Patients With MEN1 Are at an Increased Risk for Venous Thromboembolism

Abstract Background Multiple endocrine neoplasia type 1 (MEN1) is a rare inherited disorder predisposing the development of multiple functional and nonfunctional neuroendocrine tumors (NETs). Only uncommon MEN1-associated functional NETs such as glucagonomas (<1%) and adenocorticotropic hormone-producing tumors (<5%) are known to be associated with hypercoagulability. It is unknown if patients with MEN1 generally have an increased risk of venous thromboembolism (VTE). Methods We queried a prospective natural history study of germline mutation-positive MEN1 patients (n = 286) between 1991 and 2019 for all lifetime events of VTE. The search terms were: DVT, thromb, embol, PE, pulmonary embolism, clot, hematology consult, anticoagulant, coumadin, lovenox, xarelto, warfarin, aspirin, rivaroxaban, and apixaban. Incidence rates were calculated, accounting for age and sex. Comparisons were made to published incidence rates in healthy populations, different types of cancer, and Cushing’s syndrome. Results Thirty-six subjects (median age 45 years, range 16–75) experienced a VTE event, yielding a prevalence rate of 12.9%. The age–sex adjusted incidence rate of VTE is 9.11 per 1000 patient-years, with a sex-adjusted lifetime incidence rate of 2.81 per 1000 patient-years. MEN1-associated lifetime incidence rates are ~2-fold higher than the estimated annual incidence rate in the general population and are comparable to the known risk in the setting of various types of cancer. Approximately 80% of patients who had a VTE were diagnosed with pancreatic NETs, of which 24% were insulinomas. Fourteen patients (42%) experienced perioperative VTE events. Conclusions MEN1 patients have an increased risk of VTE. Further mechanistic investigation and validation from other MEN1 cohorts are needed to confirm the increased prevalence of VTE in MEN1.

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Emotional states and future risk of venous thromboembolism

Thrombosis and Haemostasis ◽

10.1160/th11-09-0667 ◽

2012 ◽

Vol 107 (03) ◽

pp. 485-493 ◽

Cited By ~ 13

Author(s):

Sigrid K. Brækkan ◽

Ida J. Hansen-Krone ◽

John-Bjarne Hansen ◽

Kristin F. Enga

Keyword(s):

Venous Thromboembolism ◽

Incidence Rate ◽

Population Based ◽

Emotional States ◽

Depressive Feelings ◽

Increased Risk ◽

Adjusted Incidence Rate ◽

Adjusted Incidence ◽

Reduced Risk

SummaryEmotional states of depression and loneliness are reported to be associated with higher risk and optimism with lower risk of arterial cardiovascular disease (CVD) and death. The relation between emotional states and risk of venous thromboembolism (VTE) has not been explored previously. We aimed to investigate the associations between self-reported emotional states and risk of incident VTE in a population-based, prospective study. The frequency of feeling depressed, lonely and happy/optimistic were registered by self-administered questionnaires, along with major co-morbidities and lifestyle habits, in 25,964 subjects aged 25–96 years, enrolled in the Tromsø Study in 1994–1995. Incident VTE-events were registered from the date of inclusion until September 1, 2007. There were 440 incident VTE-events during a median of 12.4 years of follow-up. Subjects who often felt depressed had 1.6-fold (95% CI:1.02–2.50) higher risk of VTE compared to those not depressed in analyses adjusted for other risk factors (age, sex , body mass index, oes-trogens), lifestyle (smoking, alcohol consumption, educational level) and co-morbidities (diabetes, CVD, and cancer). Often feeling lonely was not associated with VTE. However, the incidence rate of VTE in subjects who concurrently felt often lonely and depressed was higher than for depression alone (age-and sex-adjusted incidence rate: 3.27 vs. 2.21). Oppositely, subjects who often felt happy/optimistic had 40% reduced risk of VTE (HR 0.60, 95% CI: 0.41–0.87). Our findings suggest that self-reported emotional states are associated with risk of VTE. Depressive feelings were associated with increased risk, while happiness/ optimism was associated with reduced risk of VTE.

