Efficacy and safety of tirzepatide versus placebo in overweight or obese adults without diabetes: a systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: Tirzepatide was approved to treat type 2 diabetes and obesity, but its efficacy and safety in patients without diabetes has not been investigated. AIM: This meta-analysis aimed to evaluate the efficacy and safety of tirzepatide compared to placebo in overweight or obese patients without diabetes. METHOD: PubMed, Embase and Cochrane were searched on January 18, 2024. Randomized controlled trials (RCTs) that used tirzepatide in overweight or obese adults without diabetes were included. Efficacy outcomes included the proportion of participants achieving weight loss targets, changes in body weight (%), body mass index (BMI), waist circumference (WC), and blood pressure (BP). Safety outcomes were commonly reported adverse events. Standardized mean differences (SMD) or odds ratios (OR) with 95% confidence intervals (CIs) were used for continuous and dichotomous outcomes, respectively. RESULTS: Three RCTs with 3901 participants were included. Tirzepatide was associated with increased proportion of participants achieving weight loss targets, reduced body weight (SMD - 1.61, 95% CI - 2.20 to - 1.02), BMI (SMD - 2.13, 95% CI - 3.08 to - 1.18), WC (SMD - 0.91, 95% CI - 1.14 to - 0.69), and BP versus placebo. However, the risk of adverse events such as nausea (OR 4.26, 95% CI 2.60 to 3.81), vomiting (OR 8.35, 95% CI 5.19 to 13.45), and diarrhea (OR 3.57, 95% CI 2.80 to 4.57) was significantly higher for tirzepatide versus placebo. CONCLUSION: Tirzepatide significantly reduced weight and improved metabolic markers among overweight or obese without diabetes. However, increased adverse events highlights the need for benefits versus risks assessment before initiation and continuous monitoring.

Quantity, Duration, Adherence, and Reasons for Dietary Supplement Use among Adults: Results from NHANES 2011-2018.

Dietary supplement use is common among US adults. We aimed to investigate the quantity, duration, adherence, and reasons for supplement use in individuals who take supplements. Data from 2011 to 2018 from the National Health and Nutrition Examination Survey (NHANES) dataset were analyzed. Four cycles of data were combined to estimate these outcomes. Results are presented as overall group and by subgroups. All analyses were weighted to be nationally representative. The Taylor Series Linearization approach was used to generate variance estimates. A total of 12,529 participants were included. Over 70% of these individuals reported taking more than one unit of dietary supplements daily. Notably, approximately 40% had been taking supplements for more than five years and about 67% were highly adherent to at least one supplement. However, only 26.9% of these supplements were taken following a doctor's recommendation. The primary reasons for dietary supplements intake included improving overall health (37.2%), maintaining health (34.7%), bone health (21.4%), and diet supplementation (20.3%). Our findings indicate that most participants proactively used multiple dietary supplements focused on self-managed health and prevention, with substantial dedication to long-term use and high adherence. Healthcare professionals should play a more active role in guiding such behaviors to optimize the health outcomes of dietary supplement users across the United States.

Vonoprazan-based therapies versus PPI-based therapies in patients with H. pylori infection: Systematic review and meta-analyses of randomized controlled trials.

BACKGROUND: This study aims to evaluate the efficacy and safety of vonoprazan-amoxicillin (VA), vonoprazan-amoxicillin-clarithromycin (VAC), vonoprazan-based bismuth-containing quadruple therapy (VBQT), and PPI-based triple (PAC) or quadruple therapy (PBQT) for H. pylori infection with the consideration of duration of therapy and amoxicillin dose (H: high; L: low). MATERIALS AND METHODS: PubMed, Embase, and the Cochrane Central Register of Controlled Trials were searched for eligible randomized controlled trials (RCTs) up to December 15, 2023. The efficacy outcome was eradication rate, and safety outcomes included the rates of adverse events and treatment discontinuation. RESULTS: Twenty-seven RCTs were included. The pooled eradication rates were 82.8% for VA, 89.1% for VAC, and 91.8% for VBQT, which increased with the higher amoxicillin frequency of administration and extended duration of therapy within each regimen. There were no significant differences in eradication rate when comparing 7-VA versus 7-VAC and 14-VA versus 14-VAC. VA was at least comparable to PAC. The eradication rate did not differ significantly between 10-H-VA or 14-H-VA versus 14-PBQT. 7-L-VAC demonstrated higher eradication rate versus 7-PAC and comparable rate to 14-PAC. 14-VBQT showed higher eradication rates versus 14-PBQT. The adverse events rate was 19.3% for VA, 30.6% for VAC, and 38.4% for VBQT. VA had similar risk of adverse events versus VAC and significantly fewer adverse events compared to PBQT. The treatment discontinuation rate did not differ significantly between treatments. CONCLUSIONS: The eradication rate of VBQT was the highest at above 90% followed by VAC and VA. VA was as effective as VAC and superior to PPI-based therapies with favorable safety, highlighting the potential of VA therapy as a promising alternative to traditional PPI-based therapies. VPZ-based triple or quadruple therapies was more effective than PPI-based therapies. Further studies are needed to establish the optimal treatment regimen especially in the western countries.

