DOCSLIB.ORG

Index 499 Abacavir Case Study, 359 Drug Labeling And, 448 Infectious Diseases And, 317 Pharmacist And, 465 Pharmacodynamics Of

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Index 499 Abacavir Case Study, 359 Drug Labeling And, 448 Infectious Diseases And, 317 Pharmacist And, 465 Pharmacodynamics Of Index 499 A Allele, 3, 8 detection of, 59, 70-71, 74, 92, 94 Abacavir discrimination, 59, 68, 70-72, 74-75, 88, 90-92, case study, 359 94 drug labeling and, 448 frequency calculations for, 34 infectious diseases and, 317 genetics and, 19, 20, 22, 28-30, 32, 34-47, 49, 52-53 pharmacist and, 465 methodologies, 59, 60, 70-75, 85-94, 96-97 pharmacodynamics of, 198 respiratory diseases and, 327, 336-338, 343, toxicogenomics of, 367 346 ABC transporters, 153-154 -specific amplifications, 92-93 ABCB1, 154-158, 160-161, 258, 263, 314 Allele-specific oligonucleotide (ASO) hybridiza- ABCC transporter family, 161-168 tion, 59, 74, 90-91 Allelic drift, 38 ABCC1, 161-162 All-trans retinoic acid (ATRA), 271 ABCC2, 162-163 Alpha-glucosidase inhibitors, 406, 421-422 ABCC3, 163 gene polymorphisms and, 425 ABCC4, 163 Alzheimer’s disease, 201, 296 ABCC5, 163 American Academy for Study of Liver Diseases, ABCC6, 166 322 American College of Cardiology, 228 ABCC8, 407-409, 410-411, 414, 446 American College of Medical Genetics working ABCC11, 166-167 group, 475 ABCG2, 167-168 American Heart Association Foundation, 228 Acamprosate, 394 American Hospital Formulary Service Drug Infor- Acarbose, 421-422 mation, 461 Americans with Disabilities Act, 479 Access issues, 474 Amino acid, 25 Accreditation Counsel for Pharmacy Education, 461 Amiodarone, 243-244 Accuracy, 72 Amitriptyline, 285 ACE inhibitors, 194-195, 200, 230, 232-233, 296 Analytical specificity, 71-72 Acenocoumarol, 222 Ancillary information, 467-468, 470, 473, 475-477, Acetaminophen, 112 480-481 Anderson, Keri C., 453-466 Acute lymphoblastic leukemia, 270-271 Angiotensin II receptor blockers, 230, 232-233 Acute myeloid leukemia, 271 Angiotensin-converting enzyme inhibitors, 10, 170 Adams, Patti W., 375-403 Annealing, 65, 66 Addiction disorders, 299, 375-403 Ansong, Miriam A., 491-498 Adipokinins, 421 Anthracyclines, 167, 263 ADRB2, 445 Anthracenediones, 263 Antiarrhythmic agents, 124, 242-244, 444, 473 Adverse drug event (ADE), 107, 108, 111 Antibiotics, metabolomics and transporters affect- Adverse drug reaction (ADR) ing, 313-314 drug metabolism and, 107, 108, 111, 119, 123, 130, Anticoagulants, 217-223 133-134, 136 Anticonvulsants, 157 ethics and, 472-473 Antidepressants, 121, 124, 157, 160-161, 290-292, 300 increased incidence of, 197-201 Antiepileptic drugs, 163, 294 Aerosolized tobramycin, 345 Antihistamines, 157 Afatinib, 204, 269 Antihypertensives, 124 Age dilemma, 476-477 Antineoplastic response, 196 Agranulocytosis, 293, 294 Antiplatelets, 217-223 Albuterol, 331 Antipsychotics, 124, 199-200, 292-294, 473 Antiretroviral hypersensitivity, 317-320 Alcohol addiction, 192 Antiretroviral resistance testing, 318 pharmacotherapy for, 393-394, 396 Antiretroviral therapy, 192, 200-201 treatments, 299 Antisense strand, 24 Alectinib, 205 Apixaban, 223 Alert, 453, 457-458 Apyrase, 78 Alkylating agents, 268 AQP2 gene variant, 420 Unauthenticated | Downloaded 10/02/21 05:47 PM UTC 500 CONCEPTS IN PHARMACOGENOMICS Arachidonate 5-lipoxygenase gene (ALOX5), resistance protein, 263 337-338 