Tag: pubmed

J Am Pharm Assoc (2003). 2024 May 31:102138. doi: 10.1016/j.japh.2024.102138. Online ahead of print.

ABSTRACT

BACKGROUND: Kratom is an herbal supplement that has drawn attention for its use in the self-treatment of opioid withdrawal, and its widespread availability with minimal restrictions. Past web-based research has attempted to determine patterns and trends of use, but generalizability to underserved populations is unclear.

OBJECTIVE: The purpose of this study was to characterize behavior related to kratom, attitudes toward kratom, and knowledge of kratom in a rural, underserved population.

METHODS: We developed, refined, and administered a cross-sectional, 36-item survey to examine use, attitudes, and knowledge of kratom. We recruited participants and administered the survey alongside medical office appointments between January and April 2023. Data were summarized using descriptive statistics.

RESULTS: A convenient sample of 186 patients (of the 907-patient clinic panel) were invited to participate and 150 returned the survey. A majority of patients were female (52.0%) and White (86.6%), and about half had an income below the federal poverty level (48.5%). Seventeen participants reported prior experience with kratom use, with one actively using kratom. The most commonly reported reasons for use were pain (47.1%) and mental health (41.2%). Kratom knowledge was low regardless of kratom use history, with the majority of respondents correctly answering between 1 and 3 questions (n = 71 of 86; 82.3%) of the 5 knowledge-focused items.

CONCLUSION: Results suggest that while active kratom use is uncommon in this Oregon population, one in ten surveyed had used kratom. Regardless of past use, respondents had limited knowledge of kratom. Future research should focus on understanding trends in kratom use behaviors in underserved populations, addressing patient knowledge gaps, and evaluating patient safety and health equity implications.

PMID:38825151 | DOI:10.1016/j.japh.2024.102138

Neurosci Lett. 2024 May 31:137849. doi: 10.1016/j.neulet.2024.137849. Online ahead of print.

ABSTRACT

INTRODUCTION: Transcranial alternating current stimulation (tACS) at 5-Hz to the right hemisphere can effectively alleviate anxiety symptoms. This study aimed to explore the neural mechanisms that drive the therapeutic benefits.

METHODS: We collected electroencephalography (EEG) data from 24 participants with anxiety disorders before and after a tACS treatment session. tACS was applied over the right hemisphere, with 1.0 mA at F4, 1.0 mA at P4, and 2.0 mA at T8 (10-10 EEG convention). With eLORETA, we transformed the scalp signals into the current source density in the cortex. We then assessed the differences between post- and pre-treatment brain maps across multiple spectra (delta to low gamma) with non-parametric statistics.

RESULTS: We observed a trend of heightened power in alpha and reduced power in mid-to-high beta and low gamma, in accord with the EEG markers of anxiolytic effects reported in previous studies. Additionally, we observed a consistent trend of de-synchronization at the stimulating sites across spectra.

CONCLUSION: tACS 5-Hz over the right hemisphere demonstrated EEG markers of anxiety reduction. The after-effects of tACS on the brain are intricate and cannot be explained solely by the widely circulated entrainment theory. Rather, our results support the involvement of plasticity mechanisms in the offline effects of tACS.

PMID:38825146 | DOI:10.1016/j.neulet.2024.137849

J Manag Care Spec Pharm. 2024 Jun;30(6):588-598. doi: 10.18553/jmcp.2024.30.6.588.

ABSTRACT

BACKGROUND: Attention-deficit/hyperactivity disorder (ADHD) is a heterogeneous condition with extensive psychiatric comorbidities. ADHD has been associated with substantial clinical and economic burden; however, little is known about the incremental burden specifically attributable to psychiatric comorbidities of ADHD in adults.

OBJECTIVE: To assess the impact of psychiatric comorbidities, specifically anxiety and depression, on health care resource utilization (HRU) and costs in treated adults with ADHD in the United States.

METHODS: A retrospective case-cohort study was conducted. Adults with ADHD were identified in the IQVIA PharMetrics Plus database (10/01/2015-09/30/2021). The index date was defined as the date of initiation of a randomly selected ADHD treatment. The baseline period was defined as the 6 months prior to the index date, and the study period as the 12 months following the index date. Patients with at least 1 diagnosis for anxiety and/or depression during both the baseline and study periods were classified in the ADHD+anxiety/depression cohort, whereas those without diagnoses for anxiety or depression at any time were classified in the ADHD-only cohort. Entropy balancing was used to create reweighted cohorts with similar baseline characteristics. All-cause HRU and health care costs were assessed during the study period and compared between cohorts using regression analyses. Cost analyses were also conducted in subgroups stratified by comorbid conditions.

