Background and aims Multidomain strategies (i.e. two or more strategies) for managing chronic pai... more Background and aims Multidomain strategies (i.e. two or more strategies) for managing chronic pain are recommended to avoid excessive use of opioids while producing the best outcomes possible. The aims of this systematic review were to: 1) determine if patient-reported pain management is consistent with the use of multidomain strategies; and 2) identify the role of opioids and non-steroidal anti-inflammatory drugs (NSAIDs) in patient-reported pain management. Methods Bibliographic databases, websites, and reference lists of included studies were searched to identify published articles reporting community-based surveys of pain self-management from January 1989 to June 2017 using controlled vocabulary (and synonyms): pain; self-care; self-management; self-treatment; and adult. Two independent reviewers screened studies and extracted data on subject demographics, pain characteristics, pain self-management strategies, and pain outcomes. Pain self-management strategies were organized acc...
Background: One approach postulated to improve the provision of health care is effective utilizat... more Background: One approach postulated to improve the provision of health care is effective utilization of team-based care including pharmacists. Objective: The objective of this study was to conduct a comprehensive systematic review with focused meta-analyses to examine the effects of pharmacist-provided direct patient care on therapeutic, safety, and humanistic outcomes. Methods: The following databases were searched from inception to January 2009: NLM PubMed; Ovid/MEDLINE; ABI/IN-FORM; Health Business Fulltext Elite; Academic Search Complete; International Pharmaceutical Abstracts; PsycINFO; Cochrane Database of Systematic Reviews; National Guideline Clearinghouse; Database of Abstracts of Reviews of Effects; ClinicalTrials.gov; LexisNexis Academic Universe; and Google Scholar. Studies selected included those reporting pharmacistprovided care, comparison groups, and patient-related outcomes. Of these, 56,573 citations were considered. Data were extracted by multidisciplinary study review teams. Variables examined included study characteristics, pharmacists' interventions/services, patient characteristics, and study outcomes. Data for meta-analyses were extracted from randomized controlled trials meeting meta-analysis criteria. Results: A total of 298 studies were included. Favorable results were found in therapeutic and safety outcomes, and meta-analyses conducted for hemoglobin A1c, LDL cholesterol, blood pressure, and adverse drug events were significant (P Ͻ 0.05), favoring pharmacists' direct patient care over comparative services. Results for humanistic outcomes were favorable with variability. Medication adherence, patient knowledge, and quality of life-general health meta-analyses were significant (P Ͻ 0.05), favoring pharmacists' direct patient care. Conclusions: Pharmacist-provided direct patient care has favorable effects across various patient outcomes, health care settings, and disease states. Incorporating pharmacists as health care team members in direct patient care is a viable solution to help improve US health care.
Objective: Research was conducted on the embedded librarian program at The University of Arizona ... more Objective: Research was conducted on the embedded librarian program at The University of Arizona College of Pharmacy and the Health Sciences Library to understand how this service is relevant to users and identify the potential for further improvement. This study examined users’ information-seeking behaviors and considered the implications for the effectiveness of the embedded librarian service. Methods: The authors conducted 18 semi-structured interviews of faculty, researchers, and students at the College of Pharmacy to obtain descriptive accounts of how they seek information, manage information, and use the library and library services. The authors examined the interview transcripts through qualitative descriptive analysis. Results: The interview responses confirm that users seek information outside of the physical library and tend to ask their peers for information or assistance in obtaining information. They mostly feel comfortable in searching, but some of them may lack suffic...