Brexpiprazole, 285 Arformoterol, 445-446 Bridge amplification, 67, 68-69, 81 Arg16Gly, 332-333 Brivaracetam, 285 Aripiprazole, 285 Bromocriptine, 406 Aromatase inhibitors, 127 Bronchiectasis, 327, 341-342 ArrayExpress, 364 Buccal epithelial cells collection, 63 Arrhythmia, 215, 242-245 Bucindolol, 231 Aspirin, 129-130, 216, 223-224, 274 Budesonide, 334 resistance, 224 Buprenorphine, 394, 396 Assay(s), 59, 61-62, 70-73, 80, 85-90, 92-97 Bupropion, 128, 395, 396 Asthma, 328-340 Burkitt’s lymphoma, 34 case study, 328-329 therapy, 194 C Ataluren, 348 Cabozantinib, 204 Atenolol and warfarin case study, 21 Caffeine, 117 Atomoxetine, 125, 285, 295 Calcium channel blockers, 157 Atorvastatin, 216, 236, 240, 241 Camptothecin derivatives, 167 Ataxia telangiectasia mutated gene, 419 Camptothecins, 263 ATP-binding cassette (ABC), 9, 152 Canagliflozin, 423 Attention-deficit hyperactivity disorder, 295 Cancer/carcinoma, 202-205, 257, 259, 272 Atypical antipsychotic, 283, 293 biology, 258 Autonomy, 467, 469, 471, 474, 481 chemoprevention, 257, 261, 268-269, 272, 274 Autosomal chromosome, 34-35 chemotherapy, 257, 260-261, 266, 276 Autosome (autosomal), 19, 34 genetics, 269-274 Azathioprine, 134, 368 syndromes, 274 case study, 6 Candidate gene study, 257, 262 Azithromycin, 314, 345 Capecitabine, 129 Carbamazepine, 198, 284, 286, 298, 300, 367 B Cardiovascular diseases, 215-256, 439-440, Bacteria, 310-312 443-445 Bacterial resistance, 310-312 valid biomarkers for, 440 Barefield, Kimberly L., 405-433, 437-451 Carvedilol, 120, 125, 444, 445 Basal insulin, 406 Case-control studies, 52 BChE enzyme, 131-132 Celecoxib, 120 Beclomethasone dipropionate, 334 Cell Beneficence, 467, 469, 470, 474, 483 differentiation, 276-277 Beta agonists/theophylline, 345 surface receptors, 189 Beta-blocker(s), 10, 157, 185, 187, 190-191, 230-232, Centers for Disease Control and Prevention, 95 444 Centers for Medicare & Medicaid Services (CMS), Beta-Blocker Evaluation in Survival Trial, 231 72, 95 Beta-2 adrenergic receptor agonists, 330, 331-333 Central nervous system disorders, 283-308, 447 Beta-adrenergic receptors, 189-190 drug targets for, 192-193 Beta-adrenoreceptor antagonists, 473 valid biomarkers for, 442 Bevacizumab, 204 Ceritinib, 205 Biguanide, 417 Cerivastatin, 14 gene polymorphisms and, 425 Cetuximab, 203, 204, 273 Binding motif, 327, 337 CFTR protein, 341-342 Bioactivation, 127 drugs for, 345-350 Biofilm, 327, 342 dysfunction classification for, 343 Biological fitness, 38 mutations of, 343-344 Biomarker(s), 3, 12-13 Chain termination sequencing, 75-76 disease states and, 201 Chemiluminescence, 74 medications and, 285-290 Chemoattractant, 327, 342 pharmacodynamics and, 183, 184, 201-202 Chemotherapeutic agents, 263-268 toxicogenomics and, 364-365, 367, 369 Children, research on, 483-484 valid. See Valid biomarkers Chlorpropamide, 407, 408 Biotransformation, 111-113 Chromatid, 19, 31 Bipolar disorder, 294-295 Chromosomal aberrations, 34 Bradykinin-mediated cough, 200 Chromosome, 19, 20, 22, 28-29, 32-34, 39-40, 43 Breast cancer, 272-273 Chronic lymphocytic leukemia, 271 Unauthenticated | Downloaded 10/02/21 05:47 PM UTC Index 501 Chronic myelogenous leukemia, 272 CYP1A2, 115-117, 300, 339 Ciclesonide, 334 CYP2A6, 392 Cimetidine, 124 CYP2B6, 117-118 Ciprofloxacin, 314 CYP2C subfamily, 118-122 Cisapride, 198, 199 Citalopram, 286 CYP2C8, 421 Clarification of Optimal Oral