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Inflammatory Bowel Disease and Risk of Major Bleeding During Anticoagulation for Venous Thromboembolism

Inflammatory Bowel Diseases ◽

10.1093/ibd/izaa337 ◽

2021 ◽

Author(s):

Susanna Scharrer ◽

Christian Primas ◽

Sabine Eichinger ◽

Sebastian Tonko ◽

Maximilian Kutschera ◽

...

Keyword(s):

Ulcerative Colitis ◽

Inflammatory Bowel Disease ◽

Venous Thromboembolism ◽

Incidence Rate ◽

Rate Ratio ◽

Incidence Rate Ratio ◽

Fatal Bleeding ◽

Adjusted Incidence Rate ◽

Inflammatory Bowel ◽

Adjusted Incidence

Abstract Background Little is known about the bleeding risk in patients with inflammatory bowel disease (IBD) and venous thromboembolism (VTE) treated with anticoagulation. Our aim was to elucidate the rate of major bleeding (MB) events in a well-defined cohort of patients with IBD during anticoagulation after VTE. Methods This study is a retrospective follow-up analysis of a multicenter cohort study investigating the incidence and recurrence rate of VTE in IBD. Data on MB and IBD- and VTE-related parameters were collected via telephone interview and chart review. The objective of the study was to evaluate the impact of anticoagulation for VTE on the risk of MB by comparing time periods with anticoagulation vs those without anticoagulation. A random-effects Poisson regression model was used. Results We included 107 patients (52 women, 40 with ulcerative colitis, 64 with Crohn disease, and 3 with unclassified IBD) in the study. The overall observation time was 388 patient-years with and 1445 patient-years without anticoagulation. In total, 23 MB events were registered in 21 patients, among whom 13 MB events occurred without anticoagulation and 10 occurred with anticoagulation. No fatal bleeding during anticoagulation was registered. The incidence rate for MB events was 2.6/100 patient-years during periods exposed to anticoagulation and 0.9/100 patient-years during the unexposed time. Exposure to anticoagulation (adjusted incidence rate ratio, 3.7; 95% confidence interval, 1.5-9.0; P = 0.003) and ulcerative colitis (adjusted incidence rate ratio, 3.5; 95% confidence interval, 1.5-8.1; P = 0.003) were independent risk factors for MB events. Conclusion The risk of major but not fatal bleeding is increased in patients with IBD during anticoagulation. Our findings indicate that this risk may be outweighed by the high VTE recurrence rate in patients with IBD.

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Dengue Fever in Italy: The “Eternal Return” of an Emerging Arboviral Disease

Tropical Medicine and Infectious Disease ◽

10.3390/tropicalmed7010010 ◽

2022 ◽

Vol 7 (1) ◽

pp. 10

Author(s):

Matteo Riccò ◽

Simona Peruzzi ◽

Federica Balzarini ◽

Alessandro Zaniboni ◽

Silvia Ranzieri

Keyword(s):

Incidence Rate ◽

Central Italy ◽

Denv Infection ◽

Incidence Rates ◽

Annual Incidence ◽

Annual Reports ◽

Foreign Born ◽

Time Period ◽

Adjusted Incidence Rate ◽

Adjusted Incidence

Enhanced surveillance for dengue virus (DENV) infections in Italy has been implemented since 2012, with annual reports from the National Health Institute. In this study, we summarize available evidence on the epidemiology of officially notified DENV infections from 2010–2021. In total, 1043 DENV infection cases were diagnosed, and most of them occurred in travelers, with only 11 autochthonous cases. The annual incidence rates of DENV infections peaked during 2019 with 0.277 cases per 100,000 (95% confidence interval [95% CI] 0.187–0.267), (age-adjusted incidence rate: 0.328, 95% CI 0.314–0.314). Cases of DENV were clustered during the summer months of July (11.4%), August (19.3%), and September (12.7%). The areas characterized by higher notification rates were north-western (29.0%), and mostly north-eastern Italy (41.3%). The risk for DENV infection in travelers increased in the time period 2015–2019 (risk ratio [RR] 1.808, 95% CI 1.594–2.051) and even during 2020–2021 (RR 1.771, 95% CI 1.238–2.543). Higher risk for DENV was additionally reported in male subjects compared with females subjects, and aged 25 to 44 years, and in individuals from northern and central Italy compared to southern regions and islands. In a multivariable Poisson regression model, the increased number of travelers per 100 inhabitants (incidence rate ratio [IRR] 1.065, 95% CI 1.036–1.096), the incidence in other countries (IRR 1.323, 95% CI 1.165–1.481), the share of individuals aged 25 to 44 years (IRR 1.622, 95% CI 1.338–1.968), and foreign-born residents (IRR 2.717, 95% CI 1.555–3.881), were identified as effectors of annual incidence. In summary, although the circulation of DENV remains clustered among travelers, enhanced surveillance is vital for the early detection of human cases and the prompt implementation of response measures.

