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1.
J Affect Disord ; 290: 324-333, 2021 Jul 01.
Artigo em Inglês | MEDLINE | ID: mdl-34020207

RESUMO

BACKGROUND: Major depressive and bipolar disorders are associated with impaired quality of life and high economic burden. Although progress has been made in our understanding of the underlying pathophysiology and the development of novel pharmacological treatments, a large unmet need remains for finding effective treatment options. The purpose of this study was to identify potential new mechanisms of actions or treatment targets that could inform future research and development opportunities for major depressive and bipolar disorders. METHODS: A self-controlled cohort study was conducted to examine associations between 1933 medications and incidence of major depressive and bipolar disorders across four US insurance claims databases. Presence of incident depressive or bipolar disorders were captured for each patient prior to or after drug exposure and incident rate ratios were calculated. Medications that demonstrated ≥50% reduction in risk for both depressive and bipolar disorders within two or more databases were evaluated as potential treatment targets. RESULTS: Eight medications met our inclusion criteria, which fell into three treatment groups: drugs used in substance use disorders; drugs that affect the cholinergic system; and drugs used for the management of cardiovascular-related conditions. LIMITATIONS: This study was not designed to confirm a causal association nor inform current clinical practice. Instead, this research and the methods employed intended to be hypothesis generating and help uncover potential treatment pathways that could warrant further investigation. CONCLUSIONS: Several potential drug targets that could aid further research and discovery into novel treatments for depressive and bipolar disorders were identified.

2.
Curr Med Res Opin ; : 1-8, 2021 Apr 29.
Artigo em Inglês | MEDLINE | ID: mdl-33818238

RESUMO

BACKGROUND: Following a partial response of first-line antidepressant therapy for the treatment of major depressive disorder (MDD), there is a choice to augment treatment with another agent or switch to a different antidepressant. OBJECTIVE: To report the prevalence and compare the characteristics of patients switching from their initial selective serotonin reuptake inhibitor or serotonin-norepinephrine reuptake inhibitor (SSRI/SNRI) to a new SSRI/SNRI versus those augmenting SSRI/SNRI therapy with a second-generation antipsychotic (SGA). METHODS: MDD patients receiving first-line SSRI/SNRI treatment were identified from a large US-based claims database during 2000-2019. Patients augmenting therapy with an SGA were compared with those who switched to a new SSRI/SNRI. The date of the treatment change was the index date. Previously diagnosed comorbid conditions, medication use and demographics were captured. Treatment patterns following the index date were also captured. Standardized differences (StdDiff) were used to quantify dissimilarities between the two groups. RESULTS: There were 4572 SGA add-on and 24,409 switching patients identified. SGA augmentation patients had more severe disease (diagnosed severe recurrent major depression: 24.7% vs. 9.5%, StdDiff = 0.41) and more diagnosed psychiatric conditions, including: suicidal thoughts (10.7% vs. 3.2%, StdDiff = 0.29), post-traumatic stress disorder (6.1% vs. 2.6%, StdDiff = 0.17) and alcohol abuse (5.4% vs. 2.7%, StdDiff = 0.14). SGA augmentation patients had higher rates of prior use of anxiolytics (37.4% vs. 28.2%, StdDiff = 0.20) and anticonvulsants (26.0% vs. 13.1%, StdDiff = 0.33). CONCLUSIONS: Patients adding an SGA to their SSRI/SNRI therapy appeared to have more severe depression and comorbid psychiatric profile than those switching their SSRI/SNRI. These differences are important to consider and adequately control for in any future comparative outcome research between these two groups.

