Medication Adjustments Research Articles

Long-Term Impact of PM2.5 Exposure on Diabetic Kidney Disease Patients Considering Time-Dependent Medication Adjustment

Long-Term Impact of PM2.5 Exposure on Diabetic Kidney Disease Patients Considering Time-Dependent Medication Adjustment

A Unique Presentation of Excitatory Catatonia Alongside AntiNmda Receptor Encephalitis: A Case Report

Introduction: Anti-NMDA receptor encephalitis, first described in 2007, is a prominent cause of autoimmune encephalitis, predominantly affecting females. Its clinical presentation includes a prodromal phase with flu-like symptoms, followed by psychosis, unresponsiveness, hyperkinesis, and recovery [1]. Catatonia can coexist sounds better than cooccur in patients with anti-NMDA receptor encephalitis, complicating diagnosis and effective treatment. Case Summary: This case report discusses a 41-year-old African American female with a history of seizure disorder, schizoaffective disorder with catatonia, developmental delay, Catatonia in itself is not the diagnosis as per dsm 5. We could use it as a specifier with other diagnosis, be it schizoaffective disorder or seizure disorder here. So we could mention as schizoaffective disorder with catatonia. and recent bereavement. Her symptoms included variable motor hyperactivity, alternating between restlessness and sedation, with an initial Busch Francis Rating Scale score of 18. Initially diagnosed with excitatory catatonia secondary to schizoaffective disorder and treated with benzodiazepines, her condition failed to improve, prompting further investigation. Despite additional treatment for a urinary tract infection and medication adjustment, which included adding valproic acid and amantadine, her condition remained uncontrolled. Subsequent lumbar puncture revealed inflammatory markers, and her anti-NMDA receptor IgG antibody assay was positive at 1:1280, confirming the diagnosis of anti-NMDA receptor encephalitis. Treatment was escalated to include methylprednisolone and intravenous immunoglobulin, alongside six sessions of ECT for management of her catatonia. The patient showed significant improvement, achieving functional recovery and independence in daily activities before discharge. Conclusion: This case emphasizes the importance of considering anti-NMDA receptor encephalitis in patients with unexplained, refractory neuropsychiatric symptoms, such as catatonia, and highlights the value of a multidisciplinary approach in managing and rehabilitating affected individuals. Prompt diagnosis and treatment are crucial to improving outcomes and reducing the risk of persistent cognitive deficits.

Levodopa / opicapone as a complement to STN-DBS in clinical practice. A retrospective single-centre analysis.

ObjectiveDeep brain stimulation of the subthalamic nucleus (STN-DBS) is a well-established treatment option in Parkinson's disease with motor and non-motor fluctuations allowing for postoperative reduction of dopaminergic medication. However, evidence is scarce on optimal medication adjustments following STN-DBS implantation. Opicapone allows for long-lasting inhibition of the catechol-O-methyltransferase (COMT) thereby enabling more constant dopaminergic stimulation compared to levodopa alone. However, especially COMT inhibitors are regularly discontinued after STN-DBS surgery. In this single-centre retrospective analysis, we aimed to analyse the clinical phenotype of patients selected for opicapone treatment following STN-DBS implantation and to define clinical determinants of patients requiring more intense dopamine-stabilising strategies after STN-DBS implantation. MethodsA patient cohort treated with STN-DBS + levodopa + opicapone (n = 16) was compared to an age-matched control cohort without opicapone treatment at baseline before and ≥ 5 months post-surgery. As main outcomes we assessed the MDS-UPDRS III and IV scores and reduction of the cumulative dopaminergic medication quantified by the levodopa equivalent dosages (LED). ResultsWhilst the MDS-UPDRS III (median [min – max]) in patients with STN-DBS as well as anatomical electrode positions did not differ significantly between the opicapone 20 [4–40] and control cohort 14 [1–44], the patients selected for opicapone treatment showed a significantly higher degree of dyskinesias already preoperatively as reflected by a UPDRS-IV A subscore of 2 [0–4] compared to controls 0 [0–4]. Postoperatively, the opicapone cohort showed stronger motor fluctuations MDS-UPDRS IV 6 [0–14] compared to the controls 0 [0−10], albeit without statistical significance. Moreover, the opicapone cohort showed significantly less reduction of dopaminergic medication (−36.4 % vs. -46.2 % in the control cohort) following STN-DBS implantation independent from the intake of dopamine agonists. ConclusionThese results indicate a clinical phenotype characterised by more motor fluctuations requiring a more stable dopamine replacement therapy to address the patients' disease biology. In these cases, levodopa + COMT inhibition by opicapone represents a therapeutic approach but determination of the potential clinical benefit requires further prospective studies.

