and opportunities for further research in implementing pharmacogenomics in clinical practice are also outlined.
Naloxegol is a peripherally selective μ-opioid receptor antagonist approved for treating opioid-induced constipation. It is a pegylated derivative of naloxone that is not absorbed systemically due to its large size. This allows it to selectively target μ-opioid receptors in the gastrointestinal tract without impacting receptors in the central nervous system. A phase 3 randomized controlled trial found that 25mg and 12.5mg doses of naloxegol significantly improved the response and bowel movement rates in patients with non-cancer pain and opioid-induced constipation compared to placebo with generally mild adverse effects.
This presentation and our commentary and responses to your questions may contain forward-looking statements, including comments concerning drug development programs, evaluation of potential opportunities, the level of corporate expenditures, the assessment of our technology by potential corporate partners, capital market conditions, timing of events, cash consumption and other subjects. Information concerning factors that could cause actual results to differ materially from those set forth in our regulatory filings from time to time.
The document summarizes recommendations for nurse follow-up of patients on oral chemotherapy at CCH Paynesville, Specialty Services-Oncology. It provides background information on oral chemotherapy and discusses the importance of patient education and monitoring by nurses. The document recommends that nurses follow-up with patients weekly for the first month, every other week for months two and three, and monthly thereafter. It also provides tips on documenting education and monitoring side effects.
This talk discusses GI/liver side effects of commonly used drugs and provides guidance on advising patients and monitoring or preventing adverse effects. It covers factors that may contribute to side effects like drug interactions and underlying diseases. Specific drugs discussed include statins, NSAIDs, aspirin, and ketoconazole. The speaker emphasizes advising patients on medication use and seeking medical help if unwell, considering individual risk factors when prescribing or recommending prophylaxis, and consulting specialists if serious adverse effects occur.
2015 04-13 Pharma Nutrition 2015 Philadelphia Alain van GoolAlain van Gool
Keynote lecture at the Pharma-Nutrition 2015 conference, outline global paradigm shifts and activities in pharma, personalized healthcare and pharmanutrition combination therapies.
38 use of drugs in children with impaired renal functionDang Thanh Tuan
The document discusses several key issues regarding drug dosing in pediatric patients with impaired renal function:
1) Most drug studies are performed on adults and two-thirds of drugs are excreted by the kidneys, so dosing children with renal impairment requires careful consideration.
2) Factors like a child's absorption, distribution, and developmental physiology must be accounted for in dosing, as well as the drug's pharmacokinetic properties and metabolism.
3) Guidelines provide recommendations for adjusting drug dosages based on a child's renal function and monitoring drug levels, but balancing specificity and generalizability remains challenging.
bevacizumab chemotherapy treatment of metastastic colorectal cancer metasta...Мандухай Г.
Bevacizumab is one of the chemotherapy for metastatic colorectal cancer. It is effective with Irinotecan, fluorouracil,, and Leucovorin for metastatic colorectal cancer.
This document discusses the emerging field of personalized or tailored medicine. It begins with an introduction to personalized medicine, defining it as tailoring medical treatments to an individual's characteristics. The document then covers the history and driving factors behind personalized medicine. It discusses the goals and benefits of personalized medicine, as well as some limitations. Potential applications discussed include pharmacogenetics, pharmacometabonomics, and cancer management. Several examples of personalized cancer treatments and diagnostics are provided. The document emphasizes that a one-size-fits-all approach to medicine is often ineffective and can cause harm, whereas personalized medicine aims to provide each patient with the right treatment.
This document summarizes a study on polypharmacy among patients in South India. The study defined polypharmacy as using 2-4 drugs as minor polypharmacy and 5 or more drugs as major polypharmacy. It found that 59.82% of patients had major polypharmacy, occurring most in cardiovascular diseases. Polypharmacy was more prevalent in males and in ages 19-60 years. Hospital stays were longer for major polypharmacy. The study suggests simplifying treatment regimens by eliminating unnecessary drugs and dosages to reduce problems from polypharmacy.
