CPX-351 for Acute Myeloid Leukaemia: Real World Results Are Comparable to Trial Outcomes and Exceeds Them in Non-Adverse Risk Patients- a Multicentre Experience from West Midlands Hospitals on Behalf of West Midlands Research Consortium ( WMRC) UK

Abstract Patients with secondary AML or MDS derived AML have poor outcomes compared to de-novo AML. The benefits of intensive chemotherapy without anticipated transplant consolidation have been previously doubted. Outcomes in USA trial centres have not often been closely replicable in real world settings. From November 2018 CPX-351 has been available in the UK for secondary AML, therapy related AML, AML with MDS related Karyotype (AML-MRC) and licensed but not funded for AML with myelodysplastic related changes. Objectives Here we report our experience specifically on patient outcomes and toxicity across 5 Hospitals in West Midlands, UK Methods Patients receiving CPX 351 outcomes were evaluated retrospectively from 2018 to 2021. Baseline genetics, CPX 351 indications, patient's comorbidities, overall survival, remission status, number of cycles delivered, early mortality, reasons for early discontinuation, intensive care admission and time for neutrophil recovery (>0.5) was recorded. Time-to-event outcomes reported here are from a data cut on 01-06-21 Results In a total cohort of 57 patients baseline characteristics are shown on table 1 and compared with the original trial CPX-351 group. Median follow up was 376 days (range 21 to 1248 days). The mean age was 63, 17 patients were under 60, 31 males and 26 females. The most common indication for CPX-351 was AML with antecedent MDS/MPN 51% (N=29), therapy related 14% (N=8), MDS related karyotype (AML-MRC) 19% (N=11) and 16% (N=9) other patients. Mean Charleston co-morbidity score was 2.7 (range 0-6), 10.5% (N=6) had previous non myeloid malignancies, 8.7% (N=5) had prior ischaemic heart disease, only 3.5% (N=2) had ejection fractions under 50%. The most common mutations were TP53 21% (N=12), ASXL1 15.7% (N=9), TET2 15.7% (N=9), IDH2 10.5% (N=6), RUNX1 10.5% (N=6), SRSF2 7% (N=4), JAK2 3.5% (N=2), FLT3 5% (N=3), NPM1 5%(N=3) and IDH1 5% (N=3). MRC cytogenetic risk was adverse in 19 patients (33%), intermediate in 35 patients (61%) and favourable in 3 patients (5%). 30 patients (53%) had adverse European Leukaemia Network classification, 17 (30%) had intermediate and 10 (17%) had favourable. 30-day mortality was 3/57 (5%), 60-day mortality was 6 (10.5%) comparable to the 5.9% and 10.6% rates for the original trial. 9% or 5/57 patients were admitted to ITU with 2 survivors beyond 60 days. Neutropenic fever requiring antibiotics was 100% whereas only 5/57 (9%) had radiological evidence of fungal infection. Only one patient died from COVID 19. The mean time to neutrophil recovery was 35 days with a range of 12 to 84 days. 29 patients completed 1 cycle, 25 completed 2 cycles, only 3 completed 3 cycles. The reasons for stopping were death, refractory disease, drop in performance status, alternative chemotherapy chosen or moving to transplantation (39%). Composite remission rate including CRi was 61% 36/57, adverse ELN group demonstrated 50% 15/30, intermediate 76% 13/17 and favourable 80% 8/10. Mutated P53 was associated with a 50% 6/12 rate whereas in wild type P53 the remission rate was 60% 30/45. Overall median survival from diagnosis was 429 days [95% CI 274 to 788 days]. To compare with the original trial, we removed the under 60s and those with less than 1 year follow up, in this cohort of 30 patients the median survival was 289 days (9.5 months) with 95% CI of 255 to 476 days. P53 mutated patients had an estimated median survival of 257 days versus wild type p53 with 524 days hazard ratio of 2.418 (CI 1.077 to 5.248) with p value of 0.032. Median survival for ELN groups was 373 days (adverse), 413 days (intermediate) and not reached for favourable. Of the 36 patients who achieved a remission, 22 went on to receive an allogenic transplant with follow from 254 to 1248 days, median survival estimated 706 days (95% CI 429-not reached). Patients in remission who haven't received a transplant have a similar estimated survival of 788 days (305-not reached) pending longer follow up. Conclusion This is the first UK multicentre analysis to show comparable results to the landmark trial (median survival 9.5 months in equivalent cases). The improved overall remission rate 61% versus the 47% in the trial and the longer median survival 14 months versus 9.5 months in the trial is expected given the younger age and increase in favourable risk genetics. This study therefore supplies further data of CPX-351 efficacy in younger patients not included in the original studies and may now be used as a standard comparator arm. Figure 1 Figure 1. Disclosures No relevant conflicts of interest to declare.