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Abstract T MP99: What Are the Blood Pressure Levels Associated With the Lowest Stroke Rates in the Elderly? Findings From the Reasons for Geographic and Racial Differences in Stroke (regards) Cohort Study

Stroke ◽

10.1161/str.45.suppl_1.tmp99 ◽

2014 ◽

Vol 45 (suppl_1) ◽

Author(s):

Maciej Banach ◽

Samantha Bromfield ◽

George Howard ◽

Virginia J Howard ◽

Alberto Zanchetti ◽

...

Keyword(s):

Blood Pressure ◽

Incidence Rate ◽

Racial Differences ◽

Stroke Risk ◽

Reference Group ◽

Elderly Persons ◽

Stroke Incidence ◽

Increased Risk ◽

Adjusted Incidence Rate ◽

Adjusted Incidence

OBJECTIVES: To identify the blood pressure (BP) level associated with the lowest stroke incidence in elderly persons taking antihypertensive medication in the REasons for Geographic And Racial Differences in Stroke (REGARDS) study. METHODS: We categorized 13,948 REGARDS participants with hypertension into 3 age groups: 55-64, 65-74 and ≥75 years old and 5 levels of treated systolic BP (SBP): <120 (reference group), 120-129, 130-139, 140-149, and ≥150 mmHg, and 4 levels of diastolic BP (DBP) levels: <70 (reference group), 70-79, 80-89, and ≥90 mmHg. Participants without a history of stroke were followed for a median of 5.7 years (maximum 8.5 years) for incident stroke (n=425). RESULTS: For participants at age 55-64 SBP level <120 mmHg and DBP <70 mmHg were associated with the lowest risk of stroke (incidence per 1,000 person-years: 2.4, 95%Cl: 1.4-4.0 and 2.5, 95%Cl: 1.3-4.7, respectively). Higher stroke risk was observed at SBP ≥140 mmHg. For those aged 65-74, stroke incidence was increased at SBP ≥130 mmHg and at lower DBP levels (with the lowest stroke risk for DBP ≥90 mmHg). For participants ≥75 years SBP ≥150 mmHg was associated with the highest risk of stroke (incidence rate: 15.0, 95%Cl: 10.5-21.3) but no increased risk was observed for SBP between 120-149 mmHg. For DBP, stroke incidence was highest for DBP <70 mmHg (adjusted incidence rate: 9.8; 95%Cl: 6.8-14.1), and lowest for DBP ≥90 mmHg (adjusted incidence rate: 6.5; 95%Cl: 2.9-14.5) (see table). CONCLUSIONS: These results suggest that the lowest risk for stroke for the participants between 55-64 years old are at BP levels <140/70 mmHg, for persons 65-74 we should aim at SBP levels <130 mmHg, and for the oldest patients at SBP <150 with DBP ≥90 mmHg for both groups. For participants aged ≥65 a caution should be kept with the reduction of DBP <90 mmHg, what requires further investigations. Key words: blood pressure, elderly, hypertension, treatment, mortality, stroke.