This document discusses pharmacokinetics and important drug interactions for treating HIV. It describes the four components of pharmacokinetics - absorption, distribution, metabolism and excretion - and explains how the liver's cytochrome P450 system plays a key role in drug metabolism. It provides examples of cytochrome P450 inducers and inhibitors and how they can affect substrate drugs. Specifically, it notes that the antibiotic rifampin is a strong inducer that significantly decreases levels of protease inhibitors, NNRTIs, methadone and antifungals by inducing cytochrome P450. Managing interactions is important for successful HIV treatment.
This document summarizes a systematic review that analyzed randomized controlled drug trials for fibromyalgia syndrome (FMS) and painful diabetic peripheral neuropathy (DPN) to determine the impact of nocebo effects on adverse events reported. The review found that nocebo effects substantially accounted for adverse events in the drug groups for both conditions. Specifically, nocebo effects accounted for 72.0% of dropouts due to adverse events in the FMS drug groups and 44.9% in the DPN drug groups. The review calls for standards to better assess and report adverse events in clinical trials to more accurately determine the risks and benefits of drug therapies.
Ocrelizumab is a humanized monoclonal antibody that selectively targets CD20-positive B cells. Two phase III trials, OPERA I and OPERA II, compared ocrelizumab to interferon beta-1a in patients with relapsing-remitting multiple sclerosis. The studies found that ocrelizumab significantly reduced annualized relapse rates, disability progression, and MRI activity compared to interferon beta-1a over 96 weeks with an acceptable safety profile. Ocrelizumab was generally well-tolerated with a higher rate of infusion-related reactions but lower rates of serious adverse events and infections compared to interferon beta-1a. The trials provide support for the role of B
2015 10-06 Building Bridges Biomarker symposium FIMM Helsinki, Alain van GoolAlain van Gool
A unique honour and opportunity to give a 1.5 hour lecture to young biomarker scientists to introduce biomarkers and their importance in translational medicine and personalized healthcare.
Advances in induction in Acute Lymphocytic Leukemiaspa718
This document summarizes key findings from recent studies on improving induction therapy for acute lymphocytic leukemia (ALL). It describes trials showing that intensified chemotherapy regimens based on pediatric protocols improved outcomes for young adults compared to historical regimens. A trial incorporating the targeted therapy ponatinib into frontline therapy for Philadelphia chromosome-positive ALL achieved high rates of complete response and molecular response. Combining the epigenetic agents decitabine and vorinostat with chemotherapy showed tolerability and clinical benefit for relapsed/refractory ALL. Overall, the document discusses advances demonstrating that pediatric-inspired and targeted regimens are feasible and effective for certain adult ALL patients.
This document summarizes research on improving adherence to oral chemotherapy through nursing interventions. It describes barriers to adherence such as side effects and costs. It then outlines several studies that tested nursing interventions like education using tools like MOATT, follow-up calls, and oral chemotherapy clinics. These interventions showed improvements in medication knowledge and adherence and reduced side effects and health care costs. The document advocates for standardizing oral chemotherapy education and monitoring to help patients better manage treatment at home.
Pharmacogenetics is the study of how genetic factors influence individual responses to drugs. Variations in genes involved in drug metabolism and response can help explain differences in drug efficacy and toxicity between individuals. Understanding these genetic factors may allow doctors to personalize drug selection and dosing for each patient, improving outcomes by decreasing adverse reactions and increasing efficacy. However, concerns remain regarding the reliability of pharmacogenetic tests, healthcare providers' preparedness to apply this information, and potential issues around discrimination and privacy with a personalized medicine approach.
This document discusses bridging system biology research to personalized healthcare. It summarizes:
1) System biology considers genetics, metabolism, mental state, and environment to yield personalized profiles for personalized healthcare solutions using lifestyle, food, and/or pharmaceutical interventions.
2) Personalized healthcare involves stratifying patients using multilevel diagnosis, respecting patient treatment preferences, and involving care communities.
