Spot Urine Sodium-to-Potassium Ratio Is a Predictor of Stroke

Background and Purpose— Dietary sodium reduction with concurrent increase in potassium intake is a current public health priority to reduce risk of cardiovascular events. This study explored associations between the spot urine sodium-to-potassium ratio and cardiovascular events in the MESA (Multi-Ethnic Study of Atherosclerosis) longitudinal cohort. Methods— The MESA is a prospective cohort study of 6814 adults from 4 ethnic groups (European-, Asian-, African- and Hispanic-American) with a mean age of 62 (±10.2) years and an average of 11.7 (±2.2) years of follow-up. Participants were free of clinical cardiovascular disease at baseline. Spot urine sodium and potassium excretion, as a marker of dietary intake, was collected at baseline. The impact of urinary sodium-to-potassium ratio on adjudicated cardiovascular events was assessed using Cox proportional hazards models. Results— Only 39% of MESA participants had a urinary sodium-to-potassium ratio ≤1, and these participants experienced only 74 of the 236 strokes. A sodium-to-potassium ratio >1 was associated with a hazard ratio of 1.47 (95% CI,1.07–2.00) for risk of stroke, adjusting for age, sex, race, cardiovascular risk factors, socio-demographic characteristics, body size, and kidney function. Conclusions— The spot urine sodium-to-potassium ratio (measurable in routine care) is associated with stroke. A urine sodium-to-potassium ratio of ≤1, may be related to a clinically relevant reduction in stroke risk and is a feasible target for health interventions.

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Added value of cardiovascular calcifications for prediction of recurrent cardiovascular events and cardiovascular interventions in patients with established cardiovascular disease

The International Journal of Cardiovascular Imaging ◽

10.1007/s10554-021-02164-9 ◽

2021 ◽

Author(s):

Cilie C. van ’t Klooster ◽

◽

Yolanda van der Graaf ◽

Hendrik M. Nathoe ◽

Michiel L. Bots ◽

...

Keyword(s):

Cardiovascular Disease ◽

Heart Valve ◽

Cardiovascular Events ◽

Proportional Hazards ◽

Cox Proportional Hazards ◽

Added Value ◽

Cvd Risk ◽

Major Cardiovascular Events ◽

Cox Proportional Hazards Models ◽

Cardiovascular Interventions

AbstractThe purpose is to investigate the added prognostic value of coronary artery calcium (CAC), thoracic aortic calcium (TAC), and heart valve calcium scores for prediction of a combined endpoint of recurrent major cardiovascular events and cardiovascular interventions (MACE +) in patients with established cardiovascular disease (CVD). In total, 567 patients with established CVD enrolled in a substudy of the UCC-SMART cohort, entailing cardiovascular CT imaging and calcium scoring, were studied. Five Cox proportional hazards models for prediction of 4-year risk of MACE + were developed; traditional CVD risk predictors only (model I), with addition of CAC (model II), TAC (model III), heart valve calcium (model IV), and all calcium scores (model V). Bootstrapping was performed to account for optimism. During a median follow-up of 3.43 years (IQR 2.28–4.74) 77 events occurred (MACE+). Calibration of predicted versus observed 4-year risk for model I without calcium scores was good, and the c-statistic was 0.65 (95%CI 0.59–0.72). Calibration for models II–V was similar to model I, and c-statistics were 0.67, 0.65, 0.65, and 0.68 for model II, III, IV, and V, respectively. NRIs showed improvement in risk classification by model II (NRI 15.24% (95%CI 0.59–29.39)) and model V (NRI 20.00% (95%CI 5.59–34.92)), but no improvement for models III and IV. In patients with established CVD, addition of the CAC score improved performance of a risk prediction model with classical risk factors for the prediction of the combined endpoint MACE+ . Addition of the TAC or heart valve score did not improve risk predictions.

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Failure to reach uric acid target of <0.36 mmol/L in hyperuricaemia of gout is associated with elevated total and cardiovascular mortality

RMD Open ◽

10.1136/rmdopen-2019-001015 ◽

2019 ◽

Vol 5 (2) ◽

pp. e001015 ◽

Cited By ~ 10

Author(s):

Fernando Pérez Ruiz ◽

Pascal Richette ◽

Austin G Stack ◽

Ravichandra Karra Gurunath ◽

Ma Jesus García de Yébenes ◽

...