Cenobamate's Efficacy for Seizure Treatment in Tuberous Sclerosis Complex

BackgroundEpilepsy is prevalent, and seizure control is challenging in patients with tuberous sclerosis complex (TSC). Cenobamate (CBM) has proven efficacy in several studies; however, its benefit in the TSC population is not known. MethodsWe performed a retrospective review of patients with TSC who received adjunctive CBM for seizure treatments. We assessed treatment efficacy by comparing seizure frequencies three months before CBM (baseline) and those at 3-, 6-, 12-, and 18- month follow-ups. ResultsWe identified 70 patients with TSC receiving CBM and excluded 16 with insufficient data. Fifty-four patients aged 2 to 39 years, with an average baseline seizure of 66.1 ± 88.9 per month, were analyzed. Treatment retention rates at 3, 6, 12, and 18 months were 94.4%, 79.6%, 66.7%, 44.4%, and responder rates (proportions of patients who remained on treatment and had ≥50% seizure reduction) were 38.1%, 51.7%, 53.1%, and 59.1%, respectively. Seizure-free rates at these respective follow-ups were 7.1%, 13.8%, 6.3%, and 9.1%. For patients experiencing reduced seizures, the mean percentage of change ranged from 61.5% to 74.6%. Side effects were common (64.8%), particularly sedation (42.6%), behavioral disturbance (24.1%), and gastrointestinal disturbance (22.2%). ConclusionsMost patients in this study showed seizure reduction; however, the overall responder and seizure-free rates were lower than the literature, likely due to the unique underlying epileptogenesis in TSC and the challenges of tolerating CBM. The lower treatment retention rates signal areas for improvement in concurrent medication adjustment practices.

Medication reconciliation enhances the accuracy of gastric emptying scintigraphy

BackgroundGastroparesis (GP) is a prevalent sensorimotor disorder characterized by delayed gastric emptying without mechanical obstruction, posing significant diagnostic challenges. Gastric emptying scintigraphy (GES) is the gold standard for diagnosing GP. However, its accuracy can be compromised by many medications that affect gastric motility. This study evaluates the impact of medication reconciliation on the diagnostic accuracy of GES.ResultsA significant proportion of patients (75%) were on medications known to affect gastric motility. Recommendations for medication adjustments were communicated, with 30% non-adherence. Adjustments in GES interpretations were necessary for 20% of patients following comprehensive medication reviews. The involvement of radiopharmacists facilitated accurate diagnostic conclusions, underscoring the critical role of medication reconciliation in GES accuracy.ConclusionMedication reconciliation enhanced the accuracy of GES in diagnosing gastroparesis, emphasizing the need to integrate clinical pharmacy practices into nuclear medicine. This interdisciplinary approach not only improves diagnostic accuracy but also enhances patient safety, advocating for the adoption of such practices in the management of gastroparesis.

Intervening on Metabolic Dysfunction-Associated Steatotic Liver Disease in Latino/a and Black Patients with Diabetes: A Feasibility Pilot.

Patients with type 2 diabetes (T2D), particularly those from historically marginalized racial and ethnic groups, are at high risk of poor outcomes from metabolic dysfunction-associated steatotic liver disease (MASLD). Evidence-based management (EBM) of MASLD can prevent its progression to cirrhosis and poor outcomes, yet rates of EBM of MASLD are low in T2D. In this pilot study of ten participants, we examined the feasibility and acceptability of a telehealth intervention that delivered EBM of MASLD in Latino/a and Black patients with T2D in the Duke Healthcare System. The intervention included: (a) MASLD education; (b) diet/lifestyle counseling; (c) T2D medication adjustment (i.e., to promote liver health) and (d) ordering of clinically indicated tests and referrals. This 3-month intervention was delivered by an endocrinologist over three virtual study visits. Phone interviews were conducted at study conclusion. We examined rates of recruitment, retention, T2D medication adjustment, and ordering of clinically indicated tests/referrals. The median age of our cohort was 54.0 (44.0, 59.0); six and four participants self-identified as Latino/a ethnicity and Black race, respectively. Retention rate in this study was 100% (n = 10/10), and all scheduled visits were completed (n = 30/30). Recruitment occurred over one month, and the rate was 25.8% (n = 8/31) by telephone call and 10% (n = 2/20) by electronic health record message. The intervention was highly acceptable based on a median Treatment Acceptability and Preferences score of 4.0 (4.0, 4.0). In exit interviews, all participants reported improved understanding of MASLD and its link to diabetes. All participants received T2D medication adjustment (n = 5/10) and/or clinically indicated testing/referral (n = 10/10) for the purpose of improving MASLD. We demonstrated that a telehealth intervention designed to proactively deliver EBM of MASLD was feasible and acceptable in a cohort of Latino/a and Black patients with T2D. Opportunities existed to better align each participants' care with guideline-based care of MASLD.