3) Applying novel technologies in clinical care requires a balance of research/technology push to add useful biomarkers with considerations of daily practice needs and costs.
Pharmacogenetics and pharmacogenomics is an upcoming branch in therapeutics. Various pharmacogenomic tests are currently available to aid in actual clinical practice. It has shown to have promising results in personalized medicine It is my attempt to compile the basic concepts from various books, articles, and online journals. Please feel free to comment.
This document summarizes the results of the DECISION trial, a phase 3 randomized controlled trial evaluating the effectiveness of sorafenib in patients with radioactive iodine-refractory differentiated thyroid cancer. The trial found that treatment with sorafenib resulted in a significant improvement in median progression-free survival compared to placebo (10.8 months vs 5.8 months). Sorafenib also increased disease control rates and prolonged time to progression. The most common adverse events were consistent with the known safety profile of sorafenib.
This document discusses the use of pharmacogenomics for personalized medicine. It defines key terms like pharmacogenomics and pharmacogenetics. It describes how genetic variations can be identified and linked to differences in drug response and phenotypes. Specific examples are given of actionable genotypes for warfarin and codeine metabolism. Challenges and opportunities for further research in implementing pharmacogenomics in clinical practice are also outlined.
Naloxegol is a peripherally selective μ-opioid receptor antagonist approved for treating opioid-induced constipation. It is a pegylated derivative of naloxone that is not absorbed systemically due to its large size. This allows it to selectively target μ-opioid receptors in the gastrointestinal tract without impacting receptors in the central nervous system. A phase 3 randomized controlled trial found that 25mg and 12.5mg doses of naloxegol significantly improved the response and bowel movement rates in patients with non-cancer pain and opioid-induced constipation compared to placebo with generally mild adverse effects.
This presentation and our commentary and responses to your questions may contain forward-looking statements, including comments concerning drug development programs, evaluation of potential opportunities, the level of corporate expenditures, the assessment of our technology by potential corporate partners, capital market conditions, timing of events, cash consumption and other subjects. Information concerning factors that could cause actual results to differ materially from those set forth in our regulatory filings from time to time.
The document summarizes recommendations for nurse follow-up of patients on oral chemotherapy at CCH Paynesville, Specialty Services-Oncology. It provides background information on oral chemotherapy and discusses the importance of patient education and monitoring by nurses. The document recommends that nurses follow-up with patients weekly for the first month, every other week for months two and three, and monthly thereafter. It also provides tips on documenting education and monitoring side effects.
This talk discusses GI/liver side effects of commonly used drugs and provides guidance on advising patients and monitoring or preventing adverse effects. It covers factors that may contribute to side effects like drug interactions and underlying diseases. Specific drugs discussed include statins, NSAIDs, aspirin, and ketoconazole. The speaker emphasizes advising patients on medication use and seeking medical help if unwell, considering individual risk factors when prescribing or recommending prophylaxis, and consulting specialists if serious adverse effects occur.
2015 04-13 Pharma Nutrition 2015 Philadelphia Alain van GoolAlain van Gool
Keynote lecture at the Pharma-Nutrition 2015 conference, outline global paradigm shifts and activities in pharma, personalized healthcare and pharmanutrition combination therapies.
This document discusses drug risk assessment and pharmacoepidemiology. It notes that clinical trials prior to drug approval are limited in detecting uncommon or long-term side effects. Observational studies using large patient populations are needed to further evaluate drug safety issues and understand rare or long-term side effects. The document compares different pharmacoepidemiological study designs like cohort studies and case-control studies that can be used to investigate drug safety questions following a drug's approval and entry into widespread use.
1) Obesity is a complex, multifactorial disease with significant health risks and economic costs. Lifestyle interventions are often ineffective long-term, so medications and surgery may be considered.
2) Common obesity drug options include phentermine, orlistat, sibutramine, topiramate, metformin, exenatide, and rimonabant. They work via appetite suppression, fat absorption inhibition, or other mechanisms.
