Real-world Prescribing Research Articles

Understanding real-world prescribing practices for maintenance treatment in bipolar disorders – focus on antidepressants

Understanding real-world prescribing practices for maintenance treatment in bipolar disorders – focus on antidepressants

Real-world prescription patterns for reproductive assistance patients in China: A trend analysis from 2016 to 2020

Background: Pharmacotherapy is one of the primary treatments for patients with Assisted reproductive technology (ART). Despite the publication of various research on ART treatment, there is no clear conclusion regarding the choice of drug treatment in China. Our research intends to examine the trend of widely prescribed medications for ART patients in China. For instance, the study examines the logic of drug indications, usage, and dose in patient prescriptions. Methods: We did a cross-sectional study of the data from the hospital prescription analysis cooperation project supervised by the China Medical Association. The information is extracted from the prescriptions of reproductive assistance outpatients from January 2016 to December 2020. We used the U.S. Food and Drug Administration (FDA) classification to quantify the frequency of drug use and the categories of drugs. We manually extract the information of patients who require ART treatment, divide the patients into various age groups and geographies, followed by study the indications, utilization, and rationale of the most important therapeutic medications. Results: Among the 225225 patients included in this study, Guangzhou (47.83%), Shanghai (19.84%), and Zhengzhou (9.36%) were the top three cities. In the past 5years, the average age was 32.99, and 60.38% of women were between the age of 25 and 34. The main therapeutic medicines taken by each patient, primarily hormone therapies, were tallied. Eleven types of primary therapeutic medicines were employed. Different progesterone preparations (47472, 21.08%), chorionic gonadotrophin gondotrophin for injection (38932, 17.29%), dydrogesterone tables (33591, 14.91%), and triptorelin for injection (26959, 11.97%) rounded out the top five. According to the data on outpatient medications in major cities in China, the variety and proportion of injections are the highest, including the most frequent types of ovulation induction and urotropia, as well as triptorelin and progesterone. Even though the total dosage of urotropin was the highest in 5years, it showed a declining trend. The dosages of progesterone and didroxyprogesterone increased, with progesterone showing the most rapid increase. The top five most expensive prescription medications are triptorelin, urotropin, progesterone, didroxyprogesterone, and leuprorelin, in that order. Goserelin, leuprorelin, triptorelin, growth hormone, and didroxyprogesterone are among the top five most expensive medications per capita. Conclusion: The average age of patients has not increased considerably over the past 5years. However, the opportunity cost of childbirth for women has increased, which has significantly enhanced their willingness for childbearing intentions. The medication selection is reasonable overall. In this study, the recommended dosages of first-line medicines (urotropin and chorionic gonadotropin) are likewise high. In contrast, the dosage of oral first-line treatment for ovarian stimulation in unexplained infertility is modest, and the dosage of progesterone is steadily increasing. In addition, the price of certain medicines is high, which will increase the patients' financial burden. Future research will focus on enhancing the degree of rational drug use among outpatients and realizing the economical, safe, and effective use of pharmaceuticals to lessen the economic burden of patients.

LABA/LAMA as First-Line Therapy for COPD: A Summary of the Evidence and Guideline Recommendations.

Inhaled bronchodilators (alone or in combination) are the cornerstone of treatment for symptomatic patients with COPD, either as initial/first-line treatment or for second-line/treatment escalation in patients who experience persistent symptoms or exacerbations on monotherapy. The Global Initiative for Chronic Obstructive Lung Disease 2022 report recommends initial pharmacological treatment with a long-acting muscarinic antagonist (LAMA) or a long-acting β2-agonist (LABA) as monotherapy for most patients, or dual bronchodilator therapy (LABA/LAMA) in patients with more severe symptoms, regardless of exacerbation history. The recommendations for LABA/LAMA are broader in the American Thoracic Society treatment guidelines, which strongly recommend LABA/LAMA combination therapy over LAMA or LABA monotherapy in patients with COPD and dyspnea or exercise intolerance. However, despite consistent guideline recommendations, real-world prescribing data indicate that LAMA and/or LABA without an inhaled corticosteroid are not the most widely prescribed therapies in COPD. This article reviews global and regional/national guideline recommendations for the use of LABA/LAMA in COPD, examines the evidence for the effectiveness and safety of LABA/LAMA versus other therapies and offers a practical guide for clinicians to help ensure appropriate use of LABA/LAMA therapy.

