Medication Changes Research Articles

Enhanced Recovery after Surgery in Open Fetal Spina Bifida Repair

Introduction: For open fetal spina bifida (fSB) repair, a maternal laparotomy is required. Hence, enhanced maternal recovery after surgery (ERAS) is paramount. A revision of our ERAS protocol was made, including changes in operative techniques and postoperative pain management. This study investigates eventual benefits. Methods: Our study included 111 women with open fSB repair at our center. The old protocol group (group 1) either received a transverse incision of the fascia with transection of the rectus abdominis muscle (RAM) or a longitudinal incision of the fascia without RAM transection, depending on placental location. The new protocol required longitudinal incisions in all patients (group 2). Postoperative pain management was changed from tramadol to oxycodone/naloxone. Outcomes of the two different protocol groups were analyzed and compared regarding the primary endpoint, the length of hospital stay (LOS) after fetal surgery, as well as regarding the following secondary endpoints: postoperative pain scores, day of first mobilization, removal of urinary catheter, bowel movement, and the occurrence of maternal and fetal complications. Results: Out of 111 women, 82 (73.9%) were in group 1 and 29 (26.1%) were in group 2. Women in group 2 showed a significantly shorter LOS (18 [14–23] days vs. 27 [18–39] days, p = 0.002), duration until mobilization (3 [2–3] days vs. 3 [3–4] days, p = 0.03), and removal of urinary catheter (day 3 [3–3] vs. day 4 [3–4], p = 0.004). Group 2 less often received morphine subcutaneously (0% vs. 35.4%, p < 0.001) or intravenously (0% vs. 17.1%, p = 0.02) but more often oxycodone (69.0% vs. 18.3%, p < 0.001). No significant differences were seen regarding pain scores, bowel movement, and maternal and/or fetal complications. Conclusion: The new ERAS protocol that combined changes in surgical technique and pain medication led to better outcomes while reducing LOS. Continuous revisions of current ERAS protocols are essential to improve patient care continuously.

Behavioral physical activity counselling to promote an active healthy lifestyle among adolescent psychiatric outpatients. The TRANSPAC-study

Introduction&#x0D; Mental health disorders are one of the main reasons for disability in adolescents worldwide (Dahl et al., 2018). Sleep disturbances are an important contributor to a vicious cycle of increased vulnerability during this developmental period. Interventions that improve sleep are suggested to improve psychosocial outcomes. One such intervention may be physical activity (PA), with a beneficial effect on both sleep and mental health. Yet, PA levels are declining during adolescent years, with even higher inactivity levels for individuals with psychiatric disorders. Guidance on how to address PA counselling (PAC) among psychiatric adolescents in routine clinical practice has the potential to improve clinical and psychosocial outcomes.&#x0D; Methods&#x0D; During this ongoing randomized waitlist controlled trial, 18 adolescent psychiatric outpatients have been recruited from local clinics and private practices. Those who met inclusion criteria were aged 12 to 18 years, suffered from sleep problems, and had at least one additional mental health diagnosis. Exclusion criteria included organic sleep and brain disorders and changes in medication. At baseline, participants completed questionnaires related to sleep and psychopathology. For the next seven days, participants wore an Actigraph to track PA and sleep patterns. Participants were serially randomized into two groups after baseline: PAC or Treatment as usual (TAU). At 3-month follow-up, all tests were repeated. Additionally, a semi structured interview was conducted with intervention participants. To assess intervention effects, mixed model ANOVAs were conducted for PA, psychopathology, and composite sleep health.&#x0D; The 6-session intervention builds on previous standardized and theory-based PAC programs (Gerber et al., 2019).&#x0D; Results&#x0D; By 2023, follow-up data were available from 12 participants (Mage 15.33 yrs; 75% females). Preliminary data show a significant trend for increased PA on school days, and composite sleep health (p = .07). Yet, compliance of Actigraph wear time was low. No changes were observed for psychopathology. The post-intervention interview revealed positive experiences.&#x0D; Discussion/Conclusion&#x0D; The preliminary data show the feasibility of the intervention. It is likely that improvements in PA and sleep patterns must first stabilize before they can have a meaningful impact on psychopathology. However, more data is needed to confirm the results. The interviews revealed that the content and mode of delivery were generally accepted. Considering the many other obligations adolescents face in their everyday lives, including homework and psychotherapy, the combination of online and face-to-face sessions was well received. Because of the low compliance rate of Actigraph wear time, alternative devices should be considered for this population.&#x0D; References&#x0D; Dahl, R. E., Allen, N. B., Wilbrecht, L., &amp; Suleiman, A. B. (2018). Importance of investing in adolescence from a developmental science perspective. Nature, 554(7693), 441–450. https://doi.org/10.1038/nature25770&#x0D; Gerber, M., Beck, J., Brand, S., Cody, R., Donath, L., Eckert, A., Faude, O., Fischer, X., Hatzinger, M., Holsboer-Trachsler, E., Imboden, C., Lang, U., Mans, S., Mikoteit, T., Oswald, A., Pühse, U., Rey, S., Schreiner, A. K., Schweinfurth, N., … Zahner, L. (2019). The impact of lifestyle physical activity counselling in IN-PATients with major depressive disorders on physical activity, cardiorespiratory fitness, depression, and cardiovascular health risk markers: Study protocol for a randomized controlled trial. Trials, 20(1), 1–21. https://doi.org/10.1186/s13063-019-3468-3