3) While medications can modestly aid weight loss, they also carry risks and are generally not intended for long-term use. Bariatric surgery may be considered for patients with BMI >35 and comorbidities.
Presentation was originally done at Group Health Cooperative’s National Summit on Opioid Safety: http://www.ghinnovates.org/?p=3502
Presentation by: Roger Chou, MD, Associate Professor of Medicine for Oregon Health & Science University
and Director of Pacific Northwest Evidence-based Practice Center.
This document summarizes the research of Dr. Sattva Neelapu on novel targeted therapies for B-cell non-Hodgkin lymphomas. It discusses several targeted agents including Btk inhibitors like ibrutinib, PI3K inhibitors like idelalisib, and exportin 1 inhibitors like selinexor. Studies are presented showing promising response rates and outcomes when these agents are used as monotherapy or in combination with rituximab or chemotherapy for relapsed/refractory lymphomas. Adverse events are typically manageable. Ongoing research continues to evaluate these and new targeted agents to improve outcomes for patients with B-cell lymphomas.
Living Well with Cancer Presentation (Webinar)KellyGCDET
This document discusses the importance of nutrition for cancer patients. It notes that malnutrition is common in 50% of cancer patients and is associated with weight loss, fatigue, weakness and impaired treatment tolerance. Early nutrition intervention can help preserve muscle mass and strength, improving quality of life and ability to complete cancer treatment. Screening tools like the Malnutrition Screening Tool and Patient Generated Subjective Global Assessment are recommended to assess nutritional status and guide appropriate nutrition support and interventions.
Docetaxel plus prednisone is the standard first-line chemotherapy for metastatic castration-resistant prostate cancer. Cabazitaxel is an option for second-line chemotherapy.
Other options include:
- Abiraterone acetate (CYP17 inhibitor) plus prednisone
- Enzalutamide (second-generation antiandrogen)
- Radium-223 (alpha particle-emitting radiopharmaceutical) for symptomatic bone metastases
- Investigational therapies through clinical trials
Close monitoring of response and side effects is important with any of these advanced therapies. Palliative care should also be incorporated to maximize quality of life.
012012 v156 i2 cytisine increased smoking cessation in adultsGeorgi Daskalov
Cytisine, a partial nicotine receptor agonist, increased smoking cessation rates more than placebo in a randomized controlled trial of 740 adult smokers in Poland. Participants received a 25-day tapering course of cytisine or placebo along with minimal behavioral counseling. At 6-month and 12-month follow-ups, cytisine led to higher rates of smoking abstinence compared to placebo, with numbers needed to treat of 16 to 17. Cytisine was associated with more gastrointestinal side effects than placebo. While promising, further studies are still needed to confirm the findings, assess safety, and determine optimal dosing and cost-effectiveness before cytisine can be recommended for smoking cessation.
The document discusses pharmacotherapy and adherence to Beers criteria in the elderly. It provides an overview of medication use challenges in older adults, including age-related changes to pharmacokinetics and pharmacodynamics. It also discusses tools to evaluate inappropriate medications like Beers criteria and STOPP/START criteria. Beers criteria lists potentially inappropriate medications or classes to avoid in older adults due to risks of adverse effects. STOPP/START criteria addresses medications that should be avoided as well as those that should be considered.
The document discusses the use of biologicals such as infliximab and adalimumab in treating Crohn's disease. It provides details on their indications, administration protocols, effectiveness, safety considerations like risks of tuberculosis and autoimmune reactions, and constraints to their use like cost and lack of insurance coverage. Special precautions are needed with biologicals regarding vaccinations, screening for latent infections, and monitoring for adverse effects. Overall, biologicals are effective for inducing and maintaining remission in severe Crohn's disease and fistulizing disease when conventional treatments have failed or are not tolerated.