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Real-world effectiveness of app-based treatment for urinary incontinence: a cohort study

BMJ Open ◽

10.1136/bmjopen-2020-040819 ◽

2021 ◽

Vol 11 (1) ◽

pp. e040819

Author(s):

Pontus Rygh ◽

Ina Asklund ◽

Eva Samuelsson

Keyword(s):

Urinary Incontinence ◽

Cohort Study ◽

Real World ◽

Short Form ◽

Pelvic Floor Muscle ◽

Controlled Trial ◽

Healthcare Services ◽

International Consultation ◽

The Mean

ObjectivesThe efficacy of app-based treatment for stress urinary incontinence (SUI) has been demonstrated in a randomised controlled trial (RCT). In this study, we investigate the user characteristics and the effectiveness of the same app when freely available, and compare these results with the RCT.DesignProspective cohort study.ParticipantsDuring a 17-month period, 24 602 non-pregnant, non-postpartum women older than 18 years downloaded the app and responded anonymously to a questionnaire. Of these, 2672 (11%) responded to the 3-month follow-up.InterventionThree months’ use of the app Tät, containing information, a pelvic floor muscle training programme and lifestyle advice.Main outcome measuresChange in symptom severity (International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)) and subjective improvement (Patient Global Impression of Improvement (PGI-I)).ResultsOf the respondents, 88% lived in Sweden and 75% (18 384/24 602) were incontinent with a mean age of 45.5 (SD 14.1) years. The UI types, based on symptoms, were SUI (53%), urgency UI (12%), mixed UI (31%) and undefined (4%). The mean ICIQ-UI SF score was 8.2 (SD 4.0) at baseline. The mean ICIQ-UI SF score reduction at follow-up was 1.31 (95% CI: 1.19 to 1.44) with a larger reduction in those with more severe incontinence at baseline (severe/very severe 3.23 (95% CI: 2.85 to 3.61), moderate 1.41 (95% CI: 1.24 to 1.59) and slight 0.24 (95% CI 0.06 to 0.42). When the results were weighted to match the distribution of severity in the RCT, the ICIQ-UI SF score reduction was 2.2 compared with 3.9 in the RCT. Regarding PGI-I, 65% experienced improvement compared with 92% in the RCT.ConclusionsThe app Tät was effective for self-management of UI even in the real world. Although the reduction in incontinence symptoms was less than in the RCT, two-thirds of the users improved. App-based treatment reaches many women without requiring resources from ordinary healthcare services.

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Real-World Clinical Outcomes Associated with Canagliflozin in Patients with Type 2 Diabetes Mellitus in Spain: The Real-Wecan Study

Journal of Clinical Medicine ◽

10.3390/jcm9072275 ◽

2020 ◽

Vol 9 (7) ◽

pp. 2275

Author(s):

Juan J. Gorgojo-Martínez ◽

Manuel A. Gargallo-Fernández ◽

Alba Galdón Sanz-Pastor ◽

Teresa Antón-Bravo ◽

Miguel Brito-Sanfiel ◽

...