Modeling Invasive Aspergillosis Risk for the Application of Prophylaxis Strategies.

The epidemiology of invasive aspergillosis (IA) is evolving. To define the patient groups who will most likely benefit from primary or secondary Aspergillus prophylaxis, particularly those whose medical conditions and IA risk change over time, it is helpful to depict patient populations and their risk periods in a temporal visual model. The Sankey approach provides a dynamic figure to understand the risk of IA for various patient populations. While the figure depicted within this article is static, an internet-based version could provide pop-up highlights of any given flow's origin and destination nodes. A future version could highlight links to publications that support the color-coded incidence rates or other actionable items, such as bundles of applicable pharmacologic or non-pharmacologic interventions. The figure, as part of the upcoming Infectious Diseases Society of America's aspergillosis clinical practice guidelines, can guide decision-making in clinical settings.

A grumbling concern: A survey of gastrointestinal symptoms in cystic fibrosis in the modulator era

Background Gastrointestinal symptoms in cystic fibrosis (CF) are common and intrusive to daily life. Relieving gastrointestinal symptoms was identified as an important research priority and previously explored in an international survey in 2018. However, following the widespread introduction of cystic fibrosis transmembrane conductance regulator (CFTR) modulators in 2019, the landscape of CF treatment has changed. We repeated an online survey to further describe gastrointestinal symptoms and their effect on quality of life (QoL) in the CFTR modulator era. Methods An electronic survey consisting of closed questions and free text responses was distributed via social media and professional networks for a period of one month between March - April 2022. People with CF (pwCF), their family and friends, and healthcare professionals (HCPs) were invited to take part. Results There were 164 respondents: 88 pwCF (54%), 22 (13%) family, and 54 (33%) healthcare professionals (HCPs). A total of 89/110 (81%) pwCF or family members reported CFTR modulator treatment. The most commonly reported symptoms were wind / gas and rumbling stomach noises (borborygmi) in both the modulator and non-modulator groups in addition to loose motions (modulator group) and bloating (no modulator group). Abdominal pain and bloating had the greatest impact on QoL. For those on a CFTR modulator, the proportion of pwCF reporting “no change” or “worse” for all of the symptoms surveyed was greater than the proportion reporting an improvement. For some symptoms such as stomach pains and reduced appetite, improvements were perceived more commonly in HCPs than what was reported by pwCF. Following modulator introduction, dietary changes to manage GI symptoms were recommended by 28/35 (80%) of HCPs and reported by 38/76 (50%) lay respondents. Changes in medication were recommended by 19/35 (54%) HCPs and reported by 44/76 (58%) of patients and family members. Conclusion This survey has shown that gastrointestinal symptoms remain prevalent in pwCF in the CFTR modulator era, though the nature of these symptoms may have changed. A better understanding of the underlying pathophysiology of these symptoms is essential. Future clinical studies should focus on improving symptoms and QoL.

(270) Application of ISSWSH Consensus PGAD/GPD Diagnostic Algorithm to Eight Cases