This document summarizes the results of a randomized, prospective, open-label clinical trial evaluating the efficacy and safety of Sulfad tablets for the management of non-alcoholic steatohepatitis (NASH) patients. The trial involved 100 patients taking Sulfad tablets for 3 months. Significant improvements were seen in liver enzymes and lipid profiles after 1, 2, and 3 months of treatment. No major safety issues were reported. The study concluded that Sulfad tablets were well-tolerated and effective for the management of NASH patients.
efficacy and safety of Sulfad tablets in the management of NASH
patients: A randomized ,prospective, open label, multi-center,
controlled, phase III clinical trial.
A Little Bit of Everything, Quick & Snappy: Probiotics to Advances in the Car...PASaskatchewan
As pharmacists, you are rarely faced with a consistent patient population with similar problems and questions. More likely, each patient you interact with has unique and varied concerns that you must be ready to address in an instant. This session reflects the diversity of patients a pharmacist will face in day-to-day practice and covers a range of topics in a quick and snappy format. This session will cover the evidence as it relates to concurrent probiotic and antibiotic use, second line treatment for patients with type 2 diabetes, and explore new utilization strategies of using drugs traditionally used in the treatment of type 2 diabetes for patients with type 1 diabetes.
Strict Glycemic Control in Critically ill patients: The Demise of another ver...Prof. Mridul Panditrao
Prof. Mridul M. Panditrao tries to explain the pros and cons about the good strategy, whcih became controversial and almost obsolete. He also tries to tract the whole aspect of the phenomenon and reviews/ RCTs/
Strict (Tight) Glycemic control (SGC/TGC), as it is called, was and still is a good strategy. It can be defined as maintenance of the blood glucose level in the range of 80-110 mg /dl. with help of dose variable and intensive insulin therapy (IIT). Since its introduction, there have been conflicting reports of its efficacy and complications. This resulted in slow but steady neglect of this very good idea leading to its almost complete demise.
An effort has been made in this review, to impartially analyze all the available evidence and try to find the reasons for the negative publicity which led to the neglect or worse still, the wrong use of this protocol. Some suggestions for fair and proper implementation of the strategy are put forward.
etc/
The document discusses polypharmacy and its risks in elderly patients. It notes that 12% of the population is aged 65+ but this group accounts for 30% of prescription drug use and 50% of over-the-counter drug use. Polypharmacy increases the risk of adverse drug reactions in elderly patients due to changes in pharmacokinetics and pharmacodynamics with aging as well as an increased likelihood of drug-drug interactions. Prudent prescribing for older adults includes considering potential drug-disease interactions, assessing compliance, and considering non-pharmacological options before prescribing additional medications.
This document discusses the metabolic side effects of drugs used in psychiatry. It begins by defining metabolic syndrome and describing the classification of antipsychotic drugs. It then discusses the historical recognition of metabolic and cardiovascular side effects of first-generation antipsychotics. Several studies are summarized that show associations between various antipsychotic drugs and risks of diabetes, metabolic syndrome, cardiovascular effects, and hyperprolactinemia. Risks are compared between different drug classes and specific antipsychotics. Management of metabolic abnormalities is also briefly addressed.
Similar to Dia philadelphia juni 2012 (2) (1) (20)
STUDIES IN SUPPORT OF SPECIAL POPULATIONS: GERIATRICS E7shruti jagirdar
Unit 4: MRA 103T Regulatory affairs
This guideline is directed principally toward new Molecular Entities that are
likely to have significant use in the elderly, either because the disease intended
to be treated is characteristically a disease of aging ( e.g., Alzheimer's disease) or
because the population to be treated is known to include substantial numbers of
geriatric patients (e.g., hypertension).
Pictorial and detailed description of patellar instability with sign and symptoms and how to diagnose , what investigations you should go with and how to approach with treatment options . I have presented this slide in my 2nd year junior residency in orthopedics at LLRM medical college Meerut and got good reviews for it
After getting it read you will definitely understand the topic.
Travel Clinic Cardiff: Health Advice for International TravelersNX Healthcare
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1. Clash between old and older ?
Some considerations
Presenter Chris Mulder
Gastroenterologist
2. Disclaimer
• The views and opinions expressed in the following PowerPoint
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attributed to Drug Information Association, Inc. (“DIA”), its
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organization with which the presenter is employed or affiliated.