Anticoagulation CYP2C9, 118-121, 413-414, 416, 439-440, 443-444 through Genetics, 221-222 CYP2C10, 121-122 Clarithromycin, 199, 313 CYP2C19, 122-124, 413-414, 444, 447, 448 Clearance, 127 CYP2D6, 5, 8, 29, 96, 124-128, 444-445 Cleavage-based assays, 86-87 case study, 62 Cleavase/FRET (fluorescence resonance energy Cysteinyl LT receptor genes, 338 transfer), 87, 88 Cystic fibrosis, 201-202, 328, 340-350 Clinical coordinator, 456 case study, 329 Clinical decision support, 453, 456, 461 Cystic Fibrosis Foundation, 341 Clinical interventions, 453, 456, 457-459 Cytochrome P (CYP), 267-268 Clinical Laboratory Improvement Amendment isoforms of, 111 (CLIA) of 1988, 72, 95 phenotypes, characteristics of, 114-115 Clinical pharmacist/pharmacy specialist, 456 Cytochrome P450 (CYP450), 29, 107 Clinical Pharmacogenetics Implementation CNS and, 292 Consortium, 115, 223, 284, 365-366 drug labeling and, 439-440, 443-444 Clinical practice, 477, 480-481, 491-498 drug metabolism and, 111-112, 115-129 Clinical protocols, 453, 457 isoforms in drug metabolism, 109 Clinical validity, 437 Phase I and, 115-117 Clobazam, 286 Cytosolic receptors, 193 Clomipramine, 286 Clopidogrel, 472 D cardiovascular treatment with, 216, 224-229 Dabigatran, 223 drug labeling of, 444 Dabrafenib, 205, 270, 273 drug metabolism for, 121, 122, 124, 128 Dapagliflozin, 423 Clozapine, 116-117, 286 Dapsone, 313 -induced agranulocytosis, 294 Daptomycin, 314 Darifenacin, 125 Cobimetinib, 205 Dasatinib, 269 Cocaine, 131 Data analysis, 95 Codeine, 126-127, 299 Data interpretation, 61 case study, 110 Deletion mutation, 33 Coding region SNPs, 30 Delta opioid receptor, 386-387 Colorectal cancer, 273 Denaturation, 65, 66 Deoxyribonucleic acid (DNA), 3, 5, 6 Combinatorial probe-anchor ligation, 83-84 amplification of, 64-70 Communitarianism, 472 clinical practice and, 391, 494 Copy number variant polymorphisms, 19 diabetes mellitus and, 405, 418 Copy number variation, 257, 262 genetic basis and, 19-33, 46 Corticosteroids, 345 hematology/oncology and, 258-260, 274-275 infectious disease and, 309, 311 Corticotrophin-releasing hormone receptor-1, 335 isolation of, 64 Cox, Arthur G., 151-181 microarrays of, 90-92 COX inhibitors, 195 pharmacodynamics, pharmacogenomics of, 183, Crizotinib, 205 184, 187, 196-197, 200, 202 Crossover recombination, 40 pharmacogenomics methodologies and, 60, CTRB1, CTRB2, 422 61, 71 preparation of, 61 Culturing, 310-311 sample collection, 63 Cyclic reversible chain termination, 81 sequencing, 75-85 Cyclophosphamide, 117-118, 168, 264, 268 sequencing cost of, 97-98 Cyclosporine, 157 structure of, 23 Unauthenticated | Downloaded 10/02/21 05:47 PM UTC 502 CONCEPTS IN PHARMACOGENOMICS toxicogenomics and, 357, 360-361, 368 ELISA, 321 Dependence, 375, 376, 387 Elongation, of polypeptide chain, 27 Desipramine, 128, 286 Empagliflozin, 423 Dextromethorphan and quinidine, 286 Emulsion PCR, 68, 69 Diabetes mellitus, 405-433 Endocrinology diseases, 446 early development of, 412-413 valid biomarkers for, 440 Diagnostic and Statistical Manual of Mental Endoxifen, 127 Disorders (5th edition), 392 Enhanced Sensitivity Trofile
Load more

Recommended publications
  • !Hcl^S Office Filed Under Seal