Keyword(s):

Diabetes Mellitus ◽

Real World ◽

Primary Outcome ◽

Baseline Hba1c ◽

Real World Setting ◽

Antihyperglycemic Therapy ◽

The Mean ◽

Hba1c Levels

The aims of this multicentric retrospective study were to assess in a real-world setting the effectiveness and safety of canagliflozin 100 mg/d (CANA100) as an add-on to the background antihyperglycemic therapy, and to evaluate the intensification of prior sodium–glucose co-transporter type 2 inhibitor (SGLT-2i) therapy by switching to canagliflozin 300 mg/d (CANA300) in patients with T2DM. One cohort of SGLT2i-naïve patients with T2DM who were initiated on CANA100 and a second cohort of patients with prior background SGLT-2i therapy who switched to CANA300 were included in the study. The primary outcome of the study was the mean change in HbA1c over the follow-up time. In total, 583 patients were included—279 in the cohort of CANA100 (HbA1c 8.05%, weight 94.9 kg) and 304 in the cohort of CANA300 (HbA1c 7.51%, weight 92.0 kg). Median follow-up periods in both cohorts were 9.1 and 15.4 months respectively. CANA100 was associated to significant reductions in HbA1c (−0.90%) and weight (−4.1 kg) at the end of the follow-up. In those patients with baseline HbA1c > 8% (mean 9.25%), CANA100 lowered HbA1c levels by 1.51%. In the second cohort, patients switching to CANA300 experienced a significant decrease in HbA1c (−0.35%) and weight (−2.1 kg). In those patients with baseline HbA1c > 8% (mean 8.94%), CANA300 lowered HbA1c levels by 1.12%. There were significant improvements in blood pressure in both cohorts. No unexpected adverse events were reported. In summary, CANA100 (as an add-on therapy) and CANA300 (switching from prior SGLT-2i therapy) significantly improved several cardiometabolic parameters in patients with T2DM.

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Abstract 1122‐000142: Safety and Efficacy of Surpass Streamline for Intracranial Aneurysms: A Multicenter US Real‐World Experience (SESSIA)

Stroke: Vascular and Interventional Neurology ◽

10.1161/svin.01.suppl_1.000142 ◽

2021 ◽

Vol 1 (S1) ◽

Author(s):

Juan Vivanco‐Suarez ◽

Alan Mendez‐Ruiz ◽

Farooqui Mudassir ◽

Cynthia B Zevallos ◽

Milagros Galecio‐Castillo ◽

...

Keyword(s):

Real World ◽

Intracranial Aneurysms ◽

The United States ◽

Chromium Alloy ◽

Cobalt Chromium ◽

Anterior Circulation ◽

Safety And Efficacy ◽

Post Marketing ◽

The Mean

Introduction : Flow diversion has established itself as standard treatment of wide complex intracranial aneurysms (IA). Its recognition has been validated with positive occlusion rates and favorable clinical outcomes. The Surpass Streamline (SS) flow diverter (FD) is a braided cobalt/chromium alloy implant with 72 or 96 wires approved by the FDA in 2018. The aim of this study is to determine the safety and efficacy of the SS in a post‐marketing large US cohort. Methods : We performed a multicenter, retrospective study for consecutive patients treated with the SS FD for IA between January 2018 and June 2021 in the United States. Inclusion criteria for participants were: 1. Adults (≥ 18 years) and 2. Treatment with SS FD for IA. Primary safety end point was a major ipsilateral stroke (increase in National Institutes of Health Stroke Scale Score of ≥ 4) or neurological death within 12 months. Primary efficacy was assessed using the 3‐point Raymond‐Roy (RR) occlusion scale on digital subtraction angiography (DSA) at 6‐12‐month follow‐up. Results : A total of 276 patients with 313 aneurysms were enrolled. The median age was 59 years and 199 (72%) were females. The most common comorbidities included hypertension in 156 (57%) subjects followed by hyperlipidemia in 76 (28%) patients. One hundred and twenty‐two (44%) patients were asymptomatic while subarachnoid hemorrhage was present in only 10 (4%) patients. A total of 143 (46%) aneurysms were left‐sided. Aneurysms were located as follows: 274 (88%) were in the anterior circulation with paraophthalmic being the most common in 120 (38%) followed by petrocavernous ICA in 81 (26%); 33 (11%) aneurysms were located in the posterior circulation with basilar trunk being the most common in 14 (5%). The mean maximum aneurysm dome width was 5.77 ± 4.7 mm, neck width 4.22 ± 3.8 mm and dome to neck ratio was 1.63 ± 1.3 mm. The mean number of SS FD implanted per aneurysm was 1.06 (range 1–3) with more than one SS FD implanted in 21 (7%) aneurysms. Modified Rankin Scale (mRS) of 0–2 was present in 206/213 (97%) patients at 6–12 month follow‐up. The complete aneurysm occlusion (RR 1) rate was 145/175 (83%) among subjects who had angiographic follow‐up at 6–12 months. Major stroke and death was encountered in 7 (2%) and 5 (1.8%) of the patients respectively. Conclusions : Our data represent the largest real‐world study using SS FD. These results corroborate its post‐marketing safety and efficacy for the treatment of intracranial aneurysms showing more favorable rates to the initial experience during SCENT trial.