3.
CNS Drugs ; 35(2): 243-251, 2021 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-33537916

RESUMO

BACKGROUND: Observational data may inform novel drug development programs by identifying previously unappreciated, clinical benefits of existing drugs. Several preclinical and clinical studies have suggested emergent therapeutic utility of drugs acting on the N-methyl-D-aspartate (NMDA) receptor, a subtype of glutamate receptors, including the antidementia drug memantine. METHODS: Using a self-controlled cohort study design, the association of exposure to the NMDA receptor antagonist memantine with the incidence of all observed disease outcomes in four US administrative claims databases, spanning from January 2000 through January 2019, was assessed. The databases used in this study were the IBM MarketScan® Commercial Database (CCAE), the IBM MarketScan® Multi-State Medicaid Database (MDCD), the IBM MarketScan® Medicare Supplemental Database (MDCR), and the Optum©â€¯De-Identified Clinformatics® Data Mart Database. Outcomes were defined according to the unique Systematized Nomenclature of Medicine-Clinical Terms (SNOMED CT) classification system codes and required a diagnosis on two or more distinct dates. Of 20,953 outcomes assessed, only those for which memantine was associated with a ≥ 50% reduction in risk in two or more databases were included. A meta-analysis with random effects was used to pool data across the databases. RESULTS: Overall, 312,336 patients were exposed to memantine during the study. After removing conditions related to dementia and memory loss, 60 outcomes met the threshold criteria. Results fell into five disease categories: mental disorders, substance use disorders, pain, gastrointestinal and colon disorders, and demyelinating disease. The bulk of findings fell into the first two groups, with 28 outcomes related to mental disorders and 24 related to substance use disorders. CONCLUSION: The present results confirm that NMDA receptor antagonism may have broader therapeutic utility than previously recognized. Further observational and clinical research may be warranted to explore the therapeutic benefit of NMDA antagonists for the outcomes found in this study.

4.
J Affect Disord ; 283: 262-264, 2021 03 15.
Artigo em Inglês | MEDLINE | ID: mdl-33571795

RESUMO

In the absence of head-to-head studies directly comparing the efficacy of intranasal esketamine to that of intravenous ketamine, valid conclusions regarding comparative efficacy cannot be made based on the existing data from trials using markedly differing study designs and patient populations.


Assuntos
Transtorno Depressivo Maior , Transtorno Depressivo Resistente a Tratamento , Ketamina , Antidepressivos/uso terapêutico , Depressão , Transtorno Depressivo Maior/tratamento farmacológico , Transtorno Depressivo Resistente a Tratamento/tratamento farmacológico , Humanos , Ketamina/uso terapêutico
5.
Depress Anxiety ; 38(5): 521-527, 2021 05.
Artigo em Inglês | MEDLINE | ID: mdl-33475213

RESUMO

INTRODUCTION: It is critical to assess who is being treated with a new marketed drug like esketamine to understand how it is used in the real-world setting and the effects of the medication. METHODS: Retrospective analysis using two large U.S. health care databases that included commercially insured and Medicaid patients. Patients treated with esketamine were identified and their baseline characteristics described and compared with the baseline characteristics of patients with treatment resistant depression (TRD) and with patients undergoing transcranial magnetic stimulation (TMS). To quantify the differences, standardized mean differences were calculated. RESULTS: In the commercially insured database, 418 patients were treated with esketamine and 830,047 patients were in the TRD group. Large differences in baseline characteristics were observed. Patients in the esketamine group were more likely to have severe depression, suicidal thoughts, and prior treatments with TMS or electroconvulsive therapy than the TRD control group. Patients in the esketamine group had more comorbid psychiatric conditions (anxiety disorder, posttraumatic stress disorders, substance use disorders) and higher exposure to antipsychotics, antiepileptics, hypnotics and sedatives. In terms of general health, patients in the esketamine group had many more outpatient visits, were more likely to have chronic pain and higher Charlson comorbidity scores, a predicator of mortality. Results were similar for both the Medicaid and TMS populations. CONCLUSION: Patients treated with esketamine have a higher burden of disease than other patients with TRD. In any real-world comparative effectiveness or safety study these differences need to be understood and accounted for to produce valid results.