Abstract 50: The Comparison of Office Blood Pressure with Morning Home Blood Pressure: Self-Automated Measurement

Background: Morning hypertension is associated with poor cardiovascular outcomes. However, office blood pressure (OBP) remains a gold standard in hypertension monitoring and management. Unfortunately, the accuracy in OBP measurement is problematic. Objectives: This study aimed to determine whether routine or unattended OBP could accurately represent home blood pressure (HBP) in patients with hypertension. Methods: We conducted a single-center, cross-sectional study. Hypertensive patients aged between 18 and 80 years, capable of performing self-automated blood pressure measurement, were included in the study. Three self-automated methods of blood pressure measurement were performed: Routine OBP, unattended OBP, and HBP. All participants were instructed to rest for at least 5 minutes prior to measuring blood pressure, and HBP was recorded twice daily, in the morning and at night, for a week after the enrolled visit without antihypertensive medication adjustment. Results: Overall 190 consecutive patients were enrolled, with a mean age of 65.2 ±7.5 years old. Half of the patients had coronary artery disease or type 2 diabetes as comorbidities. Routine OBP was significantly higher than unattended OBP and HBP. Interestingly, Systolic values of unattended OBP were similar to those of morning HBP (mean difference -0.6 ±16.0 mmHg, p=0.641) with moderate correlation (r=0.516, p<0.001). Although diastolic values of unattended OBP were lower than those of morning HBP (mean difference -3.3 ±9.0 mmHg, p<0.001), the values were moderately correlated (r=0.581, p<0.001). Bland-Alman plots between unattended OBP and morning HBP were shown in Figure 1. Both systolic and diastolic values of unattended OBP and average HBP were significantly different (mean difference -3.5 ±14.9 mmHg, p=0.002, and 1.6 ±8.6 mmHg, p=0.013, respectively). Conclusion: Unattended OBP method could effectively represent morning HBP, thus advocating to use in clinical practice.

High rate of uncontrolled hypertension among adults receiving integrated HIV and hypertension care with aligned multi-month dispensing in Malawi: results from a cross-sectional survey and retrospective chart review.

People living with HIV have high rates of hypertension. Integrated HIV and hypertension care with aligned multi-month dispensing of medications (MMD) could decrease the burden of care for individuals and health systems. We sought to describe hypertension control and evaluate its association with different durations of MMD among Malawian adults receiving integrated care with aligned dispensing of antiretroviral therapy (ART) and antihypertensive medication. We conducted a cross-sectional survey and retrospective chart review of adults (≥18 years) receiving integrated HIV and hypertension care on medications for both conditions for at least 1 year, with aligned MMD at seven clinics in Malawi. Data were collected from July 2021 to April 2022 and included socio-demographics, clinical characteristics, antihypertensive medications and up to the three most recent blood pressure measurements. Bivariate analyses were used to characterize associations with hypertension control. Uncontrolled hypertension was defined as ≥2 measurements ≥140 and/or ≥90 mmHg. Chart reviews were conducted for a random subset of participants with uncontrolled hypertension to describe antihypertensive medication adjustments in the prior year. We surveyed 459 adults receiving integrated care with aligned dispensing (58% female; median age 54 years). Individuals most commonly received a 3-month aligned dispensing of ART and antihypertensive medications (63%), followed by every 6 months (16%) and every 4 months (15%). Hypertension control was assessed in 359 respondents, of whom only 23% had controlled hypertension; 90% of individuals in this group reported high adherence to blood pressure medications (0-1 missed days/week). Control was more common among those with longer aligned medication dispensing intervals (20% among those with 1- to 3-month dispensing vs. 28% with 4-month dispensing vs. 40% with 6-month dispensing, p = 0.011). Chart reviews were conducted for 147 individuals with uncontrolled hypertension. Most had high self-reported adherence to blood pressure medications (89% missing 0-1 days/week); however, only 10% had their antihypertensive medication regimen changed in the prior year. Uncontrolled hypertension was common among Malawian adults receiving integrated care with aligned MMD and was associated with shorter refill intervals and few antihypertensive medication escalations. Integrated care with aligned MMD is promising, but further work is needed to understand how to optimize hypertension outcomes.