Increasing gabapentinoid use has raised concerns of misuse and abuse in the United States (US). L... more Increasing gabapentinoid use has raised concerns of misuse and abuse in the United States (US). Little is known about the characteristics of gabapentinoid use in general clinical practice over time. This cross-sectional study used data from the National Ambulatory Medical Care Survey. We examined the trends of patient and prescriber characteristics and the diagnoses associated with US ambulatory care visits involving gabapentinoids for adult visits from 2003 to 2016. Using multivariable logistic regression, we estimated the adjusted proportion of gabapentinoid-involved visits among all visits and tested for trend significance. Among the weighted estimate of 260.1 million gabapentinoid-involved visits (aged 18–64 years: 61.8%; female: 61.9%; white: 85.5%), the adjusted annual proportion of gabapentinoid-involved visits nearly quadrupled from 2003 to 2016 (9.1 to 34.9 per 1000 visits; Ptrend < 0.0001), driven mainly by gabapentin. Nearly half had concurrent use with opioids (32.9%) or benzodiazepines (15.3%). Primary care physicians (45.8%), neurologists (8.2%), surgeons (6.2%), and psychiatrists (4.8%) prescribed two-thirds of the gabapentinoids. Most (96.6%) of the gabapentinoid visits did not have an approved indication for gabapentinoids among the first three diagnoses. Among US ambulatory care visits from 2003 to 2016, gabapentinoid use increased substantially, commonly prescribed by primary care physicians.
Objective. To assess the validity of an exposure score obtained from the Xm2tool for all pharmaco... more Objective. To assess the validity of an exposure score obtained from the Xm2tool for all pharmacological and nonpharmacological strategies used by individuals to manage chronic pain.Methods. Using data from individuals with chronic pain, eXposuremultimodal (Xm2) scores were calculated by assigning one point for every 100 mg of morphine equivalent used (opioid medications); 25% of the maximum recommended exposure used (nonopioid medications); and any use of another strategy then summed. Content, criterion, construct, and convergent validity were assessed.Results. The sample of 149 individuals used a mean of 12.6 (SD = 4.6) strategies to manage pain and had a mean Xm2score of 16.8 (SD = 9.1). Content validity was established by demonstrating that the pain management strategies identified were also reported in the literature. Criterion validity was established by the positive association of exposure scores with the following: interference with work (odds ratio (OR) = 2.23, 95% confiden...
Economic Evaluation of Ibrutinib Versus Acalabrutinib Versus Zanubrutinib for Patients with Relapsed or Refractory Mantle Cell Lymphoma
Blood
Background . Refractory or relapsed mantle cell lymphoma (R/R MCL) is generally associated with p... more Background . Refractory or relapsed mantle cell lymphoma (R/R MCL) is generally associated with poor outcomes; median overall survival (OS) is 4-5 years. First generation Bruton's tyrosine kinase inhibitor (BTKi) (Ibrutinib) and second generation BTKi (acalabrutinib and zanubrutinib) have led to significant improvements in efficacy and safety over conventional chemoimmunotherapy in treating R/R MCL. In the absence of direct head to head clinical trials compare between BTKi, indirect comparisons between the first and second BTKi generations show possible differences in safety and efficacy. We used existing evidence from phase I/II clinical trials for second BTKi generation to evaluate the cost-effectiveness of ibrutinib vs acalabrutinib vs zanubrutinib in treating patients with R/R MCL from the US payer perspective. Methods. A Markov model with two health states (progression-free [PF] and progression or death) was specified. Kaplan-Meier (KM) curves of PF survival (PFS) from the ...
Aims: Six Delta is a six-dimensional independent platform for outcome-based pricing/contracting. ... more Aims: Six Delta is a six-dimensional independent platform for outcome-based pricing/contracting. The six dimensions have been described separately: (d1) cost-effectiveness analysis and cost-utility analysisbased pricing; (d2) willingness-to-pay-based pricing; (d3) reference-based pricing; (d4) safety-based pricing; (d5) risk of efficacy failure-based pricing; and (d6) adherence-based pricing. The final step is to integrate the various dimension-specific pricing estimates into a composite estimate termed the All-Dimensional Price (ADP). We describe the methodology for this integration and present a proof-ofconcept application to the treatment of non-small cell lung cancer (NSCLC) with EGFR mutation with osimertinib. Materials and methods: For better accuracy in estimating the ADP, we used the prices generated from the six dimensions at scenario levels, not at the dimension-specific price (DSP) level. We pooled the price estimates and performed Monte Carlo Simulations (MCS) for the price scenarios generated by the six dimensions. We used the results of the proof-of-concept exercise involving osimertinib in NSCLC with EGFR mutation to estimate the ADP in two hypothetical contracts: 1-year (2019-2020) and 2-year contract (2019-2021).