    IN THE UNITED STATES DISTRICT COURT P FOR THE DISTRICT OF MASSACHUSETTS !^D !HCL^S OFFICE Civil Action No. 03-10641-NG-RWZ Civil Action No. 11-10398-NG-RWZ UNITED STATES OF AMERICA, et at, ex rel GREGORY W. THORPE and BLAIR HAMRICK, Plaintiffs, v. SMITH KLINE BEECHAM, INC., and GLAXOSMITHKLINE PLC d/b/a GLAXOSMITHKLINE, Defendants. SEVENTH AMENDED COMPLAINT FILED UNDER SEAL PURSUANT TO 31 U.S.C. §§ 3729 etseq. Matthew J. Fogelman, Esquire FOGELMAN & FOGELMAN LLC 100 Wells Avenue William J. Leonard, pro hac vice Newton, MA 02459 Richard P. Limburg, pro hac vice Kimberly D. Sutton, pro hac vice Brian P. Kenney Alex P. Basilevsky,/>/"6> hac vice M. Tavy Deming OBERMAYER REBMANN MAXWELL & Emily C. Lambert HIPPEL LLP KENNEY & McCAFFERTY, PC One Perm Center, 19th floor 3031 Walton Road, Suite C202 1617 John F. Kennedy Boulevard Plymouth Meeting, PA 19462 Philadelphia, PA 19103 A Homeys for Plaintiffs-Relators Gregory W. Thorpe and Blair Hamrick 4612364 TABLE OF CONTENTS I. BACKGROUND.....................................................................................................2 II. PARTIES ................................................................................................................4 III. JURISDICTION AND VENUE............................................................................6 IV. GENERAL ALLEGATIONS...............................................................................7 A. Drugs Marketed By GSK For Off-Label Use...............................................12 1. Advair ...................................................................................................13
    [Show full text]
  • Sleepless No More SUB.1000.0001.1077
    SUB.1000.0001.1077 2019 Submission - Royal Commission into Victoria's Mental Health System Organisation Name: Sleepless No More SUB.1000.0001.1077 1. What are your suggestions to improve the Victorian community’s understanding of mental illness and reduce stigma and discrimination? Australia is unfortunately a country with pervasive Incorrect Information, Lack of Information, Unsubstantiated Information and Out of Date Information about mental health, emotional health and the underlying reasons for emotional challenges. The reason people do not understand emotional challenges, being promoted as “mental illness”, is that they are not being given full and correct, up to date and relevant information. The Australian public is being given information which is coming from the ‘mental health industry’ not information that reduces mental health problems. The information is industry driven. “Follow the money” is a phrase very relevant in this field. People need to be given correct information that empowers them and ensures that they continue to be emotionally resilient. The information being promoted, marketed as ‘de-stigmatising mental health’ has resulted in people incorrectly self-diagnosing and presenting to their medical professionals asking for help with their anxiety (mental health problem), depression (mental health problem), bipolar (mental health problem), etc. Examples of information and mental health developments I do not see mentioned or promoted in Australia as part of making Australians emotionally resilient, and therefore not diagnosed and medicated as mentally ill: The flaws in the clinical trial process, and how to check the strategies being promoted by health care professionals, the government, doctors and psychiatrists. Making Medicines Safer for All of Us.
    [Show full text]
  • What Influences Healthcare Providers' Prescribing Decisions?
