Real-world Registry Study Research Articles

Associations of long-term clinical recovery and improved quality of life across ICD-11 chronic pain categories in a real-world registry study.

There is little knowledge of what factors are needed for successful chronic pain management. We aim to identify psychosocial and treatment predictors of clinical recovery and improved quality of life (QOL) at 12-month follow-up across three chronic pain groups, based on the International Classification of Diseases-11: neuropathic pain, secondary non-neuropathic pain, and primary pain. Furthermore, we investigate baseline differences across diagnostic groups. The sample included baseline and 12-month follow-up data from 1056 chronic pain patients from the Oslo University Hospital's Pain Registry. Logistic regression models investigated longitudinal associations between psychosocial and treatment characteristics, and the outcome measures clinical recovery and improved QOL. Characteristics were compared across the diagnostic groups. Increased odds of clinical recovery and improved QOL were seen in patients receiving invasive treatment (OR = 8.04, 95% CI = 3.50-19.40; OR = 5.47, 95% CI = 2.42-12.86), while decreased odds of clinical recovery were seen for secondary non-neuropathic pain patients with pain-related disability (0.05, 95% CI = 0.01-0.29). In comparing baseline characteristics, neuropathic pain patients had lower QOL, and more severe insomnia compared to the other groups. Invasive treatment modalities were strongly associated with clinical recovery and improved QOL. Although this could be due to patient selection, it does warrant further examination as an intervention alternative for chronic pain. Intervention efficacy, risk factors and predictors of clinical recovery across diagnostic groups should be further investigated through longitudinal RCTs. This observational study indicates a potential advantage in sustained recovery for pre-selected individuals with chronic pain who undergo invasive treatments. The relationship between sustained recovery and psychosocial factors differs across neuropathic, secondary non-neuropathic, and primary pain patients. This suggests that employing ICD-11 for classifying patients into mechanistically distinct pain groups could inform the evaluation and management of chronic pain. Furthermore, factors previously identified as negative indicators for long-term outcomes in chronic pain cohorts were not clinically significant in this study.

FRI444 Testosterone Therapy in Men with Classical vs Functional Hypogonadism: Results from a Controlled 9-year, Real-world Registry Study

Abstract Disclosure: M. Zitzmann: None. Background and Significance: Long-term data on Testosterone therapy (TTh) in hypogonadal men are limited and the clinical value, especially in men with functional hypogonadism (FH) is debated. A long-term, real-world registry study comprising groups of patients with hypogonadism of various etiologies provides a suitable and novel approach to this clinical issue. Methods: A registry spanning 9 years comprising 650 patients with hypogonadism included 188 patients with FH (mean age 42.3±11.3 years) and 462 men with classical hypogonadism (CH). Of these, 266 men had primary hypogonadism (PH, mean age 34.0±11.7 years) and 196 secondary hypogonadism (SH, mean age 31.9±12.0 years). All men uniformly received intramuscular T undecanoate (1000 mg). Effects of TTh on anthropometric parameters, as well as metabolic and safety parameters were compared. Results: The registry contained metabolic and safety parameters in individual duration of TTh spanning 1 to 9 years. Serum T concentrations increased from 6.6±2.4 nmol/L to 19.3±2.9 nmol/L in all patients (duration-of-treatment-dependent averages, mixed linear model for repeated measurements with the fixed variable “time x visit interaction”: p<0.001). In both categories of hypogonadism, TTh was associated with significant weight loss and decrease in waist circumference (WC, both p<0.001). Cox regression and Kaplan-Meier models revealed differences of inter-individual check-points: men with FH were more likely to lose >10% weight and >5% of WC than men with CH (hazard ratio 1.3 [1.1-1.4], p=0.008 and hazard ratio 1.4 [1.3-1.5], p=0.001). There was no difference between groups for the overall marked increase in hematocrit. Changes in PSA levels were more likely to occur in FH (hazard ratio 1.3 [1.1-1.6], p=0.003). During TTh, patients with FH exhibited significantly more pronounced changes of favourable nature in metabolic parameters than patients with CH (total cholesterol, triglycerides, LDL- and HDL-cholesterol and fasting glucose). The same applied to scores of AMS and IIEF-EF questionnaires. Effects on most parameters, especially hematocrit, were significantly modulated by age and baseline values for weight, WC und T. Conclusions: Findings regarding effects and safety of TTh in different groups of hypogonadal men are provided. Effects on factors associated with cardiovascular health are modulated by diagnosis and age. Patients with FH seem to benefit to a larger extent from TTh, most likely attributable to their more pronounced risk factor profile at baseline. Presentation Date: Friday, June 16, 2023

Comorbidities and high in-hospital mortality of cancer-associated pulmonary embolism: findings from a real-world registry study.