141P Real-world study of cabozantinib treatment of advanced renal cell carcinoma in Taiwan

This study describes the real-world prescribing patterns, effectiveness, and tolerability of cabozantinib in patients in Taiwan with advanced renal cell carcinoma (aRCC) that progressed despite prior antiangiogenic therapy.

Acceptability and Efficacy of the SMARxT Media Literacy Education Program to Counter Pharmaceutical Marketing Influences among Medical Trainees.

Evidence-based prescribing (EBP) results in decreased morbidity and reduces medical costs. However, pharmaceutical marketing influences medication requests and prescribing habits, which can detract from EBP. Media literacy, which teaches critical thinking, is a promising approach for buffering marketing influences and encouraging EBP. The authors developed the "SMARxT" media literacy education program around marketing influences on EBP decision-making. The program consisted of six videos and knowledge assessments that were delivered as an online educational intervention through the Qualtrics platform. In 2017, we assessed program feasibility, acceptability, and efficacy of enhancing knowledge among resident physicians at the University of Pittsburgh. Resident physicians (n=73) responded to pre-test items assessing prior knowledge, viewed six SMARxT videos, and responded to post-test items. A 6-month follow-up test was completed to quantitatively assess sustained changes in knowledge and to qualitatively assess summative feedback about the program (n=54). Test scores were assessed from pre- to post-test and from pre-test to follow-up using paired-sample t-tests. Qualitative results were synthesized through content analysis. Proportion of correct knowledge responses increased from pre-test to immediate post-test (31% to 64%, P<0.001) at baseline. Correct responses also increased from pre-test to 6-month follow-up (31% to 43%, P<0.001). Feasibility was demonstrated by 95% of enrolled participants completing all baseline procedures and 70% completing 6-month follow-up. Quantitative measures of acceptability yielded positive scores and qualitative responses indicated participants' increased confidence in understanding and countering marketing influences due to the intervention. However, participants stated they would prefer shorter videos, feedback about test scores, and additional resources to reinforce learning objectives. The SMARxT media literacy program was efficacious and acceptable to resident physicians. Participant suggestions could be incorporated into a subsequent version of SMARxT and inform similar clinical education programs. Future research should assess program impact on real-world prescribing practices.

Prescription Pathways from Initial Medication Use to Triple Therapy in Older COPD Patients: A Real-World Population Study

Background and objective Triple therapy with an inhaled corticosteroid (ICS), a long-acting β2-agonist bronchodilator (LABA) and a long-acting muscarinic antagonist (LAMA) is recommended as step-up therapy for chronic obstructive pulmonary disease (COPD) patients who continue to have persistent symptoms and increased risk of exacerbation despite treatment with dual therapy. We sought to evaluate different treatment pathways through which COPD patients were escalated to triple therapy. Methods We used population health databases from Ontario, Canada to identify individuals aged 66 or older with COPD who started triple therapy between 2014 and 2017. Median time from diagnosis to triple therapy was estimated using the Kaplan-Meier method. We classified treatment pathways based on treatments received prior to triple therapy and evaluated whether pathways differed by exacerbation history, blood eosinophil counts or time period. Results Among 4108 COPD patients initiating triple therapy, only 41.2% had a COPD exacerbation in the year prior. The three most common pathways were triple therapy as initial treatment (32.5%), LAMA to triple therapy (29.8%), and ICS + LABA to triple therapy (15.4%). Median time from diagnosis to triple therapy was 362 days (95% confidence interval:331–393 days) overall, but 14 days (95% CI 12–17 days) in the triple therapy as initial treatment pathway. This pathway was least likely to contain patients with frequent or severe exacerbations (22.0% vs. 31.5%, p < 0.001) or with blood eosinophil counts ≥300 cells/µL (18.9% vs. 22.0%, p < 0.001). Conclusion Real-world prescription of triple therapy often does not follow COPD guidelines in terms of disease severity and prior treatments attempted.