Medication adherence in Medicare-enrolled older adults with asthma and chronic obstructive pulmonary disease before and during COVID-19 pandemic.

Background: Medication adherence in Medicare-enrolled older adults with asthma and chronic obstructive pulmonary disease (COPD) before and during the coronavirus disease 2019 (COVID-19) pandemic is unknown. Objectives: To evaluate medication adherence and determinants of high adherence before and during the COVID-19 pandemic in this population. Design: Retrospective cohort study. Methods: The proportion of days covered (PDC) reflected medication adherence from January to July 2019 and from January to July 2020. Patients <65 years of age, with COPD or asthma alone, or with cystic fibrosis were excluded. Paired t tests were used to assess adherence changes. Logistic regression explored association of age, sex, diagnosis of depression, number of medications, medication-related problems, prescribers, pharmacies, controller medication classes, albuterol rescue inhaler fills, oral corticosteroid fills, and having a 90-day supply with high adherence (PDC ⩾ 80%). Results: This analysis included 989 patients. In this cohort, 61.2% of patients received oral corticosteroids. Over 60% of patients had ⩾3 rescue fills in both 2019 and 2020. Medication adherence to controller medications significantly decreased for all controller medications (p < 0.001) in 2020. In 2019 and 2020, number of controller medication classes and having a 90-day supply were associated with high adherence (p < 0.001). In 2019, variables associated with high adherence also included number of medication-related problems and having ⩾3 albuterol rescue inhalers (p < 0.001). Conclusion: Medication adherence to controllers significantly decreased during the pandemic among older adults with asthma and COPD. Patients with multiple controller classes and a 90-day supply were more likely to be highly adherent. A 90-day supply of medications should be used to facilitate access to medication during the pandemic. Healthcare professionals should assess medication adherence, resolve the barriers of adherence and medication-related problems to achieve desired clinical outcomes among older adults with both asthma and COPD.

Efficacy and safety of probiotics and synbiotics for functional constipation in children: A systematic review and meta-analysis of randomized clinical trials.

BACKGROUND & AIM: We aimed to evaluate the efficacy and safety of probiotics and synbiotics in childhood functional constipation. METHODS: PubMed, Embase, Cochrane Library, ClinicalTrials.gov, and the International Clinical Trials Registry Platform (ICTRP) were searched up to June 2023. Randomized controlled trials involving children diagnosed with FC with Rome III/IV criteria were included. Treatment success, defecation frequency, stool consistency, painful defecation, fecal incontinence, and adverse events were assessed as outcomes. Odds ratios (ORs) and standard mean difference (SMD) with 95% confidence intervals (CIs) were calculated for dichotomous and continuous variables as appropriate. Cochrane risk-of-bias tool version 2 assessed the risk of bias. RESULTS: Seventeen RCTs with 1504 patients were included. Compared to placebo, probiotics significantly improved defecation frequency (SMD 0.40, 95% CI 0.10 to 0.70, I2 = 0%) and fecal incontinence (OR 0.53, 95% CI 0.29 to 0.96, I2 = 0%). However, it did not significantly improve treatment success, painful defecation, and abdominal pain. Probiotics, as add-on therapy, failed to yield a significant difference in treatment success (OR 0.82, 95% CI 0.15 to 4.48, I2 = 52%), defecation frequency (SMD 0.13, 95% CI -0.13 to 0.39, I2 = 0%), defecation consistency (SMD -0.01, 95% CI -0.40 to 0.38, I2 = 1%), fecal incontinence (OR 0.95, 95% CI 0.48 to 1.90, I2 = 0%), and abdominal pain (OR, 0.60, 95% CI 0.24 to 1.53, I2 = 0%) versus laxatives monotherapy. Synbiotics plus laxatives showed no significant effect on defecation frequency (SMD -0.57; 95% CI -1.29 to 0.14, I2 = 74%) and painful defecation (OR, 3.39; 95% CI 0.74 to 15.55, I2 = 0%) versus laxatives alone. CONCLUSIONS: Current evidence did not advocate using probiotics and synbiotics in treating functional constipation in children. At this time, the effects of strain-specific probiotics, probiotics mixtures, and the optimal doses and treatment durations of the probiotics and synbiotics were unclear. Additional rigorous evidence is required to evaluate and establish the effectiveness and safety of probiotics and synbiotics for childhood functional constipation. PROSPERO ID: CRD42020195869.