Aims: Six Delta is a six-dimensional independent platform for outcome-based pricing/contracting. ... more Aims: Six Delta is a six-dimensional independent platform for outcome-based pricing/contracting. The third dimension (d3) estimates prices on the basis of international drug price referencing methods. We describe this dimension's methodology and present a proof-of-concept application to the treatment of non-small cell lung cancer (NSCLC) with EGFR mutation with osimertinib. Materials and methods: The reference-based pricing dimension utilizes a six-step method: (1) selecting foreign countries based on a set of four criteria (drug is available in the foreign country, price information is available in the foreign country, foreign countries are members within the organization for Economic Cooperation and Development, pricing methods in the foreign countries involve value assessment); (2) adjusting for exchange rates; (3) generating reference price (RP) scenarios; (4) adjusting with the medical inflation rate; (5) pooling all generated RP scenarios and calculating average and standard deviation (SD); (6) and Monte Carlo Simulation (MCS) to estimate the dimension-specific DSP Reference. A proof-of-concept exercise with osimertinib in NSCLC was performed for two hypothetical outcome-based contracts: 1-year (2019-2020) and 2-year (2019-2021). Results: The United Kingdom and Canada met the four criteria. For the osimertinib 1-year contract price, the average of eight RP scenarios, adjusted for inflation by 0.
Background: The use of anti-cytotoxic T-lymphocyte antigen 4 (anti-CTLA4) therapy (ipilimumab) an... more Background: The use of anti-cytotoxic T-lymphocyte antigen 4 (anti-CTLA4) therapy (ipilimumab) and anti-programmed cell-death 1 (anti-PD1) agents (nivolumab and pembrolizumab) in advanced melanoma have been associated with immune-related adverse events (irAEs) including colitis. We aimed to estimate the incidence and the risk of colitis in elderly patients with advanced melanoma treated with anti-CTLA4 and anti-PD1 in the real-world setting. Methods: Elderly patients (age ⩾ 65 years) diagnosed with advanced melanoma between 2011 and 2015 and treated with anti-CTLA4 or anti-PD1 agents were identified from the Surveillance, Epidemiology, and End Results (SEER)–Medicare data. We estimated the risk of colitis from start of treatment up to 90 days from the last dose of therapy. We used the log-rank test and logistic regression with adjustment for potential confounders using the inverse probability of treatment weighting method. We conducted several sensitivity analyses. Results: A total ...
Dual‐trajectories of opioid and gabapentinoid use and risk of subsequent drug overdose among Medicare beneficiaries in the United States: a retrospective cohort study
Ex Ante Economic Evaluation of Arg389 Genetically Targeted Treatment with Bucindolol versus Empirical Treatment with Carvedilol in NYHA III/IV Heart Failure
Ex ante economic evaluation of genetic testing for the ARG389 beta1-adrenergic receptor polymorphism to support bucindolol treatment decisions in Stage III/IV heart failure
Expert Review of Precision Medicine and Drug Development
Nationally Representative Health Care Expenditures of Community-Based Older Adults with Pain in the United States Prescribed Opioids vs Those Not Prescribed Opioids
Pain Medicine
Objective To compare health care expenditures between older US adults (≥50 years) with pain who w... more Objective To compare health care expenditures between older US adults (≥50 years) with pain who were prescribed opioid medications and those who were not. Design Cross-sectional. Setting Community-based adults in the 2015 Medical Expenditure Panel Survey (MEPS). Subjects Nationally representative sample of US adults alive for the calendar year, aged 50 years or older, who reported having pain in the past four weeks. Methods Older US adults (≥50 years) with pain in the 2015 MEPS data were identified. The key independent variable was opioid prescription status (prescribed opioid vs not prescribed opioid). Hierarchical linear regression models assessed health care expenditures (inpatient, outpatient, office-based, emergency room, prescription medications, other, and total) in US dollars for opioid prescription status from a community-dwelling US population perspective, adjusting for covariates. Results The 2015 study cohort provided a national estimate of 50,898,592 noninstitutionalize...