Comparing Prescribing Practices of Statin Therapy in Atherosclerotic Cardiovascular Disease Patients with Varying Levels of Chronic Kidney Disease

Lead Author's Financial Disclosures Nothing to disclose. Study Funding None. Background/Synopsis Evidence supporting high-intensity statin therapy in patients with atherosclerotic cardiovascular disease (ASCVD) and advanced chronic kidney disease (CKD), not on dialysis, is not robust. Cardiovascular risk reduction from statin therapy within this population is predominantly derived from post-hoc subgroup analysis of larger trials. This subset of ASCVD patients is often at higher risk for medication-related adverse effects, secondary to reduced renal clearance, polypharmacy, and high prevalence of co-morbidities. This increased risk may result in provider hesitation and under prescribing of high-intensity statin therapy among ASCVD patients. Of the available high-intensity statins atorvastatin does not require renal dose adjustments although rosuvastatin does. On a population level, prescribing of statins among patients with ASCVD and CKD has improved in recent years but remains sub-optimal. Results from this study can provide insight into whether providers are following guideline recommendations and package labeled dosing when prescribing statin therapy in a real-world setting. Objective/Purpose This study aims to evaluate real-world prescribing patterns of statin-therapy among ASCVD patients with non-dialysis dependent Stage 4-5 CKD and Stage 3a and 3b CKD. Methods This study is a retrospective, cross-sectional observational study and has been reviewed by the Colorado Multiple Institutional Review Board as exempt. Patients with a diagnosis of clinical ASCVD, non-dialysis dependent CKD stage 3a-5, and prescribed a statin between 1/1/2020-9/30/2021 were identified. The primary outcome will be prescribing ahigh-intensityy statin among patients with eGFR <30 mL/min compared to patients with eGFR 30-<60 mL/min. Secondary outcomes will include differences in mean LDL-C between the two groups and proportion of patients on FDA approved dosing of rosuvastatin. A chi-square test will be used for qualitative data and a student t-test for quantitative data. Results A total of 6000 patients have been identified and will be evaluated for inclusion into this study. Results are currently in progress. Conclusions Will be presented. Nothing to disclose.

Integrated antibiotic clinical decision support system (CDSS) for appropriate choice and dosage: an analysis of retrospective data.

Decision-making for inpatient antibiotic prescribing is complex due to many considerations to be taken. So far, clinical decision support systems (CDSS) have been rarely used in antibiotic stewardship (ABS) and even less integrated in computerized physician order entry systems (CPOE). We developed a guideline-based, CPOE-integrated CDSS (ID ANTIBIOTICS) to support antibiotic selection and dosing. We compared routine antibiotic inpatient prescribing data with CDSS-generated recommendations in the initial antibiotic selection, the duration of therapies, and costs. Finally, we assessed possible benefits of the CDSS by its performance in German ABS-guideline quality indicators (ABS-QIs). The requirements of several ABS-QIs can be supported with ID ANTIBIOTICS: electronic local guidelines, electronic decision-support, renal dosage adjustments, local guideline-based initial selection (all not quantified), and therapy durations for the treatment of pneumonia (significantly) without increasing costs. Performance in ABS-QIs for extensive therapies for community-acquired pneumonia could be improved with the CDSS by 20.2% (OR 0.134; 95% CI: 0.101-0.178); for hospital-acquired pneumonia by 3.7% (OR 0.742; 95% CI: 0.629-0.877). There was no difference in median daily drug costs between real-world prescriptions and CDSS recommendations (both: € 4.78, p=0.081). In retrospective analyses, antibiotic CDSS can show possible performance in antibiotic stewardship through quality indicators (ABS-QIs). Further research and pilot testing of the software are needed to provide more insights into ABS-QI evaluation, user acceptance, and real-world effectiveness. Deep integration of antibiotic CDSS into existing medication processes without using multiple systems could contribute to the necessary acceptance of clinical practitioners.

Antidepressant prescribing patterns in Australia.