Assuntos
Transtorno Depressivo Resistente a Tratamento , Antidepressivos/uso terapêutico , Efeitos Psicossociais da Doença , Transtorno Depressivo Resistente a Tratamento/tratamento farmacológico , Transtorno Depressivo Resistente a Tratamento/epidemiologia , Humanos , Ketamina , Estudos Retrospectivos
6.
Ther Innov Regul Sci ; 2020 Nov 09.
Artigo em Inglês | MEDLINE | ID: mdl-33165761

RESUMO

BACKGROUND: An important component of a systematic strategy for safety surveillance is prospective identification of anticipated serious adverse events (SAEs). Developing a structured approach to identify anticipated events and estimating their incidence can help align the safety strategy and the safety surveillance efforts. METHODS: We developed a novel approach to identify anticipated events for a hypothetical randomized, double-blind, controlled trial in subjects with bipolar disorder using the adverse events reported in the placebo arm of trials from the ClinicalTrials.gov database. We searched the ClinicalTrials.gov database for all trials on bipolar depression with similar inclusion/exclusion criteria and study duration as our hypothetical study. The frequencies of anticipated events in placebo arms were abstracted from each trial and 95% confidence intervals (CI) were calculated using the Clopper-Pearson method. Meta-analysis with a random effects model was performed to obtain a summary estimate and 95% CI for the events identified in more than one trial. RESULTS: A total of 129 clinical trials were initially identified, and 18 were ultimately selected as they met all the selection criteria. There were 69 unique anticipated SAEs identified, and 13 out of 69 were reported in at least 2 clinical trials. The top 5 anticipated SAEs for our study were: (1) hospitalization, psychiatric symptom (3.57%); (2) suicidal behavior, overdose (3.57%), (3) cholecystitis (2.86%); (4) fall (2.86%); (5) road traffic accident, injury (2.86%). CONCLUSION: We successfully identified the anticipated events from registered trials that included a population similar to our trial. This method for identifying anticipated events could be applied to other disease areas.

7.
J Pain Res ; 13: 2431-2442, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-33061558

RESUMO

Introduction: Opioid overdose deaths in the United States have climbed sharply over the past two decades. Simultaneously, increased awareness of inadequately treated chronic pain has resulted in increased opioid analgesic prescribing. The correlation between these two phenomena has led policymakers to posit that they are causally linked, and to implement policy changes supporting safe opioid prescribing. Purpose: To evaluate the impact of its Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) program, the US Food and Drug Administration (FDA) requested the opioid manufacturers responsible for implementing that program provide information regarding opioid policy changes from 2016 to 2018. FDA also requested a survey of state requirements for pain and opioid prescribing continuing education (CE), the number of prescribers affected by those requirements, the extent to which a REMS-compliant CE program would meet each state's requirements, and the number of relevant CE programs available. Results: Results indicate that 527 federal and state opioid-related policies (statutes, rules/regulations, and guidelines) were approved during the 2016-2018 study period. While the largest number of these policies focused on prescription drug monitoring programs, 170 specifically imposed limits on opioid prescribing and an additional 35 specifically referred to, or incorporated, the Centers for Disease Control and Prevention opioid prescribing guideline. We also found that 46 states and the District of Columbia mandated some amount of pain or opioid prescribing CE for prescribers renewing their licenses. These mandates potentially affected as many as 1.7 million prescribers. In 69% of cases, a REMS-compliant CE program would fully meet the state mandates for various types of prescribers. Conclusion: The severity and complexity of the problems of pain management and opioid overdose have led to large-scale intervention by policymakers. Assessing the impact of these changes is difficult, at best, but will be necessary if interventions are to be refined to increase their effectiveness.

8.
Pain Med ; 2020 Oct 27.
Artigo em Inglês | MEDLINE | ID: mdl-33106880

RESUMO

OBJECTIVE: To conduct a retrospective analysis of sequential cross-sectional data of opioid prescribing practices in patients with no prior history of opioid use. METHODS: Individuals filling an oral opioid prescription who had 1 year of prior observation were identified from four different administrative claims databases for the period between January 1, 2002, and December 31, 2018: IBM MarketScan® Commercial Database (CCAE), Multi-State Medicaid Database (MDCD), Medicare Supplemental Database (MDCR), and Optum©â€¯De-Identified Clinformatics® Data Mart Database. Outcomes included incidence of new opioid use and characteristics of patients' first opioid prescription, including dispensed morphine milligram equivalent (MME) per day, total MME dispensed, total MME ≥300, and days' supply of prescription for ≤3 or ≥30 days. RESULTS: There were 40,600,696 new opioid users identified. The incidence of new opioid use in the past 17 years ranged from 6% to 11% within the two commercially insured databases. Incidence decreased over time in MDCD and was consistently higher in MDCR. Total MME dispensed decreased in MDCD and increased in CCAE, with no major changes in the other databases. The proportion of patients receiving ≥30-day prescriptions decreased and the proportion of patients receiving ≤3-day prescriptions increased in MDCD, while ≥30-day prescriptions in the Optum database dramatically increased (low of 3.0% in 2003 to peak of 16.9% in 2017). CONCLUSIONS: Opioid prescribing practices varied across different populations of insured individuals during the past 17 years. The most substantial changes in opioid prescriptions over time have occurred in MDCD, with reductions in use across multiple metrics.