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A-136 The Transfer of Cognitive Training to Real-World Functioning: Results of our First Six Pilot Subjects at Six-Month Follow-Up

Archives of Clinical Neuropsychology ◽

10.1093/arclin/acab062.154 ◽

2021 ◽

Vol 36 (6) ◽

pp. 1187-1188

Author(s):

Jason A Blake ◽

Brandon Mitchell ◽

Staci McKay ◽

Gitendra Uswatte ◽

Edward Taub

Keyword(s):

Cognitive Training ◽

Real World ◽

Cognitive Task ◽

Case Series ◽

Performance Measure ◽

The Real ◽

Cognitive Activities ◽

The Mean ◽

Laboratory Measures

Abstract Objective Currently, the majority of cognitive training research measures treatment efficacy using in-laboratory measures, with minimal focus on real-world treatment changes. This case series demonstrates the feasibility of transferring cognitive improvements from the laboratory into the everyday life setting. Method This case series includes 6 chronic post-stroke participants; mild to moderate cognitive impairment. The intervention combines cognitive training with behavioral techniques, known as the Transfer Package (TP). The TP involves components that target functionality on IADLs in the real-world. Performance on cognitively-based IADLs in the real world are measured pre-treatment, post, and 6-month follow-up. Measures of real-world ability are the: Canadian Occupational Performance Measure (COPM), Cognitive Task Activity Log (CTAL) and Inventory of Improved and New Abilities (INCA). In-laboratory measures included the D-KEFS and Timed IADL assessments. Results The real-world outcome measures used in this study were the COPM and two measures developed for this study, the CTAL and INCA. The mean change from pre to post on the COPM Performance Scale was 2.18 (SD = 1.33) and the mean change on the COPM Satisfaction Scale was 2.70 (SD = 1.27). The mean change on the CTAL was 1.96 (SD = 0.93). On the INCA, the mean number of improved real-world cognitive activities was 11.8 (SD = 4.9) and the mean number of new cognitive activities was 7.6 (SD = 3.9). Follow-up reported near-perfect retention on CTAL and continued improvement on the INCA. There were minimal changes on in-laboratory measures. Conclusions This case series provides a framework for achieving the transfer of cognitive training treatment effects in the real-world life situation by overcoming behavioral barriers to functioning.

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Reduced Clinical Efficacy of Pazufloxacin against Gonorrhea Due to High Prevalence of Quinolone-Resistant Isolates with the GyrA Mutation

Antimicrobial Agents and Chemotherapy ◽

10.1128/aac.42.3.579 ◽

1998 ◽

Vol 42 (3) ◽

pp. 579-582 ◽

Cited By ~ 16

Author(s):

Masatoshi Tanaka ◽

Tetsuro Matsumoto ◽

Misao Sakumoto ◽

Koichi Takahashi ◽

Takeshi Saika ◽

...