RESULTS: After reweighting, patients in the ADHD-only cohort (N = 276,906) and ADHD+anxiety/depression cohort (N = 217,944) had similar characteristics (mean age 34.1 years; 54.8% male). All-cause HRU was higher in the ADHD+anxiety/depression cohort than the ADHD-only cohort (incidence rate ratios for inpatient admissions: 4.5, emergency department visits: 1.8, outpatient visits: 2.0, and psychotherapy visits: 6.4; all P < 0.01). All-cause health care costs were more than 2 times higher in the ADHD+anxiety/depression cohort than the ADHD-only cohort (mean per-patient per-year [PPPY] costs in ADHD-only vs ADHD+anxiety/depression cohort: $5,335 vs $11,315; P < 0.01). Among the ADHD+anxiety/depression cohort, average all-cause health care costs were $9,233, $10,651, and $15,610 PPPY among subgroup of patients with ADHD and only anxiety, only depression, and both anxiety and depression, respectively.

CONCLUSIONS: Comorbid anxiety and depression is associated with additional HRU and costs burden in patients with ADHD. Comanagement of these conditions is important and has the potential to alleviate the burden experienced by patients and the health care system.

PMID:38824634 | DOI:10.18553/jmcp.2024.30.6.588

J Manag Care Spec Pharm. 2024 Jun;30(6):609-616. doi: 10.18553/jmcp.2024.30.6.609.

ABSTRACT

Medicare’s Part D Medication Therapy Management (MTM) programs serve approximately 4.5 million eligible beneficiaries. Prior research suggested that the thresholds to enter Part D MTM programs would disproportionately favor White beneficiaries compared with Black or Hispanic beneficiaries. This article summarizes those initial studies and compares the results with more recent analyses of racial and ethnic differences in MTM program enrollment, which, in general, show higher odds of MTM enrollment for minority beneficiaries compared with White beneficiaries. Disparities in the utilization of comprehensive medication review (CMR), a core MTM service, are also discussed. Although trends vary, disparities exist for various minority groups. For example, Black beneficiaries and Hispanic beneficiaries are less likely to be offered a CMR compared with White beneficiaries. Additionally, minority (Asian, Hispanic, and North American Native) beneficiaries are less likely to receive a CMR after being offered the service compared with White beneficiaries. Black, Hispanic, and Asian beneficiaries are more likely than White beneficiaries to have a longer duration between MTM enrollment and CMR offer. There is also a distinct difference in the type of pharmacist (ie, plan pharmacist, MTM vendor pharmacist, or community pharmacist) completing the CMR for certain racial and ethnic groups. For example, compared with White beneficiaries, Black beneficiaries were less likely to receive a CMR from a community pharmacist, whereas Asian beneficiaries were more likely.

PMID:38824629 | DOI:10.18553/jmcp.2024.30.6.609

J Manag Care Spec Pharm. 2024 Jun;30(6):528-540. doi: 10.18553/jmcp.2024.30.6.528.

ABSTRACT

BACKGROUND: Head-to-head trials comparing centanafadine, an investigational therapy for adults with attention-deficit/hyperactivity disorder (ADHD), with other treatment options are lacking.

OBJECTIVE: To compare safety and efficacy outcomes of centanafadine sustained-release vs lisdexamfetamine dimesylate (lisdexamfetamine), atomoxetine hydrochloride (atomoxetine), and viloxazine extended-release (viloxazine ER), respectively, using matching-adjusted indirect comparison (MAIC).

METHODS: This MAIC included patient-level data pooled from 2 centanafadine trials (NCT03605680 and NCT03605836) and published aggregate data from comparable trials of 3 comparators-lisdexamfetamine (NCT00334880), atomoxetine (NCT00190736), and viloxazine ER (NCT04016779)-in adult patients with ADHD. Propensity score weighting was used to match characteristics of individual patients from the centanafadine trials to aggregate baseline characteristics from the respective comparator trials. Safety outcomes were rates of adverse events for which information was available in the centanafadine and respective comparator trials. Efficacy outcome was mean change from baseline in the Adult ADHD Investigator Symptom Rating Scale (AISRS) score (ADHD Rating Scale [ADHD-RS] was used as proxy in the comparison with lisdexamfetamine). Anchored indirect comparisons were conducted across matched populations of the centanafadine and respective comparator trials.