10.
BMC Neurol ; 20(1): 296, 2020 Aug 11.
Artigo em Inglês | MEDLINE | ID: mdl-32781983

RESUMO

BACKGROUND: The treatment landscape for multiple sclerosis (MS) is quickly evolving. Understanding real-world treatment patterns of patients is necessary to identifying potential gaps in care. METHODS: Patients with incident MS were identified from a large national claims database during 1/1/2014-6/30/2019. Patients had ≥2 diagnoses for MS or an inpatient hospitalization with a primary diagnosis of MS. Patients were required to have enrollment in the database ≥1 year prior to and ≥ 1 year following their first MS diagnosis. Treatment sequences were captured for all available disease modifying therapies (DMTs) during all available follow-up. Presence of comorbid conditions were captured during the one year prior to and following (and including) the index date; absolute change in prevalence from the pre- to post-index periods was calculated. RESULTS: We identified 5691 patients with incident MS. Common comorbidities included physical symptoms (e.g., pain, weakness, fatigue), mental health conditions (anxiety, depression), and cardiovascular/metabolic conditions (hypertension, hyperlipidemia, diabetes, obesity). Just 1994 (35.0%) of patients received a DMT at any time during follow-up. Of those receiving a DMT, 28.2% went on to receive a second line of therapy, 5.8% received a third, and just 0.9% went on to a fourth line. Use of more than one DMT concomitantly occurred in just 1.8% of all treated patients. Glatiramer and dimethyl fumarate were by far the most common first-line treatments received accounting for nearly 62% of patients receiving a DMT. CONCLUSION: Approximately two-thirds of patients newly diagnosed with MS did not receive a DMT and the disease is accompanied by a significant comorbid burden.

11.
J Clin Lipidol ; 14(4): 515-521, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32622845

RESUMO

BACKGROUND: Reports suggest low levels of cholesterol are associated with depression. However, results have not been replicated, the direction of the associations among types of cholesterol levels is not consistent, there is large study heterogeneity, and many studies have small samples. OBJECTIVE: The objective of the study was to assess the association of cholesterol with depression. METHODS: This is a cross-sectional study using the National Health and Nutrition Examination Survey (NHANES). The NHANES is a research program that collects health information from a representative U.S. SAMPLE: We included subjects aged ≥18 years who responded to NHANES surveys from 2009 to 2015. Subjects were classified as having major depression if the Patient Health Questionnaire scores were ≥10. Exposures were total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, and triglyceride levels. We considered the age, body mass index, gender, smoking, alcohol use, health status, and exposure to statins and antipsychotics as potential confounders. To assess the association of the exposures with depression, we used decision tree and logistic regression models. RESULTS: A total of 19,527 subjects were analyzed, and 8% had depression. Subjects with depression were more likely to be women and smokers, and to have higher body mass index, poor health, higher levels of total cholesterol and triglycerides and lower levels of high-density lipoprotein cholesterol than subjects with no depression. After adjustment, low levels of total cholesterol (<129 mg/dL) were associated with decreased risk of depression compared with higher levels, OR = 0.64 and 95% CI (0.42-0.98). CONCLUSION: This large population-based study found no association of low cholesterol or any other lower type of cholesterol levels with increased risk of depression. These findings are generalizable to the U.S.