Abstract Introduction Persistent Genital Arousal Disorder/Genito-Pelvic Dysthesia (PGAD/GPD) is a debilitating, but the mechanism of disease and treatment are poorly understood. To address this gap in knowledge, the ISSWSH consensus statement proposed a diagnostic and treatment algorithm for PGAD/GPD. The algorithm proposes five possible regions of etiologies for the purposes of diagnosis and treatment. These regions include end organ (clitoris, vagina, vulva, etc), pelvis/perineum, spinal cord, cauda equina and brain. Objective The purpose of this retrospective case series is to apply the ISSWSH diagnostic and treatment algorithm to nine cases, in order to demonstrate the efficacy of the algorithm, as well as present uniform manner for reviewing PGAD/GPD cases. Methods Individuals were identified by the Principal Investigator and colleagues. ISSWSH diagnostic and treatment algorithm was used to note pertinent positives and negatives in history and physical exam, as well as analyze treatment. Results Cases of eight patients are reviewed using the algorithm to analyze the treatments and possible etiologies of each patient. Patients presented anywhere from experiencing symptoms for five days to three years. Half of the patients experienced relief of symptoms with treatment of lumbar pathology demonstrated on MRI. Four of the patients found relief with spinal epidural injections performed by a pain medicine physician, two found relief with pelvic floor physical therapy and two found relief with medications including gabapentin and pregabalin. Conclusions These cases demonstrate the utility of the ISSWSH consensus algorithm in guiding initial diagnosis and treatment of PGAD/GPD. However, it has limitations due to the multifactorial nature of PGAD/GPD, it is helpful in guiding initial treatment of the disorder. The cases in this series illustrate the importance of MRI in diagnosis of PGAD/GPD etiologies. Fifty percent of the cases in this series included an MRI that revealed lumbar pathologies that could be managed by pain management physician. As shown in these cases, PGAD/GPD can have a significant negative impact on mental health and activities of daily living, therefore it is critical to be systematic and efficient. The steps demonstrated to be most important in these cases include review of recent medication changes, physical examination (with anesthesia testing, if possible), lumbar MRI and referral to pain medicine specialist. The primary limitation of this study is that it is a retrospective chart review and as such, there was no standardization of the work up for each patient and information on each patient was limited to the notes in their charts. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Johnson and Johnson.

(209) Four-Year Real-world Sexual Function Outcomes of Rezum Therapy in Patients With and Without Erectile Dysfunction

Abstract Introduction Multiple studies have demonstrated Rezum therapy to effectively alleviate lower urinary tract symptoms secondary to benign prostatic hyperplasia while preserving sexual function. However, long-term real-world outcomes on sexual function are lacking in patients with baseline erectile dysfunction (ED) following Rezum treatment. Objective To compare four-year sexual function outcomes after Rezum between patients with and without baseline ED. Methods A retrospective study was conducted on patients from a multiethnic population treated with Rezum between 2017-2019. Patients were stratified into one of two cohorts based on presence or absence of ED at baseline. Sexual function was assessed with the validated 15-question International Index of Erectile Function (IIEF) questionnaire. Those who completed the IIEF questionnaire at baseline and 6-, 12-, and/or 48-months postoperatively were included. Function domains were calculated based on IIEF guidelines on clinical application of the questionnaire, and included erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. Results Ninety-one patients were included: 44% (40) with baseline ED and 56% (51) without baseline ED. At baseline, 50% of the ED cohort were taking ED medications. No significant differences were found in age, prostate volume, and past medical history of hypertension or dyslipidemia between the cohorts. The ED cohort had a significantly greater proportion of patients with diabetes mellitus when compared to non-ED cohort (35 vs 15.7%, p=0.048). At baseline, the ED cohort had significantly lower scores for the IIEF domains of erectile function (p=0.007), orgasmic function (p=0.034), intercourse satisfaction (p=0.033), and overall satisfaction (p=0.002) when compared to the no ED cohort. Between the cohorts, no significant differences in the number of injections utilized during treatment in the lateral or medial prostatic lobes were observed. Compared to baseline, there was no significance in any IIEF domains in either cohort at 6-months. At 12-months, the ED cohort had significant percent decreases in orgasmic function (-25%, p=0.018), sexual desire (-22.2%, p=0.039), and overall satisfaction (-33.3%, p=0.004), while the non-ED cohort had a significant percent increase in erectile function (5%, p=0.04) when compared to baseline. At 48-months, the non-ED cohort had no significant changes in any IIEF domains, while the ED cohort had significant percent increases in erectile function (30%, p=0.013), sexual desire (22.5%, p=0.023), intercourse satisfaction (20%, p=0.011), and overall satisfaction (58.3%, p=0.008). At 48-months, there were no cases of de novo ED in the non-ED cohort and no significant changes in ED medications in the ED cohort when compared to baseline (53.3 vs 46.7%, p=0.72). Conclusions At long-term, Rezum preserved sexual function in patients with no baseline ED and improved sexual function in patients with baseline ED. However, patients with baseline ED may experience temporary decreases in sexual function at 12-months postoperatively. Additional larger studies are warranted to further evaluate these real-world results. Disclosure No.

Treatment of chronic symptoms following mild traumatic brain injury with transcranial LED: a sham run-in pilot study of photobiomodulation therapy

ABSTRACT Primary Objective We evaluated whether photobiomodulation with red/near infrared light applied transcranially via light emitting diodes (LED) was associated with reduced symptoms and improved cognitive functioning in patients with chronic symptoms following mild traumatic brain injury. Research Design Participants (3 men, 6 women; 22–61 years-old) underwent a 6-week intervention involving 18 40-minute transcranial LED treatment sessions. Methods and Procedures Reliable change indices were calculated for 10 neuropsychological test scores and 3 self-report questionnaires of subjective cognition, post-concussion symptoms, and depression at baseline and following treatment. Questionnaires were also administered after 2-week sham and at 1-month and 2-month follow-ups. Main Outcome and Results Only 2 participants improved on neuropsychological testing. On questionnaires, 4 reported improved cognition, 5 reported improved post-concussion symptoms, and 3 reported improved depression. Significant improvement in 2 or more domains was reported by 4 participants and mostly maintained at both follow-ups. Conclusions Most participants did not improve on neuropsychological testing. A minority self-reported improvement in symptoms, potentially explained by the intervention, psychiatric medication changes, placebo effects, or other factors. Selecting participants with different clinical characteristics, and dosing and delivery system changes, may produce different results. A study design accounting for placebo effects appears warranted in future trials.