Abstract MP11: Evaluation of a Remote Patient Monitoring Hypertension Program with Telehealth Pharmacist Management in Nephrology Clinic Patients

Introduction: Remote patient monitoring (RPM) and physician-pharmacist collaborative models have potential in improving hypertension control. Herein, we report the effectiveness of a community based, self-measured blood pressure (SMBP) RPM program on BP control and healthcare utilization in a largely rural health system. Methods: A multidisciplinary team developed a self-measured blood pressure (SMBP) RPM program in central and northeast PA using a virtual platform with bluetooth-connected BP devices targeting patients with BP ≥140/90 mmHg seen in nephrology clinics. From 3/2022 to 9/2022, high BP notifications were transmitted to nephrologists. After 9/2022, BP notifications were transmitted first to pharmacists, who co-managed BP through collaborative practice agreements via telehealth. We captured pharmacist interventions by reviewing electronic health record documentation. Changes in SMBP over time and the effect of pharmacist interventions were analyzed using mixed effects models. All-cause hospitalizations and emergency room (ER) visits were compared in 6-month pre/post-enrollment periods. Results: A total of 205 patients (mean age 62.3y, clinic BP 146/84, 3.1 BP classes, 48% female, 53% CKD) were enrolled into the program and had ≥ 6 months follow-up data. SMBP control <140/90 improved from 30% during week 1 to 67% at 6 months and 74% at 12 months. Overall, systolic SMBP improved over the first 6 months with stronger effect on patients with higher baseline BP (baseline BP ≥150/100 mmHg: -3.3 mmHg/month (95% CI: -3.5, -3.1); baseline 140-149/90-99: -2.4 (95% CI: -2.6, -2.1) mmHg/month; baseline <140/90: -0.6 (-0.9, -0.4) mmHg/month). Pharmacist telehealth encounters were documented in 65% of patients; 46% had a BP medication adjustment; 37% had new BP medication classes, including 9% mineralocorticoid receptor antagonist. Pharmacist medication intervention was associated with greater decline in systolic BP over time (-1.3 mmHg/month; 95% CI: -1.6, -1.1). Comparing the 6 months pre vs. post-enrollment, patients experienced a reduction in hospitalizations (6.0% vs. 0%; Exact Mcnemar p=0.0005) and no difference in ER visits (14.9% vs. 12.9%; p=0.6). Conclusion: Participation in a nephrologist-pharmacist SMBP RPM program was associated with improvement in BP control and reduced hospitalizations. Future efforts are underway to refine delivery of this program for the largest impact on improving BP control.

Impact of Pharmacist-Led Interventions on Hypertension Management in Cancer Patients Undergoing Chemotherapy

Background: Hypertension (HT) is a common cardiovascular condition, particularly prevalent among cancer patients, with approximately 40% exhibiting concurrent diseases. This study aimed to investigate the relationship between hypertension and cancer, focusing on how anticancer treatments contribute to hypertension and its cardiovascular complications. Methods: A retrospective analysis was conducted at a specialized pharmacy involving adults receiving oral chemotherapy. Participants were divided into control (n=50) and intervention (n=29) groups, based on their enrollment in a pharmacist-led hypertension management program. Data were collected on blood pressure (BP) measurements and interventions, with statistical analyses employed to assess differences between groups. Results: The intervention group demonstrated significant improvement in BP management, with 19 out of 29 patients achieving controlled BP by February 2023 (p=0.04), compared to 21 out of 50 in the control group. Continuous monitoring led to a gradual decline in average BP measurements in the intervention group, indicating effective management. Pharmacists made recommendations to physicians, achieving a 100% acceptance rate for medication adjustments. Conclusion: Integrating pharmacist-led interventions in managing hypertension among cancer patients significantly improves BP control and patient outcomes. Given the rising prevalence of hypertension in this population, further research is necessary to explore the long-term effects of such interventions and their broader implementation in clinical practice.

Role of new generation implantable loop recorders in managing undiagnosed pediatric cardiac symptoms