The Royal Australian and New Zealand College of Psychiatrists clinical practice guidelines for mood disorders (MDcpg2015 and MDcpg2020) provide evidence-based and consensus-based recommendations for managing mood disorders. We examined Australian real-world prescribing habits to determine whether management in clinical practice aligned with MDcpg2015 recommendations. A retrospective analysis of a cohort of patients ≥16 years old who had been dispensed a Pharmaceutical Benefits Scheme (PBS)-listed antidepressant between July 2013 and June 2019 was conducted using Australian Commonwealth Department of Human Services PBS 10% sample data. Between July 2013 and June 2019, 239 944 patients in Australia commenced antidepressant treatment. Of these, 22% (52 694 patients) received a second treatment (a new class of treatment after a period of discontinuation or additional antipsychotic therapy) and 6% (15 741 patients) received a third treatment. Patients were initially prescribed primarily selective serotonin reuptake inhibitors (SSRIs; 52% of prescriptions) or tricyclic antidepressants (TCAs; 25%), even though TCAs are not recommended for first-line treatment. Fewer than one-quarter of patients were prescribed serotonin-noradrenaline reuptake inhibitors (13%) or other agents (10%). General practitioners (GPs) were more likely to initiate TCAs than psychiatrists (22% v. 7%).Once initiated, the overall median time patients remained on treatment was 4.5 months; this was highest with SSRIs (5.8 months) and lowest with TCAs (0.9 months). First-line prescribing broadly follows guidelines. GP and psychiatrist prescribing patterns differ, perhaps reflecting different patient groups and the need to tailor treatment to individuals. Future guidelines should aim to capture the different presentations and complexity of depression.

Real-World Prescription Patterns and Barriers Related to the Use of Sodium-Glucose Cotransporter 2 Inhibitors among Korean Patients with Type 2 Diabetes Mellitus and Cardiovascular Disease.

BackgroundTo evaluate prescription trends and clinical factors of the sodium-glucose cotransporter 2 inhibitors (SGLT2i) use according to the presence of atherosclerotic cardiovascular disease (ASCVD) or heart failure (HF) in Korean patients with type 2 diabetes mellitus (T2DM).MethodsPrescription patterns of SGLT2i use between 2015 and 2019 were determined using the Korean National Health Insurance Service database of claims.ResultsOf all patients with T2DM (n=4,736,493), the annual prescription rate of SGLT2i increased every year in patients with ASCVD (from 2.2% to 10.7%) or HF (from 2.0% to 11.1%). After the first hospitalization for ASCVD (n=518,572), 13.7% (n=71,259) of patients initiated SGLT2i with a median of 10.6 months. After hospitalization for HF (n=372,853), 11.2% (n=41,717) of patients initiated SGLT2i after a median of 8.8 months. In multivariate regression for hospitalization, older age (per 10 years, odds ratio [OR], 0.57; 95% confidence interval [CI], 0.56 to 0.57), lower household income (OR, 0.93; 95% CI, 0.92 to 0.95), rural residents (OR, 0.95; 95% CI, 0.93 to 0.97), and dipeptidyl peptidase-4 inhibitor (DPP-4i) users (OR, 0.82; 95% CI, 0.81 to 0.84) were associated with lesser initiation of SGLT2i in ASCVD. Additionally, female gender (OR, 0.97; 95% CI, 0.95 to 0.99) was associated with lesser initiation of SGLT2i in HF.ConclusionThe prescription rate of SGLT2i increased gradually up to 2019 but was suboptimal in patients with ASCVD or HF. After the first hospitalization for ASCVD or HF, older age, female gender, low household income, rural residents, and DPP-4i users were less likely to initiate SGLT2i.

Frequency and outcomes of molecularly guided off-label targeted agent prescriptions in the VA National Precision Oncology Program (NPOP).