Cognitive outcomes in patients with essential tremor treated with deep brain stimulation: a systematic review.

Essential tremor (ET) is a common neurological disease. Deep brain stimulation (DBS) to the thalamic ventral intermediate nucleus (VIM) or the adjacent structures, such as caudal zona incerta/ posterior subthalamic area (cZi/PSA), can be effective in treating medication refractory tremor. However, it is not clear whether DBS can cause cognitive changes, in which domain, and to what extent if so. We systematically searched PubMed and the Web of Science for available publications reporting on cognitive outcomes in patients with ET who underwent DBS following the PICO (population, intervention, comparators, and outcomes) concept. The PRISMA guideline for systematic reviews was applied. Twenty relevant articles were finally identified and included for review, thirteen of which were prospective (one also randomized) studies and seven were retrospective. Cognitive outcomes included attention, memory, executive function, language, visuospatial function, and mood-related variables. VIM and cZi/PSA DBS were generally well tolerated, although verbal fluency and language production were affected in some patients. Additionally, left-sided VIM DBS was associated with negative effects on verbal abstraction, word recall, and verbal memory performance in some patients. Significant cognitive decline after VIM or cZi/PSA DBS in ET patients appears to be rare. Future prospective randomized controlled trials are needed to meticulously study the effect of the location, laterality, and stimulation parameters of the active contacts on cognitive outcomes while considering possible medication change post-DBS, timing, standard neuropsychological battery, practice effects, the timing of assessment, and effect size as potential confounders.

Perception and Practices of Self-medication Practices among Health Science Students during the ongoing COVID-19 Pandemic in Mangalore, India.

Health science students are prone to self-medication due to easy accessibility to medicines, background medical knowledge, and their ability to diagnose illnesses. The ongoing COVID-19 pandemic has further encouraged this practice due to the fear of contracting the virus by visiting healthcare establishments. This study was conducted to assess the perception and practices of self-medication among health science students during the background of the COVID-19 pandemic. This cross-sectional study was conducted in July 2021 during the second wave of COVID-19. Data were collected using a Microsoft form circulated among students using WhatsApp or email. The mean age of the 350 participants was 20.8 ± 1.5 years. About 165(47.1%) participants had self-medicated over the past one year. The most common mode of self-medication was using previous consultation notes [121(73.3%)]. The most common reason for self-medication stated was the mild nature of the illness [131(79.4%)]. Fifteen (9.1%) participants reported changes in medication from one to another during self-medication. Sixteen (9.7%) participants increased drug dosage during self-medication. Sixteen (26.2%) out of 61 participants who self-medicated with antibiotics did not complete the course. Forty-six (27.9%) out of the 165 participants were not aware of the adverse effects of the drugs being self-medicated on most occasions. One hundred and sixty seven (47.7%) of the total participants did not feel that self-medication practices are harmful. Ninety-five (27.1%) felt that self-medication practices are acceptable during the COVID-19 pandemic. Eighty-six (90.5%) of them thought so to avoid getting COVID-19 infection by visiting healthcare establishments. In multivariable analysis, participants in the final year and those with chronic morbidities were associated with self-medication practices. Self-medication practices were present among 47.1% of participants. More than onefourth of them were not aware of the side effects of self-medicated drugs on most occasions. About 47.7% participants felt that self-medication practices are not harmful and more than one-fourth of them felt that it was acceptable during the COVID-19 pandemic. Therefore, the students need to be made aware of the harmful consequences of self-medication.

Investigating the Influence of Patient Eligibility Characteristics on the Number of Deferrable Rheumatologist Visits: Planning for a Patient-Initiated Follow-Up Strategy.