RESULTS: After matching, baseline characteristics in the centanafadine trials were the same as those in the respective comparator trials. Compared with lisdexamfetamine, centanafadine was associated with a significantly lower risk of lack of appetite (risk difference [RD] in percentage points: 23.42), dry mouth (19.27), insomnia (15.35), anxiety (5.21), nausea (4.90), feeling jittery (3.70), and diarrhea (3.47) (all P < 0.05) but a smaller reduction in the AISRS/ADHD-RS score (6.58-point difference; P < 0.05). Compared with atomoxetine, centanafadine was associated with a significantly lower risk of nausea (RD in percentage points: 18.64), dry mouth (17.44), fatigue (9.21), erectile dysfunction (6.76), lack of appetite (6.71), and urinary hesitation (5.84) (all P < 0.05) and no statistically significant difference in the change in AISRS score. Compared with viloxazine ER, centanafadine was associated with a significantly lower risk of fatigue (RD in percentage points: 11.07), insomnia (10.67), nausea (7.57), and constipation (4.63) (all P < 0.05) and no statistically significant difference in the change in AISRS score.

CONCLUSIONS: In an anchored MAIC, centanafadine showed a significantly better short-term safety profile than lisdexamfetamine, atomoxetine, and viloxazine ER; efficacy was lower than with lisdexamfetamine and comparable (ie, nondifferent) with atomoxetine and viloxazine ER. This MAIC provides important insights on the relative safety and efficacy of common treatment options to help inform treatment decisions in adults with ADHD. Safety assessment was limited to rates of adverse events reported in both trials of a given comparison.

STUDY REGISTRATION NUMBERS: NCT03605680, NCT03605836, NCT00334880, NCT00190736, and NCT04016779.

PMID:38824626 | DOI:10.18553/jmcp.2024.30.6.528

J Manag Care Spec Pharm. 2024 Jun;30(6):549-559. doi: 10.18553/jmcp.2024.30.6.549.

ABSTRACT

BACKGROUND: Schizophrenia and schizoaffective disorder require long-term antipsychotic treatment with antipsychotic medications, but poor medication adherence can lead to increased health care utilization and costs. Long-acting injectable antipsychotics (LAIs) offer potential therapeutic advantages in that they require less frequent dosing and improved medication adherence. South Carolina has the highest adoption of LAIs among US states, making it an ideal population for comparing the effectiveness of LAIs vs oral antipsychotics (OAPs) in treating schizophrenia or schizoaffective disorder.

OBJECTIVE: To evaluate the effect of LAIs compared with OAPs on medication adherence, health care resource utilization, and costs among South Carolina Medicaid beneficiaries with schizophrenia or schizoaffective disorder.

METHODS: South Carolina Medicaid beneficiaries with at least 1 claim for an LAI or OAP between January 1, 2015, and December 31, 2018, aged 18 to 65, with at least 2 claims with diagnoses of schizophrenia or schizoaffective disorder were included. Propensity scores (PSs) were calculated using logistic regression adjusting for confounders and predictors of the outcome. We estimated the “average treatment effect on the treated” by employing PS-weighted t-tests and chi-square tests.

RESULTS: A total of 3,531 patients met the inclusion criteria, with 1,537 (44.5%) treated with LAIs and 1,994 (56.5%) treated with OAPs. In PS-weighted analyses, the LAI cohort had a greater proportion of days covered than the OAP cohort with a 365-day fixed denominator (69% vs 64%; P < 0.0001), higher medication possession ratio with a variable denominator while on therapy (85% vs 80%; P < 0.0001), and higher persistence (82% vs 64%; P < 0.0001). The average number of inpatient visits and emergency department visits did not significantly differ between cohorts (0.28 hospitalizations, P = 0.90; 3.68 vs 2.96 emergency department visits, P = 0.19). The number of outpatient visits, including visits for medication administration, were greater in the LAI cohort (23.1 [SD 24.2]) vs OAP (16.9 [SD 21.2]; P < 0.0001); however, including the costs for medication administration visits, outpatient costs (per member) were approximately $2,500 lower in the LAI cohort (P < 0.0001). The number of pharmacy visits was greater in the OAP cohort (LAI 21.0 [SD 17.0] vs OAP 23.0 [SD 15.0]; P = 0.006). All-cause total costs were greater in the LAI cohort ($26,025 [SD $29,909]) vs the OAP cohort ($17,291 [SD $25,261]; P < 0.0001) and were driven by the difference in pharmaceutical costs (LAI $15,273 [SD $16,183] vs OAP $4,696 [SD $10,371]; P < 0.0001).