Keyword(s):

Susceptibility Testing ◽

Oral Dosage ◽

Antibiotic Susceptibility Testing ◽

Wild Type ◽

Gonococcal Urethritis ◽

Negative Culture ◽

High Prevalence ◽

The Mean ◽

Gyra Mutation

ABSTRACT Forty-two men with gonococcal urethritis were treated with an oral dosage of 200 mg of pazufloxacin, a new fluoroquinolone, three times daily for 3 days. Only 28 of the 42 men (66.7%) had negative culture results for Neisseria gonorrhoeae during follow-up. Of the 42 isolates, 41 could be recultured for antibiotic susceptibility testing and DNA sequencing. In 26 of the 41 isolates (63.4%), GyrA mutations with or without ParC mutations were identified. Among the 26 isolates, 23 contained a single GyrA mutation, 1 contained two GyrA mutations, and 2 contained three mutations including double GyrA and single ParC mutations. A single Ser-91-to-Phe mutation, which was detected in 14 of the 26 isolates, was the most common GyrA mutation, followed by an Ala-75 to Ser mutation and an Asp-95 to Asn or Gly mutation in GyrA. All three isolates with two or three mutations contained the Ser-91-to-Phe GyrA mutation. Eleven of the 14 isolates with the single Ser-91-to-Phe mutation within GyrA and all 3 isolates with two or three mutations persisted after pazufloxacin treatment. On the other hand, all 15 wild-type and 9 mutant isolates with a substitution at codon Ala-75 or Asp-95 were eradicated. The mean MIC of pazufloxacin for mutants with the single Ser-91-to-Phe mutation in GyrA was 66-fold higher than that for the wild type. The results obtained in this study suggest that a high prevalence of fluoroquinolone-resistant gonococcal isolates with the Ser-91-to-Phe mutation in GyrA reduced the efficacy of pazufloxacin as treatment for gonococcal urethritis.

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Real-World Results of Aflibercept versus Ranibizumab for the Treatment of Exudative AMD Using a Fixed Regimen

BioMed Research International ◽

10.1155/2018/9276580 ◽

2018 ◽

Vol 2018 ◽

pp. 1-7 ◽

Cited By ~ 2

Author(s):

Joana Providência ◽

Tiago M. Rodrigues ◽

Mariana Oliveira ◽

João Bernardes ◽

João Pedro Marques ◽

...

Keyword(s):

Real World ◽

Age Related Macular Degeneration ◽

Treatment Protocols ◽

Corrected Visual Acuity ◽

Age Related ◽

Significant Difference ◽

Clinical Practice Setting ◽

The Mean ◽

Endothelial Growth Factors

Intravitreal injections of antivascular endothelial growth factors have been considered a milestone in the treatment of neovascular age-related macular degeneration (nAMD). However, the increasing incidence of AMD and the burden of visits and injections overcharge both the patient and the healthcare systems. Real-world solutions depend on treatment protocols aimed at optimizing the number of clinical visits while guaranteeing good functional outcomes. We performed a retrospective analysis of 72 eyes from 63 naïve patients diagnosed with nAMD that underwent a fixed intravitreal protocol consisting of bimonthly injections after a three-month loading dose, with either Aflibercept or Ranibizumab (no predefined criteria for treatment selection). Best corrected visual acuity (BCVA) and optical coherence tomography were analyzed at baseline and during follow-up clinical visits (months 3, 6, 12, and 18). From the included participants, 42 followed a fixed regimen with Aflibercept and 30 with Ranibizumab. At the 12-month visit, there was not a statistically significant difference in the mean change of BCVA between the two groups (p=0.121); however, the mean difference in the central retinal thickness was significantly superior in the Aflibercept group (-142.2 versus -51.5, p=0.011). The described fixed regimen seems to be efficient in the treatment of nAMD in a clinical practice setting.

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Vasculitis Associated with Large Granular Lymphocytes Leukemia

Blood ◽

10.1182/blood.v120.21.5109.5109 ◽

2012 ◽

Vol 120 (21) ◽

pp. 5109-5109

Author(s):

Alexandra Audemard ◽

Thierry Lamy ◽

Benoit Bareau ◽

Felipe Suarez ◽

Margaret Macro ◽

...