Keyword(s):

Uric Acid ◽

Proportional Hazards ◽

Cox Proportional Hazards ◽

First Year ◽

Cox Proportional Hazards Models ◽

Crude Mortality ◽

Risk Patients ◽

The Impact ◽

Related Mortality

ObjectiveTo determine the impact of achieving serum uric acid (sUA) of <0.36 mmol/L on overall and cardiovascular (CV) mortality in patients with gout.MethodsProspective cohort of patients with gout recruited from 1992 to 2017. Exposure was defined as the average sUA recorded during the first year of follow-up, dichotomised as ≤ or >0.36 mmol/L. Bivariate and multivariate Cox proportional hazards models were used to determine mortality risks, expressed HRs and 95% CIs.ResultsOf 1193 patients, 92% were men with a mean age of 60 years, 6.8 years’ disease duration, an average of three to four flares in the previous year, a mean sUA of 9.1 mg/dL at baseline and a mean follow-up 48 months; and 158 died. Crude mortality rates were significantly higher for an sUA of ≥0.36 mmol/L, 80.9 per 1000 patient-years (95% CI 59.4 to 110.3), than for an sUA of <0.36 mmol/L, 25.7 per 1000 patient-years (95% CI 21.3 to 30.9). After adjustment for age, sex, CV risk factors, previous CV events, observation period and baseline sUA concentration, an sUA of ≥0.36 mmol/L was associated with elevated overall mortality (HR=2.33, 95% CI 1.60 to 3.41) and CV mortality (HR=2.05, 95% CI 1.21 to 3.45).ConclusionsFailure to reach a target sUA level of 0.36 mmol/L in patients with hyperuricaemia of gout is an independent predictor of overall and CV-related mortality. Targeting sUA levels of <0.36 mmol/L should be a principal goal in these high-risk patients in order to reduce CV events and to extend patient survival.

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Current treatments, determinants of use, and survival for patients with hepatoma in the United States from 1998–2002

Journal of Clinical Oncology ◽

10.1200/jco.2006.24.18_suppl.4138 ◽

2006 ◽

Vol 24 (18_suppl) ◽

pp. 4138-4138

Author(s):

A. B. Siegel ◽

R. McBride ◽

D. Hershman ◽

R. S. Brown ◽

J. Emond ◽

...

Keyword(s):

Tumor Size ◽

Proportional Hazards ◽

Case Series ◽

Tumor Grade ◽

The United States ◽

Cox Proportional Hazards ◽

Data Set ◽

Cox Proportional Hazards Models ◽

Highly Correlated ◽

The Impact

4138 Background: Multiple case series have described the use of current therapies for hepatocellular carcinoma (HCC), but recent estimates of treatment utilization in the general population and the impact of various treatments on survival are not known. Methods: We first identified 2898 adults diagnosed with HCC with known tumor size and stage in the Surveillance, Epidemiology, and End-Results Program (SEER), from 1998–2002. Treatment was categorized as transplant, resection, ablation, or none of these. We created a second data set of 1856 HCC patients who were potentially operable, as defined by SEER. We used these patients to construct Kaplan-Meier survival curves and adjusted Cox proportional hazards models. Results: The median age of the larger cohort at HCC diagnosis was 62 (range:18–96). Approximately 42% were white, 32% Asian, 16% Hispanic, and 10% African American. Overall, 10% received a transplant, 18% resection, 8% ablation, and 65% none of these. Only 5% of African Americans with HCC received a transplant, versus 12% of whites, 10% of Hispanics, and 8% of Asians. Asians were most likely to receive resection (24%) and ablation (9%), and least likely to have non-surgical treatment (60%). Using the restricted cohort, improved survival in the multivariate analysis was seen with later year of diagnosis, younger age, female sex, Asian race, smaller tumor size, lower tumor grade, and localized disease. Treatment was highly correlated with survival. This was greatest in the transplanted group (1, 3, and 5-year survivals 93%, 79%, and 71%), followed by resection (70%, 45%, and 29%), and ablation (71%, 33%, and 18%). The non-surgical group had poor survival (33%, 9%, and 0%). Conclusions: Transplantation yields excellent survival on a population scale, similar to reported series, and resection gives relatively good outcomes as well. Asians are more likely to be resected and ablated than other groups. They also had better survival than other groups, perhaps due to underlying etiology of HCC (hepatitis B) and better preserved liver function. No significant financial relationships to disclose.

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The impact of sorafenib on the treatment and survival of advanced hepatocellular carcinoma (HCC): Analysis of the National Cancer Database (NCDB) from 2004 to 2014.