    Research in Social and Administrative Pharmacy xxx (xxxx) xxx Contents lists available at ScienceDirect Research in Social and Administrative Pharmacy journal homepage: www.elsevier.com/locate/rsap What influenceshealthcare providers’ prescribing decisions? Results from a national survey Simani M. Price a,*, Amie C. O’Donoghue b, Lou Rizzo a, Saloni Sapru a, Kathryn J. Aikin b a Westat, Inc., Rockville, MD, USA b U.S. Food and Drug Administration, Silver Spring, MD, USA ARTICLE INFO ABSTRACT Keywords: Background: Prior U.S. Food and Drug Administration (FDA) surveys with healthcare providers (HCPs) have Healthcare providers focused on attitudes toward direct-to-consumer advertising and have not specifically examined professionally- Prescription drug promotion targeted prescription drug promotion. Similarly, there are no recent national surveys of HCPs examining their Detailing interactions with the pharmaceutical industry. Pharmaceutical opinion leaders Objectives: The goal of this study was to use a national sample of HCPs to examine exposure to professionally- Off-label prescribing Prescribers targeted prescription drug promotions and interactions with industry, and knowledge, attitudes and practices related to FDA approval of prescription drugs. Methods: An online national survey was conducted with 2000 HCPs representing primary care physicians (PCPs), specialists (SPs), physician assistants (PAs), and nurse practitioners (NPs). The sample was randomly drawn from WebMD’s Medscape subscriber network, stratified by HCP group, and designed to yield target numbers of completed surveys in each group. Weights were computed to correct for unequal selection probabilities, dif­ ferential response rates, and differential coverage and used to generalize completed surveys to a national pop­ ulation of PCPs, SPs, NPs, and PAs.
    [Show full text]
  • Comments to Draft
    March 8, 2021 Institute for Clinical and Economic Review Two Liberty Square, Ninth Floor Boston, MA 02109 Re: Comments to Draft Evidence Report on Anti B-Cell Maturation Antigen CAR T-cell and Antibody Conjugate Therapy for Heavily Pre-Treated Relapsed and Refractory Multiple Myeloma Introduction The Alliance for Regenerative Medicine (ARM) appreciates the opportunity to submit the following comments to the Institute for Clinical and Economic Review (ICER) February 11, 2021 draft report on Anti B-Cell Maturation Antigen CAR T-cell and Antibody Conjugate Therapy for Heavily Pre-Treated Relapsed and Refractory Multiple Myeloma (“Draft Evidence Report”).1 ARM is the leading international advocacy organization dedicated to realizing the promise of regenerative medicines and advanced therapies. ARM promotes legislative, regulatory and reimbursement initiatives to advance this innovative and transformative sector, which includes cell therapies, gene therapies and tissue-based therapies. In its 11-year history, ARM has become the global voice of the sector, representing the interests of 380+ members worldwide, including small and large companies, academic research institutions, major medical centers and patient groups. Although focused on one type of rare cancer, the Draft Evidence Report raises important issues for ARM members because of its potential negative impact on the development of the therapies under review and future therapies. ARM is concerned that the timing of the review prevents ICER from taking into account the FDA’s perspective on the appropriate patient population (i.e., through the label), that of expert providers’ perspectives (i.e., through recognized compendia), and the technology’s durability. Consequently, ARM is concerned that the Draft Evidence Report may harm market and patient access.
    [Show full text]
  • Study 329: Trials Why Is It So Important?
    © July - August 2016 RIAT ; Restoring Invisible and Abandoned Study 329: Trials Why is it so important? tudy 329 is a GlaxoSmithKline (GSK) sponsored trial with S22 academic authors that compared paroxetine, imipra- mine, and placebo for adolescent depression. In this trial 275 safetysaafee adolescents with major depression were randomized in a dou- y ble-blind fashion to paroxetine (93), imipramine (95) or pla- cebo (87) for 8 weeks. Those who completed 8 weeks were efficacy studied in a 6-month continuation phase. Published 8-week results (2001)1: Compared with placebo, paroxetine demonstrated significantly greater improvement in The publications report in detail the methods used 3 selected depression rating scales and a Clinical Global Im- to re-analyze Study 329. Notably, they followed the provement score of 1 or 2. The response to imipramine was protocol (and amendments) established by GSK7 not significantly different from placebo for any measure. and used all appropriate procedural steps to avoid Authors’ conclusions: “Paroxetine is generally well tol- bias. They have also made the original anonymous erated and effective for major depression in adolescents.”1 patient data available for others to analyze. This trial has been cited over 600 times and was very influ- RIAT analysis of Study 329 ential in increasing prescribing of paroxetine in this clinical (acute phase) setting.2 The trial protocol7 specified two primary effica- Did these published conclusions reflect cy variables: change in total score on a Hamilton “reality”? depression rating scale (HAM-D) from baseline Critical appraisal of the 2001 publication would have led to endpoint, and the proportion of responders at to questions about the authors’ conclusions.
