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Oral Prednisolone in the Treatment of Acute Gout: A Pragmatic, Multicenter, Double-Blind, Randomized Trial
92 recurrence rate at 90 days. The mean RRE score was 2.2 in the recurrence group compared to 1.0 in the group without additional ischemic events. Patients who presented with large artery atherosclerosis were more likely to have recurrence. The overall risk of stroke recurrence was found to be significantly higher in patients with higher RRE scores (p<0.001). The authors concluded that the RRE is a valid method of assessing the risk of stroke recurrence in a multicenter study with a diverse patient population. The investigators suggest that the RRE may become a useful clinical tool when deciding which patients are high-risk versus low-risk for targeted stroke prevention. [Sarah Krajicek, MD Denver Health Medical Center, Denver, CO] Comment: This study adds to the growing body of evidence in support of the RRE as a prediction tool to assess individuals at high risk for recurrent stroke. Additional studies are indicated to assess the role of the RRE in the setting of standardized treatment protocols for post-stroke care. , CANNABIS USE AND RISK OF PSYCHIATRIC DISORDERS. Blanco C, Hasin DS, Wall MM, et al. JAMA Psychiatry. 2016;73:388-395 Marijuana use is becoming more prevalent in the general population secondary to medicinal programs and legalization of marijuana in several states across the United States. There are known associations between cannabis use and psychiatric disorders. However, there have not been prospective studies looking at the incidence of mood disorders, anxiety, and substance abuse in association with cannabis use. The objective of this study was to prospectively evaluate the association between cannabis use and the risk of mental health disorders and substance abuse problems in the adult population. Patients ages $ 18 years were interviewed in two waves between 2001-2002 and 2004-2005 using the National Epidemiologic Survey on Alcohol and Related Conditions (NESARC). The investigators used multiple regression and propensity score matching to ascertain whether cannabis use in wave one was associated with psychiatric disorders at wave two. Psychiatric diagnoses were determined in wave two according to the Diagnostic and Statistical Manual of Mental Disorders IV criteria using the Alcohol Use Disorder and Associated Disabilities Interview Schedule (AUDADIS-IV). Thirty four thousand six hundred and fifty three respondents were enrolled in the study. Forty eight percent of the respondents were male. One thousand two hundred seventy nine individuals used cannabis in wave one. Cannabis use in wave one was associated with substance use disorders in wave two, including any substance use disorder (odds ratio [OR] 6.2 95% confidence interval [CI] 4.1-9.4), alcohol use disorder OR 2.7 (95% CI 1.9-3.8), any cannabis use disorder (OR 9.9.5 (95% CI 6.4-14.1). No association was found between first wave cannabis use and any mood disorder (OR 1.1, 95% CI 0.8-1.4) and anxiety disorder (OR 0.9, 95% CI 0.7-1.1). The authors concluded that in the general adult population, cannabis use in the first wave was associated with increased
Abstracts incidence of substance use disorders but not mood or anxiety disorders. [Sarah Krajicek Denver Health Medical Center, Denver, CO] Comment: As marijuana legalization is becoming more common in the United States, both policy makers and physicians will need to consider the associations cannabis use can have with other substance abuse disorders. This study provides insight into substance abuse patterns that may be associated with cannabis use. Additional investigations to identify individuals who use cannabis who are at risk for substance dependence may afford opportunities for early intervention. , ORAL PREDNISOLONE IN THE TREATMENT OF ACUTE GOUT: A PRAGMATIC, MULTICENTER, DOUBLE-BLIND, RANDOMIZED TRIAL. Rainer TH, Cheng CH, Janssens H, et al. Ann Intern Med. 2016;164:464-471 Gout is an inflammatory arthropathy which causes presentations to emergency departments due to acute pain. The standard of care for many years has been nonsteroidal anti-inflammatory drugs (NSAIDs), with the possible addition of colchicine. As gout is an inflammatory condition, it is logical to conclude that corticosteroids may be an effective treatment option for gout. This study seeks to expand on the existing evidence from several smaller trials that oral corticosteroids, rather than NSAIDs, are a safe and effective option for the treatment of gout. This was a multi-center, double blinded, randomized controlled trial in which 416 patients were enrolled and assigned to receive either indomethacin plus placebo or prednisolone plus placebo, each for 5 days. Each group also received acetaminophen for breakthrough pain. The primary outcomes were joint pain at rest and with activity; the secondary outcomes included adverse events, clinical appearance (erythema, tenderness, edema) of the involved joint, need for breakthrough medications, and need for further treatment, among others. Pain was assessed on the visual analogue scale, and +/- 13 mm was considered statistically significant. Patients’ pain was assessed by a research associate, at rest and during movement, prior to medication administration, and then at 30, 60, 90, and 120 minutes after administration while in the emergency department. After discharge, the patient performed self assessments daily on days 2-14. Pain assessments were analyzed using t tests, and adverse events were analyzed using chi square tests. They performed both per-protocol and intention-to-treat (ITT) analyses. Of the 416 patients enrolled (all analyzed by ITT), 40 did not complete the study (376 by per-protocol analysis). Both the indomethacin plus placebo and the prednisolone plus placebo groups shared similar baseline characteristics. Both groups had statistically significant reduction in pain scores during the 2 week study period. During their time in the emergency department, there was no statistically significant difference between groups for pain scores at rest (p=0.69) or with activity (p=0.56). During post ED follow up, there was also no statistically significant difference between groups for pain scores at