An Alternative Approach to Tablet Splitting and Grinding for Medication Administration.

Tablet formulations fail to meet the needs of patients unable to swallow tablets such as pediatric, elderly, and patients that must receive medications via feeding tubes. Our objective was to develop and test a new, simple device (XTEMP-R) and the methodology for converting tablets into a homogeneous suspension for medication administration. We developed a new device comprised of a flexible receptacle, a tight-fitting cap, and a suction cup bottom to convert tablets into liquid preparations. Tuberculosis treatment drugs, TBAJ-876 and TBI-223, were dispersed within the device utilizing water and commonly available suspending vehicles. We investigated the effectiveness of the XTEMP-R device in dispersing tablets. This was accomplished by visual observations, determining the fineness of dispersion, and measuring the total drug recovery from the dispersions in XTEMP-R. We investigated the accuracy and reproducibility of delivering aliquots from these suspensions by determining the dose reproducibility upon suspension and upon redispersion after 24 hours. The effectiveness of the device was also evaluated using commercially available tablets of acetaminophen, amlodipine, glimepiride, metformin, and valsartan. The suspensions were visually uniform without any large particles. The suspensions passed through a #18 sieve confirming that the particles were less than 1000 µm. The average total dose recovery of three suspensions each was determined to be 101.3% and 99.2% for TBI-223 and TBAJ-876, respectively. Reproducibility from aliquots of 2 mL each was 98.9% to 99.7% for three replicates of TBI-223 suspensions, and 102.6% to 103.2% for TBAJ-876 suspensions. Aliquots tested after 24 hours confirmed uniform redispersibility. We have demonstrated that XTEMP-R can be utilized to prepare homogeneous suspensions conveniently and efficiently in less than 10 minutes without any drug loss. Aliquots for partial dose delivery can be withdrawn accurately. These findings demonstrate that XTEMP-R can be used to accurately deliver doses of suspensions for patients who cannot swallow tablets.

Urine Drug Test Results Among Adolescents and Young Adults in an Outpatient Office-Based Opioid Treatment Program.

PURPOSE: Urine drug testing (UDT) is an important feature of outpatient treatment for opioid use disorder, but associations with patient characteristics among adolescent and young adult patients are unknown. This study assessed UDT results in office-based opioid treatment and characteristics associated with treatment compliance. METHODS: This was a retrospective study of adolescent and young adult patients enrolled in office-based opioid treatment between January 1, 2009, and December 31, 2020. UDT results were described as positive results or expected and unexpected results. Expected results were negative UDTs for opioids, marijuana (THC [tetrahydrocannabinol]), or cocaine/methamphetamine, or a positive UDT for buprenorphine. Unexpected results were positive UDTs for opioids, THC, or cocaine/methamphetamine, or a negative UDT for buprenorphine. Treatment compliance was defined as ≥75% of UDTs provided being expected results. Counts and percentages described UDT results. Regressions evaluated associations between patient characteristics (retention time, age, sex, race/ethnicity, insurance, and comorbid mental health diagnoses) with treatment compliance, and assessed change of positivity rates for UDTs over time. RESULTS: A total of 407 patients were included. Overall, 305 patients (74.9%) demonstrated treatment compliance. Rates of expected UDT results increased with longer retention time (p <.001), except for methamphetamine. Buprenorphine expected results ranged from 77.0% to 96.5%. Diagnosis of stimulant use disorder was associated with decreased compliance (p = .04), while diagnoses of depression, anxiety, nicotine use disorder, and post-traumatic stress disorder were associated with increased compliance (p ≤.04). DISCUSSION: Proportion of expected UDT results increased with retention time. Diagnosis of specific mental health conditions affected treatment compliance. Further research regarding long-term health outcomes is needed.

