Effectiveness, toxicity and safety of opioid and benzodiazepine substitutes

阿片类药物和苯二氮卓类替代品的有效性、毒性和安全性

基本信息

批准号：
10393057
负责人：
Yong-Fang Kuo
金额：
$ 35.55万
依托单位：
UNIVERSITY OF TEXAS MED BR GALVESTON
依托单位国家：
美国
项目类别：
财政年份：
2016
资助国家：
美国
起止时间：
2016-09-15 至 2024-04-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10393057
关键词：
Acceleration Address Anxiety Benzodiazepines Cancer Patient Cancer Survivor Centers for Disease Control and Prevention (U.S.)Chronic Clinical Data Data Analytics Data Mart Data Set Databases Dentists Disabled Persons Disease Dose Drug Combinations Drug toxicity Effectiveness Elderly Emergency department visit Fracture Frequencies Guidelines Health Insurance Home Care Services Hospitalization Hydrocodone Knowledge Laws Measures Medical Marijuana Medicare Methods Norepinephrine Nurse Practitioners Operative Surgical Procedures Opioid Opioid Rotation Outcome Outcome Assessment Pain Pain management Patients Pattern Persons Pharmaceutical Preparations Physical Function Physician Assistants Physicians Policies Population Prevention Guidelines Provider Publications Reporting Research Risk Role Safety Scanning Schedule Selective Serotonin Reuptake Inhibitor Series Serotonin Sertraline Sleep Sleep Apnea Syndromes Sleeplessness Time Toxic effect Trees Variant Vertebral column aged analytical method base data mining disability dosage effectiveness study falls federal policy gabapentin high risk high risk population improved inhibitor longitudinal analysis multilevel analysis opioid mortality opioid overdose opioid policy opioid use opioid user pregabalin prescription opioid provider factors reuptake zolpidem

项目摘要

Project Summary/Abstract In 2016, the Centers for Disease Control and Prevention (CDC) issued guidelines for “all prescribers to avoid co-prescribing of benzodiazepine (benzo) and opioids”. Other guidelines also advise against benzos for anxiety because safer substitutes exist (serotonin–norepinephrine reuptake inhibitors [SNRIs] and selective serotonin reuptake inhibitors [SSRIs]). Since the 2016 CDC guideline, use of gabapentinoids as an opioid substitute has risen. While recent data showed a decline in opioid prescribing rates after publication of the CDC guideline, a knowledge gap exists in terms of the rates, effectiveness and safety of opioid/benzo substitute prescribing and co-prescribing, especially in populations at high risk of drug toxicity: persons living with disabilities, the elderly and Medicare enrollees in home health care. We now propose to address this gap in knowledge by comprehensively evaluating the toxicity and effectiveness of opioid and benzo substitutes, alone or in combination, compared to opioids and benzos. We anticipate the emergence of previously unrecognized toxicities from drug substitution and co-prescribing. Our Specific Aims are: 1. Assess temporal change in prescribing rates of opioids, opioid substitutes, benzos and benzo substitutes and their co-prescribing among commercially insured and Medicare patients, and the role of provider, patient, federal and state policy on drug substitution and co-prescribing. 2. Examine toxicities (e.g., falls, fractures, emergency room visits) related to substitutes for opioids and benzos, and how toxicities vary with different combinations of drug substitution and co-prescribing, using longitudinal data analytic methods as well as data mining methods for previously unrecognized toxicities. 3. Examine changes in physical function and measures of pain and anxiety in Medicare enrollees prescribed substitutes for both opioids and benzos, and how these outcomes vary with different combinations of drug substitution and co-prescribing among Medicare enrollees in home health care. We will use 20% national Medicare data to identify the elderly and the disabled Medicare populations, and the Clinformatics Data Mart to identify commercially insured populations. Our overall hypotheses is that the substitute drugs, alone or in combination, have considerably lower rates of serious toxicity than do opioids and benzos, with similar effectiveness in many clinical situations. If this is the case, its demonstration by our proposed research should result in acceleration in the shift away from opioids and benzos to safer alternatives.

项目概要/摘要 2016 年，美国疾病控制与预防中心 (CDC) 发布了指导方针，要求“所有处方者避免使用其他指南也建议不要使用苯并类药物来治疗焦虑。因为存在更安全的替代品（血清素-去甲肾上腺素再摄取抑制剂 [SNRIs] 和选择性血清素自 2016 年 CDC 指南以来，已使用加巴喷丁类药物作为阿片类药物替代品。尽管最近的数据显示，在 CDC 指南发布后，阿片类药物的处方率有所下降，但在阿片类药物/苯并替代品的处方率、有效性和安全性方面存在知识差距共同处方，特别是在药物毒性高风险人群中：残疾人、老年人我们现在建议通过以下方式解决这一知识差距。综合评价阿片类药物和苯并替代品单独或联合使用的毒性和有效性与阿片类药物和苯并类药物相比，我们预计会出现以前未被识别的药物。我们的具体目标是： 1. 评估药物替代和联合处方的毒性。阿片类药物、阿片类替代品、苯并类药物和苯并替代品的处方率及其共同处方商业保险和医疗保险患者，以及提供者、患者、联邦和州药物政策的作用替代和共同处方 2. 检查与相关的毒性（例如跌倒、骨折、急诊室就诊）。阿片类药物和苯并类药物的替代品，以及药物替代品和苯并类药物的不同组合的毒性如何变化共同处方，使用纵向数据分析方法以及先前的数据挖掘方法 3. 检查身体机能的变化以及疼痛和焦虑的测量医疗保险参保者开出了阿片类药物和苯并类药物的替代品，以及这些结果如何随药物的变化而变化家庭医疗保健中医疗保险参保者之间药物替代和共同处方的不同组合。我们将使用20%的全国医疗保险数据来识别老年人和残疾人医疗保险人群，并且我们的总体假设是，通过临床信息学数据集市来识别商业保险人群。单独或与阿片类药物联合使用的替代品，其严重毒性发生率比阿片类药物和药物要低得多苯并类药物在许多临床情况下具有类似的功效如果是这种情况，我们的证明。拟议的研究应该会加速从阿片类药物和苯并类药物转向更安全的替代品。