12.
Pain Med ; 21(9): 1818-1824, 2020 09 01.
Artigo em Inglês | MEDLINE | ID: mdl-32529224

RESUMO

OBJECTIVE: Refilling an opioid prescription early is an important risk factor of prescription opioid abuse and misuse; we aimed to understand the scope of this behavior. This study was conducted to quantify the prevalence and distribution of early refills among patients prescribed opioids. METHODS: We conducted a retrospective cohort study utilizing dispensed prescription records. Patients filling one or more prescription opioids were identified and followed for one year. Early refills were defined as having a second prescription filled ≥15% early relative to the days' supply of the previous prescription for the same opioid (according to the National Drug Code [NDC]). The distribution of the number of early refills and patient characteristics were assessed. RESULTS: A total of 60.6 million patients met the study criteria; 28.8% had two or more opioid prescriptions for the same opioid during follow-up. Less than 3% of all patients receiving an opioid had an early refill. Approximately 10% of those with two or more opioid prescriptions for the same drug had an early refill. For patients with multiple fills (N = 1.5 million with extended-release long-acting [ER/LA] opioids; N = 17.1 million with immediate-release short-acting [IR/SA] opioids), early refills were more common among patients with an ER/LA opioid (18.5%) compared with an IR/SA opioid (8.7%). Three-quarters of patients with an early refill had only one (70.9% and 78.4% for ER/LA and IR/SA, respectively). CONCLUSION: Refilling an opioid prescription with the same opioid early is an infrequent behavior within all opioid users, but more common in ER/LA users. Patients who refilled early tended to do so just once.

13.
J Pain Res ; 13: 689-701, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32308468

RESUMO

Background/Rationale: Little is known about the reasons for visiting multiple doctors/pharmacies, known as doctor/pharmacy shopping, to obtain opioids. Objective: To investigate patients' self-reported reasons for doctor/pharmacy shopping and assess whether doctor/pharmacy shopping behavior can be used as a surrogate measure of opioid abuse/misuse. Methods: We conducted a cross-sectional web-based survey among adult patients with ≥2 pharmacy claims for immediate-release or extended-release/long-acting opioids between 7/1/2015 and 12/31/2016, identified from a large United States (US) commercial claims database. Patients were classified into no, mild, moderate, or severe shopping categories based on their claims. Reasons for doctor/pharmacy shopping and opioid abuse/misuse were determined from patient responses to the Prescription Opioid Misuse and Abuse Questionnaire. Results: A random sample of 10,081 patients was invited to participate in the survey and 1085 (11%) completed surveys. The most frequently reported reasons for doctor/pharmacy shopping were convenience, availability, price, and multiple morbidities requiring pain management. Among patients in the no, minimal, moderate, and severe shopping categories, only 7.8%, 8.5%, 11.8% and 12.6% reported opioid abuse/misuse, respectively. Conclusion: In this commercially-insured population, patient-reported reasons for doctor/pharmacy shopping do not suggest opioid abuse/misuse. Less than 15% of patients with shopping behavior in the past 3 months reported any reasons attributable to opioid abuse/misuse, indicating that shopping behavior in this population may not be a good surrogate for abuse/misuse.

14.
Psychiatry Res ; 285: 112810, 2020 Jan 28.
Artigo em Inglês | MEDLINE | ID: mdl-32062326

RESUMO

This study sought to: 1. determine the frequency of rehospitalization with diagnosis of suicidal ideation or suicide attempt (SI/SA) within a year and how often patients had multiple rehospitalizations; 2. identify the time period for which the risk of rehospitalization is highest; and 3. determine the characteristics of patients with multiple rehospitalizations. We conducted a retrospective cohort study of adults with depression using 4 US health claims databases. We defined hospitalization as an inpatient or emergency room visit with codes indicating a suicide attempt or suicidal thoughts using a validated algorithm. Rates of rehospitalization with SI or SA were analyzed together and separately, including multiple re-hospitalizations with SI/SA. Across all databases 121,065 patients were hospitalized with a diagnosis of SI/SA. Rates of rehospitalization within a year ranged from 7.96% to 11.24%. The risk of rehospitalization with SI/SA is highest during the first month. Nearly 50% of rehospitalizations occurred within 3 months after initial hospitalization. Patients with rehospitalization(s) had more anxiety disorders, sleep disorders and substance use disorders than patients without. Among patients with depression hospitalized for SI/SA, rehospitalization for SI/SA within a year is not uncommon. Risk of rehospitalization with a diagnosis of SI/SA is highest during the first month.