Retention in Office-Based Opioid Treatment and Impact on Emergency Department Use in Adolescents and Young Adults With Opioid Use Disorder.

PURPOSE: Longer retention in medication treatment (MT) of addiction is associated with improved health outcomes among adults with opioid use disorder. MT remains underutilized among adolescents and young adults (AYA); factors associated with MT retention are not well-defined and effect of retention on treatment outcomes is unknown. This study examined patient characteristics associated with retention in an office-based opioid treatment program for AYA patients and determined the impact of retention time on emergency department (ED) utilization. METHODS: This was a retrospective study of AYA patients from January 1, 2009, to December 31, 2020. Retention time was the difference between first and last appointment, analyzing follow-up periods of one and two years. Linear regression assessed factors associated with retention. Negative binomial regression showed effect of retention on ED utilization. RESULTS: A total of 407 patients were included. Factors positively associated with retention were diagnosis of anxiety, depression, and nicotine use disorder, White race, private insurance, and Medicaid insurance; however, stimulant/cocaine use disorder was negatively associated (one-year follow-up, p ≤ .028; two-year follow-up, p ≤ .017). Longer retention was associated with reduced risk of ED utilization at one-year (incident rate ratio = 0.84, 95% confidence interval: 0.72-0.99; p = .03) and two-year follow-ups (incident rate ratio = 0.86 95% confidence interval: 0.77-0.96; p = .008). DISCUSSION: Diagnosis of anxiety, depression, nicotine use disorder, and stimulant/cocaine use disorder, and insurance and race can influence retention in MT. Longer retention in MT was associated with lower ED visits, decreasing health care utilization. MT programs should evaluate various interventions to optimize opportunities for increasing retention among their patient cohorts.

Treatment of Helicobacter pylori Infection in Patients with Penicillin Allergy.

Helicobacter pylori is among the prevalent causes of infections worldwide, and its resistance rate to antibiotics has been rising over time. Amoxicillin is the cornerstone for the treatment regimen. However, the prevalence of penicillin allergy ranges from 4% to 15%. In patients with true allergy, Vonoprazan-Clarithromycin-Metronidazole and bismuth quadruple therapy have demonstrated excellent eradication and high adherence rates. Vonoprazan-based therapy is administered less frequently and may be better tolerated than bismuth quadruple therapy. Therefore, vonoprazan-based therapy may be considered as a first-line therapy if accessible. Bismuth quadruple therapy can be used as the initial therapy when vonoprazan is unavailable. Levofloxacin or sitafloxacin-based regimens achieve a moderately high eradication rate. However, these are associated with potentially serious adverse effects and should only be used when other effective and safer regimens are unavailable. Cephalosporins such as cefuroxime have been used as an alternative to amoxicillin. Microbial susceptibility studies can guide the selection of appropriate antibiotics. PPI-Clarithromycin-Metronidazole fails to achieve a high eradication rate and should be used as a second-line therapy. PPI-Clarithromycin-Rifabutin should not be used because of low eradication rate and frequent adverse reactions. The choice of the most effective antibiotic regimen can enhance clinical outcomes in patients with H. pylori infection and penicillin allergy.

The Efficacy and Safety of Vonoprazan and Amoxicillin Dual Therapy for Helicobacter pylori Infection: A Systematic Review and Network Meta-Analysis.

The eradication of Helicobacter pylori (H. pylori) infection remains challenging due to increasing bacterial resistance. Resistance rates to clarithromycin, metronidazole, and levofloxacin were higher than 30% in the USA, making current therapies less effective. Vonoprazan triple therapy (VAC) has demonstrated similar efficacy and safety profiles compared to PPI-based triple therapy (PPI). However, the eradication rate of vonoprazan dual therapy (VA) for H. pylori infection in comparison to VAC, and PPI was poorly established. Electronic databases were searched up to 6 October 2022, to identify studies examining the safety and efficacy of VA compared to VAC and PPI. Six studies were included. For empiric therapies among treatment naïve patients, VA, VAC, and PPI did not achieve high cure rates (>90%). The comparative efficacy ranking showed VAC was the most effective therapy, followed by VA, and PPI. The results were similar for clarithromycin-resistant infections. The comparative safety ranking showed VA ranked first, whereas PPI triple therapy was the least safe regimen. These findings should guide the selection of the most effective and safe treatment and conduct additional studies to determine the place of vonoprazan dual versus triple therapies in patients with H. pylori from various countries across the world.