Background: The use of ipilimumab, nivolumab, and pembrolizumab as monotherapies or in combinatio... more Background: The use of ipilimumab, nivolumab, and pembrolizumab as monotherapies or in combination has transformed the management of advanced melanoma even though these drugs are associated with a new profile of immune-related adverse events (irAEs). The incidence of irAEs from clinical trials of these agents is an important factor for clinicians when treating patients with advanced melanoma. In the current study, we aimed to profile the incidence of potential irAEs of these agents when used as monotherapy and as combination therapy. Methods: We searched the Medline, Embase, and Cochrane databases; clinicaltrials.gov; and websites of regulatory agencies in the USA, Europe, Australia, and Japan for phase 1-3 trials of ipilimumab, nivolumab, and pembrolizumab for advanced melanoma. Random effect meta-analysis was utilized to profile the incidence of potential irAEs. Results: A total of 58 reports of 35 trials including 6,331 patients with advanced melanoma and reporting irAE data were included in the meta-analyses. We found higher incidences of potential irAEs in combination therapies vs. monotherapies for most of the types of irAEs. Among the monotherapies, ipilimumab users had the most frequent incidence of potential irAEs related to the gastrointestinal system (diarrhea, 29%; and colitis, 8%) and skin (rash, 31%; pruritus, 27%; and dermatitis, 10%), with hypophysitis in 4% of the patients. The most frequent potential irAEs among nivolumab users were maculopapular rash (13%), erythema (4%), hepatitis (3%), and infusion-related reactions (3%), while they were arthralgia (12%), hypothyroidism (8%), and hyperglycemia (6%), among pembrolizumab users. Almutairi et al. Immune-Related Adverse Events of Immunotherapies in Melanoma Conclusion: Especially the combination therapies tend to elevate the incidence of potential irAEs. Clinicians should be vigilant about irAEs following combination therapy as well as gastrointestinal and skin irAEs following ipilimumab therapy, in addition to being aware of potential irAEs leading to hyperglycemia, thyroid, hepatic, and musculoskeletal disorders following nivolumab and pembrolizumab therapy.
Background and aims Multidomain strategies (i.e. two or more strategies) for managing chronic pai... more Background and aims Multidomain strategies (i.e. two or more strategies) for managing chronic pain are recommended to avoid excessive use of opioids while producing the best outcomes possible. The aims of this systematic review were to: 1) determine if patient-reported pain management is consistent with the use of multidomain strategies; and 2) identify the role of opioids and non-steroidal anti-inflammatory drugs (NSAIDs) in patient-reported pain management. Methods Bibliographic databases, websites, and reference lists of included studies were searched to identify published articles reporting community-based surveys of pain self-management from January 1989 to June 2017 using controlled vocabulary (and synonyms): pain; self-care; self-management; self-treatment; and adult. Two independent reviewers screened studies and extracted data on subject demographics, pain characteristics, pain self-management strategies, and pain outcomes. Pain self-management strategies were organized acc...
Background: One approach postulated to improve the provision of health care is effective utilizat... more Background: One approach postulated to improve the provision of health care is effective utilization of team-based care including pharmacists. Objective: The objective of this study was to conduct a comprehensive systematic review with focused meta-analyses to examine the effects of pharmacist-provided direct patient care on therapeutic, safety, and humanistic outcomes. Methods: The following databases were searched from inception to January 2009: NLM PubMed; Ovid/MEDLINE; ABI/IN-FORM; Health Business Fulltext Elite; Academic Search Complete; International Pharmaceutical Abstracts; PsycINFO; Cochrane Database of Systematic Reviews; National Guideline Clearinghouse; Database of Abstracts of Reviews of Effects; ClinicalTrials.gov; LexisNexis Academic Universe; and Google Scholar. Studies selected included those reporting pharmacistprovided care, comparison groups, and patient-related outcomes. Of these, 56,573 citations were considered. Data were extracted by multidisciplinary study review teams. Variables examined included study characteristics, pharmacists' interventions/services, patient characteristics, and study outcomes. Data for meta-analyses were extracted from randomized controlled trials meeting meta-analysis criteria. Results: A total of 298 studies were included. Favorable results were found in therapeutic and safety outcomes, and meta-analyses conducted for hemoglobin A1c, LDL cholesterol, blood pressure, and adverse drug events were significant (P Ͻ 0.05), favoring pharmacists' direct patient care over comparative services. Results for humanistic outcomes were favorable with variability. Medication adherence, patient knowledge, and quality of life-general health meta-analyses were significant (P Ͻ 0.05), favoring pharmacists' direct patient care. Conclusions: Pharmacist-provided direct patient care has favorable effects across various patient outcomes, health care settings, and disease states. Incorporating pharmacists as health care team members in direct patient care is a viable solution to help improve US health care.