• These PowerPoint slides are the intellectual property of the
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registered trademarks. All other trademarks are the property of
their respective owners.
2
3. Agenda
• Introduction
• Drug rediscovery Model Case IBD
–
–
–
–
Current therapy and pharmaceutical needs
Safety
Efficacy
Availability
• Regulatory aspects
–
–
–
–
Clinical Research
Investment
Pharmaco-economics
Authorisation
• Summary
4. Introduction VUmc
• Prof. dr. C.J.J. Mulder
• Gastroenterologist
• Head of departement
• Expertise Coeliac disease, IBD, GI-malignancies,
Auto-immune Liver diseases, drug rediscovery 6Tg, 2-CDA
• Drug rediscovery: 2-CDA, 6-Tg, Dapson,
Budesonide
• Chairman Dutch Society of Gastroenterology
6. Introduction (Ctn’d)
• Knowledge + Experience + Curiosity lead to
new applications of old “drugs”
• Just Off-label use of old drugs or Creating
evidence base
• Example: the use of 6-Tg in IBD
6
9. Thiopurines in IBD
State of the art therapy - L Derijks 2005 :
•
•
Thiopurines have proven efficacy in IBD.
Initial response efficacy is reasonably well sustained with remission
rates of 95%, 69% and 55% after 1, 3 and 5 years respectively.
• AZA and 6-MP efficacy in induction of remission in active Crohn’s
with OR : 3.5.
• Thiopurines have steroidsparing effect.
• Combination of AZA with prednisolone is superior to prednisolone alone [2,
7].
PhD 2005
10. Sorry: too much information
Lindqvist Appell and Haglund 2009
14. Failure of thiopurines
(AZA / 6-MP)
30-40 % of IBD patients
discontinues the use
due to therapeutic failure or the
development of adverse events
Jahrap et al IBD
2010
CM: << 5 yrs 50 % stops
20. TPMT: a key enzyme
High TPMT activity:
• High concentration of 6-MMP =Liverproblems
• Low concentration of 6-TGN = Ineffective
.
treatment
Low TPMT activity :
• Low concentration of 6-MMP
• High concentration 6-TGN
21. Myelotoxicity and TPMT
•
•
•
•
•
•
N=262 AZA treated adult IBD patients
Leucopenia in 4,6 %
Frequency of mutant TPMT alleles was significantly
higher in the myelotoxic group (20,8 % versus 4 %)
y?
it
ic
x
to
nt IBD patients
N=72 AZA treated paediatric
ve
re
Leucopenia in 2,8 %
p
s
idid not explain adverse events
TPMT status
es
Do
Zelinkova et al. 2006
de Ridder et al 2006
22. TPMT determination ?
• Myelotoxicity may be avoided
• Dose adjustment according to
TPMT status
• Cost-effective
Winter et al. 2005
VUMC : too expensive , doesn’t protect
24. Literature
6-TGN > 490
Increased risk on
myelotoxicity
6-TGN < 235
Less efficacy
6-MMP > 5700
Hepatotoxicity
Dubinsky 2000, Al Hadithi 2004, Jahrap IBD 2010
25. TDM conclusions
• Dose adjustment according to
metabolites
• Evaluation of compliance
• Role in clinical practice needs to be
established
We can’t work without in VUMC
30. Efficacy 6-TG treatment
Patients
(numbers
)
Duration
(weeks)
6-TG Dose
(mg/day)
Toxicity
(%)
Respons
e
(%)
10
16
20
70%
16
!