Pediatric cardiac symptoms such as palpitations, syncope, or seizure-like episodes pose diagnostic challenges for general pediatricians. These symptoms, though often benign, may reveal underlying arrhythmias or inherited cardiac conditions (ICCs), affecting the quality of life and limiting activity participation. The purpose of this study is to determine the effectiveness and safety of implantable loop recorders (ILRs) in diagnosing and managing arrhythmias in pediatric patients. A retrospective cohort study conducted over an 8-year period from January 2016 to December 2023 in a single pediatric cardiology center. A cohort of 155 pediatric patients (median age 11.4 years) who underwent ILR implantation were selected based on symptoms such as palpitations, chest pain, or syncope, and those with previously recorded arrhythmias or high-risk ICCs. The primary outcomes were the diagnostic yield of ILRs for arrhythmias and subsequent changes in patient management. Diagnostic yield was defined as the detection of relevant arrhythmias, such as pauses of 3 s or longer, high-degree AV block, sinus node dysfunction, supraventricular tachycardia, ventricular tachycardia, or inappropriate sinus tachycardia. The median follow-up period was 2.3 years (845 days). Diagnostic arrhythmias were recorded in 60% of patients with symptom-activated transmissions and 80% of device-activated transmissions. Sinus pauses (37.5%) and VT (30%) were the most common arrhythmias detected. In patients with syncope (n = 76), 30% had relevant arrhythmias. In the palpitations group (n = 20), 35% had relevant arrhythmias. Approximately 80% of patients with ILR-diagnosed arrhythmias underwent targeted management, including medication changes and additional procedures. No significant complications were observed; minor complications occurred in 2.5% of patients.Conclusions: New generation ILRs are effective and safe for diagnosing and managing pediatric arrhythmias, providing significant reassurance to patients and families. Further studies are needed to evaluate the impact of ILRs on quality of life and sports participation in high-risk young patients.What is Known:• Pediatric Cardiac Symptoms: Symptoms like palpitations, syncope, and seizure-like episodes in pediatric patients pose significant diagnostic challenges.• Diagnostic Tools: Traditional diagnostic tools such as ECG, Holter monitors, and external loop recorders often have low diagnostic yields due to the sporadic nature of symptoms.• Implantable Loop Recorders (ILRs): ILRs have been shown to improve the diagnostic yield for arrhythmias in adults and provide long-term rhythm monitoring.What is New:• Effectiveness in Pediatrics: This study demonstrates that new generation ILRs significantly enhance the diagnostic yield for arrhythmias in pediatric patients with undiagnosed cardiac symptoms.• Safety and Efficacy: The study confirms that ILRs are both safe and effective in the pediatric population, with minimal complications and high diagnostic accuracy.• Targeted Management: Findings show that ILR-diagnosed arrhythmias lead to targeted management changes in approximately 80% of cases, including medication adjustments and additional procedures.• Long-term Monitoring: ILRs provide continuous long-term monitoring, offering reassurance to patients and families, and potentially improving quality of life and participation in activities for high-risk young patients.

Constipation is associated with an increased risk of major adverse cardiac events in a UK population.

Traditional cardiovascular risk factors, including hypertension, only explain part of major adverse cardiac events (MACEs). Understanding what other risk factors contribute to MACE is essential for prevention. Constipation shares common risk factors with hypertension and is associated with an increased risk of several cardiovascular diseases. We hypothesized that constipation is an underappreciated risk factor for MACE. We used the population healthcare and genomic data in the UK Biobank (n = 408,354) to study the contribution of constipation (ICD10 K59.0) to the risk of MACE, defined by any episode of acute coronary syndrome (ACS), ischemic stroke, and heart failure (HF). Analyses were controlled for traditional cardiovascular risk factors. We also assessed genetic correlations (rg) between constipation and MACE. Constipation cases (n = 23,814) exhibited a significantly higher risk of MACE compared with those with normal bowel habits [odds ratio (OR) = 2.15, P < 1.00 × 10-300]. Constipation was also significantly associated with individual MACE subgroups, in order: HF (OR = 2.72, P < 1.00 × 10-300), ischemic stroke (OR = 2.36, P = 2.02 × 10-230), and ACS (OR = 1.62, P = 5.82 × 10-113). In comparison with patients with constipation-free hypertension, patients with hypertension with constipation showed significantly higher odds of MACE (OR = 1.68, P = 1.05 × 10-136) and a 34% increased risk of MACE occurrence (P = 2.3 × 10-50) after adjustment for medications that affect gut motility and other traditional cardiovascular risk factors. Finally, we detected positive genetic correlations between constipation and MACE subgroups ACS (rg = 0.27, P = 2.12 × 10-6), ischemic stroke (rg = 0.23, P = 0.011), and HF (rg = 0.21, P = 0.0062). We identified constipation as a potential risk factor independently associated with higher MACE prevalence. These findings warrant further studies on their causal relationship and identification of pathophysiological mechanisms.NEW & NOTEWORTHY Analyzing 408,354 participants of the UK Biobank, we show that constipation cases exhibited a significantly higher risk of major adverse cardiac events (MACEs) than those with regular bowel habits. In comparison with patients with constipation-free hypertension, patients with hypertension with constipation showed significantly higher odds of MACE and a 34% increased risk of subsequent MACE occurrence. Finally, we detected positive genetic correlations between constipation and MACE. This association holds potential for therapeutic exploitation and prevention based on individuals' risk assessment.