Telehealth Intervention to Improve Uptake of Evidence-Based Medications among Patients with Type 2 Diabetes and Heart Failure or Cardiovascular Disease.

INTRODUCTION: Sodium glucose cotransporter-2 (SGLT-2) inhibitors and glucagon-like peptide 1 receptor (GLP-1) agonists are recommended for patients with type two diabetes (T2D) and atherosclerotic cardiovascular disease (ASCVD) or heart failure (HF) to reduce cardiovascular-related mortality. The objective of this study was to evaluate a telehealth targeted medication review (TMR) program to identify patients for uptake of these evidence-based medications. METHODS: This was an observational descriptive study of a TMR program for Medicare-enrolled, Medication Therapy Management-eligible patients in one insurance plan. Prescription claims and patient interviews identified individuals who would benefit from SGLT-2 inhibitors or GLP-1 agonists. Facsimiles were sent to providers of patients with educational information about the targeted medications. Descriptive statistics described characteristics and proportion of patients prescribed targeted medications after 120 days. Bivariate statistical tests evaluated associations between age, sex, number of medications, number of providers, and poverty level with adoption of targeted medications. RESULTS: A total of 1106 of 1127 had a facsimile sent to their provider after a conversation with the patient. Among patients with a provider facsimile, 69 (6%) patients filled a prescription for a targeted medication after 120 days. There was a significant difference in age between individuals who started a targeted medication (67 ± 10 years) compared with patients who did not (71 ± 10 years) (p = 0.001). CONCLUSIONS: A TMR efficiently identified patients with T2D and ASCVD or HF who would benefit from evidence-based medications. Although younger patients were more likely to receive these medications, the overall uptake of these medications within four months of the intervention was lower than expected.

Vonoprazan With Amoxicillin or Amoxicillin and Clarithromycin for the Treatment of Helicobacter pylori Infection.

OBJECTIVES: To describe the pharmacology, efficacy, safety, and potential role of vonoprazan with amoxicillin or amoxicillin and clarithromycin for the treatment of Helicobacter pylori infection in adults. DATA SOURCES: PubMed, Embase, Cochrane Library, and ClinicalTrials.gov were searched using the terms: (vonoprazan OR voquezna) AND ("H. pylori" OR "Helicobacter pylori") AND amoxicillin with no date limitations up to November 3, 2022. STUDY SELECTION AND DATA EXTRACTION: Studies assessing the efficacy and safety of vonoprazan with amoxicillin and/or clarithromycin were included and divided into 3 groups based on different comparisons between treatment regimens used in each group. DATA SYNTHESIS: Ten clinical trials and 17 observational studies were included. Vonoprazan-based therapy demonstrated greater acid inhibition and similar or higher efficacy than proton-pump inhibitor (PPI)-based therapy in treatment-naïve patients and with clarithromycin-resistant infections. RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE: Proton-pump inhibitor-based therapies have not reached the desired successful eradication rate of 90% for H. pylori infection. Vonoprazan-based therapies being at least as effective as PPI-based therapies offer an alternative for patients with H. pylori infection. CONCLUSION: Vonoprazan-based therapies were effective and well tolerated for the treatment of H. pylori infection in adults. These regimens provide an important alternative with prolonged acid inhibition, lower potential for CYP2C19 polymorphism, and at least comparable efficacy and safety versus PPI-based therapies in patients with H. pylori infections. Thus, vonoprazan-based therapy should be considered for certain patients, for example, those with failure to PPI-based treatments.

Social needs of dual-enrolled Medicare-Medicaid patients with medication nonadherence in a telehealth medication therapy management program.