Comorbidities and high in-hospital mortality of cancer-associated pulmonary embolism: findings from a real-world registry study.

Population-based real-world registry study to evaluate clinical outcomes of chronic graft-versus-host disease.

Chronic graft-versus-host disease (cGVHD) is a serious immune-mediated complication after allogeneic haematopoietic stem cell transplantation (HSCT), but in patients with malignancy, cGVHD development is associated with superior survival. Lack of reliable biomarkers and clinical underreporting means there is insufficient understanding of cGVHD clinical outcomes and balance between cGVHD treatment and maintaining beneficial graft-versus-tumour effects. We performed a Swedish population-wide registry study following patients who underwent allogeneic HSCT 2006-2015. cGVHD status was retrospectively classified using a real-world method based on the timing and extent of systemic immunosuppressive treatment. cGVHD incidence among patients surviving ≥6 months post-HSCT (n = 1246) was 71.9%, significantly higher than previously reported. 5-year overall survival in patients surviving ≥6 months post-HSCT was 67.7%, 63.3%, and 65.3%, in non-, mild, and moderate-severe cGVHD, respectively. Non-cGVHD patients had a mortality risk almost five-fold higher compared to moderate-severe cGVHD patients 12-months post-HSCT. Moderate-severe cGVHD patients had greater healthcare utilization compared with mild and non cGVHD patients. cGVHD incidence was high among HSCT survivors. Non-cGVHD patients had higher mortality during the first 6 months of follow-up; however, moderate-severe cGVHD patients had more comorbidities and healthcare utilization. This study highlights the urgent need for new treatments and real-time methods to monitor effective immunosuppression after HSCT.

Effectiveness and Safety of Rituximab Biosimilar in Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia: Results from a Prospective, Multicentre, Real-World Registry Study

Effectiveness and Safety of Rituximab Biosimilar in Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia: Results from a Prospective, Multicentre, Real-World Registry Study

Abstract 11722: Assessing Disparity of Performance Measure by Door-to-Balloon Time Between Rural and Urban Area for Management of Patients with ST-Segment Elevation Myocardial Infarction -Insights from the Nationwide Japan Acute Myocardial Infarction Registry-

Background: Door to balloon time (D2B) ≤90 minutes is a key indicator of quality of care for ST-segment elevation myocardial infarction (STEMI). The development of standardized management for STEMI may narrow the performance gap between rural and urban hospitals. However, there are few studies to explore the disparity of D2B and outcomes between rural and urban areas. Methods and Results: The Japan Acute Myocardial Infarction Registry (JAMIR) is a nationwide, real-world registry study. We retrospectively analyzed 17,938 STEMI patients (68±13 years, female 22.4%) treated with percutaneous coronary intervention, who were divided into the following two groups according to population density of 1147 persons/km 2 ; patients hospitalized in rural area and those in urban area. Overall, the median D2B was 72 mins and 73% achieved the target D2B ≤90 mins. Patients with D2B ≤90 mins had a lower in-hospital mortality compared with those with D2B >90 mins (4.7% vs. 8,4%, P<0.001). Rural patients were characterized by higher age, more accumulation of coronary risk factors and a higher prevalence of Killip class ≥2 at presentation compared with urban patients. The median D2B was longer (70 mins vs. 62 mins, P<0.001) and achievement rate for D2B ≤90 mins was lower (70% vs. 75%, P<0.001) in rural group than urban group ( Figure A ). In-hospital mortality tended to be higher in rural group (6.1% vs. 5.5%, P=0.06), whereas the benefit in shortening of D2B was noted equally in both groups ( Figure B ). Conclusions: The real-world nationwide study of JAMIR demonstrated that shortening of D2B time was significantly associated with survival benefit of STEMI in both rural and urban area.

707P Treatment pattern and overall survival among patients with locally advanced or metastatic urothelial carcinoma: Results from a complete nationwide unselected real-world registry study in Denmark from 2010 to 2017

Platinum-based chemotherapy (PBC) remains the cornerstone of first-line (1L) treatment of locally advanced (LA) or metastatic urothelial carcinoma (mUC). However, the optimal number of PBC cycles remains unknown. We provide a report on treatment patterns and effectiveness in the pre–immuno-oncology (IO) era.