Journal of Clinical Oncology ◽

10.1200/jco.2019.37.15_suppl.e15682 ◽

2019 ◽

Vol 37 (15_suppl) ◽

pp. e15682-e15682

Author(s):

Aman Opneja ◽

Gino Cioffi ◽

Asrar Alahmadi ◽

Nirav Patil ◽

David Lawrence Bajor ◽

...

Keyword(s):

Proportional Hazards ◽

Single Agent ◽

Cox Proportional Hazards ◽

P Value ◽

Advanced Hepatocellular Carcinoma ◽

Advanced Hcc ◽

Cox Proportional Hazards Models ◽

Before And After ◽

Time Frames ◽

The Impact

e15682 Background: HCC is a common cause of mortality in the U.S. among men and women (5thand 7th, respectively) with overall five-year survival of ~18%. Sorafenib was the only FDA approved therapy for advanced HCC from 2007 until 2018. This study analyzes trends in the treatment and survival of advanced HCC before and after sorafenib approval. Methods: Adult patients ( > 18 years) with diagnosis of HCC treated with only chemotherapy from 2004 – 2014 were identified in NCDB database. Comparisons were made between 3 time frames: 2004 – 2007 (pre-sorafenib), 2008 – 2011 (early sorafenib) and 2012 – 2014 (late sorafenib). Patients treated with single or multi-agent chemotherapy were analyzed. Cox proportional hazards models were used for univariate and multivariable analyses. Kaplan-Meier method was used for survival analysis. Results: The NCDB contained 33,136 patients with HCC diagnosed between 2004 – 2014 and treated with chemotherapy alone. Patients were generally men (77.4%), over the age of 50 years (92.4%), with an elevated AFP at diagnosis (64.4%), and had limited co-morbidities (76.0%, Charlson/Deyo score of 0-1). The T-stages were T1 (26.3%), T2 (20.5%), T3 (25.6%), and T4 (16.2%). The number and proportion of patients treated with single agent chemotherapy increased significantly during the study period: 2,733 (45.3%) pre-sorafenib, 9,723 (72.7%) early sorafenib, and 13,502 (86.1%) late sorafenib. The proportion of all HCC patients in the NCDB receiving only chemotherapy increased from 17.2% to 26.4% to 28.3% across the 3 time frames. The survival of patients with advanced HCC treated only with chemotherapy improved significantly in the early and late sorafenib cohorts compared to the pre-sorafenib cohort (10.3 months (95% CI: 9.8-10.6) vs. 12.3 months (12.0-12.7) vs. 15.5 months (15.1-15.9), p-value < 0.001). Age > 70 years, male sex, higher Charlson/Deyo score ( > 1), elevated AFP at diagnosis, and higher T-stage were associated with worse survival (p value < 0.001). Conclusions: The approval of sorafenib has dramatically increased the use of chemotherapy for the treatment of advanced HCC and has resulted in a significant survival advantage.

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Clinical Outcomes of Patients with Combined Idiopathic Pulmonary Fibrosis and Emphysema in the IPF-PRO Registry

Lung ◽

10.1007/s00408-021-00506-x ◽

2022 ◽

Author(s):

Hyun J. Kim ◽

Laurie D. Snyder ◽

Megan L. Neely ◽

Anne S. Hellkamp ◽

David L. Hotchkin ◽

...

Keyword(s):

Idiopathic Pulmonary Fibrosis ◽

Pulmonary Fibrosis ◽

Clinical Outcomes ◽

Proportional Hazards ◽

Cox Proportional Hazards ◽

Cox Proportional Hazards Models ◽

Baseline Variable ◽

Former Smokers ◽

The Impact ◽

Baseline Covariates

Abstract Purpose To assess the impact of concomitant emphysema on outcomes in patients with idiopathic pulmonary fibrosis (IPF). Methods The IPF-PRO Registry is a US registry of patients with IPF. The presence of combined pulmonary fibrosis and emphysema (CPFE) at enrollment was determined by investigators’ review of an HRCT scan. Associations between emphysema and clinical outcomes were analyzed using Cox proportional hazards models. Results Of 934 patients, 119 (12.7%) had CPFE. Compared with patients with IPF alone, patients with CPFE were older (median 72 vs 70 years); higher proportions were current/former smokers (88.2% vs 63.7%), used oxygen with activity (49.6% vs 31.9%) or at rest (30.8% vs 18.4%), had congestive heart failure (13.6% vs 4.8%) and had prior respiratory hospitalization (25.0% vs 16.7%); they had higher FVC (median 71.8 vs 69.4% predicted) and lower DLco (median 35.3 vs 43.6% predicted). In patients with CPFE and IPF alone, respectively, at 1 year, rates of death or lung transplant were 17.5% (95% CI: 11.7, 25.8) and 11.2% (9.2, 13.6) and rates of hospitalization were 21.6% (14.6, 29.6) and 20.6% (17.9, 23.5). There were no significant associations between emphysema and any outcome after adjustment for baseline variables. No baseline variable predicted outcomes better in IPF alone than in CPFE. Conclusion Approximately 13% of patients in the IPF-PRO Registry had CPFE. Physiologic characteristics and comorbidities of patients with CPFE differed from those of patients with IPF alone, but the presence of emphysema did not drive outcomes after adjustment for baseline covariates. Trial registration ClinicalTrials.gov, NCT01915511; registered August 5, 2013.