d
o
o
0
26
20-40
50
88%
37
26
40-80
16
57%
Bonaz et al. 2003
49
52
20
10
79%
Qasim et al. 2007
40
34
40
33
73%
Trials
Dubinsky et al. 2001
Herrlinger et al. 2003a
Herrlinger et al. 2003b
g
Is
31. Tolerability 6-TG treatment
n=113 ; Mean daily dose: 0.25 – 0,35 mg/kg
P<0.001
40
35
30
25
20
15
10
5
0
245 treatment years
31
40
( 27% )
6-TG cont inuat ion
6-TG w it hdraw al
8
Median t reat m ent durat ion
( m ont hs)
82
( 73% )
32. Paediatric
• 2003
:
16/26 = 62% NRH
however
> 40 mg
Dubinsky et al, 2003
26 out of 111
90 % pre-6TG hepatotoxicity
34. Clinical recommendations
•
•
•
Azathiopurine is sufficient in 50%
6-MP has 20 % less side-effects
6TG = Lanvis is good in 90 % of
AZA/6MP intolerant patients
Read: M.L. Seinen etc in 2010
Journal of Digestive Liver Diseases
CM: Money
issue 6-Tg: < $ 1.000
1 year
35. Clinical recommendations
•
•
•
Azathiopurine is sufficient in 50%
6-MP has 20 % less side-effects
6TG=Lanvis is good in 90 % of
AZA/6MP intolerant patients
Read M.L. Seinen etc in the next issue of
Journal of Digestive Liver Diseases
Cheaper than MAB’s
MABS : > $ 20.000 year
37. Dosages
• Azathioprine
• 2 – 2.5 mg/kg/daily
• 6-Mercaptopurine
the
• 1 – 1.5 mg/kg/daily in
G
6- T
on
nts
ti e
pa
(Imuran ®)
s
nd
rla
he
et
N
(Purinethol ®)
• 6-TG
(Lanvis®)
0.3
8•00 mg/kg/daily VUMC in A’dam
201
N>
2
38. Toxicity on classic thiopurines:
6-Thioguanine (Lanvis®)
Option after adverse events due
to classical thiopurines
Less toxic metabolites, more 6-TGN
At 1 year: > 80% continued 6-TG use
Less than $ 1.000 per year
40. Clinical recommendations
•
Therapeutic drug monitoring:
– Compliance control
– During toxicity or exacerbation of disease
– 6-Tg is useful
CM: At least once a year
This will help you a lot in the United States
Seinen ML et al JGLD 2010 september
41. Regulatory aspects
• Clinical Research
– Combination of treatment with clinical research
– Recue medication
• Investment
– Drug rediscovery is not sponsored by
pharmaceutical industry
– Drug rediscovery is not enthusiastically
absorbed in academic setting (not easy to come
in Lancet)
41
44. Prevalence of NRH in IBD
( Non AZA users )
•
•
•
•
Non-thiopurine users
IBD surgery
Biopsy during operation
N=130
none
NRH
de Boer et al. 2008
present
94 %
6%
45. 6-TG 2008
N de Boer
• Absence of nodular regenerative
hyperplasia after low-dose 6 thioguanine
maintenance therapy in inflammatory
bowel disease patients
N.K.H. de Boer, P.E. Zondervan, L.P.L. Gilissen, G. den Hartog, B.D. Westerveld,
L.J.J. Derijks, E. Bloemena, L.G.J.B. Engels, A.A. van Bodegraven, C.J.J. Mulder
• Gepubliceerd in Digestive & Liver Disease
40 (2008) 108–113
46. 6-TG 2008
N de Boer
• Conclusion:
“We have demonstrated that low-dose 6-
thioguanine maintenance therapy in
inflammatory bowel disease patients is not
likely to be associated with induction of
nodular regenerative hyperplasia. The
induction of nodular regenerative
hyperplasia appears to be 6-thioguanine
dose or 6-thioguaninenucleotides level
dependent.”