1057-P: Long-Term Testosterone Therapy Results in Remission of Type 2 Diabetes (T2DM) in 34.3% (61 of 178) Men with Hypogonadism and T2DM in a Real-World Registry Study

Background: In 2018, ADA Standards of Medical Care in Diabetes added measurement of testosterone levels in men with T2DM as new recommendation. Methods: A registry of men with hypogonadism (testosterone ≤12.1 nmol/L) was initiated in 2004 in a urological practice setting. 356 of 858 patients (41.5%) had T2DM diagnosed and treated in a diabetes center. Of these men, 178 received testosterone undecanoate (TU) injections 1000 mg/12 weeks (T-group) following an initial 6-week interval. Anthropometric and metabolic parameters were measured at least twice a year. Fasting insulin was used to calculate HOMA-IR. Results: After a mean follow-up of 7.7±3.0 (minimum 2, maximum 11 years), 61 patients (34.3%) were in remission, defined as discontinuation of all diabetes medications and stable HbA1c <6.5%. In men who went into remission, HbA1c dropped from 8.7±1.0% at baseline to 5.4±0.1% at the last measurement, HOMA-IR from 10.2±2.5 to 1.7±0.5. In men who never received insulin, HOMA%S increased from 11.1±1.5 to 15.8±2.4. Anthropometric parameters: Body weight declined progressively from 113.6±13.8 to 90.9±8.4 kg by 22.6±8.0 kg, waist circumference from 111.1±7.5 to 98.3±4.6 cm by 12.6±4.3 cm. All patients were on metformin at baseline. 22 patients were on insulin. The average observation time was 130.7±25.9 months (10.9±2.2 years). The average time to discontinuation of diabetes medication was 8.6±2.9 years, average follow-up after achieving remission 2.5±2.3 years. Medication adherence to TU was 100% as all injections were administered in the office and documented. PSA and hematocrit stayed within normal range during the entire observation period. Discussion: The effects of testosterone were likely mediated by sustained weight loss, increased lean body mass and a profound and sustained reduction of insulin resistance. Conclusions: Long-term testosterone treatment in men with hypogonadism may result in remission of T2DM. Disclosure K.S. Haider: None. A. Haider: None. F. Saad: Consultant; Self; Bayer AG. Stock/Shareholder; Self; AbbVie Inc., Bayer AG. Funding Bayer AG

P3719Myocardial injury during TAVI with self-expanding prosthesis is not associated with patient-prosthesis features, hemodynamics or clinical outcome

Abstract Background Transcatheter aortic valve implantation (TAVI) has been associated with increases in markers of myocardial injury but underlying mechanisms as well as relevance for prosthesis hemodynamics, cardiac function and clinical outcome remain unclear. Purpose To study the trajectory of high-sensitivity troponin T (hs-TnT) during TAVI and elucidate putative associations with demographics, anatomical and procedural features, as well as clinical and echocardiographic outcome. Methods This prospective real-world registry study included all patients (n=275) undergoing transfemoral TAVI using a self-expanding or balloon-mounted system at a large tertiary university hospital over the most recent three-year period. Plasma levels of hs-TnT (reference level 0–14 ng/l) at 24 hours (h) before TAVI and at 9h, 18h, 30h, 42h and 72h after TAVI were analyzed. Patients with ongoing myocardial ischemia and acute coronary syndrome were excluded. We studied the association between hs-TnT values and patient characteristics, echocardiographic and CT findings at baseline as well as procedural features including the use of pre- and postdilatation. Moreover, we studied the association between hs-TnT and and echocardiography and clinical outcome at 1 year after TAVI. Results In this real-world TAVI cohort (median age 83.2±0.2 years; 48.7% women; 5.2±0.2 comorbidities; eGFR 58.0±6.0 ml/min/1.73m2; mean±standard error), 100% of patients exhibited significant elevations of hs-TnT at approximately 9-fold (207.0±11.0) compared to baseline (23±0.2 ng/L, median±SE). Peak hs-TnT values were reached at 9 h post-TAVI (207±11 ng/L) with subsequent gradual decline (figure). Myocardial injury was confirmed by elevated creatin kinase (CK) and CKMB isozyme. No significant association was found between peak hs-TnT, delta hs-TnT (peak minus baseline values) or area under the curve (AUC) of hs-TnT on the one hand, and patient demographics including renal dysfunction, comorbidity, age and gender on the other side. Moreover, no significant association between hs-TnT and anatomical features, prosthesis sizing, or use of pre- and postdilatation was found. No association between hs-TnT during TAVI and NYHA functional class, transvalvular pressure gradient, cardiac function or survival at 1 year was found. In subjects with at least one year of follow-up after TAVI (n=138), NYHA functional class (1.7 vs 2.7) and NT-proBNP plasma levels (1126±316 vs 1581±563 ng/L) were significantly lower compared to pre-TAVI. Conclusions Modest transient elevations of hs-TnT occur in all patients undergoing TAVI and are consistent with subtle myocardial injury. The lack of significant association between the extent of myocardial injury during TAVI and clinical and hemodynamic outcome as well as all-cause mortality is reassuring for current real-world practice.