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Heparin-induced antibodies and cardiovascular risk in patients on dialysis

Thrombosis and Haemostasis ◽

10.1160/th08-03-0144 ◽

2008 ◽

Vol 100 (09) ◽

pp. 498-504 ◽

Cited By ~ 10

Author(s):

Jodi B. Segal ◽

Laura C. Plantinga ◽

Nancy E. Fink ◽

Jonathan S. Kerman ◽

Thomas S. Kickler ◽

...

Keyword(s):

Venous Thromboembolism ◽

Clinical Outcomes ◽

Vascular Access ◽

Cardiovascular Events ◽

Proportional Hazards ◽

Cox Proportional Hazards ◽

Adverse Outcomes ◽

Dialysis Patients ◽

Cox Proportional Hazards Models ◽

Stage Renal Disease

SummaryThe clinical relevance of heparin-induced antibodies (HIA) in the absence of thrombocytopenia remains to be defined. The aims of this study were (i) to determine the prevalence of HIA in patients treated by dialysis, (ii) to determine the prevalence of thrombocytopenia and heparin-induced thrombocytopenia (HIT), and (iii) to test whether HIA are associated with adverse outcomes. Sera from 740 patients treated by hemodialysis (HD, n=596) and peritoneal dialysis (PD, n=144) were tested for HIA (IgG, IgA or IgM) by masked investigators at approximately six months after enrolment in the Choices for Healthy Outcomes in Caring for End-Stage Renal Disease (CHOICE) study. We assessed, with time-to-event Cox proportional hazards models, whether the presence of HIA predicted any of four clinical outcomes: arterial cardiovascular events, venous thromboembolism, vascular access occlusion and mortality. HIA prevalence was 10.3% overall. HIA positivity did not predict development of thrombocytopenia or any of the four clinical outcomes over a mean follow-up of 3.6 years, with hazard ratios for arterial cardiovascular events of 0.98 (95% confidence interval 0.70–1.37), venous thromboembolism 1.39 (0.17–11.5), vascular access occlusion 0.82 (0.40–1.71), and mortality 1.18 (0.85–1.64). Chronic intermittent heparin exposure was associated with a high seroprevalence of HIA. In dialysis patients these antibodies were not an independent risk factor for cardiovascular events and mortality. Our data do not suggest that dialysis patients should be monitored for HIA antibodies in the absence of thrombocytopenia.

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Impact of anxiety and depression on progression to glaucoma among glaucoma suspects

British Journal of Ophthalmology ◽

10.1136/bjophthalmol-2020-316617 ◽

2020 ◽

pp. bjophthalmol-2020-316617

Author(s):

Samuel Berchuck ◽

Alessandro Jammal ◽

Sayan Mukherjee ◽

Tamara Somers ◽

Felipe A Medeiros

Keyword(s):

Proportional Hazards ◽

Cox Proportional Hazards ◽

Anxiety And Depression ◽

Pressure Measurements ◽

Health Records ◽

Cox Proportional Hazards Models ◽

History Of ◽

The Impact ◽

Over Time

AimsTo assess the impact of anxiety and depression in the risk of converting to glaucoma in a cohort of glaucoma suspects followed over time.MethodsThe study included a retrospective cohort of subjects with diagnosis of glaucoma suspect at baseline, extracted from the Duke Glaucoma Registry. The presence of anxiety and depression was defined based on electronic health records billing codes, medical history and problem list. Univariable and multivariable Cox proportional hazards models were used to obtain HRs for the risk of converting to glaucoma over time. Multivariable models were adjusted for age, gender, race, intraocular pressure measurements over time and disease severity at baseline.ResultsA total of 3259 glaucoma suspects followed for an average of 3.60 (2.05) years were included in our cohort, of which 911 (28%) were diagnosed with glaucoma during follow-up. Prevalence of anxiety and depression were 32% and 33%, respectively. Diagnoses of anxiety, or concomitant anxiety and depression were significantly associated with risk of converting to glaucoma over time, with adjusted HRs (95% CI) of 1.16 (1.01, 1.33) and 1.27 (1.07, 1.50), respectively.ConclusionA history of anxiety or both anxiety and depression in glaucoma suspects was associated with developing glaucoma during follow-up.