e18676 Background: The increasing availability of comprehensive genomic profiling (CGP) and a growing number of targeted agents (TAs) has led to substantial improvements in outcomes among cancer pts with actionable mutations. CGP has led to identification of both on-label (level 1) variants, for which TAs have known efficacy, and off-label variants with lesser strength of supporting data. We sought to evaluate real-world prescription patterns and outcomes of off-label TA prescriptions among pts who underwent CGP. Methods: The NPOP database and VA Corporate Data Warehouse were queried to identify pts who had underwent CGP between February 2019 and December 2021 and were prescribed at least 1 of 73 TAs before January 2022. TAs prescribed for FDA-approved indications not relying on CGP as a companion diagnostic were excluded. OncoKB was used to annotate gene variants and evaluated against prescriptions to select pts who received off-label TAs. The frequency of off-label TA use, and for those treated &gt; 4 weeks, rate of pts treated for 6 months or longer, median treatment duration and overall survival (OS) were computed. Results: Of the 18686 patients who underwent CGP, 2107 (11%) were prescribed any TA, and 191 (1%) were prescribed off-label TAs, with 31 receiving multiple concurrent or sequential off-label TAs. Mean age was 65.5 years, and 88% were male. TAs were most often prescribed for cancers of unknown primary (CUP, 29), NSCLC (24), and colorectal cancer (22). Frequency of off-label prescriptions was highest for pts who completed CGP for thyroid cancer (9%), breast cancer (8%), and CUP (2%). Most common variants involved BRAF (21%), ERBB2 (18%), BRCA1/BRCA2/ATM (9%), and PIK3CA (6%). Among all 164 pts treated &gt; 4 weeks, 40% received TAs for 6 months or longer, including 50%, 47%, and 46% of pts bearing BRAF-, ERBB2-, and PIK3CA-mutant disease, respectively. Median therapy duration and OS was 141 [78.5 – 317, IQR] days and 181 [96.5 – 304.5, IQR] days, respectively. Conclusions: Though overall use of off-label TAs following CGP is low, nearly 10% of advanced thyroid and breast cancer patients are prescribed TAs for off-label indications. Forty percent of all pts receiving off-label TAs continue for at least 6 months, with higher rates for pts bearing BRAF-, ERBB2-, and PIK3CA-mutant disease. CGP-guided off-label treatment approaches offer unique options for advanced stage cancer with amenable molecular profiles.

Real-World Prescription Patterns For Patients With Young-Onset Parkinson's Disease in China: A Trend Analysis From 2014 to 2019.

Introduction Pharmacotherapy is one of the main treatments for patients with young-onset Parkinson’s disease (YOPD). Although numerous studies on the treatment of YOPD have been published, the real-world prescription patterns of these populations remain unclear in China. Methods A national comprehensive evaluation was performed to reveal the pharmacological treatment patterns in Chinese patients with Parkinson’s disease from 1 January 2014 to 31 December 2019, with patients aged 21–50 years classified as having YOPD for the subgroup analysis. Information on patients and drugs was extracted to analyse the demographic characteristics, prescription patterns, and levodopa equivalent daily dose (LED) during disease progression. Results A total of 1,134 patients with YOPD were included, and the majority were aged 41–50 years. Prescription of L-DOPA/benserazide and pramipexole accounted for more than 30 and 20%, respectively, in each year from 2014 to 2019. There was no difference in prescription patterns in terms of age, sex and geographical areas. Half of the patients with YOPD were on monotherapy, but the proportion decreased from 2016. Correspondingly, the proportion of patients receiving polytherapy increased, especially those who were prescribed more than two anti-Parkinson’s disease drugs. During the disease course, LED showed high variability, which increased over time. Conclusion L-DOPA/benserazide and pramipexole were the most frequently prescribed anti-PD drugs for patients with YOPD in China. There was a slight trend in the transition from monotherapy to polytherapy. LED increased with disease duration. Thus, we provided an overview of the prescription patterns for patients with YOPD in China.

New insights into the optimal management of COPD: extracts from CHEST 2021 annual meeting (October 17–20, 2021)