Objective: Research was conducted on the embedded librarian program at The University of Arizona ... more Objective: Research was conducted on the embedded librarian program at The University of Arizona College of Pharmacy and the Health Sciences Library to understand how this service is relevant to users and identify the potential for further improvement. This study examined users’ information-seeking behaviors and considered the implications for the effectiveness of the embedded librarian service. Methods: The authors conducted 18 semi-structured interviews of faculty, researchers, and students at the College of Pharmacy to obtain descriptive accounts of how they seek information, manage information, and use the library and library services. The authors examined the interview transcripts through qualitative descriptive analysis. Results: The interview responses confirm that users seek information outside of the physical library and tend to ask their peers for information or assistance in obtaining information. They mostly feel comfortable in searching, but some of them may lack suffic...
Increasing gabapentinoid use has raised concerns of misuse and abuse in the United States (US). L... more Increasing gabapentinoid use has raised concerns of misuse and abuse in the United States (US). Little is known about the characteristics of gabapentinoid use in general clinical practice over time. This cross-sectional study used data from the National Ambulatory Medical Care Survey. We examined the trends of patient and prescriber characteristics and the diagnoses associated with US ambulatory care visits involving gabapentinoids for adult visits from 2003 to 2016. Using multivariable logistic regression, we estimated the adjusted proportion of gabapentinoid-involved visits among all visits and tested for trend significance. Among the weighted estimate of 260.1 million gabapentinoid-involved visits (aged 18–64 years: 61.8%; female: 61.9%; white: 85.5%), the adjusted annual proportion of gabapentinoid-involved visits nearly quadrupled from 2003 to 2016 (9.1 to 34.9 per 1000 visits; Ptrend < 0.0001), driven mainly by gabapentin. Nearly half had concurrent use with opioids (32.9%) or benzodiazepines (15.3%). Primary care physicians (45.8%), neurologists (8.2%), surgeons (6.2%), and psychiatrists (4.8%) prescribed two-thirds of the gabapentinoids. Most (96.6%) of the gabapentinoid visits did not have an approved indication for gabapentinoids among the first three diagnoses. Among US ambulatory care visits from 2003 to 2016, gabapentinoid use increased substantially, commonly prescribed by primary care physicians.
Objective. To assess the validity of an exposure score obtained from the Xm2tool for all pharmaco... more Objective. To assess the validity of an exposure score obtained from the Xm2tool for all pharmacological and nonpharmacological strategies used by individuals to manage chronic pain.Methods. Using data from individuals with chronic pain, eXposuremultimodal (Xm2) scores were calculated by assigning one point for every 100 mg of morphine equivalent used (opioid medications); 25% of the maximum recommended exposure used (nonopioid medications); and any use of another strategy then summed. Content, criterion, construct, and convergent validity were assessed.Results. The sample of 149 individuals used a mean of 12.6 (SD = 4.6) strategies to manage pain and had a mean Xm2score of 16.8 (SD = 9.1). Content validity was established by demonstrating that the pain management strategies identified were also reported in the literature. Criterion validity was established by the positive association of exposure scores with the following: interference with work (odds ratio (OR) = 2.23, 95% confiden...