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Differences in survival for metastatic colorectal cancer patients by lines of therapy received.

Journal of Clinical Oncology ◽

10.1200/jco.2012.30.15_suppl.e14016 ◽

2012 ◽

Vol 30 (15_suppl) ◽

pp. e14016-e14016

Author(s):

Brian S. Seal ◽

Benjamin Chastek ◽

Mahesh Kulakodlu ◽

Satish Valluri

Keyword(s):

Proportional Hazards ◽

Survival Rates ◽

Patient Characteristics ◽

Cox Proportional Hazards ◽

Research Database ◽

First Line ◽

Cox Proportional Hazards Models ◽

Stage 4 ◽

Similar Survival ◽

The Impact

e14016 Background: Improvements in survival for advanced-stage CRC patients who receive chemotherapy have been reported. We compared survival rates for patients with 3+ vs. <3 lines of therapy. Methods: Adult patients with a diagnosis of CRC between 01/01/05 and 05/31/10 were identified from the Impact Intelligence Oncology Management (IIOM) registry. Patients with either stage 4 CRC at original diagnosis or development of metastasis were included. Registry data included original stage and date of diagnosis. Linked healthcare claims from the Life Sciences Research Database, a large US health insurance database affiliated with OptumInsight, were used to identify lines of therapy after metastases and patient characteristics. Death data were obtained from the Social Security Administration’s master death file. Patients were categorized by number of lines of therapy received (0, 1, 2, 3+) and original stage at diagnosis (0-2, 3, 4, unknown). Survival following metastases was evaluated using Cox proportional hazards models controlling for lines of therapy received, stage, and other patient characteristics. Results: 598 patients, followed for a mean of 653 days after becoming metastatic, were included. Mean unadjusted length of follow-up was lowest among patients who received no chemotherapy (516 days) or only 1 line (511 days), and increased to 627 days for those with 2 lines and 930 days for those with 3+ lines. However, multivariate analysis indicated that patients with 3+ lines had comparable survival vs. those with 0 (HR=0.79), 1 (HR=1.59), or 2 (HR=1.15) lines of therapy (p>0.05 for all comparisons). Compared to patients who presented with stage 4 CRC, those who progressed from stage 0-2 (HR=1.22), stage 3 (HR=0.83), or unknown stage (HR=1.18) had similar survival after metastases (p>0.05 for all comparisons). After excluding 94 patients who didn’t receive chemotherapy, patients treated with an oxaliplatin-based regimen (HR=1.28; p=0.24) in first line had similar survival compared to patients treated with an irinotecan-based or anti-EGFR regimen in first line. Conclusions: Lines of therapy received and initial stage were not associated with survival after development of metastases.

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Impact of radiotherapy duration on outcomes in patients with esophageal cancer treated with definitive concurrent radiotherapy and chemotherapy on RTOG trials 8501 and 9405.

Journal of Clinical Oncology ◽

10.1200/jco.2015.33.3_suppl.119 ◽

2015 ◽

Vol 33 (3_suppl) ◽

pp. 119-119

Author(s):

Christopher Leigh Hallemeier ◽

Jennifer Moughan ◽

Michael G. Haddock ◽

Arnold M. Herskovic ◽

Bruce D. Minsky ◽

...