ABSTRACT Introduction Discordance between real-world prescribing patterns and global treatment guidelines for the treatment of chronic obstructive pulmonary disease (COPD) with inhaled single or dual long-acting bronchodilator maintenance therapy is increasingly being reported in the literature, particularly with regard to addition of inhaled corticosteroids (ICS). Patient-related factors, e.g. inhalation technique and inspiratory flow, are key to disease control in COPD. Treatment discordance and patient-related factors can lead to high-cost side effects and sub-optimal treatment benefit; furthermore, the COVID-19 pandemic has led to new challenges in COPD management. Areas Covered This article summarizes a series of presentations sponsored by Boehringer Ingelheim and delivered at the annual CHEST congress 2021 (October 17–20, 2021) that explored new insights into the optimal management of COPD. Expert Opinion/Commentary There is a concerning high degree of discordance with GOLD recommendations. Dual therapy without addition of ICS does not increase exacerbation risk and could reduce pneumonia risk, and unnecessary prescription of triple therapy has financial implications. Clinic-based spirometry may not reflect the home setting, and training is required; inhalers that operate independently of users’ inhalation profiles should be considered. Integration of digital healthcare solutions into clinical studies is suggested in the post-COVID setting, although further evaluation is required.

Patient Visits and Prescribing Patterns Associated with Rosacea in Korea: A Real-World Retrospective Study Based on Electronic Medical Records.

Rosacea is a common and chronic inflammatory skin disorder. The visiting trends and prescribing patterns involving Korean patients with rosacea have not been thoroughly examined. To examine the visiting trends of patients with rosacea, and to analyze the prescription patterns of Korean dermatologists managing such patients, a retrospective cross-sectional study on dermatology outpatients who visited the seven affiliated hospitals of The Catholic University of Korea between 2007 and 2018 was performed. A total of 56,651 visits were made by rosacea patients. The mean annual number of hospital visits made by rosacea patients over a 6-year period increased from 2456 in 2007–2012 to 6985 in 2013–2018. Hospital visits were most prevalent in female patients aged 40 to 59 years. There was no statistically significant difference in patient visitation between the seasons. As for prescriptions, systemic antibiotics were most commonly prescribed, followed by antihistamines, non-steroidal anti-inflammatory drugs, and retinoids. Among the topical agents, metronidazole was the most prescribed agent during 2007–2012, whereas calcineurin inhibitors were favored most during 2013–2018. Dermatology outpatient visits by individuals with rosacea have increased in Korea over time. The real-world prescription trend presented here may help dermatologists facilitate better treatment strategies and provide appropriate guidance to patients with rosacea.

Psychotropic drug utilization patterns in pregnant women with bipolar disorder: A 16-year population-based cohort study

Despite growing concern about reproductive safety of psychotropic drugs, there is a paucity of research assessing prenatal prescribing practices for bipolar disorder (BD). This population-based cohort study identified women aged 15–50 years with BD diagnosis, who delivered their first and singleton child between 2003 and 2018 in Hong Kong, with an aim to examine temporal trends and predictors of prenatal psychotropic drug use as well as drug utilization patterns before and during pregnancy were evaluated. Data were retrieved from territory-wide medical-record database of public healthcare services. Of 302 identified women, 202 (66.9%) and 180 (59.6%) redeemed at least 1 prescription for psychotropic drugs in 12 months pre-pregnancy and during pregnancy, respectively. Psychotropic drug treatment (OR = 16.14 [95% CI: 8.79–29.65]) and psychiatric admission (OR = 4.12 [95% CI: 1.66–10.24]) within 12 months pre-pregnancy were associated with prenatal drug use. Second-generation antipsychotic use during pregnancy increased over time, while prenatal use of lithium, anti-epileptics and first-generation-antipsychotics showed declining trend. Use of psychotropic drugs progressively decreased across pre-pregnancy and trimesters of pregnancy. Forty-two (23.3%) women received polypharmacy during pregnancy. Antidepressant use accounted for 17% of all monotherapy episodes. A significant proportion of women exposed to valproate in 12 months pre-pregnancy (27.2%) and first-trimester (16%). In conclusion, our results generally indicate trajectories of reduced psychotropic drug use across pregnancy. Deviations between real-world prescribing patterns and treatment guidelines underscore the need for comprehensive review of current clinical practices. Further research clarifying relationships of prenatal psychotropic drug exposure with maternal and fetal outcomes is warranted.

Prescribing Patterns of Antihypertensive Agents and Blood Pressure Control Among Patients With Incident Stage 2 Hypertension.