15.
PLoS One ; 15(2): e0228632, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32053653

RESUMO

OBJECTIVE: Some patients who are given opioids for pain could develop opioid use disorder. If it was possible to identify patients who are at a higher risk of opioid use disorder, then clinicians could spend more time educating these patients about the risks. We develop and validate a model to predict a person's future risk of opioid use disorder at the point before being dispensed their first opioid. METHODS: A cohort study patient-level prediction using four US claims databases with target populations ranging between 343,552 and 384,424 patients. The outcome was recorded diagnosis of opioid abuse, dependency or unspecified drug abuse as a proxy for opioid use disorder from 1 day until 365 days after the first opioid is dispensed. We trained a regularized logistic regression using candidate predictors consisting of demographics and any conditions, drugs, procedures or visits prior to the first opioid. We then selected the top predictors and created a simple 8 variable score model. RESULTS: We estimated the percentage of new users of opioids with reported opioid use disorder within a year to range between 0.04%-0.26% across US claims data. We developed an 8 variable Calculator of Risk for Opioid Use Disorder (CROUD) score, derived from the prediction models to stratify patients into higher and lower risk groups. The 8 baseline variables were age 15-29, medical history of substance abuse, mood disorder, anxiety disorder, low back pain, renal impairment, painful neuropathy and recent ER visit. 1.8% of people were in the high risk group for opioid use disorder and had a score > = 23 with the model obtaining a sensitivity of 13%, specificity of 98% and PPV of 1.14% for predicting opioid use disorder. CONCLUSIONS: CROUD could be used by clinicians to obtain personalized risk scores. CROUD could be used to further educate those at higher risk and to personalize new opioid dispensing guidelines such as urine testing. Due to the high false positive rate, it should not be used for contraindication or to restrict utilization.


Assuntos
Coleta de Dados/métodos , Informática Médica/métodos , Transtornos Relacionados ao Uso de Opioides/epidemiologia , Adolescente , Adulto , Idoso , Algoritmos , Analgésicos Opioides/uso terapêutico , Área Sob a Curva , Dor Crônica/tratamento farmacológico , Estudos de Coortes , Prescrições de Medicamentos , Feminino , Humanos , Masculino , Anamnese , Pessoa de Meia-Idade , Transtornos Relacionados ao Uso de Opioides/diagnóstico , Dor , Doenças do Sistema Nervoso Periférico , Análise de Regressão , Medição de Risco , Fatores de Risco , Inquéritos e Questionários , Estados Unidos , Adulto Jovem
16.
J Pain Res ; 13: 157-169, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32021405

RESUMO

Introduction: The United States (US) Food and Drug Administration (FDA) required a Risk Evaluation and Mitigation Strategy (REMS) for extended-release and long-acting (ER/LA) opioid analgesics on 09 July 2012. Methods: This study compared the incidence of opioid overdose before (July 2010-June 2012) and after (July 2013-September 2016) the initiation of the Risk Evaluation and Mitigation Strategy (REMS) for extended-release and long-acting (ER/LA) opioid analgesics. We identified patients with ≥1 ER/LA opioid dispensing in either time period in national data from the HealthCore Integrated Research DatabaseSM (HIRD) and in United States (US) Medicaid claims data from four states. We described each population, calculated the incidence rate (IR) of opioid overdose, and assessed crude and propensity score adjusted incidence rate ratios (IRR) comparing the overdose rate after vs before implementation of the REMS. Results: A total of 121,229 commercially insured and 11,488 Medicaid patients were included in the analysis. Rates of overdose were substantially higher in Medicaid patients than in the commercially insured patients (IR 192.0, 95% confidence interval [CI] 162.60-225.18 versus 102.60, 95% CI 93.0-112.93 in the active period). The IRRs for opioid overdose were 1.01 (95% CI 0.87-1.17) in the commercially insured population and 0.70 (95% CI 0.52-0.93) in Medicaid. Conclusion: This leveling off of overdose rates among commercially insured patients and decline among Medicaid patients is encouraging, but it is difficult to disentangle the specific impact of the REMS from many other ongoing initiatives with similar goals.