Keyword(s):

Esophageal Cancer ◽

Proportional Hazards ◽

Negative Impact ◽

Standard Dose ◽

Cox Proportional Hazards ◽

High Dose ◽

Risk Of Death ◽

Kaplan Meier ◽

Cox Proportional Hazards Models ◽

The Impact

119 Background: Radiotherapy (RT) interruptions have a negative impact on outcomes in many epithelial malignancies treated with definitive RT. The purpose of this study was to analyze the impact of RT duration on outcomes in patients (pts) with esophageal cancer treated with definitive chemoradiotherapy (CRT). Methods: Pts treated with definitive CRT on RTOG trials 8501 and 9405 were included. Separate analyses were performed in pts receiving standard dose (SD-CRT; 50 Gy + 5FU + cisplatin) and high dose (HD-CRT; 64.8 Gy + 5FU + cisplatin) CRT. Local (LF) and regional (RF) failure were estimated by the cumulative incidence method. Disease-free (DFS) and overall (OS) survival were estimated by the Kaplan-Meier method. Univariate (UVA) and multivariate (MVA) Cox proportional hazards models were utilized to examine for correlation between RT duration (< vs. ≥ median) with LF, RF, DFS and OS. Results: In the SD-CRT cohort (n=235), 96 pts (41%) had ≥ 1 RT interruption for a median of 3 (IQR 1-6) days. The median RT duration was 39 (IQR 37-43) days. In UVA and MVA, RT duration was not associated with LF, RF, DFS, or OS. Estimated outcome rates are in the table. In the HD-CRT cohort (n=107), 64 pts (60%) had ≥ 1 RT interruption for a median of 3.5 (IQR 2-7.5) days. The median RT duration was 52 (IQR 50-57) days. In UVA, RT duration ≥ 52 days was associated with a 33% reduction in risk of DFS failure (HR=0.66, 95% CI [0.44-0.98], p=0.039) and a 29% reduction in risk of death (HR=0.71, 95% CI [0.48-1.06], p=0.09). When excluding the 25 pts with RT dose < 64.8 Gy, RT duration was not associated with DFS or OS. Conclusions: In pts with esophageal cancer receiving definitive SD-CRT, an association between RT duration and outcomes was not observed. In pts receiving HD-CRT, longer RT duration was associated with improved DFS, which may have been due to a significant number of deaths at RT dose < 64.8 Gy. Supported by NCI U10 grants CA21661, CA180868, CA180822, CA37422. Clinical trial information: NCT00002631. [Table: see text]

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Efficacy of apalutamide (APA) plus ongoing androgen deprivation therapy (ADT) in patients (pts) with nonmetastatic castration-resistant prostate cancer (nmCRPC) and baseline (BL) comorbidities (CM).

Journal of Clinical Oncology ◽

10.1200/jco.2019.37.15_suppl.5023 ◽

2019 ◽

Vol 37 (15_suppl) ◽

pp. 5023-5023 ◽

Cited By ~ 3

Author(s):

Eric Jay Small ◽

Fred Saad ◽

Simon Chowdhury ◽

Stephane Oudard ◽

Boris A. Hadaschik ◽

...

Keyword(s):

Proportional Hazards ◽

Progression Free Survival ◽

Cox Proportional Hazards ◽

Castration Resistant Prostate Cancer ◽

Free Survival ◽

Proportional Hazards Models ◽

Castration Resistant ◽

Cox Proportional Hazards Models ◽

The Impact ◽

Clinical Trial Information

5023 Background: The addition of APA to ongoing ADT in pts with nmCRPC significantly prolonged metastasis-free survival (MFS), time to symptomatic progression (SymProg), and second progression-free survival (PFS2) in SPARTAN. We assessed the impact of APA on these end points in pts with or without BL CM. Methods: Using Cox proportional hazards models, treatment effect of APA was evaluated in SPARTAN pts with CM at BL, stratifying by the presence of BL diabetes/hyperglycemia (D/H), cardiovascular disease (CVD), hypertension (HTN), and renal insufficiency (RI). Results: Of 1207 SPARTAN pts, 1062 (88%) had ≥ 1 BL CM, including 703/806 (87%) APA pts and 359/401 (90%) PBO pts. A total of 226 (19%), 398 (33%), 798 (66%), and 774 (64%) pts had D/H, CVD, HTN, and RI, respectively; 323 (27%), 412 (34%), 259 (21%), and 68 (6%) pts had 1, 2, 3, and 4 CM, respectively. Incidence of CM was balanced between arms. Pts with CM were older than pts with no CM (median age, 75 vs 69 yrs, APA; 74 vs 69 yrs, PBO). MFS, SymProg, and PFS2 benefit with APA was significant in all CM subgroups, except PFS2 for pts with D/H (Table) and regardless of the number of CM. The incidence of any treatment-emergent AE was balanced between pts with and without CM. AEs with APA were not affected by any CM. Clinical trial information: NCT01946204. Conclusions: The benefit of APA + ongoing ADT in pts with nmCRPC was maintained in pts with D/H, CVD, HTN, and RI. The safety profile of APA was not affected by any CM.[Table: see text]

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