    [Show full text]
  • In Re: Glaxosmithkline Plc Securities Litigation 05-CV-3751
    UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF NEW YORK __________________________________________ ) In re: GlaxoSmithKline plc Securities ) Civil Action No. 05 CIV. 3751 (LAP) Litigation ) ) DEMAND FOR JURY TRIAL __________________________________________) CONSOLIDATED SECOND AMENDED COMPLAINT JURISDICTION AND VENUE 1. The claims asserted herein arise under §§ 10(b) and 20(a) of the Securities Exchange Act of 1934 (“1934 Act”) and Rule 10b-5. Jurisdiction is conferred by § 27 of the 1934 Act, and 28 U.S.C. §1331. Venue is proper here pursuant to § 27 of the 1934 Act. GlaxoSmithKline plc and SmithKline Beecham Corporation doing business as GlaxoSmithKline plc (collectively “GSK”) is headquartered in London, England, but conducts business in this District. GSK’s ADRs trade on the New York Stock Exchange headquartered in this District. THE PARTIES 2. Lead Plaintiff Joseph J. Masters (“Plaintiff”) acquired publicly traded securities of GSK during the Class Period and was damaged thereby. 3. Defendant GlaxoSmithKline plc is a public company. GlaxoSmithKline plc’s ADRs trade in an efficient market on the NYSE under the symbol “GSK.” GlaxoSmithKline plc’s ordinary shares trade in an efficient market on the London Stock Exchange. Defendant SmithKline Beecham Corporation is a Delaware corporation, which is a wholly-owned subsidiary of GlaxoSmithKline plc. GlaxoSmithKline plc was created in December 2000 when Glaxo Wellcome merged with SmithKline Beecham. Both GlaxoSmithKline plc and SmithKline Beecham, as well as all of their predecessors, subsidiaries and successors, are referred to herein collectively as “GSK.” 4. Defendant Jean-Pierre Garnier (“Garnier”) was CEO and Chairman of GSK throughout the Class Period. By reason of his position, Garnier had access to material inside information about GSK and was able to control directly or indirectly the acts of GSK and the contents of the representations disseminated during the Class Period by or in the name of GSK.
    [Show full text]
  • Annotated Bibliography of Published Studies Addressing Searching for Unpublished Studies and Obtaining Access to Unpublished Data
    Providing consultancy and research in health economics for the NHS, pharmaceutical and health care industries since 1986 Annotated bibliography of published studies addressing searching for unpublished studies and obtaining access to unpublished data MICK ARBER, Information Specialist MARIA CIKALO, Associate JULIE GLANVILLE, Associate Director CAROL LEFEBVRE, Associate DANIELLE VARLEY, Research Assistant HANNAH WOOD, Information Specialist JUNE 2013 Contents Page No. Acknowledgements Section 1: Introduction 1 1.1 Introduction 1 1.2 Objectives 1 Section 2: Methods 2 2.1 Criteria for considering studies for this Annotated Bibliography 2 2.2 Search methods for identification of studies 3 Section 3: Results 5 3.1 Search results 5 3.2 Structured abstracts 6 Appendices: Appendix A: Search Strategies Appendix B: Papers which we have not been able to obtain and / or assess for relevance All reasonable precautions have been taken by YHEC to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall YHEC be liable for damages arising from its use. Acknowledgements We are grateful to the following individuals and their colleagues, who supplied copies of their publications or information about their publications: Iain Chalmers Kay Dickersin Jini Hetherington Sally Hopewell Chris Hyde Tom Jefferson John Kirwan Steve McDonald David Moher Lorenzo Moja Helen Worthington How to cite this document: Arber M, Cikalo M, Glanville J, Lefebvre C, Varley D, Wood H. Annotated bibliography of published studies addressing searching for unpublished studies and obtaining access to unpublished data.