The Journal of Emergency Medicine rest (p=0.80) or with activity (p=0.20). The investigators identified an increased incidence of minor adverse events in the indomethacin group, such as dizziness in the ED (p<0.001), and nausea and vomiting during the follow up period (p=0.009 and p=0.006, respectively). The prednisolone group only experienced increased skin rash during the follow up period (p=0.011). They conclude that oral prednisolone is as effective as indomethacin for analgesia in acute gout. They report no serious adverse events in either group. Despite their report that there were no major adverse events in either group, they conclude that corticosteroids may be safer than NSAIDs in populations with comorbid conditions, based largely on evidence from prior studies. They assert that oral corticosteroids should be considered first line alternatives to oral NSAIDs for acute gout. [Kathryn Majors-Foley, MD Denver Health Medical Center, Denver, CO] Comment: There are risks for adverse outcomes with both NSAIDs (e.g. GI bleed) and oral corticosteroids (e.g. hyperglycemia, psychosis). This study demonstrates that both medications are reasonable alternatives for analgesia in acute gout. However, clinicians should consider individual patient-level factors when deciding which, if either, class of medications to prescribe for gout. , USE OF AND BARRIERS TO ACCESS TO OPIOID ANALGESICS: A WORLDWIDE, REGIONAL, AND NATIONAL STUDY. Berterame S, Erthal J, Thomas J, et al. Lancet. 2016;387:1644–56 While some countries struggle with increasing use of opioids, and the concomitant rise in opioid dependence and abuse, many developing nations do not have equitable access to these medications, including in palliative care settings. This paper examines trends in worldwide use of opioids during the period 2001-2013 and delineates how barriers to access impact use throughout the world. Data was obtained through databases maintained by several United Nations agencies. The unit of measure ‘‘defined daily dose for statistical purposes (S-DDD)’’ is an artificially constructed technical measure that serves as an approximation of the amount of opioids an average patient might be prescribed for one day. The authors divided the amount of opioids used in each country or region included in their study by 365 days, then divided by the appropriate population, then divided by S-DDD, to determine levels of use for each region. They performed statistical analysis using generalized estimating equation modeling (which estimates the average effect over population) which controlled for differences in countries’ gross domestic product (GDP) and human development index (HDI) to observe how opioid use changed during the study period. They also collected data from questionnaires sent to various national health authorities regarding barriers to opioid use, and prevalence of conditions, such as cancer, for which opioid use is likely indicated. Data was assessed for the world, for each defined region, and for each country included in the study. During the study period, opioid use increased dramatically in North America and Western Europe; increased modestly in
93 Latin America and the Middle East; increased slightly in Russia and Central Asia; and was largely unchanged throughout the rest of the world. After further analysis, it was apparent that GDP and HDI were both significant determinants of use (p<0.0001 for both). They also show that prevalence of conditions warranting opioid use (e.g. cancer, AIDS) does not correlate with use and that in many countries the levels of use appear inadequate compared to the burden of disease. Impediments to use varied by region; for example, difficulty sourcing these medications is a major barrier in Africa, whereas in Southeast Asia fear of addiction and diversion were the largest barriers. Their analyses demonstrate that more barriers to access reported by a country or region were correlated with lower levels of use (incidence rate ratio 0.39 (95% confidence interval [CI] 0.29-0.52), but the correlation did not exist after adjusting for GDP and HDI (incidence rate ratio 0.91 [95% CI 0.731.14]). Although worldwide use of opioids doubled during the study period, the authors found that use largely remains restricted to affluent countries in the developed world, which account for nearly all of the increased use worldwide. They conclude that although many countries report perceived barriers to use, these barriers are not statistically correlated with use, but rather that opioid use is instead linked closely to financial indicators such as GDP and HDI. They therefore advocate for the creation of international strategies to address the inequities surrounding access to opioids. [Kathryn Majors-Foley, MD Denver Health Medical Center, Denver, CO] Comment: For many of us practicing in resource rich environments, increasing opioid use is a concerning phenomenon; however; we must not allow ourselves to lose sight of the global inequities surrounding access to adequate analgesia, especially in palliative care contexts in the developing world. Although increasing opioid use (and presumably misuse) is demonstrated in North America and Western Europe, much of the developing world still needs global support in accessing and distributing appropriate analgesics to patients in need. , TELEMEDICINE IN PREHOSPITAL STROKE EVALUATION AND THROMBOLYSIS: TAKING STROKE TREATMENT TO THE DOORSTEP. Itrat A, Taqui A, Cerego R, et al. JAMA Neurology. 