Naldemedine for opioid-induced constipation in patients receiving palliative care: A real-world registry study (Phase-R OIC Study).

11582 Background: Although naldemedine, a new peripherally-acting mu-opioid receptor antagonist, was approved for the management of opioid-induced constipation (OIC), its safety and effectiveness in real world clinical practice is unknown. Methods: We conducted a real world registry study in 14 hospital palliative care teams and inpatient palliative care units in Japan between April and December 2018. Consecutive cancer patients who received naldemedine for OIC were enrolled in a 7-day observational study. All treatment and assessment procedures were performed according to the accepted clinical practice. The primary outcome of the study was the proportion of patients who experienced spontaneous bowel movement within 24 hours after the initial administration of naldemedine. Adverse events, which indicated a possible or stronger causal relationship with naldemedine treatment, were reported according to the Common Terminology Criteria for Adverse Events (CTCAE) ver 4.0. Results: Overall, 204 patients were enrolled in the study. The mean age of the patients was 63±14 years, and 103 (50.5%) were male. The most common primary cancer site was lung (23.5%), followed by gastrointestinal (13.7%), and urological organs (9.3%). The proportion of patients undergoing active cancer treatment was 59.9%. Oxycodone was the most frequently used regular opioid (n = 115, 56.4%), and the median oral morphine-equivalent daily dose of opioids was 30 mg (interquartile range: 20-60 mg). Magnesium oxide (64.2%) and Senna (17.2%) were used as concomitant laxatives. All patients received 0.2 mg of naldemedine orally once daily. Most patients (90.2%) completed the 7-day observation. In 146 patients, spontaneous bowel movement was observed within 24 hour after the first administration of naldemedine (71.6%, 95% confidence interval 65.4-77.8%). Nearly two-thirds of the patients experienced increased frequency of spontaneous bowel movement in the week after naldemedine administration. The most prevalent adverse events were diarrhea (CTCAE grade 1-2, 35 cases; grade 3, 1 case) and abdominal pain (CTCAE grade 1-2, 10 cases; grade 3, 1 case). No serious adverse events including gastrointestinal perforation were reported. Conclusions: Naldemedine for opioid-induced constipation is safe and effective in the real world oncology and palliative care settings. Clinical trial information: UMIN000031381.

China STudy of valsartan/amlodipine fixed-dose combination-bAsed long-Term blood pressUre management in HypertenSive patients: a one-year registry (China STATUS III)

Objective: The present observational study evaluated long-term management of hypertension in patients who received treatment with valsartan and amlodipine in a single-pill combination (Val/Aml SPC) in a real-world setting in China (Chinese Clinical Trial Registry number ChiCTR1900021324).Methods: This was a prospective, observational, multicenter, real-world registry study wherein patients with hypertension who had already received Val/Aml SPC (80/5 mg) for at least 4 weeks before study enrollment were observed for 1 year. Investigators recorded patient data every 3 months and essentially five times during the 1 year follow-up period. Effectiveness was assessed by the blood pressure (BP) control rate and average duration of treatment at the end of the study. Safety was monitored by the incidence of adverse events (AEs) and serious adverse events (SAEs).Results: Overall, 985 patients were enrolled (mean ± standard deviation [SD] age: 60.3 ± 11.5 years); of these, 894 were included in the full analysis set, 758 of whom completed the study. At baseline, BP was controlled (<140/90 mmHg) in 64.3% of patients on Val/Aml SPC for at least 4 weeks before enrollment. Office BP control rates significantly improved from baseline in 74.1% of patients at 1 year (p < .0001). Overall, 575 (87.0%) patients remained on Val/Aml SPC at 1 year (average exposure: 311.5 days). AEs were reported in 23.3% of patients. The majority of AEs were mild to moderate, and 0.6% of patients discontinued Val/Aml SPC because of SAEs.Conclusion: This study provides evidence that Val/Aml SPC effectively reduced BP over the long term among Chinese hypertensive patients, with a good adherence and tolerability profile, and that most hypertensive patients may benefit from this combination.Trial registration: Chinese Clinical Trial Registry identifier: ChiCTR1900021324.

Batroxobin in combination with anticoagulation may promote venous sinus recanalization in cerebral venous thrombosis: A real-world experience.