Transition of mild cognitive impairment to Alzheimer's disease: Medications as modifiable risk factors.

Mild cognitive impairment (MCI) is a pre-clinical stage of Alzheimer's disease (AD). Understanding the transition probabilities across the disease continuum of AD, ranging from MCI to AD to Mortality is crucial for the economic modeling of AD and effective planning of future interventions and healthcare resource allocation decisions. This study uses the Multi-state Markov model to quantify the transition probabilities along the disease progression and specifically investigates medications as modifiable risk factors of AD associated with accelerated or decelerated transition times from MCI to AD, MCI to mortality, and AD to mortality. Individuals with MCI were identified from the National Alzheimer's Coordinating Center between September 2005 and May 2021. A three-state Markov model was postulated to model the disease progression among three states: MCI, AD, and mortality with adjustment for demographics, genetic characteristics, comorbidities and medications. Transition probabilities, the total length of stay in each state, and the hazard ratios of the use of medications for diabetes, hypertension, and hypercholesterolemia (the known modifiable risk factors of AD) were evaluated for these transitions. 3,324 individuals with MCI were identified. The probability of developing AD after one year since the initial diagnosis of MCI is 14.9%. After approximately 6 years from the initial diagnosis of MCI, the probability of transitioning to AD increases to nearly 41.7% before experiencing a subsequent decline. The expected total lengths of stay were 5.38 (95% CI: 0.002-6.03) years at MCI state and 7.61 (95%CI: 0.002-8.88) years at AD state. Patients with active use of lipid-lowering agents were associated with significantly lower hazards of transitioning from MCI to AD (HR: 0.83, 95%CI:0.71-0.96), MCI to mortality (HR: 0.51, 95%CI:0.34-0.77), and AD to mortality (HR: 0.81, 95%CI:0.66-0.99). Results suggest that lipid-lowering agents may confer a protective effect, delaying the onset of AD. Additionally, lipid-lowering agents indicate a favorable association with a longer survival time.

Digital Twin in Managing Hypertension Among People With Type 2 Diabetes: 1-Year Randomized Controlled Trial

BackgroundDigital twin (DT)-guided lifestyle changes induce type 2 diabetes (T2D) remission but effects on hypertension (HTN) in this population are unknown. ObjectivesThe purpose of this study was to assess effects of DT vs standard of care (SC) on blood pressure (BP), anti-HTN medication, HTN remission, and microalbuminuria in participants with T2D. MethodsThis is a secondary analysis of a randomized controlled trial in India of 319 participants with T2D. Participants were randomized to DT group (N = 233), which used artificial intelligence-enabled DT technology, or SC group (N = 86). A Home Blood Pressure Monitoring system guided anti-HTN medication adjustments. BP, anti-HTN medications, HTN remission rates, and microalbuminuria were compared between groups. ResultsAmong the 319 participants, 44 in DT and 15 in SC group were on anti-HTN medications, totaling 59 (18.4%) participants. DT group achieved significant reductions in systolic blood pressure (−7.6 vs −3.2 mm Hg; P < 0.007) and diastolic blood pressure (−4.3 vs −2.2 mm Hg; P = 0.046) after 1 year compared with SC group. 68.2% of DT group remained off anti-HTN medications compared to none in SC group. Among participants with HTN, DT subgroup achieved higher rates of normotension (40.9% vs 6.7%; P = 0.0009) and HTN remission (50% vs 0%; P < 0.0001) than SC subgroup. DT group had a higher rate of achieving normoalbuminuria (92.4% vs 83.1%; P = 0.018) at 1 year compared with SC group. ConclusionsArtificial intelligence -enabled DT technology is more effective than SC in reducing BP and anti-HTN medications and inducing HTN remission and normoalbuminuria in participants with HTN and T2D. (A Novel WholeBody Digital Twin Enabled Precision Treatment for Reversing Diabetes; CTRI/2020/08/027072)

The reduction of LEDD leads to visual dysfunction in patients with PD after STN-DBS: a randomized clinical trial