Patient-initiated follow-up (PIFU) for rheumatoid arthritis (RA) is a model of care delivery wherein patients contact the clinic when needed instead of having regularly scheduled follow-up. Our objective was to investigate the influence of different patient eligibility characteristics on the number of potentially deferred visits to inform future implementation of a PIFU strategy. We conducted a retrospective chart review of 7 rheumatologists' practices at 2 university-based clinics between March 1, 2021, and February 28, 2022. Data extracted included the type and frequency of visits, disease management, comorbidities, and care complexities. Stable disease was defined as remission or low disease activity with no medication changes at all visits. The influence of patient characteristics on the number of deferrable visits in patients with stable disease was explored in 4 criteria sets that were based on early disease duration, medication prescribed, presence of care complexity elements, and comorbidity burden. Records from 770 visits were reviewed from 365 patients with RA (71.5% female, 70% seropositive). Among all criteria sets, the proportion of visits that could be redirected varied between 2.5% and 20.9%. The highest proportion of deferrable visits was achieved when eligibility criteria included only stable disease activity and patients with RA on conventional synthetic disease-modifying antirheumatic drugs or no medications (n = 161, 20.9%). PIFU may result in a more efficient use of specialist healthcare resources. However, the applicability of such models of care and the number of deferred visits is highly dependent on patient characteristics used to establish eligibility criteria for that model. These findings should be considered when planning implementation trials.

Evaluation of prescription medication changes following sleeve gastrectomy surgery.

The increasing global prevalence of obesity, coupled with its association with chronic health conditions and rising healthcare costs, highlights the need for effective interventions; however, despite the availability of treatment options, the ongoing success of primary interventions in maintaining long-term weight loss remains limited. This study examined the prescription medication dispensing changes following sleeve gastrectomy in Australians aged 45years and over. In a retrospective analysis of 847 bariatric surgery patients from the New South Wales 45 and Up Study, the assessment of medication patterns categorizing into three groups: gastrointestinal, metabolic, cardiorespiratory, musculoskeletal, and nervous systems was conducted. Each drug class was analyzed, focusing on patients with dispensing records within the 12months before surgery. This study employed interrupted time-series analysis to compare pre- and post-surgery medication usage. With a predominantly female population (76.9%) and an average age of 57.2 (standard deviation 5.71), there were statistically significant reductions in both unique medications (12.5% decrease, p=0.004) and total medications dispensed (15.9% decrease, p=0.003) from 12months before surgery to 13-24months after bariatric surgery. All medication categories, except opioids, showed reductions. Notably, the most significant reductions were observed in diabetes (38.6%), agents acting on the renin-angiotensin system (40.4%), lipid modifying agents (26.5%), anti-inflammatory products (46.3%), and obstructive airway diseases (53.3%) medications during this time frame. These findings suggest that sleeve gastrectomy provides an effective therapeutic intervention for patients with comorbidities requiring multiple medications, especially for obesity-related diseases such as diabetes, cardiovascular, respiratory and musculoskeletal disorders.

Actioning the findings of hard endpoint clinical trials as they emerge in the realm of chronic kidney disease care: a review and a call to action.

Fewer than half of patients treated with hemodialysis survive 5 years. Multiple therapeutics are used to address the complications of advanced chronic kidney disease but most have not been found to improve clinical outcomes. Clinical trials of treatment innovations for chronic kidney diseases and dialysis care have been suboptimal in number and quality. Recent trials are changing this trend. Practice and policy change when new evidence emerges remains frequently impeded by resource and organizational constraints and accordingly, clinical practice guidelines are updated years or decades after definitive evidence is produced. Ultimately, practice change in health systems is slow, leading to impaired uptake of effective medical interventions and lower value healthcare, although innovations in rapid guideline production are emerging. What can be done to ensure that conclusive evidence is taken up in practice, policy and healthcare funding? We use the example of the recently published hard endpoint study "Comparison of high-dose HDF with high-flux HD" (CONVINCE) (hemodiafiltration versus hemodialysis), to explain how a new trial can impact on medical knowledge and change in practices. We (i) assess how the trial can be placed in the context of the totality of the evidence, (ii) define whether or not further trials of convective dialysis therapies are still needed and (iii) examine whether the evidence for convective therapies is now ready to inform practice, policy and funding change. When looking at CONVINCE in the context of the totality of evidence, we show that it addresses dialysis quality improvement priorities and is consistent with other trials evaluating convective dialysis therapies, and that the evidence for convective dialysis therapies is now definitive. Once updated evidence for cost-effectiveness in specific healthcare settings and patient-reported outcomes become available, we should therefore determine whether or not clinical practice guidelines should recommend uptake of convective dialysis therapies routinely, and move on to evaluating other treatments.

Initiative to improve handover notes in a tertiary psychiatric hospital

Clinical handover is an important process in hospital settings, but it is often carried out inadequately, posing potentially serious consequences for the patients. This project aimed to increase the effectiveness...