2016;73:162-168 Acute ischemic stroke is a time sensitive diagnosis, yet many patients cannot or do not access acute care services within the 3 hour window during which intravenous (IV) tissue plasminogen activator (tPA) is thought to be most effective. There is increasing national interest in mobile stroke treatment units (MSTU), in the hope of decreasing time-to-treatment in stroke. This prospective observational study compared patients with clinical presentations concerning for possible stroke treated by MSTU versus a similar cohort of patients that presented to area emergency departments by traditional EMS. The study authors had access to data from all of MSTU activations during the study period and compared these patients to a matched group of patients who presented via EMS during similar hours who were
Abstracts incidence of substance use disorders but not mood or anxiety disorders. [Sarah Krajicek Denver Health Medical Center, Denver, CO] Comment: As marijuana legalization is becoming more common in the United States, both policy makers and physicians will need to consider the associations cannabis use can have with other substance abuse disorders. This study provides insight into substance abuse patterns that may be associated with cannabis use. Additional investigations to identify individuals who use cannabis who are at risk for substance dependence may afford opportunities for early intervention. , ORAL PREDNISOLONE IN THE TREATMENT OF ACUTE GOUT: A PRAGMATIC, MULTICENTER, DOUBLE-BLIND, RANDOMIZED TRIAL. Rainer TH, Cheng CH, Janssens H, et al. Ann Intern Med. 2016;164:464-471 Gout is an inflammatory arthropathy which causes presentations to emergency departments due to acute pain. The standard of care for many years has been nonsteroidal anti-inflammatory drugs (NSAIDs), with the possible addition of colchicine. As gout is an inflammatory condition, it is logical to conclude that corticosteroids may be an effective treatment option for gout. This study seeks to expand on the existing evidence from several smaller trials that oral corticosteroids, rather than NSAIDs, are a safe and effective option for the treatment of gout. This was a multi-center, double blinded, randomized controlled trial in which 416 patients were enrolled and assigned to receive either indomethacin plus placebo or prednisolone plus placebo, each for 5 days. Each group also received acetaminophen for breakthrough pain. The primary outcomes were joint pain at rest and with activity; the secondary outcomes included adverse events, clinical appearance (erythema, tenderness, edema) of the involved joint, need for breakthrough medications, and need for further treatment, among others. Pain was assessed on the visual analogue scale, and +/- 13 mm was considered statistically significant. Patients’ pain was assessed by a research associate, at rest and during movement, prior to medication administration, and then at 30, 60, 90, and 120 minutes after administration while in the emergency department. After discharge, the patient performed self assessments daily on days 2-14. Pain assessments were analyzed using t tests, and adverse events were analyzed using chi square tests. They performed both per-protocol and intention-to-treat (ITT) analyses. Of the 416 patients enrolled (all analyzed by ITT), 40 did not complete the study (376 by per-protocol analysis). Both the indomethacin plus placebo and the prednisolone plus placebo groups shared similar baseline characteristics. Both groups had statistically significant reduction in pain scores during the 2 week study period. During their time in the emergency department, there was no statistically significant difference between groups for pain scores at rest (p=0.69) or with activity (p=0.56). During post ED follow up, there was also no statistically significant difference between groups for pain scores at