17.
JMIR Public Health Surveill ; 6(1): e13018, 2020 01 08.
Artigo em Inglês | MEDLINE | ID: mdl-31913130

RESUMO

BACKGROUND: Identifying the medical conditions that are associated with poor health is crucial to prioritize decisions for future research and organizing care. However, assessing the burden of disease in the general population is complex, lengthy, and expensive. Claims databases that include self-reported health status can be used to assess the impact of medical conditions on the health in a population. OBJECTIVE: This study aimed to identify medical conditions that are highly predictive of poor health status using claims databases. METHODS: To determine the medical conditions most highly predictive of poor health status, we used a retrospective cohort study using 2 US claims databases. Subjects were commercially insured patients. Health status was measured using a self-report health status response. All medical conditions were included in a least absolute shrinkage and selection operator regression model to assess which conditions were associated with poor versus excellent health. RESULTS: A total of 1,186,871 subjects were included; 61.64% (731,587/1,186,871) reported having excellent or very good health. The leading medical conditions associated with poor health were cancer-related conditions, demyelinating disorders, diabetes, diabetic complications, psychiatric illnesses (mood disorders and schizophrenia), sleep disorders, seizures, male reproductive tract infections, chronic obstructive pulmonary disease, cardiomyopathy, dementia, and headaches. CONCLUSIONS: Understanding the impact of disease in a commercially insured population is critical to identify subjects who may be at risk for reduced productivity and job loss. Claims database studies can measure the impact of medical conditions on the health status in a population and to assess changes overtime and could limit the need to collect prospective collection of information, which is slow and expensive, to assess disease burden. Leading medical conditions associated with poor health in a commercially insured population were the ones associated with high burden of disease such as cancer-related conditions, demyelinating disorders, diabetes, diabetic complications, psychiatric illnesses (mood disorders and schizophrenia), infections, chronic obstructive pulmonary disease, cardiomyopathy, and dementia. However, sleep disorders, seizures, male reproductive tract infections, and headaches were also part of the leading medical conditions associated with poor health that had not been identified before as being associated with poor health and deserve more attention.

18.
BMC Psychiatry ; 20(1): 4, 2020 01 03.
Artigo em Inglês | MEDLINE | ID: mdl-31900133

RESUMO

BACKGROUND: Understanding how patients are treated in the real-world is vital to identifying potential gaps in care. We describe the current pharmacologic treatment patterns for the treatment of depression. METHODS: Patients with depression were identified from four large national claims databases during 1/1/2014-1/31/2019. Patients had ≥2 diagnoses for depression or an inpatient hospitalization with a diagnosis of depression. Patients were required to have enrollment in the database ≥1 year prior to and 3 years following their first depression diagnosis. Treatment patterns were captured at the class level and included selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors, tricyclic antidepressants, other antidepressants, anxiolytics, hypnotics/sedatives, and antipsychotics. Treatment patterns were captured during all available follow-up. RESULTS: We identified 269,668 patients diagnosed with depression. The proportion not receiving any pharmacological treatment during follow-up ranged from 29 to 52%. Of the treated, approximately half received ≥2 different classes of therapy, a quarter received ≥3 classes and more than 10% received 4 or more. SSRIs were the most common first-line treatment; however, many patients received an anxiolytic, hypnotic/sedative, or antipsychotic prior to any antidepressive treatment. Treatment with a combination of classes ranged from approximately 20% of first-line therapies to 40% of fourth-line. CONCLUSIONS: Many patients diagnosed with depression go untreated and many others receive a non-antidepressant medication class as their first treatment. More than half of patients received more than one type of treatment class during the study follow up, suggesting that the first treatment received may not be optimal for most patients.