The medical emergency team pharmacist: describing an overnight service

AbstractBackgroundClinical practice after hours and attendance at medical emergency team (MET) calls are two novel and emerging areas of pharmacy practice. During the COVID‐19 pandemic, our institution's pharmacy services expanded from 8 am–5 pm to 24 h daily, including MET call attendance.AimThis study aimed to describe pharmacist roles, including medications charted by the general medicine and intensive care unit pharmacists during the period of extended‐hours pharmacy practice and the characteristics of MET calls attended.MethodThis descriptive, cross‐sectional study included patients admitted to the Alfred Hospital, Victoria, Australia between 3 April 2020–28 February 2021, when a MET was called between 5 pm–8 am, a pharmacist attended, and medication changes occurred. Data collected included whether the MET call was medication related and a description of medication changes. Ethics approval was granted by the Alfred Hospital Human Research Ethics Committee (Reference no: 297/21).ResultsOne thousand six hundred and forty‐four MET calls (average 5.4 calls per night) were attended by pharmacists during extended hours. Medication changes were made in response to clinical deterioration at 627 (38%) calls. The most frequent change was the initiation of cardiovascular medications (n = 206). Partnered pharmacist medication charting, including commencing, ceasing, or changing medications, occurred at 39% of MET calls with therapy changes.ConclusionPharmacists can play a key role in managing deteriorating patients as part of a MET team. Medications may be implicated in clinical deterioration of patients and are frequently administered at MET calls. The expansion of pharmacy services provided the opportunity for pharmacists to contribute to MET calls across the 24‐h period.

Dietary (poly)phenols as modulators of the biophysical properties in endothelial cell membranes: its impact on nitric oxide bioavailability in hypertension.

Hypertension is a major contributor to premature death, owing to the associated increased risk of damage to the heart, brain and kidneys. Although hypertension is manageable by medication and lifestyle changes, the risk increases with age. In an increasingly aged society, the incidence of hypertension is escalating, and is expected to increase the prevalence of (cerebro)vascular events and their associated mortality. Adherence to plant-based diets improves blood pressure and vascular markers in individuals with hypertension. Food flavonoids have an inhibitory effect towards angiotensin-converting enzyme (ACE1) and although this effect is greatly diminished upon metabolization, their microbial metabolites have been found to improve endothelial nitric oxide synthase (eNOS) activity. Considering the transmembrane location of ACE1 and eNOS, the ability of (poly)phenols to interact with membrane lipids modulate the cell membrane's biophysical properties and impact on nitric oxide (·NO) synthesis and bioavailability, remain poorly studied. Herein, we provide an overview of the current knowledge on the lipid remodeling of endothelial membranes with age, its impact on the cell membrane's biophysical properties and ·NO permeability across the endothelial barrier. We also discuss the potential of (poly)phenols and other plant-based compounds as key players in hypertension management, and address the caveats and challenges in adopted methodologies.

REAL WORLD EFFECTIVENESS OF JAK INHIBITOR UPADACITINIB IN ULCERATIVE COLITIS VERSUS CROHN’S DISEASE IN AN IBD TERTIARY CARE CENTER

Abstract BACKGROUND Upadacitinib is a selective Janus kinase inhibitor approved for the management of Crohn’s Disease (CD) and Ulcerative Colitis (UC). AIMS To compare response to upadacitinib between patients with UC and CD in a real world tertiary care center. METHODS Retrospective cohort study of adult patients with CD vs UC seen at UCSF Colitis and Crohn’s Disease Center from 2019-2023. The primary outcome was endoscopic remission as noted in post-induction staging scope. Endoscopic remission was assessed using SES-CD and Mayo scores for CD and UC, respectively. Outcomes were assessed at 3 or 6 months after starting upadacitinib for UC and CD, respectively. Failure was considered failure to meet remission criteria, change in medications shortly after induction, or surgery. RESULTS A total of 60 patients were reviewed, 26 with Crohn’s Disease and 34 with Ulcerative Colitis, who had taken Upadacitinib and had post-induction follow up data in EHR review. 10 patients with CD achieved remission (38.5%) compared to 17 patients with UC (50%). This difference was found to be nonsignificant (P=0.38). CONCLUSION In this real-world cohort of IBD patients seen at a tertiary care center, there was no significant difference in response between patients with CD or UC.