    [Show full text]
  • Psychiatry Research Review Issue 39
    Psychiatry Research Review TM Making Education Easy Issue 39 – 2015 Welcome to issue 39 of Psychiatry Research Review. In this issue: An association exists between selective serotonin reuptake inhibitors (SSRIs) and violent crime, report researchers from the University of Oxford. In particular, subgroup analysis highlighted that this association was evident in people aged Reanalysis of Study 329: 15–24 years, but not significant for those aged ≥25 years. As the study authors note, the data do not prove causation, paroxetine efficacy disputed since possible confounding by one or more unidentified factors linked to both SSRI use and violent crime may explain the results. Nevertheless, the data have good credibility: this was a large study from Sweden, involving about 850,000 An association between individuals (10.8% of the Swedish population) who were prescribed SSRIs over the 3-year study period; 1% of these SSRIs and violent crime individuals were convicted of a violent crime. In another study, a research group from Wellington, New Zealand, linked national breast and colorectal cancer registrations (2006–2010) in order to explore cancer survival in the context of mental illness. Their data attest to poorer CBT improves insomnia survival after diagnosis with breast or colorectal cancer among men and women with a history of recent psychiatric associated with comorbid service use compared with those without such a history. The researchers call for further investigation of the cancer mental illness treatment journey amongst those with experience of mental illness, to help explain this survival difference. We hope you find this issue useful for your daily practice and we welcome any comments or feedback.
    [Show full text]
  • Registration, Results Reporting, and Publication Bias of Clinical Trials Supporting FDA Approval of Neuropsychiatric Drugs Befor
    Zou et al. Trials (2018) 19:581 https://doi.org/10.1186/s13063-018-2957-0 RESEARCH Open Access Registration, results reporting, and publication bias of clinical trials supporting FDA approval of neuropsychiatric drugs before and after FDAAA: a retrospective cohort study Constance X. Zou1, Jessica E. Becker2,3,4, Adam T. Phillips5, James M. Garritano1, Harlan M. Krumholz6,7,8, Jennifer E. Miller9 and Joseph S. Ross7,8,9* Abstract Background: Mandatory trial registration, and later results reporting, were proposed to mitigate selective clinical trial publication and outcome reporting. The Food and Drug Administration (FDA) Amendments Act (FDAAA) was enacted by Congress on September 27, 2007, requiring the registration of all non-phase I clinical trials involving FDA- regulated medical interventions and results reporting for approved drugs. The association between FDAAA enactment and the registration, results reporting, and publication bias of neuropsychiatric trials has not been studied. Methods: We conducted a retrospective cohort study of all efficacy trials supporting FDA new drug approvals between 2005 to 2014 for neuropsychiatric indications. Trials were categorized as pre- or post-FDAAA based on initiation and/or completion dates. The main outcomes were the proportions of trials registered and reporting results in ClinicalTrials.gov, and the degree of publication bias, estimated using the relative risks pre- and post-FDAAA of both the publication of positive vs non-positive trials, as well as of publication of positive vs non-positive trials without misleading interpretations. Registration and results reporting proportions were compared pre- and post-FDAAA using the two-tailed Fisher exact test, and the degrees of publication bias were compared by calculating the ratio of relative risks (RRR) for each period.