BACKGROUND: Telehealth services that identify and address the social needs of patients can improve access to health care and social services. The social needs of medication therapy management (MTM)-eligible Medicare-Medicaid dual-enrolled patients are unknown. OBJECTIVE: To describe the social needs of Medicare-Medicaid dual-enrolled patients participating in a telephonic MTM program. METHODS: This study evaluated the findings of a social needs survey implemented within a telehealth MTM program. Surveys were offered telephonically to eligible Medicare-Medicaid patients of one insurance plan who were identified with medication nonadherence between July 13, 2020, and December 31, 2020. This study described patients who completed the survey during provision of a comprehensive medication review (CMR). Questions screened for social needs in the following social determinant of health domains: community and social context, economic stability, and neighborhood and physical environment. Descriptive statistics were used to describe results. RESULTS: Among 461 patients who completed CMRs, 358 completed the social needs survey. The most prevalent needs and concerns identified included lacking support to perform daily activities (165 [47%]), lacking companionship (81 [23%]), feeling left out (71 [20%]), feeling isolated (81 [23%]), not having enough money to pay bills (177 [49%]), worrying about running out of food (77 [22%]), or having run out of food within the last 12 months (81 [23%]). In this sample, 54 (15%) patients reported avoiding a provider visit because of transportation barriers. Certain individuals were without a steady place to live or were worried about losing their home (40 [11%]) and 35 (10%) reported struggling to keep a job. CONCLUSIONS: The identification of social needs among patient populations is necessary to reduce barriers to medication adherence and optimize health care utilization. This study described important social needs identified during the provision of a telehealth CMR among MTM-eligible Medicare-Medicaid dual-enrolled patients. DISCLOSURES: Dr Nahata was supported in part by the Avatar Foundation. Dr Silva Almodóvar works as a research pharmacist within a medication management program, which provides medication therapy management services.

Gaps in Evidence-based Treatment of Concurrent Attention Deficit Hyperactivity Disorder and Opioid Use Disorder: A Scoping Review.

OBJECTIVES: To describe the effectiveness of medications for the treatment of opioid use disorder (OUD) and attention deficit/hyperactivity disorder (ADHD). DATA SOURCES: Literature search of PubMed, Embase, Web of Science, CINAHL, Medline, PsycINFO, and Google Scholar was performed for studies published from inception to October 25, 2022. STUDY SELECTION AND DATA EXTRACTION: Studies were included if patients were diagnosed with OUD and ADHD and had pharmacotherapy for either condition. Abstracts, commentaries, reviews, case reports, case series, non-English articles, and animal studies were omitted. DATA SYNTHESIS: This review found 18 studies. Treatment of ADHD was evaluated for impact on ADHD and OUD outcomes, while treatment of OUD was evaluated for OUD-related outcomes. Outcomes assessed included markers for symptom intensity, adherence, and treatment failure. While results were mixed, treatment of ADHD was largely associated with improvements in ADHD severity and retention in OUD treatment programs. ADHD severity was associated with higher rates of illicit substance abuse and worse OUD-related outcomes. It could not be determined which medications for treatment of OUD should be prioritized. RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE: This review summarized key findings from studies that treated ADHD or OUD among dually diagnosed patients and highlighted methodological considerations for future research. CONCLUSIONS: Treatment of ADHD is warranted among patients with OUD and ADHD to improve retention in OUD treatment programs and reduce illicit substance abuse. Pharmacotherapy for the treatment of ADHD or OUD should continue to be determined based on patients' characteristics and the capabilities of the treatment program.

High opioid doses, naloxone, and central nervous system active medications received by Medicare-enrolled adults.