Economic Evaluation of Ibrutinib Versus Acalabrutinib Versus Zanubrutinib for Patients with Relapsed or Refractory Mantle Cell Lymphoma
Blood
Background . Refractory or relapsed mantle cell lymphoma (R/R MCL) is generally associated with p... more Background . Refractory or relapsed mantle cell lymphoma (R/R MCL) is generally associated with poor outcomes; median overall survival (OS) is 4-5 years. First generation Bruton's tyrosine kinase inhibitor (BTKi) (Ibrutinib) and second generation BTKi (acalabrutinib and zanubrutinib) have led to significant improvements in efficacy and safety over conventional chemoimmunotherapy in treating R/R MCL. In the absence of direct head to head clinical trials compare between BTKi, indirect comparisons between the first and second BTKi generations show possible differences in safety and efficacy. We used existing evidence from phase I/II clinical trials for second BTKi generation to evaluate the cost-effectiveness of ibrutinib vs acalabrutinib vs zanubrutinib in treating patients with R/R MCL from the US payer perspective. Methods. A Markov model with two health states (progression-free [PF] and progression or death) was specified. Kaplan-Meier (KM) curves of PF survival (PFS) from the ...
Aims: Six Delta is a six-dimensional independent platform for outcome-based pricing/contracting. ... more Aims: Six Delta is a six-dimensional independent platform for outcome-based pricing/contracting. The six dimensions have been described separately: (d1) cost-effectiveness analysis and cost-utility analysisbased pricing; (d2) willingness-to-pay-based pricing; (d3) reference-based pricing; (d4) safety-based pricing; (d5) risk of efficacy failure-based pricing; and (d6) adherence-based pricing. The final step is to integrate the various dimension-specific pricing estimates into a composite estimate termed the All-Dimensional Price (ADP). We describe the methodology for this integration and present a proof-ofconcept application to the treatment of non-small cell lung cancer (NSCLC) with EGFR mutation with osimertinib. Materials and methods: For better accuracy in estimating the ADP, we used the prices generated from the six dimensions at scenario levels, not at the dimension-specific price (DSP) level. We pooled the price estimates and performed Monte Carlo Simulations (MCS) for the price scenarios generated by the six dimensions. We used the results of the proof-of-concept exercise involving osimertinib in NSCLC with EGFR mutation to estimate the ADP in two hypothetical contracts: 1-year (2019-2020) and 2-year contract (2019-2021).
Aims: Six Delta is a six-dimensional independent platform for outcome-based pricing/contracting. ... more Aims: Six Delta is a six-dimensional independent platform for outcome-based pricing/contracting. The third dimension (d3) estimates prices on the basis of international drug price referencing methods. We describe this dimension's methodology and present a proof-of-concept application to the treatment of non-small cell lung cancer (NSCLC) with EGFR mutation with osimertinib. Materials and methods: The reference-based pricing dimension utilizes a six-step method: (1) selecting foreign countries based on a set of four criteria (drug is available in the foreign country, price information is available in the foreign country, foreign countries are members within the organization for Economic Cooperation and Development, pricing methods in the foreign countries involve value assessment); (2) adjusting for exchange rates; (3) generating reference price (RP) scenarios; (4) adjusting with the medical inflation rate; (5) pooling all generated RP scenarios and calculating average and standard deviation (SD); (6) and Monte Carlo Simulation (MCS) to estimate the dimension-specific DSP Reference. A proof-of-concept exercise with osimertinib in NSCLC was performed for two hypothetical outcome-based contracts: 1-year (2019-2020) and 2-year (2019-2021). Results: The United Kingdom and Canada met the four criteria. For the osimertinib 1-year contract price, the average of eight RP scenarios, adjusted for inflation by 0.
Background: The use of anti-cytotoxic T-lymphocyte antigen 4 (anti-CTLA4) therapy (ipilimumab) an... more Background: The use of anti-cytotoxic T-lymphocyte antigen 4 (anti-CTLA4) therapy (ipilimumab) and anti-programmed cell-death 1 (anti-PD1) agents (nivolumab and pembrolizumab) in advanced melanoma have been associated with immune-related adverse events (irAEs) including colitis. We aimed to estimate the incidence and the risk of colitis in elderly patients with advanced melanoma treated with anti-CTLA4 and anti-PD1 in the real-world setting. Methods: Elderly patients (age ⩾ 65 years) diagnosed with advanced melanoma between 2011 and 2015 and treated with anti-CTLA4 or anti-PD1 agents were identified from the Surveillance, Epidemiology, and End Results (SEER)–Medicare data. We estimated the risk of colitis from start of treatment up to 90 days from the last dose of therapy. We used the log-rank test and logistic regression with adjustment for potential confounders using the inverse probability of treatment weighting method. We conducted several sensitivity analyses. Results: A total ...