INSURANCE DENIALS AND DELAYS IN CARE FOR PEDIATRIC PATIENTS WITH INFLAMMATORY BOWEL DISEASE

Abstract INTRODUCTION Biologics are effective medications used for induction and maintenance of remission in pediatric patients with inflammatory bowel disease (IBD). Insurance companies often require clinicians to obtain prior authorization (PA) prior to administration of biologics. Recent data determined that PA was associated with delays in care in pediatric IBD patients and an increased risk of subsequent healthcare utilization. Our study aim was to assess the effect of the PA process and its impact on care delivery for pediatric patients with IBD. METHODS A retrospective chart review of pediatric patients with IBD was conducted, including those with the diagnosis of ulcerative colitis or Crohn’s disease prescribed a biologic medication. Data obtained from medical records included demographics, IBD characteristics, insurance PAs, and clinical outcomes from 2015 to 2023. Outcome measures included time from initial PA submission to completion of the PA process, time from initial PA submission to first outpatient dose, frequency of insurance mandated medication changes, and number of hospitalizations for an inpatient dose. Analyses examined differences between those with PAs that were approved versus those who were initially denied. RESULTS We analyzed 134 patients who received a new biologic during our study period, of which 100 were newly diagnosed patients. Of the total sample, mean age was 12.5 years, 53.7% were male, with 96.2% non-Hispanic, 77.6% white, and 69.4% patients had Crohn’s disease. The most common medication prescribed was infliximab (81.3%). Of the patients in the approved group, 72.9% of patients had commercial insurance compared to 52.1% in the denied group (p=0.0152). Median time from initial PA submission to completion of PA process was 13 days for those denied vs. 3 days for those approved (p&amp;lt;0.0001). Of the patients denied, median time from initial PA submission to denial was 4 days (0-27) and median time from denial to subsequent approval was 7 days (0-75). Median time from initial PA submission to first outpatient dose was 30 days in the denied group vs. 13 days for the approved group (p&amp;lt;0.0001). 51% of patients in the denied group required hospitalization for their first biologic dose after PA initiation compared to 20% in the approved group (p=0.0002). CONCLUSION We found a significant delay in care for patients who received a prior authorization denial from insurance. Time from initial authorization submission to first dose was significantly different between the approved and denied groups. Prior authorization denials were also associated with significantly higher rate of hospitalizations for an infusion, potentially driving up overall cost of care.

Greater need for treatment optimization in patients with epilepsy initiating adjunctive therapy: Results of a retrospective claims analysis of antiseizure medication drug load in the United States

BackgroundThis retrospective, observational study used US claims data to assess changes in antiseizure medication (ASM) drug load for a cohort of patients with epilepsy. MethodsAdults (≥18 years) with a diagnosis of epilepsy (ICD-10 code G40.xxx) who started new adjunctive ASM treatment with one of 4 branded (brivaracetam, eslicarbazepine, lacosamide, perampanel) or 4 unbranded (carbamazepine, lamotrigine, levetiracetam, topiramate) ASMs between January 1, 2016 and December 31, 2020 were identified from IBM MarketScan® research databases (primary study population). Patients must have been continuously enrolled 360 days before the start of the new ASM (eligibility period). Follow-up was from the start of new ASM until Day 540 (∼18 months). The primary endpoint was concomitant ASM drug load, which included all ASMs except the new (comparator) ASM. A sensitivity analysis population included adults with epilepsy who were continuously enrolled for ≥ 180 days during at least one calendar year in the study period (2016–2020), whether or not the comparator ASM was new or existing during that period. Total ASM drug load, which included comparator ASM and concomitant ASMs, was assessed in the sensitivity analysis population. ResultsIn total, 21,332 patients were included in the primary study population, of which 5767 initiated branded ASMs and 15,565 initiated unbranded ASMs. A total of 392,426 patients were included in the sensitivity analysis population during at least one calendar year 2016–2020. Concomitant ASM drug load increased in the 360 days prior to new ASM start and slightly declined thereafter. Mean concomitant ASM drug load for the primary population was 1.6 (SD 1.8) at new ASM start. Concomitant drug load was higher among those starting branded ASM comparators compared to those starting unbranded comparators. Mean total ASM drug load for patients increased over time and was approximately double for patients exposed to branded ASMs (mean range 2.1 to 2.7) compared to that of patients exposed to any unbranded ASM (mean range 1.0 to 1.3). ConclusionConcomitant ASM drug load increased prior to addition of new ASM, with higher increases observed among patients starting branded vs unbranded ASMs, followed by slight decreases thereafter. Total drug load increased linearly among all patients. These findings underscore the need for ongoing ASM regimen evaluation and treatment optimization in patients with epilepsy.

P896 You Can Lead a Horse to Water But You Can’t Make it Drink: A Study on Medication Adherence of Inflammatory Bowel Disease Patients in Ireland