BACKGROUND: A limited number of studies have analyzed prescribing among Medicare-enrolled adults at risk for opioid overdoses. The objectives of this study were to evaluate prescribing for naloxone and central nervous system (CNS) active medications and to determine the relationships of patient characteristics with exposure to these medications. METHODS: This was a retrospective cross-sectional analysis of a Medicare-enrolled medication therapy management eligible cohort. Patients were stratified into two cohorts, individuals with a mean daily morphine milligram equivalent (MME) dose <50 and individuals with MME ≥50. Medications assessed included benzodiazepines, skeletal muscle relaxants (SMR), hypnotics, gabapentanoids, selective-serotonin reuptake inhibitors (SSRI), serotonin-norepinephrine reuptake inhibitors (SNRI), tricyclic antidepressants (TCA), antipsychotics, barbiturates, other antiepileptics, hydroxyzine, and naloxone. Chi-square with odds ratios and logistic regressions determined the relationships of medications and patient characteristics with mean daily MME ≥50. Relationship between medications and opioid dose was adjusted for age and sex. RESULTS: There were 3452 patients with a daily MME <50 and 1116 with a daily MME ≥50. After adjusting for age and sex, patients with a daily MME ≥50 were more likely to be prescribed hypnotics (OR: 1.41, 95% CI 1.17-1.70), SNRIs (OR: 1.39, 95% CI 1.17-1.64), and naloxone (OR: 3.21, 95% CI 2.49-4.12) (p < 0.001). Nine percent of eligible patients received naloxone. Age groups of persons <85 years of age had 1.58-4.04 (p ≤ 0.004) times the odds of being prescribed a mean daily MME ≥50. CONCLUSION: Nearly one-fourth of patients were prescribed a mean daily opioid therapy of MME ≥50. These patients were more likely to be prescribed hypnotics, SNRIs, and naloxone. Patients receiving chronic high-dose opioid therapy were more likely to be in age groups of persons <85 years. Naloxone may be underprescribed among eligible adults. Targeted medication services may ensure optimal prescribing among Medicare patients with chronic opioid therapies.

Medication Adherence in Medicare-Enrolled Older Adults with Chronic Obstructive Pulmonary Disease before and during the COVID-19 Pandemic.

Medication adherence to controller inhalers was unknown in older Medicare patients with chronic obstructive pulmonary disease (COPD) before and during the pandemic. This study evaluated changes in medication adherence to controller medications and factors associated with high adherence. This retrospective cohort study included older Medicare patients with COPD. The proportion of days covered (PDC) reflected changes in medication adherence from January to July in 2019 and in 2020. Paired t-test evaluated changes in adherence. Logistic regression determined the association of patient characteristics with high adherence (PDC ≥ 80%). Mean adherence decreased (p < 0.001) for long-acting beta-agonists, long-acting muscarinic antagonists, and inhaled corticosteroids in 2020. The percentage of patients with high adherence dropped from 74.4% to 58.1% (p < 0.001). The number of controllers, having ≥3 albuterol fills, and a 90-day supply were associated with high adherence in 2019 and 2020 (p < 0.001). The COVID-19 pandemic may negatively impact medication adherence. Patients with evidence of more severe diseases and a 90-day supply were more likely to adhere to therapy. Healthcare professionals should prioritize prescribing 90-day supplies of medications and monitor drug-related problems as components of pharmacovigilance to enhance adherence to therapies and the desired clinical outcomes among patients with COPD.

Effects of Adjuvant Medications on A1C, Body Mass Index, and Insulin Requirements among Patients with Type 1 Diabetes.

Randomized controlled trials have demonstrated that noninsulin medications used to treat type 2 diabetes can improve health outcomes among patients with type 1 diabetes (T1D). This study assessed the effects of adjuvant diabetes medications on glycated hemoglobin (A1C), body mass index (BMI), or total daily insulin (TDI) among patients with T1D in a real-world setting. This was an analysis of the T1D Exchange Clinic Registry, using the study periods of 2010−2012, 2015−2016, and 2016−2017, to assess differences in A1C, BMI, and TDI between patients with and without adjuvant medications. The relationships between characteristics and A1C in 2015−2016 and 2016−2017 were determined. Analysis included 517 patients in the adjuvant medication cohort and 4968 in the insulin-only cohort. No significant improvement in A1C was observed. A significant difference in BMI and TDI between the insulin-only (median BMI: 25.5, 26.2, 26.4 and median TDI: 45, 44 units) and adjuvant medication cohorts (median BMI: 29.8, 30.5, 30.5 and median TDI: 51, 52 units) (p < 0.001) was observed. Patients with a continuous glucose monitor (CGM), higher education level, higher annual income, and older age were associated with lower A1C (p ≤ 0.001). Higher BMI and self-description as African American/Black were associated with higher A1C (p ≤ 0.01). Insulin pump use was associated with lower A1C (p < 0.01) in 2015−2016. Patients who used adjuvant medications did not demonstrate significant improvement in disease control. These data suggest that findings from well-designed research studies may not be consistently reproducible in real-world settings, due to patient-specific factors.