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Epidemiology of Myeloproliferative Neoplasms in Norway

Blood ◽

10.1182/blood.v124.21.1858.1858 ◽

2014 ◽

Vol 124 (21) ◽

pp. 1858-1858

Author(s):

Christina Roaldsnes ◽

Anders Waage ◽

Mette Nørgaard ◽

Waleed Ghanima

Keyword(s):

Incidence Rate ◽

Cancer Registry ◽

Research Funding ◽

Myeloproliferative Neoplasms ◽

Relative Survival ◽

Incidence Rates ◽

Age At Diagnosis ◽

Jak2 Mutation ◽

Adjusted Incidence Rate ◽

Adjusted Incidence

Abstract Background: Polycythemia vera (PV), essential thrombocythemia (ET) and myelofibrosis (MF) are clonal hematological disorders collectively named as myeloproliferative neoplasms (MPN). Discovery of JAK2 mutation in 2005, altered WHO classification for MPN diagnosis in 2008 and availability of new treatment of MPN may have substantial effect on epidemiology of MPN. Published data on epidemiology of MPN after the discovery of JAK2 mutation and the introduction of 2008 WHO classifications for MPN, in particular on the prevalence of MPN, are scarce. We aimed to study the epidemiology of MPN in Norway and to explore the impact of JAK-2 mutation and new guidelines on the incidence of MPN using data from the Norwegian cancer registry. Method: We identified 2344 persons diagnosed with MPN from the Norwegian Cancer Registry diagnosed between 1995 and 2012. Registration of cancer in the Norwegian Cancer Registry is mandatory according to the law. We report age-adjusted incidence, prevalence and relative survival of MPN. Age adjusted incidence was reported for 2 years periods from 1995 to 2012. The prevalence was calculated according to the Norwegian population per 31.12.2011. Results: A total of 945 cases of PV was identified with a median age at diagnosis of 70 years; 471 males (50%) and 474 females (50%). The overall age-adjusted incidence rate both genders was 0.4/10⁵ in 1995-1997, 0.5/10⁵ in 1998-2000, 0.7/10⁵ in 2001-2003, 0.8/10⁵ in 2004-2007, 2008-2009 and 0.7/10⁵ in 2010-12. We identified a total of 762 cases of ET with a median age at diagnosis of 65 years, 297 males (39%) and 465 females (61%). The overall age adjusted incidence rate both genders being 0.3/10⁵ in 1995-1997 and 1998-2000, 0.5/10⁵ in 2001-2003 and 2004-2006, 0.9/10⁵ in 2007-2009 and 2010-2012. A total of 418 cases of MF was identified with a median age at diagnosis of 71 years; 243 males (58%) and 175 females (42%). Age adjusted incidence rates of both genders were 0.2/10⁵ from 1995-2006, 0.3/10⁵ in 2007-2009 and 0.5/10⁵ in 2010-2012. There were a total of 219 persons with unclassified MPN both genders,119 males (54%) and 100 females (46%) and age adjusted incidence rate varied from 0.1-0.2 to 0.1/10⁵ 1995-2012. Per 31.12.2011 the prevalence of PV, ET and MF was 9.2, 8.6 and 3.0 per 10⁵ inhabitants respectively. The survival curves for males and females for the three conditions are shown in the figure. Conclusions: This population-based study shows that the incidence of ET and MF almost doubled during the years 2007-2012 as compared to 1995-2006 as shown in the table. This increment in the incidence may possibly be related to improved diagnostics including the JAK2 mutation and the introduction of 2008 WHO-guidelines for MPN. Surprisingly, the discovery of JAK2 does not seem to have had impact on the incidence of PV as indicated by steady incidence rates since 2001. The relative survival was only slightly reduced for PV and ET, but substantially reduced for MF. Only 50% of patients with MF survive for more than 5 years. Table Incidence of MPN per 105 inhabitants during the period 1995 to 2012 in Norway 1995-97 1998-2000 2001-03 2004-06 2007-09 2010-12 PV 0.4 0.5 0.7 0.8 0.8 0.7 ET 0.3 0.3 0.5 0.5 0.9 0.9 MF 0.2 0.2 0.2 0.2 0.3 0.5 Figure showing the relative survival of PV, ET and MF Figure. showing the relative survival of PV, ET and MF Disclosures Roaldsnes: Novartis Norge AS: Research Funding. Ghanima:Novartis: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding.