Keyword(s):

Nk Cell ◽

Conflicts Of Interest ◽

Remission Rate ◽

Acute Infection ◽

Response To Therapy ◽

Laboratory Findings ◽

Peripheral Neuritis ◽

The Mean ◽

Lgl Leukemia

Abstract Abstract 5109 Background: Large granular leukemia (LGL) leukemia is derived from either T-cell or NK-cell lineages. Clinical presentation of LGL leukemia is dominated by recurrent infections associated with neutropenia, anemia, splenomegaly and auto-immune diseases. The association of vasculitis and LGL leukemia has been rarely reported and investigated. Objective: To improve knowledge about this association, we retrospectively describe the clinical and biological characteristics of patients, their response to therapy and their prognosis. Methods: We performed a retrospective study based on 229 patients included in the French national LGL proliferation registry and a national mailing survey to 1350 internists in order to collect medical characteristics of patients displaying both vasculitis and LGL leukemia. We retrospectively collected medical charts from 11 patients between September 1999 and February 2012. Medical history, hematologic laboratory tests and response to therapy were compiled at first presentation of LGL leukemia associated vasculitis (LAV) and at each visit. Results: At the time of diagnosis of LGL leukemia the mean age was 60. 3 years (range, 28–74 years). They were 9 women and two men. The mean of follow up was 45 months (range, 1–108). The main LGL lineage was T-LGL (10 patients, 91%) and only one NK-LGL was identified. Hematological laboratory findings revealed that 5 patients (45%) patients presented hyperlymphocytosis. The mean absolute circulating LGL count for the series was 1. 10 9/L (range, 0. 45–4. 59 x. 10 9/L). Three patient (27%) had neutropenia (<1. 5 x. 109/L), no one had thrombocytopenia. Anemia was detected in 4 patients (36%). The most frequently observed vasculitis was cryoglobulinemia (n=5). Three patients presented cutaneous vasculitis. Two patients had ANCA negative microscopic polyangiitis and one patient presented giant cell arteritis. Clinical features were dominated by skin localization e. g. purpura (91%), arthralgia (37%), peripheral neuritis (27%) and renal glomerulonephritis (18%). Leucocytoclastic vasculitis was histologically demonstrated in 6 cases. Ten vasculitis were treated: the most delivered treatment was the association of cyclophosphamide-corticosteroid (n=3), followed to methotrexate–corticoisteroid (n=2), chlorambucil-corticosteroid (n=2) and corticosteroid alone (n=2). One patient received azathioprine and corticosteroid. The complete remission rate was high 80% and a minority of them presented vasculitis relapse (27%). Three patients (27%) died: one related to LGL leukemia (acute infection) and the 2 others related to heart failure due to vasculitis. Conclusion: Association of LGL leukemia and vasculitis is rare but not fortuitous. Based on this retrospective analysis, it seems that LAV preferentially affect female patients, with a low LGL count. LAV present with frequent cutaneous involvement and have a good response to therapy. Pathophysiological link between LGL leukemia and vasculitis remains to be investigated. Disclosures: No relevant conflicts of interest to declare.

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Effectiveness of An Impedance Cardiography Guided Treatment Strategy to Improve Blood Pressure Control in A Real-World Setting: Results from A Pilot Pragmatic Clinical Trial

10.1101/2021.04.09.21255233 ◽

2021 ◽

Author(s):

Luyan Wang ◽

Yuan Lu ◽

Hongyi Wang ◽

Jianlei Gu ◽

Zheng J. Ma ◽

...

Keyword(s):