SummaryAimsThe objective of this study was to evaluate cerebral venous recanalization with magnetic resonance black‐blood thrombus imaging (MRBTI) in patients with cerebral venous thrombosis (CVT) who underwent batroxobin treatment in combination with anticoagulation.MethodsA total of 31 CVT patients were enrolled in this real‐world registry study. The patients were divided into batroxobin (n = 21) and control groups (n = 10). In addition to the same standard anticoagulation as in the control group, patients in the batroxobin group underwent intravenous batroxobin for a total of three times.ResultsIn the batroxobin group compared with the control group, we found better odds of recanalization degree [adjusted OR (95%CI) of 8.10 (1.61‐40.7)] and segment‐stenosis attenuation [adjusted OR (95%CI) of 4.48 (1.69‐11.9)] with batroxobin treatment. We further noted a higher ratio of patients with the attenuation of stenosis [adjusted OR (95%CI) of 26.4 (1.10‐635)]; as well as a higher ratio of segments with stenosis reversion [adjusted OR (95%CI) of 4.52 (1.48‐13.8)]. However, neurological deficits between the two groups showed no statistical difference at 90‐day follow‐up (P > 0.05).ConclusionsBatroxobin may promote venous sinus recanalization and attenuate CVT‐induced stenosis. Further randomized study of this promising drug may be warranted to better delineate the amount of benefit.

PP.16.35

Objective: Despite the availability of numerous therapeutic agents and management tools, nearly half of all hypertensive patients do not have their blood pressure (BP) at goal (HSCIC data). Proteus captures and shares information about medication-taking, rest and activity patterns through an FDA-cleared and CE-marked ingestible sensor (IS), a wearable sensor adhesive patch and a mobile device and app. This platform supports provider decision-making for treating patients to goal. An open-label, observational real-world registry study evaluated this product in patients with uncontrolled hypertension. Design and method: The target sample size of the registry study is 150 patients with uncontrolled hypertension prescribed at least 2 antihypertensives. Patients co-ingested the IS with prescribed BP medications while simultaneously wearing the patch for 2 weeks. Clinic BP was measured on days 1 and 14. Adherence, activity and rest patterns, were measured via the Proteus patch and IS. Subjects returned to the clinic at week 4 to discuss the next steps in therapy based on the Proteus data. Results: In this interim analysis, 46 patients met the inclusion/exclusion criteria. The mean age was 68, 51% were male, and 36% also had diabetes. The root cause of persistent hypertension was identified for 100% of subjects; 46% had pharmacological resistance and 54% had inadequate medication use. BP control was achieved in 37% of patients after 2 weeks. The mean systolic BP decreased from 158 ± 16 to 143 ± 16, and the mean diastolic BP decreased from 83 ± 12 to 77 ± 10 after 2 weeks. BP management changes included medication reviews and/or adherence counseling in 88%, and medication changes in 24% of patients. Most patients (84%) had a good experience and thought the Proteus platform was easy to understand and convenient to use as measured by a patient satisfaction survey. Conclusions: In patients with a history of uncontrolled hypertension, the Proteus platform was able to help identify the root cause of persistent hypertension and help 37% achieve BP control within 2 weeks. The Proteus platform demonstrates the potential to help providers identify specific factors contributing to uncontrolled hypertension and facilitates interventions to improve disease management.

Cost-effectiveness of candesartan versus losartan in the primary preventive treatment of hypertension

BackgroundAlthough angiotensin receptor blockers have different receptor binding properties, no comparative randomized studies with cardiovascular event endpoints have been performed for this class of drugs. The aim of this study was to assess the long-term cost-effectiveness of candesartan (Atacand®) versus generic losartan in the primary preventive treatment of hypertension.MethodsA decision-analytic model was developed to estimate costs and health outcomes over a patient’s lifetime. Data from a clinical registry study were used to estimate event rates for cardiovascular complications, such as myocardial infarction and heart failure. Costs and quality of life data were from published sources. Costs were in Swedish kronor and the outcome was quality-adjusted life-years (QALYs).ResultsDue to reduced rates of cardiovascular complications, candesartan was associated with a QALY gain and lower health care costs compared with generic losartan (0.053 QALYs gained and reduced costs of approximately 4700 Swedish kronor for women; and 0.057 QALYs gained and reduced costs of approximately 4250 Swedish kronor for men). This result was robust in several sensitivity analyses.ConclusionWhen modeling costs and health outcomes based on event rates for cardiovascular complications from a real-world registry study, candesartan appears to bring a QALY gain and a reduction in costs compared with generic losartan in the primary preventive treatment of hypertension in Sweden.