Background: Initiation of appropriate antihypertensive therapy is crucial, particularly among patients with stage 2 hypertension, whom initiation of dual antihypertensive agents is suggested. Little is known regarding real-world prescribing of antihypertensive agents for patients with incident stage 2 hypertension. Objective: The primary objective was to describe prescribing patterns of antihypertensive therapy among patients with incident stage 2 hypertension. The secondary objectives included determining association of blood pressure (BP) control with initial multiple antihypertensive agents. Methods: Retrospective cohort analysis was conducted using electronic medical records from 6 primary care clinics between January 2014 and June 2019. Included patients were ≥18 years with an initial diagnosis of stage 2 hypertension, defined as BP ≥160/100 mm Hg Primary analysis was characterizing prescribing patterns of antihypertensive agents among patients with incident stage 2 hypertension. Investigation of BP control (<140/90 mm Hg) at 3 months of diagnosis was also performed. Results: We identified 261 patients with incident stage 2 hypertension (mean age, 52 years; 53.2% males; mean baseline BP, 162.1/100.1 mm Hg). Approximately 72% of patients were initiated on single antihypertensive agent, with the most common being angiotensin receptor blockers (ARBs; 25.7%) and angiotensin-converting-enzyme (ACE) inhibitors (24.6%). Commonly initiated multiple antihypertensive agents were ACE-inhibitor + thiazide-like diuretic (52.7%), followed by an ARB + thiazide-like diuretic (21.6%). Multiple antihypertensive therapy was associated with improved BP control at 3 months (adjusted odds ratio [OR], 3.54; 95% confidence interval [CI], 1.55-8.06). Conclusion: Majority of patients with incident stage 2 hypertension were prescribed initial single antihypertensive therapy, though better BP control at 3 months was seen among those initiated on multi-antihypertensive therapy.

Real-world dosing characteristics and utilization of parenteral treprostinil in the outpatient setting.

Real‐world dosing and titration of parenteral (subcutaneous, SC; intravenous, IV) prostacyclin, a mainstay of pulmonary arterial hypertension (PAH) treatment, is not always consistent with prescribing information or randomized trials and has yet to be adequately characterized. The current study describes real‐world outpatient dosing and titration patterns over time, in PAH patients initiated on SC or IV treprostinil. A longitudinal, cross‐sectional analysis of medication shipment records from US specialty pharmacy services between 2009 and 2018 was conducted to determine dosing and titration patterns of SC or IV treprostinil in the outpatient setting beginning with the patient's first shipment. The sample for analysis included shipment records for 2647 patients (IV = 1040, SC = 1607). Although more patients were started on SC treprostinil than IV, median initial outpatient IV treprostinil dose (11 ng/kg/min at month on therapy one [MOT1]) was consistently and statistically significantly higher than initial outpatient SC dose (7.5 ng/kg/min at MOT1; p < 0.01). However, the SC treprostinil dose acceleration rate (DAR) was more aggressive from MOT1 to MOT6, MOT12, and MOT24, leading to a higher dose achieved at later timepoints. All between‐group DAR differences were statistically significant (p < 0.001). This study provides evidence that real‐world prescribing patterns of parenteral treprostinil in the outpatient setting differs from dosing described in pivotal trials, with important differences between SC and IV administration. Although initial outpatient IV treprostinil dosing was higher, SC titration was accelerated more aggressively and a higher dose was achieved by MOT3 suggesting that factors specific to SC administration (e.g., site pain) may not limit dosing and titration as previously thought.

Trend in prescription and treatment retention of molecular-targeted drugs in 121,131 Japanese patients with rheumatoid arthritis: A population-based real-world study.

To describe the real-world prescription and treatment retention of molecular-targeted drugs for rheumatoid arthritis (RA) in Japan. A total of 204,416 patients with RA were prescribed at least one of the eight molecular-targeted drugs in 7 years from the National Database of Health Insurance Claims and Specific Health Checkups of Japan covering 98.3% of the Japanese population. The retention rates of each drug as well as head-to-head comparisons were estimated by Kaplan-Meier method. A total of 121,131 RA patients were prescribed any molecular-targeted drug for the first time, while 36,633 uses of molecular-targeted drug were switched from another (switch use). The overall retention rates of molecular-targeted drugs at 12, 36, and 60 months were 0.64, 0.42, and 0.32 for the naïve use and 0.59, 0.40, and 0.31 for the switch use, respectively. Non-tumour necrosis factor (TNF)-inhibitor molecular-targeted drugs, particularly tocilizumab and tofacitinib, had higher retention rates than TNF inhibitors for both naïve and switch uses regardless of the previous drug and showed higher retention rates in head-to-head comparisons between eight molecular-targeted drugs. Our data reveal that the real-world drug retention is overall lower than previously reported and higher with non-TNF inhibitors than with TNF inhibitors.