Background: Medication adjustment after deep brain stimulation (DBS) of the subthalamic nucleus (STN) in patients with Parkinson’s disease (PD) may influence visual function. However, no clinical trials have been designed specifically to investigate this effect. Objectives: To compare the effects of levodopa equivalent daily dose (LEDD) reduction and non-reduction on visual function in patients with Parkinson’s disease (PD) following STN-DBS. Methods: This was a multi-center, prospective, randomized, double-blinded clinical trial. A total of 208 patients with Parkinson’s disease were referred for DBS between June 2019 and July 2021 and analyzed between June 2023 and July 2023. STN-DBS was performed, and the LEDD was reduced in one study arm but not in the other. The primary outcome measure was visual impairment in Parkinson’s disease questionnaire (VIPD-Q) with or without LEDD reduction 12 months postoperatively, and the secondary outcomes included retinal nerve fiber layer (RNFL) thickness, vessel density, eye-tracking system results, contrast sensitivity and visual field. Results: During the short-term follow-up, DBS implantation and stimulation did not significantly affect visual function (VIPD-Q, baseline vs. 1 month, 9.269±8.385 vs. 8.938±7.666, Mann–Whitney U tests; P=0.6746). In the long-term follow-up, the reduction group demonstrated a significant decline in visual function, RNFL thickness, and vessel density after STN-DBS compared with the control group without STN-DBS (P&lt;0.001). Conclusions: Visual dysfunction, particularly a thinner RNFL and lower vessel density, is related to LEDD reduction after STN-DBS. Prolonged administration of dopamine-mimetic drugs prevents visual symptoms. Thus, physicians should consider LEDD adjustment when patients report visual dysfunction before surgery or severe visual symptoms after STN-DBS.

Decision Support and Behavioral Health for Reducing High-Dose Opioids in Comorbid Chronic Pain, Depression and Anxiety: Stepped-Wedge Cluster Randomized Trial.

High prevalence of depression or anxiety with opioid use for chronic pain complicates co-management and may influence prescribing behaviors. Compare clinical effectiveness of electronic medical record clinical decision support (EMR-CDS) versus additional behavioral health (BH) care management for reducing rates of high-dose opioid prescriptions. Type 2 effectiveness-implementation hybrid stepped-wedge cluster randomized trial in 35 primary care clinics within a health system in LA, USA. Patients aged 18+ receiving chronic opioid therapy for non-cancer pain with depression or anxiety and matched controls. EMR-CDS included opioid risk mitigation procedures. BH care included cognitive behavioral therapy; depression or anxiety medication adjustments; and case management. Outcomes of interest included difference-in-difference (DID) estimate of changes in probability for prescribing high-dose morphine equivalent daily dose (MEDD ≥50 mg/day and MEDD ≥90), average MEDD, and rates of hospitalization, emergency department use, and opioid risk mitigation. Most participants were female with 3+ pain syndromes. Data analysis included 632 patients. Absolute risk differences for MEDD≥50 and ≥90 decreased post-index compared to pre-index (DID of absolute risk difference [95%CI]: -0.036 [-0.089, 0.016] and -0.029 [-0.060, 0.002], respectively). However, these differences were not statistically significant. The average MEDD decreased at a higher rate for the BH group compared to EMR-CDS only (DID rate ratio [95%CI]: 0.85 [0.77, 0.93]). There were no changes in hospitalization and emergency department utilization. The BH group had higher probabilities of new specialty referrals and prescriptions for naloxone and antidepressants. Incorporation of a multidisciplinary behavioral health care team into primary care did not decrease high-dose prescribing; however, it improved adherence to clinical guideline recommendations for managing chronic opioid therapy for non-cancer pain. ClinicalTrials.gov ID NCT03889418.

Evaluation of Patient Outcomes after Pharmacological Intervention in Home Health Care Utilizing Pharmaceutical Care Records

The purpose of this study was to identify patient outcomes after pharmacist interventions in the home health care context using pharmaceutical care records accumulated during daily operations. We focused on 591 cases at Nakajima Pharmacy from April 2020 to December 2021, where dispensing fees were charged to prevent duplication of medication and unnecessary interactions of home patients (excluding those related to adjustment of ongoing medications). The study investigated the content and background of prescription changes, the follow-up rate, and patient outcomes. The most common circumstances that led to pharmacist intervention for homebound patients were symptom occurrence (uncontrolled symptom, new symptom, drug adverse event). Of the patients for whom pharmacist intervention was provided for symptoms, 72.8% received follow-up according to the pharmaceutical care records. Furthermore, 59.2% of patients with follow-up showed an improvement of their symptoms. In addition, many patients had their medications discontinued or the dosage reduced by the pharmacist despite stable symptoms. More than 90% of these patients showed no change in symptoms. Besides interventions associated with the occurrence of symptoms, many interventions related to medication adherence were found to result from the patient's physical condition, such as poor swallowing function. The results suggest that tracking pharmacy drug histories may help pharmacists to better understand the need for follow-up implementation and the changes in patient outcomes after interventions.