Abstract Background Medication adherence is important in ensuring adequate treatment of Inflammatory Bowel Disease (IBD). The High Tech Hub (HTH) is an online system used in Ireland to prescribe and monitor the ordering of High-Tech Medication, specifically oral small molecules and subcutaneously-delivered biologics. We aimed to observe compliance rates of treatment in our centre, observe trends between different medication and identify factors associated with adherence. Methods We extracted prescribing and medication dispensing information from the HTH database for our centre between May and November 2023. We collected information on patient demographics such as age and gender, patient disease subtype, medication class and duration of prescription given against the duration of prescription collected by the patient with an 85% threshold as a marker of compliance to treatment. Statistical analysis was used to compare differences in adherence between subsets of the population and a multivariate regression model was used to identify factors associated with adherence. Results We extracted information from 824 prescriptions from 644 unique patients. The median age was 42 years (IQR 32-52) with 52.2% males. 60.7% (n=391) had Crohn’s Disease, 33.4% (n=215) had Ulcerative Colitis and 3.1% (n=20) had IBD-U. Majority of patients, 77.3% (n=498), were on Anti-TNF medication, followed by 13.2% (n=75) on anti-Interleukins, 6.2% (n=40) on JAK Inhibitors and 3.3% (n=21) Anti-Integrins. 6.5% (n=42) of patients required dose optimization during the 6-month observation and 1.7% (n=11) required a change of medication. 9.5% (n=61) of patients collected prescriptions for steroids. Further analysis demonstrated no significant difference in adherence within gender (Male: 61.0% vs. Female 53.6%, p=0.056), age (&amp;lt;25 years: 66.2%, 25-39 years: 55.0%, 40-54 years: 58.6%, ≥55 years: 54.6%, p=0.346), disease type (Crohn’s: 58.6%, Ulcerative Colitis: 56.7%, IBD-U: 50%, p=0.776), medication class (Anti-TNF: 56.4%, Anti-Interleukin: 65.9%, Anti-Integrin: 57.1%, JAK Inhibitor: 52.5%, p=0.378). However, we found significant lower adherence rates in patients who required dose optimization (21.4% vs. 60.0%, p&amp;lt;0.001) and those who required a change in medication (18.2% vs. 58.1%, p=0.008) in the observation window. There was also a lower rate of adherence noted in those who received prescriptions for steroids (45.9% vs 58.9%, p=0.051). Conclusion There was a high rate of non-adherence noted in our IBD population, worse in those who ended up requiring dose optimization or change in therapy. Addressing compliance by monitoring the online dispensing of medication may be a useful way to ensure adequate treatment and avoid unnecessary treatment escalation.

P476 Correlation between fecal calprotectin and inflammation on ultrasound in fibrostenotic Crohn’s Disease

Abstract Background Fibrostenotic Crohn’s Disease (CD) is a challenging phenotype particularly due to the absence of intestinal anti-fibrotic therapies. Differentiating between strictures that are predominantly fibrotic versus inflammatory remains a diagnostic dilemma. The ability to make this differentiation is critical to inform therapeutic decisions. Fecal calprotectin (FC) is a stool marker reflective of intestinal inflammation. Very few studies have evaluated the relationship of FC concentration in ileal CD strictures and parameters of inflammation on intestinal ultrasound (IUS). Strictures on imaging are defined as 1) increased bowel wall thickness (BWT), 2) narrowed luminal apposition, and 3) pre-stenotic dilation (PSD). BWT and hyperemia (color Doppler signal (CDS)) are the most sensitive markers for CD inflammation on IUS. It is predicted that FC will match CDS in ileal strictures, similar to non-stricture phenotypes. We aim to correlate FC levels with IUS inflammation of ileal CD strictures. Methods We performed a retrospective cohort pilot study exploring the relationship between FC levels and IUS inflammatory parameters in ileal strictures. FC levels were obtained ≤ 60 days of index IUS in fibrostenotic ileal CD patients. Individuals who underwent medication changes or experienced a clinical flare during this period were excluded. Inflammation was measured as BWT and CDS using a modified Limberg (ML) score. Pearson correlation for continuous variables, Spearman rank correlation and a Kruskal-Wallis test for FC and Limberg scale were completed. Results A total of 25 fecal samples were obtained from 17 patients with ileal strictures (47% male, median age 59 years (range 18-76)) were assessed. Median FC concentrations was 204.9 ug/g, IQR: 250.4. Median ileal stricture BWT was 7.0 mm (range 3.0–10.0). 40% (10/25) had ML1 (short chains in bowel), 32% (8/25) ML2 (long chains in bowel), and 28% (7/25) ML3 (long chains and perienteric fat). There was no correlation between FC and BWT (r=0.02, p=0.92), nor FC with ML scores (r=0.20, p=0.25). In those with ML1, median FC was 232.4, while those with ML2 or 3, had a FC of 155.6 and 469.7, respectively. FC values were significantly different between the ML scores, p&amp;lt;0.0001. Conclusion FC levels were not correlated with inflammatory parameters as seen on IUS in ileal CD. This unexpected finding may be due to ML2 scores having lower FC than anticipated, and small sample size. Other imaging factors such as loss of wall stratification need to be taken into account, and are perhaps more reflective of inflammation than BWT and CDS. This study provides the initial data to assess accuracy of FC and hyperemia of ileal CD strictures on IUS compared to histologic measures of inflammation on resected specimens.