Pitfalls of Physician-Directed Treatment of Helicobacter pylori: Results from Two Phase 3 Clinical Trials and Real-World Prescribing Data

BackgroundHelicobacter pylori (H. pylori) infects ~ 35% of Americans and can lead to serious sequelae if left untreated. Growing evidence indicates that clarithromycin-based therapies (CBT) are becoming increasingly ineffective for treating H. pylori infection. RHB-105 was approved by the US Food and Drug Administration in 2019 for the treatment of H. pylori infection in adults.AimsThe primary aim of this study was to assess prescribing patterns and associated cure rates of physician-directed therapy for subjects with persistent H. pylori infection after participation in one of two Phase 3 clinical trials (ERADICATE Hp and ERADICATE Hp2).MethodsWe reviewed study reports to identify specific physician-directed regimens selected for subjects whose H. pylori infection was not eradicated. We also conducted a CYP2C19 genotype analysis of subjects who were prescribed CBT. Finally, we analyzed real-world H. pylori retail prescription data and compared these with to the physician-directed therapies in the clinical trials studies.ResultsFollowing ERADICATE Hp, CBT was prescribed for 27/31 (87%) subjects achieving a 59.3% cure rate. Following ERADICATE Hp2, CBT was prescribed for 48/94 (51%) subjects achieving a 60.4% cure rate. Rapid CYP2C19 metabolizers (2/11) had a cure rate of 18.2% with CBT. Real-world prescription data from IQVIA showed more than 80% of prescriptions for H. pylori infection were for CBT.ConclusionsRates of CBT use persist despite sub-optimal eradication rates. Since RHB-105 does not contain clarithromycin, it can be prescribed first-line without concerns about clarithromycin resistance or CYP2C19 status.NCT03198507 & NCT01980095.

Abstract 14274: Machine Learning-Enhanced Determinants of Oral Anticoagulation in Atrial Fibrillation: Findings From the PINNACLE Registry

Introduction: Current atrial fibrillation (AF) guidelines recommend use of oral anticoagulation (OAC) to reduce the risk of stroke and systemic embolism. Machine learning (ML) techniques may enhance our understanding of factors associated with gaps in real-world prescription of OAC. Hypothesis: There will be large variation in county-level OAC prescription rates among ambulatory patients with AF, and geographic and medication factors will be stronger predictors than clinical comorbidities of lack of OAC prescriptions. Methods: Between January 2017 and June 2018, we identified patients with AF from the American College of Cardiology’s (ACC) Practice Innovation and Clinical Excellence (PINNACLE) Registry. We examined associations between patient and site-of-care factors and prescription of OAC across U.S. counties. Several ML methods were used to identify factors associated with lack of OAC prescription. Results: Among 864,339 patients with AF, 586,560 (68%) were prescribed OAC. County OAC prescription rates ranged from 26.8% (15/56) to 93% (41/44), with higher OAC use in the Western US. Supervised ML analysis (extreme gradient boosting: area under the receiver operating characteristic curve [AUC]: 0.811, 95% confidence interval [CI]: 0.809-0.813) outperformed the CHA2DS2-VASc score (AUC: 0.571, 95% CI: 0.569-0.574) in predicting likelihood of OAC prescriptions and identified a rank order of patient features associated with OAC prescription. In the ML models, use of aspirin, antihypertensives, lipid modifying agents, antiarrhythmic agents, age, inter-normalized ratio, median household income, and clinic size were the most important predictors of OAC prescription. Conclusions: In a national cohort of patients with AF underuse of OAC remains high, with notable geographic variation. ML algorithms can identify factors associated with use of OAC.