Effects of an Intervention to Improve Evidence-Based Care for People With Diabetes and Cardiovascular Disease Across Sex, Race, and Ethnicity Subgroups: Insights From the COORDINATE-Diabetes Trial.

Results from the COORDINATE-Diabetes trial (Coordinating Cardiology Clinics Randomized Trial of Interventions to Improve Outcomes - Diabetes) demonstrated that a multifaceted, clinic-based intervention increased prescription of evidence-based medical therapies to participants with type 2 diabetes and atherosclerotic cardiovascular disease. This secondary analysis assessed whether intervention success was consistent across sex, race, and ethnicity. COORDINATE-Diabetes, a cluster randomized trial, recruited participants from 43 US cardiology clinics (20 randomized to intervention and 23 randomized to usual care). The primary outcome was the proportion of participants prescribed all 3 groups of evidence-based therapy (high-intensity statin, angiotensin-converting enzyme inhibitor/angiotensin receptor blocker, and sodium-glucose cotransporter-2 inhibitor or glucagon-like peptide 1 receptor agonist) at last trial assessment (6 to 12 months). In this prespecified analysis, mixed-effects logistic regression models were used to assess the outcome by self-reported sex, race, and ethnicity in the intervention and usual care groups, with adjustment for baseline characteristics, medications, comorbidities, and site location. Among 1045 participants with type 2 diabetes and atherosclerotic cardiovascular disease, the median age was 70 years, 32% were female, 16% were Black, and 9% were Hispanic. At the last trial assessment, there was an absolute increase in the proportion of participants prescribed all 3 groups of evidence-based therapy in women (36% versus 15%), Black participants (41% versus 18%), and Hispanic participants (46% versus 18%) with the intervention compared with usual care, with consistent benefit across sex (male versus female; Pinteraction=0.44), race (Black versus White; Pinteraction=0.59), and ethnicity (Hispanic versus Non-Hispanic; Pinteraction= 0.78). The COORDINATE-Diabetes intervention successfully improved delivery of evidence-based care, regardless of sex, race, or ethnicity. Widespread dissemination of this intervention could improve equitable health care quality, particularly among women and minority communities who are frequently underrepresented in clinical trials. URL: https://www.clinicaltrials.gov. Unique identifier: NCT03936660.

Evaluating the benefit of medical adjustment on the predictive accuracy of the revised trauma index

In the early 1970s, data from emergency trauma units was used to develop the trauma index (TI) as a triage tool for non-physicians. Over the next two decades several modifications were made to the TI, and in 1990 a revised trauma index (RTI) was published. Throughout the 1990s, modifications to the RTI concerning pre-existing medical conditions (PEC) have been studied. Our study incorporated a PEC scoring system into the RTI, and evaluated its performance against using the RTI alone. The addition of PECs to the trauma index improved its accuracy in predicting overall outcome as shown by the increase in the kappa score from 0.42 to 0.73. Based on this finding, we suggest incorporating a PEC scoring system into the revised trauma index to better predict patient outcomes.

Comparative Efficacy of Hypertension Management Strategies.

Hypertension (HTN) is a major cardiovascular risk factor and a significant contributor to disease burden in the United States. Despite therapeutic advances, gaps remain between clinical trials and practice. This study aims to bridge those gaps by evaluating antihypertensive strategies. This was a retrospective analysis of HTN patients seen at a hospital clinic from 2016 to 2022 with 3- and 12-month follow-up appointments. Demographics, history, blood pressure (BP), and medication regimen were recorded. Treatment strategies were categorized as follows: adding medication (AM), increasing dosage (ID), switching medications (SM), dropped medications (DrM), or no change (NC). Changes in systolic blood pressure (SBP) were compared using linear regressions to assess the efficacy of HTN management. Of 873 patient charts reviewed, 332 patients were included. The AM group had an adjusted ∆SBP of -11 mm Hg at 3 months ( p < 0.001) and -9 mm Hg at 12 months ( p = 0.006). The ID group had an ∆SBP of -8.5 mm Hg at 3 months ( p = 0.074) and -7 mm Hg at 12 months ( p = 0.3). ∆SBP between the AM and ID groups was not statistically significant ( p = 0.8). SM was associated with an ∆SBP of -3 mm Hg at 3 months ( p = 0.6) and -3 mm Hg at 12 months ( p = 0.7). There are meaningful differences in SBP reduction between antihypertensive medication adjustment strategies. AM had the greatest effect on lowering SBP, with ID having a slightly lesser effect. The difference in ∆SBP between the AM versus ID groups was not significant. While further study with a larger dataset is warranted, our findings highlight trends in the efficacy of HTN management strategies to help guide therapeutic regimens.