CONCLUSIONS: Among South Carolina Medicaid beneficiaries, treatment with LAIs for schizophrenia or schizoaffective disorder was associated with greater medication adherence rates. Patients using LAIs had higher drug costs and total costs, but lower outpatient and total nondrug costs compared with those using OAPs.

PMID:38824623 | DOI:10.18553/jmcp.2024.30.6.549

BMC Res Notes. 2024 Jun 1;17(1):150. doi: 10.1186/s13104-024-06808-6.

ABSTRACT

BACKGROUND: Worldwide ranking above HIV/AIDS, tuberculosis is continues to have a significant effect on public health and the leading cause of death due to high progression of HIV. The objective of current study was identify joint clinical determinants that affecting bivariate hematological parameter among TB/HIV co-infected adults under TB/HIV treatment in university of Gondar comprehensive specialized hospital.

METHOD: The result of these study was conducted at university of Gondar comprehensive specialized hospital, Gondar, Ethiopia by using a retrospective cohort follow up study from September 2015-march 2022 G.C. The source of data in this study was secondary data obtained from patients chart. Bayesian approach of longitudinal linear mixed effect sub model was used in panel data set to get wide range of information about TB/HIV co-infected patients.

RESULT: Out of 148 co-infected participants more than half of the patients (56.1%) and (52.7%) accounted for CPT and INH non users, of which 10.8% and 10.3% had the outcome of mortality respectively. The random intercept and slope model were selected for repeated measure hemoglobin level and hematocrit based on deviance information criteria (DIC), and probability of direction (Pd) under the full model.

CONCLUSION: Current study revealed that clinical predictors red blood cell count, platelet cell count, fair and good treatment adherence, other ART regiment, IPT drug users, and viral load count < 10,000 copies/mL, were associated with high hemoglobin level concentration while, lymphocyte count, WHO clinical stage-IV,1e ART regiment, and patients with OIs results for low hemoglobin level concentration. Likewise, red blood cell count, platelet cell count, fair and good treatment adherence, IPT drug users, and viral load count < 10,000 copies/mL co-infected patients had high hematocrit, while lymphocyte count, WHO clinical stage-III,1c ART regiment, and patients with OIs significantly leads to low hematocrit. Health professionals give more attention to these important predictors to reduce progression of disease when the co-infected patients come back again in the hospital. In addition, health staff should conduct health related education for individuals to examine continuous check-up of co-infected patients.

PMID:38824610 | DOI:10.1186/s13104-024-06808-6

Cardiooncology. 2024 Jun 1;10(1):33. doi: 10.1186/s40959-024-00237-x.

ABSTRACT

BACKGROUND: First generation Bruton tyrosine kinase inhibitors (BTKi) such as ibrutinib have been associated with cardiovascular toxicities. Newer generation BTKi (e.g.,acalabrutinib and zanabrutinib) have been associated with lower incidence of cardiotoxicity in clinical trials.

OBJECTIVE: Given paucity in real-world data on the overall cardiac risk factor profile, especially with the newer BTKi, our study evaluated the incidence of cardiotoxicity with various BTKi among a large, commercially insured population of patients.

METHODS: We performed a retrospective cohort analysis of all adults with a diagnosis of B-cell malignancy undergoing treatment with BTKi acalabrutinib and ibrutinib between January 2018 and June 2020 using Optum’s de-identified Clinformatics® Data Mart Database. We then identified patients who had pre-existing cardiac disease one year prior to starting BTKi. New incidence of atrial fibrillation/flutter, hypertension, bleeding, ventricular tachycardia/fibrillation and sudden cardiac death from the time of index presciption were compared with standard Chi Square or Student t-test where appropriate. Multivariate logistic regression models were also estimated to evaluate for confounding.