48. Conventional thiopurines and NRH
2
%
H
R
N
f
o
k
s
r
e
v
i
t
a
l
m
u
C
1
0
0
• 37 Cases / 36 centres
(France, Austria)
Conclusies:
• 1994 and 2005
1. IBD is een risico factor mbt NRH time AZA :
– Median
48 mo
2. 6-TG, azathioprine (thiopurine (6-187)
– Cumulative risk
months after starting
derivatives) ookAZAeen, dosis
afhankelijke, risico factor • 0.5% at 5 years
• 1.25% at 10
3. Groot aantal andere risicofactoren
years
12
24
at risk : 1874
36
48
60
833
72
84
96
108 120
322
(leeftijd, geneesmiddelen gebruik)
Vernier-Massouille, 2007
49. 6-TG EU Working Party
• 2005 de Boer 6 TG WP
Ref [17]
• “Low-dose 6-thioguanine may still be considered as a
rescue drug for maintenance of remission in IBD
patients failing and/or intolerant to all evidence-based
conventional
therapies including mesalamine, AZA/6-MP, MTX and
infliximab, and in whom surgery is thought to be
inappropriate”
• “Application has to be restricted to a clinical
research setting.”
50.
51. 6-TG 2010 van Asseldonk
•
Prolonged thioguanine therapy is well tolerated and safe in the
treatment of ulcerative colitis
Dirk P.van Asseldonk, BindiaJharap , DirkJ.Kuik , Nanne K.H.de
Boer , Barend D.Westerveld , Maurice G.V.M.Russel,
FrankJ.G.M.Kubben, Ad A.vanBodegraven, ChrisJ.Mulder
Gepubliceerd in Digestive and Liver Disease
Received 18 September 2009 - Accepted 23 July 2010
•
Cohort IBD patienten die 6-TG gebruiken van 2001 – 2009
•
Conclusie:
“Long-term use of thioguanine appears to be well tolerated and
relatively safe in ulcerative colitis patients who failed conventional
thiopurine therapy”
•
Onderbouwing voor “well established use “
52. 6-TG RA voorstel
• 6-TG PCH 10 mg en 20 mg tablet
• Proposed indication: Treatment of patients with
Inflammatory Bowel Disease (IBD), including
Crohn’s disease and colitis ulcerosa, resistant to
standard Thiopurine therapy, with medication
control management as proposed by the European
6-TG working party.
• Nationale indiening
• Legal basis of application: Article 10.3 (Hybrid)
• Intended filling date: 4 Q 2011 / 1 Q 2012
53. 6-TG RA voorstel
• Well established use
voor ong 1000 patienten in de laatste 7 jaren
via off label toepassing & magistrale bereiding
• Bioequivalentie studie voorstel
– 6-TG PCH 20 mg ten opzichte van halve
tablet Lanvis 40 mg
– Biowaiver voor de 6-TG PCH 10 mg
• In overleg met de Nederlandse Inspectie,
levering op artsenverklaring
55. 6-TG Samenvatting
•
•
•
•
•
6-TG structuur is variant van azathioprine en 6 – mercaptopurine
Metabolitisch gezien dichter bij werkzame metaboliet 6TGN
Effectief en veilig voor de behandeling van azathioprine en 6
mercaptopurine resistente IBD patienten, incl ziekte van Crohn & CU
Ondersteund door beroepsgroep
– NL 6-TG WG
• Amsterdam VU, Maastricht UMC, Rotterdam, Groningen
Sittard, Utrecht Arnhem, Zwolle, Heerlen, Amersfoort,
Nijmegen, Veldhoven
– EU 6-TG WG
• NL. Austria, Germany, Czech Sweden, New Zealand,
Australia
Well established use
– Jaarlijks 900 – 1000 patienten op ½ Lanvis of magistrale capsule
– Diverse promoties
– Uitgebreide bibliografie
57. 6-TG werkzaamheid en tolerantie
•
Werkzaamheid van 6-TG
diverse studies sinds 2001 response 57 % – 88 %
•
Tolerantie voor 6-TG in patienten AZA-6 MP intolerantie
diverse studies range 44 % - 87 %
aanbevolen dosis < 25 mg per dag
•
Veiligheid
onderzoek de Boer 2008 en Asseldonk 2010
- NRH bij 6-TG dosisafhankelijk, niet bij lage dosering
6-TG
•
“Well established use”
- in kliniek laatste 6 jaren jaarlijks ong 900 – 1000 patienten
behandeld
- diverse publicaties en proefschriften