    [Show full text]
  • Psychotropic Medication Utilization Parameters for Children and Youth in Behavioral Health
    Psychotropic Medication Utilization Parameters for Children and Youth in Texas Public Behavioral Health (6th Version) Developed by: The Parameters Workgroup of the Psychiatric Executive Formulary Committee, Health and Specialty Care Division, Texas Health and Human Services Commission Review and Input Provided by: The University of Texas at Austin College of Pharmacy The UT System Medical Schools Texas A&M Health Science Center Texas Tech University Health Sciences Center June 2019 Table of Contents Table of Contents ........................................................................................... 2 Introduction and General Principles .................................................................. 5 Role of Primary Care Providers ............................................................... 7 General Principles ................................................................................. 7 Use of Psychotropic Medication in Preschool Age Children ........................... 9 Treatment of Opioid Use Disorders in Adolescents ................................... 10 Levels of Warnings Associated with Medication Adverse Effects ................. 11 Criteria Indicating Need for Further Review of a Child’s Clinical Status ....... 12 Usual Recommended Doses ........................................................................... 13 Stimulants for Treatment of ADHD ........................................................ 14 Amphetamine mixed salts ........................................................... 14 Amphetamine sulfate
    [Show full text]
  • Study 329 Suggests Paroxetine to Exert An
    STUDY 329 SUGGESTS PAROXETINE TO EXERT AN ANTIDEPRESSANT EFFECT IN CHILDREN AND ADOLESCENTS Alexander Lisinski, Fredrik Hieronymus, Staffan Nilsson, Elias Eriksson Department of Pharmacology, Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Sweden Background In a recent paper in BMJ (1), Le Noury and co-workers reanalysed the results of a previously published clinical trial (Study 329) (2) addressing the tolerability and efficacy of paroxetine in adolescent depression. Noting that paroxetine did not outperform placebo with respect to the primary effect variable, the total score of the Hamilton depression rating scale (HDRS 17-sum), they concluded that paroxetine did not show efficacy. In order to shed further light on this issue, we have undertaken additional analyses of the data from Study 329. Methods Effect sizes and p-values for the difference between paroxetine and placebo were assessed using linear mixed models for each individual HDRS 17 item i) in all subjects, ii) after excluding subjects reporting <1 on the item in question at baseline and iii) after also excluding those below age 13. Figure 1 Results As reported in the original report by All subjects >= 1p baseline >= 1p, > 13 years Keller and co-workers, paroxetine 0.8 outperformed placebo with respect to * * p < 0.05 reduction in depressed mood, the * * * effect size being relatively large (0.61); 0.6 * in addition, a significant difference was obtained also in the item guilt (ES * * * 0.47). After exclusion of subjects 0.4 * displaying baseline rating <1 for the item in question, no further Effect Size differences were revealed between 0.2 the groups.
    [Show full text]
  • Modèle Word Thèse Et Mémoire
    Université de Montréal Comparison between two different antibiotic regimens for the placement of dental implants: A phase-I randomized clinical trial Par Issam Kersheh Département de santé buccale Faculté de médecine dentaire Université de Montréal Mémoire présenté à la Faculté des études supérieures et postdoctorales en vue de l’obtention du grade de Maîtrise ès Sciences (M.Sc.) en sciences buccodentaires Juillet 2017 © Issam Kersheh, 2017 Université de Montréal Faculty of Graduate and Postdoctoral Studies This thesis entitled: Comparison between two different antibiotic regimens for the placement of dental implants: A phase-I randomized clinical trial By Issam Kersheh Was evaluated by a jury composed of the following members: Dr. Elham Emami, President of the jury Dr. Robert Durand, Thesis supervisor Dr. Nathalie Rei, Thesis co-supervisor Dr. Marie-Andrée Houle, Member of the jury Résumé Introduction : Afin de minimiser la morbidité postopératoire après une chirurgie implantaire, plusieurs régimes d’antibiotiques péri-opératoires ont été suggérés, mais leurs effets sur le remodelage osseux péri-implantaire n’a pas été clairement établi. De plus, l’utilisation répandue des antibiotiques en médecine dentaire et en médecine est remise en question étant donné l’émergence récente des résistances bactériennes aux antibiotiques. Objectifs : L’objectif primaire de cette étude pilote était de produire des données préliminaires et d’évaluer si des doses postopératoires d’antibiotiques après la pose d’implant prises sur sept jours influenceraient les niveaux osseux péri-implantaires après 4 mois chez les patients en santé subissant la pose simple d’un implant de type « platform-switching ». Les objectifs secondaires étaient d’évaluer la sévérité de la douleur, la morbidité postopératoire, et le taux de survie après un an.
    [Show full text]