Assuntos
Antidepressivos/uso terapêutico , Depressão/diagnóstico , Depressão/tratamento farmacológico , Prescrições de Medicamentos , Formulário de Reclamação de Seguro/tendências , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Antidepressivos Tricíclicos/uso terapêutico , Depressão/epidemiologia , Feminino , Seguimentos , Humanos , Hipnóticos e Sedativos/uso terapêutico , Masculino , Pessoa de Meia-Idade , Inibidores de Captação de Serotonina/uso terapêutico , Inibidores da Recaptação de Serotonina e Norepinefrina/uso terapêutico , Resultado do Tratamento , Estados Unidos/epidemiologia , Adulto Jovem
19.
Postgrad Med ; 132(1): 44-51, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31721609

RESUMO

Background: Among patients with chronic pain using long-term opioid therapy, the incidence of opioid abuse, addiction, overdose, and associated death are not well quantified. The range of estimates for these adverse outcomes varies drastically and may depend on how they are measured (i.e. study definitions of outcomes) and on patient characteristics and opioid-use factors (e.g. regimen, daily dose).Methods: Based on a review of the literature, the US Food and Drug Administration (FDA) required companies that manufacture and sell extended-release/long-acting (ER/LA) opioids conduct as a postmarketing requirement (PMR) a series of observational studies to estimate the rates of treatment-emergent misuse, abuse, addiction, overdose, and death using validated measures. The companies formed a consortium, the Opioid PMR Consortium (OPC), to conduct the studies.Results: The FDA initially requested four observational studies (a cohort study, a questionnaire validation study, a code validation study, and a doctor-shopping validation study), but in order to achieve the FDA's goals of the 4 studies, OPC and FDA agreed to 10 observational studies (a prospective cohort study, a retrospective database cohort study, three questionnaire validation studies, two code validation studies, and three doctor-shopping validation studies). The studies are continuing through 2020.Conclusions: A series of 10 observational studies was or are being conducted in response to the FDA's postmarketing requirement. All studies have been feasible to conduct, although a validated algorithm for measuring abuse and addiction in databases was not successful.


Assuntos
Analgésicos Opioides/uso terapêutico , Dor Crônica/tratamento farmacológico , Preparações de Ação Retardada/uso terapêutico , Vigilância de Produtos Comercializados , Medição de Risco/métodos , Gestão de Riscos/organização & administração , Overdose de Drogas/epidemiologia , Humanos , Estudos Observacionais como Assunto , Transtornos Relacionados ao Uso de Opioides/epidemiologia , Projetos de Pesquisa , Estados Unidos/epidemiologia , United States Food and Drug Administration
20.
Pain Med ; 21(1): 92-100, 2020 01 01.
Artigo em Inglês | MEDLINE | ID: mdl-30877807

RESUMO

OBJECTIVE: To assess changes in mortality rates in extended-release and long-acting (ER/LA) opioid analgesics after the implementation of the Risk Evaluation and Mitigation Strategy (REMS). SETTING: All drug poisoning deaths in three states: Florida, Oregon, and Washington. Data were obtained through state vital records offices and the Researched Abuse, Diversion and Addiction-Related Surveillance System Medical Examiner Program. METHODS: Using cause-of-death literal text from death certificates, individual opioid active pharmaceutical ingredients (APIs) involved in each death were identified using rules-based natural language processing. Population-adjusted and prescriptions dispensed-adjusted mortality rates were calculated for all ER/LA opioid analgesic and individual opioid APIs. Rates before and after implementation of the REMS were compared. Rate changes were compared with rates from two APIs with little or no inclusion in the REMS: benzodiazepines and hydrocodone. RESULTS: The mean ER/LA opioid analgesic population-adjusted mortality rate significantly decreased in all three states (FL: P = 0.003; OR: P = 0.003; WA: P < 0.001). Mortality rates for benzodiazepines and hydrocodone also decreased and were not statistically different. Significant heterogeneity in mortality rates of individual opioids was observed between the three states. When adjusted for prescription volume, the ER/LA opioid analgesic mortality rate decreased in all three states, but was significant only for Washington (P < 0.001). CONCLUSIONS: The population-adjusted mortality rate of ER/LA opioid analgesics has decreased in three states. Notably, the contributions to mortality rates by individual opioid analgesics were not uniform across the three states in this study. However, these changes were not generally distinct from changes in mortality rates where comparator substances were involved.

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