Blood Pressure ◽

Real World ◽

Treatment Strategy ◽

Standard Care ◽

Impedance Cardiography ◽

Care Group ◽

Standard Care Group ◽

Peking University ◽

The Mean

ABSTRACTBackgroundHypertension is a hemodynamic-related disorder characterized by abnormalities of the cardiac output (CO) and/or systemic vascular resistance (SVR). We hypothesized that selecting antihypertensive therapy based on patients’ hemodynamic profile could improve blood pressure (BP) control more effectively than standard care in hypertensive patients in real-world clinical practice.MethodsWe conducted a pilot single-center, pragmatic randomized trial involving adults with uncontrolled hypertension who sought outpatient care at a hypertension clinic of the Peking University People’s Hospital, the largest teaching hospital of Peking University, in Beijing China, between December 2018 and December 2019. Participants were randomly assigned to the standard care group or the hemodynamic group in a 1:1 ratio. Impedance cardiography (ICG) was performed with all participants to measure hemodynamic parameters. Only physicians in the hemodynamic group were provided with patients’ ICG findings and a computerized clinical decision support of recommended treatment choices based on patients’ hemodynamic profiles. The primary outcomes were the changes in systolic BP (SBP) and diastolic BP (DBP) levels at the follow-up visit 4-12 weeks after baseline. Secondary outcomes included achievement of BP goal of <140/ 90 mmHg and the changes in BP by baseline BP, age, sex, and BMI.ResultsA total 102 adults (mean age was 54±14 years; 41% were women) completed the study. The mean baseline SBP was 150.9 (±11.5) mmHg and mean baseline DBP was 91.1 (±11.3) mmHg. At the follow-up visit, the mean SBP and DBP decreased by 19.9 and 11.3 mmHg in the hemodynamic group, as compared with 12.0 and 4.9 mmHg in the standard care group (P value for difference between groups <0.001 for both SBP and DBP). The proportion of patients achieving BP goal of <140/ 90 mmHg in the hemodynamic group was 67%, as compared with 41% in the standard care group (P=0.017). The hemodynamic group had a larger effect on BP reduction consistently across subgroups by age, sex, BMI, and baseline BP.ConclusionsAn ICG-guided treatment strategy led to greater reductions in BP levels than were observed with standard care in a real-world population of outpatients with hypertension. There is a need for further validation of this strategy for improving blood pressure treatment selection. (Funded by internal research grant from the Peking University People’s Hospital; ClinicalTrials.gov number: NCT04715698.)

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Regression to the mean contributes to the apparent improvement in glycemia 3.8 years after screening – the ELSA-Brasil Study

10.2337/figshare.13087271.v1 ◽

2020 ◽

Author(s):

Maria Inês Schmidt ◽

Paula Bracco ◽

Scheine Canhada ◽

Joanna MN Guimarães ◽

Sandhi Maria Barreto ◽

...

Keyword(s):

Weight Loss ◽

Real World ◽

Complete Regression ◽

Regression To The Mean ◽

Free Living ◽

Before And After ◽

Baseline Values ◽

The Mean ◽

Design And Methods

Objective Glycemic regression is common in real world settings, but the contribution of regression to the mean (RTM) has been little investigated. We aimed to estimate glycemic regression before and after adjusting for RTM in a free-living cohort of adults with newly ascertained diabetes and intermediate hyperglycemia (IH). Research Design and Methods ELSA-Brasil is a cohort study of 15,105 adults screened between 2008-2010 with standardized OGTT and HbA1c, repeated after 3.84 (0.42) years. After excluding those receiving medical treatment for diabetes, we calculated partial or complete regression before and after adjusting baseline values for RTM. Results Regarding newly ascertained diabetes, partial or complete regression was seen in 49.4% (95%CI 45.2 – 53.7); after adjustment for RTM, in 20.2% (95%CI 12.1 – 28.3). Regarding IH, regression to normal levels was seen in 39.5% (95%CI 37.9 – 41.3) or in 23.7% (95%CI 22.6% – 24.3%) depending on the WHO or the ADA definition, respectively; after adjustment, corresponding frequencies were 26.1% (95%CI 22.4 – 28.1) and 19.4% (95%CI 18.4 – 20.5). Adjustment for RTM reduced the number of cases detected at screening: 526 to 94 cases of diabetes; 3118 to 1986 cases of WHO-defined IH; and 6182 to 5711 cases of AD-defined IH. Weight loss ≥2.6% was associated with greater regression from diabetes (RR=1.52 95%CI 1.26-1.84) and IH (RR=1.30 95%CI 1.17-1.45). Conclusions In this quasi-real-world setting, regression from diabetes at ~4 years was common, less so for IH. Regression was frequently explained by RTM, but, in part, also related to improved weight loss and homeostasis over the follow-up.

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