Dual‐trajectories of opioid and gabapentinoid use and risk of subsequent drug overdose among Medicare beneficiaries in the United States: a retrospective cohort study
Ex Ante Economic Evaluation of Arg389 Genetically Targeted Treatment with Bucindolol versus Empirical Treatment with Carvedilol in NYHA III/IV Heart Failure
Ex ante economic evaluation of genetic testing for the ARG389 beta1-adrenergic receptor polymorphism to support bucindolol treatment decisions in Stage III/IV heart failure
Expert Review of Precision Medicine and Drug Development
Nationally Representative Health Care Expenditures of Community-Based Older Adults with Pain in the United States Prescribed Opioids vs Those Not Prescribed Opioids
Pain Medicine
Objective To compare health care expenditures between older US adults (≥50 years) with pain who w... more Objective To compare health care expenditures between older US adults (≥50 years) with pain who were prescribed opioid medications and those who were not. Design Cross-sectional. Setting Community-based adults in the 2015 Medical Expenditure Panel Survey (MEPS). Subjects Nationally representative sample of US adults alive for the calendar year, aged 50 years or older, who reported having pain in the past four weeks. Methods Older US adults (≥50 years) with pain in the 2015 MEPS data were identified. The key independent variable was opioid prescription status (prescribed opioid vs not prescribed opioid). Hierarchical linear regression models assessed health care expenditures (inpatient, outpatient, office-based, emergency room, prescription medications, other, and total) in US dollars for opioid prescription status from a community-dwelling US population perspective, adjusting for covariates. Results The 2015 study cohort provided a national estimate of 50,898,592 noninstitutionalize...
Background: The use of ipilimumab, nivolumab, and pembrolizumab as monotherapies or in combinatio... more Background: The use of ipilimumab, nivolumab, and pembrolizumab as monotherapies or in combination has transformed the management of advanced melanoma even though these drugs are associated with a new profile of immune-related adverse events (irAEs). The incidence of irAEs from clinical trials of these agents is an important factor for clinicians when treating patients with advanced melanoma. In the current study, we aimed to profile the incidence of potential irAEs of these agents when used as monotherapy and as combination therapy. Methods: We searched the Medline, Embase, and Cochrane databases; clinicaltrials.gov; and websites of regulatory agencies in the USA, Europe, Australia, and Japan for phase 1-3 trials of ipilimumab, nivolumab, and pembrolizumab for advanced melanoma. Random effect meta-analysis was utilized to profile the incidence of potential irAEs. Results: A total of 58 reports of 35 trials including 6,331 patients with advanced melanoma and reporting irAE data were included in the meta-analyses. We found higher incidences of potential irAEs in combination therapies vs. monotherapies for most of the types of irAEs. Among the monotherapies, ipilimumab users had the most frequent incidence of potential irAEs related to the gastrointestinal system (diarrhea, 29%; and colitis, 8%) and skin (rash, 31%; pruritus, 27%; and dermatitis, 10%), with hypophysitis in 4% of the patients. The most frequent potential irAEs among nivolumab users were maculopapular rash (13%), erythema (4%), hepatitis (3%), and infusion-related reactions (3%), while they were arthralgia (12%), hypothyroidism (8%), and hyperglycemia (6%), among pembrolizumab users. Almutairi et al. Immune-Related Adverse Events of Immunotherapies in Melanoma Conclusion: Especially the combination therapies tend to elevate the incidence of potential irAEs. Clinicians should be vigilant about irAEs following combination therapy as well as gastrointestinal and skin irAEs following ipilimumab therapy, in addition to being aware of potential irAEs leading to hyperglycemia, thyroid, hepatic, and musculoskeletal disorders following nivolumab and pembrolizumab therapy.
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