RESULTS: A total of 1691 patients were included in the final analysis. 1595 (94%, median age 75 (19-90) years, 61% male gender) patients received ibrutinib, and 96 (6%, median age 73.5 (32-90) years, 62.5% male gender) patients received acalabrutinib. The median duration of drug exposure of ibrutinib was 238 (2-1084) days vs. 150 (30-870) days for acalabrutinib. There was lower new incidence of atrial fibrillation/flutter (4.6%-vs-17%, p = 0.013), hypertension (6.3%-vs-25%, p = NS), sudden cardiac arrest/death (0% vs. 1.5%, p = NS) in the acalabrutinib group compared to ibrutinib, of which only the lower incidence of atrial fibrillation/flutter was statistically significant. This was despite the finding of a higher prevalence of atrial fibrillation/flutter at baseline in patients receiving acalabrutinib.

CONCLUSIONS: There was lower incidence of new atrial fibrillation/flutter with acalabrutinib when compared to ibrutinib in a real-world cohort of patients.

PMID:38824606 | DOI:10.1186/s40959-024-00237-x

Arthroplasty. 2024 Jun 2;6(1):27. doi: 10.1186/s42836-024-00248-0.

ABSTRACT

BACKGROUND: In the present study, the surgeon aimed to align the stem at 5° to 25° in anteversion. The robotic technology was used to measure stem anteversion with respect to proximal femur anteversion at different levels down the femur.

METHODS: A total of 102 consecutive patients underwent robotic-arm-assisted total hip arthroplasty (RTHA). 3D CT-based preoperative planning was performed to determine femoral neck version (FNV), posterior cortex anteversion (PCA), anterior cortex anteversion (ACA), and femoral metaphyseal axis anteversion (MAA) at 3 different levels: D (10 mm above lesser trochanter), E (the midpoint of the planned neck resection line) and F (head-neck junction). The robotic system was used to define and measure stem anteversion during surgery.

RESULTS: Mean FNV was 6.6° (SD: 8.8°) and the mean MAA was consistently significantly higher than FNV, growing progressively from proximal to distal. Mean SV was 16.4° (SD: 4.7°). There was no statistically significant difference (P = 0.16) between SV and MAA at the most distal measured level. In 96.1% cases, the stem was positioned inside the 5°-25° anteversion range.

CONCLUSIONS: Femoral anteversion progressively increased from neck to proximal metaphysis. Aligning the stem close to femoral anteversion 10 mm above the lesser trochanter often led to the desired component anteversion.

PMID:38824601 | DOI:10.1186/s42836-024-00248-0

Harm Reduct J. 2024 Jun 1;21(1):108. doi: 10.1186/s12954-024-01019-5.

ABSTRACT

BACKGROUND: Syringe services programs (SSPs) are critical healthcare access points for people with opioid use disorder (OUD) who face treatment utilization barriers. Co-locating care for common psychiatric comorbidities, like posttraumatic stress disorder (PTSD), at SSPs may reduce harms and enhance the health of individuals with OUD. To guide the development of onsite psychiatric care at SSPs, we collected quantitative survey data on the prevalence of PTSD, drug use patterns, treatment experiences associated with a probable PTSD diagnosis, and attitudes regarding onsite PTSD care in a convenience sample of registered SSP clients in New York City.

METHODS: Study participants were administered the PTSD Checklist for the DSM-5 (PCL-5) and asked about sociodemographic characteristics, current drug use, OUD and PTSD treatment histories, and desire for future SSP services using a structured interview. Probable PTSD diagnosis was defined as a PCL-5 score ≥ 31.

RESULTS: Of the 139 participants surveyed, 138 experienced at least one potentially traumatic event and were included in the present analysis. The sample was primarily male (n = 108, 78.3%), of Hispanic or Latinx ethnicity (n = 76, 55.1%), and middle-aged (M = 45.0 years, SD = 10.6). The mean PCL-5 score was 35.2 (SD = 21.0) and 79 participants (57.2%) had a probable PTSD diagnosis. We documented frequent SSP utilization, significant unmet PTSD treatment need, and high interest in onsite PTSD treatment.

CONCLUSIONS: Study findings point to the ubiquity of PTSD in people with OUD who visit SSPs, large gaps in PTSD care, and the potential for harm reduction settings like SSPs to reach people underserved by the healthcare system who have co-occurring OUD and PTSD.

PMID:38824597 | DOI:10.1186/s12954-024-01019-5