The Journal of Emergency Medicine rest (p=0.80) or with activity (p=0.20). The investigators identified an increased incidence of minor adverse events in the indomethacin group, such as dizziness in the ED (p<0.001), and nausea and vomiting during the follow up period (p=0.009 and p=0.006, respectively). The prednisolone group only experienced increased skin rash during the follow up period (p=0.011). They conclude that oral prednisolone is as effective as indomethacin for analgesia in acute gout. They report no serious adverse events in either group. Despite their report that there were no major adverse events in either group, they conclude that corticosteroids may be safer than NSAIDs in populations with comorbid conditions, based largely on evidence from prior studies. They assert that oral corticosteroids should be considered first line alternatives to oral NSAIDs for acute gout. [Kathryn Majors-Foley, MD Denver Health Medical Center, Denver, CO] Comment: There are risks for adverse outcomes with both NSAIDs (e.g. GI bleed) and oral corticosteroids (e.g. hyperglycemia, psychosis). This study demonstrates that both medications are reasonable alternatives for analgesia in acute gout. However, clinicians should consider individual patient-level factors when deciding which, if either, class of medications to prescribe for gout. , USE OF AND BARRIERS TO ACCESS TO OPIOID ANALGESICS: A WORLDWIDE, REGIONAL, AND NATIONAL STUDY. Berterame S, Erthal J, Thomas J, et al. Lancet. 2016;387:1644–56 While some countries struggle with increasing use of opioids, and the concomitant rise in opioid dependence and abuse, many developing nations do not have equitable access to these medications, including in palliative care settings. This paper examines trends in worldwide use of opioids during the period 2001-2013 and delineates how barriers to access impact use throughout the world. Data was obtained through databases maintained by several United Nations agencies. The unit of measure ‘‘defined daily dose for statistical purposes (S-DDD)’’ is an artificially constructed technical measure that serves as an approximation of the amount of opioids an average patient might be prescribed for one day. The authors divided the amount of opioids used in each country or region included in their study by 365 days, then divided by the appropriate population, then divided by S-DDD, to determine levels of use for each region. They performed statistical analysis using generalized estimating equation modeling (which estimates the average effect over population) which controlled for differences in countries’ gross domestic product (GDP) and human development index (HDI) to observe how opioid use changed during the study period. They also collected data from questionnaires sent to various national health authorities regarding barriers to opioid use, and prevalence of conditions, such as cancer, for which opioid use is likely indicated. Data was assessed for the world, for each defined region, and for each country included in the study. During the study period, opioid use increased dramatically in North America and Western Europe; increased modestly in
93 Latin America and the Middle East; increased slightly in Russia and Central Asia; and was largely unchanged throughout the rest of the world. After further analysis, it was apparent that GDP and HDI were both significant determinants of use (p<0.0001 for both). They also show that prevalence of conditions warranting opioid use (e.g. cancer, AIDS) does not correlate with use and that in many countries the levels of use appear inadequate compared to the burden of disease. Impediments to use varied by region; for example, difficulty sourcing these medications is a major barrier in Africa, whereas in Southeast Asia fear of addiction and diversion were the largest barriers. Their analyses demonstrate that more barriers to access reported by a country or region were correlated with lower levels of use (incidence rate ratio 0.39 (95% confidence interval [CI] 0.29-0.52), but the correlation did not exist after adjusting for GDP and HDI (incidence rate ratio 0.91 [95% CI 0.731.14]). Although worldwide use of opioids doubled during the study period, the authors found that use largely remains restricted to affluent countries in the developed world, which account for nearly all of the increased use worldwide. They conclude that although many countries report perceived barriers to use, these barriers are not statistically correlated with use, but rather that opioid use is instead linked closely to financial indicators such as GDP and HDI. They therefore advocate for the creation of international strategies to address the inequities surrounding access to opioids. [Kathryn Majors-Foley, MD Denver Health Medical Center, Denver, CO] Comment: For many of us practicing in resource rich environments, increasing opioid use is a concerning phenomenon; however; we must not allow ourselves to lose sight of the global inequities surrounding access to adequate analgesia, especially in palliative care contexts in the developing world. Although increasing opioid use (and presumably misuse) is demonstrated in North America and Western Europe, much of the developing world still needs global support in accessing and distributing appropriate analgesics to patients in need. , TELEMEDICINE IN PREHOSPITAL STROKE EVALUATION AND THROMBOLYSIS: TAKING STROKE TREATMENT TO THE DOORSTEP. Itrat A, Taqui A, Cerego R, et al. JAMA Neurology. 2016;73:162-168 Acute ischemic stroke is a time sensitive diagnosis, yet many patients cannot or do not access acute care services within the 3 hour window during which intravenous (IV) tissue plasminogen activator (tPA) is thought to be most effective. There is increasing national interest in mobile stroke treatment units (MSTU), in the hope of decreasing time-to-treatment in stroke. This prospective observational study compared patients with clinical presentations concerning for possible stroke treated by MSTU versus a similar cohort of patients that presented to area emergency departments by traditional EMS. The study authors had access to data from all of MSTU activations during the study period and compared these patients to a matched group of patients who presented via EMS during similar hours who were