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Differences in colon cancer incidence rates by latitude.

Journal of Clinical Oncology ◽

10.1200/jco.2013.31.15_suppl.e14627 ◽

2013 ◽

Vol 31 (15_suppl) ◽

pp. e14627-e14627

Author(s):

Binay Kumar Shah ◽

Krishna Bilas Ghimire ◽

Barsha Nepal

Keyword(s):

Colon Cancer ◽

Incidence Rate ◽

Incidence Rates ◽

Southern Region ◽

Southern Latitude ◽

Northern Latitude ◽

The North ◽

Northern Regions ◽

Adjusted Incidence Rate ◽

Adjusted Incidence

e14627 Background: There is significant decrease in the ultraviolet B photons reaching the earth’s surface during November to February (Holick MF Am J Clin Nutr. 2004 Dec; 80(6 Suppl):1678S-88S). This results in little if any vitamin D3 production in the skin during this period. This study was conducted to evaluate difference in colon cancer age adjusted incidence rates in the northern (latitude ≥37o N) and the southern (latitude < 37oN) regions in the contiguous United States during 1973-2008. Methods: Patients, aged 20 years and older, who had been diagnosed with colong cancer during January 1973 and December 2008, were selected from the Surveillance, Epidemiology, and End Results (SEER) 13 database. Based on the counties’ centroid, northern (latitude ≥37o N) and southern (latitude < 37oN) regions were determined. We compared age adjusted incidence rates (AAIR) of colon cancer in the southern and northern regions among cohorts of patients categorized by age (≥20, 20-64, ≥65 years), gender (Men, Women) and Race (Caucasians, Blacks, Others). The AAIR was calculated per 100,000 population. We used SEER*Stat software to calculate age adjusted incidence rate, incidence ratio, confidence interval (CI, 95%) and P value. Results: There were 314,975 cases of colon cancer diagnosed among 608,245,557 US population during 1973-2008. The overall colon cancer AAIR was 57.1 per 100,000 population studied. The incidence rates were 49.1 in the south and 58.7 in the north of 37oN latitude, (95% CI 1.18-1.20, p<0.05). The AAIRs for patients in the age group 20-64 years were 17.9 and 18.8 in the southern and northern regions, (CI 95%, 1.0346-1.0697), p<0.0005 respectively. The incidence rates for patients aged ≥65 years were 194.3 and 243.9 in the southern and northern regions, (CI 95%, 1.0346-1.0697) p<0.0005. Similarly, the AAIRs were significantly higher in the northern region compared to southern region for both sexes and all ethnic groups. Conclusions: Colon cancer age-adjusted incidence rate is significantly higher in the Northern compared to the Southern region of the US. The higher incidence of colon cancer in the North may be related to lack of sunlight exposure and relative vitamin D deficiency.

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Effects of Dose Adjustment Rules on Safety during Erythropoietic Therapy: A Retrospective Analysis of Darbepoetin alfa Administered Either Every 3 Weeks or Weekly.

Blood ◽

10.1182/blood.v106.11.3376.3376 ◽

2005 ◽

Vol 106 (11) ◽

pp. 3376-3376 ◽

Cited By ~ 4

Author(s):

Michael Hedenus ◽

Jean-Luc Canon ◽

Dusan Kotasek ◽

Tom Lillie ◽

Lisa Hendricks ◽

...

Keyword(s):

Dose Reduction ◽

Incidence Rate ◽

Darbepoetin Alfa ◽

Dose Adjustment ◽

Safety Concern ◽

Performance Status ◽

Thrombotic Event ◽

Increased Risk ◽

Adjusted Incidence Rate ◽

Adjusted Incidence

Abstract Background: Rapid increases in hemoglobin (Hb) concentrations or achievement of high Hb levels during erythropoiesis-stimulating protein (ESP) therapy may put anemic patients undergoing chemotherapy at increased risk for cardiovascular/thromboembolic adverse events (AEs). A potential safety concern of less frequent ESP administration (eg, every 3 weeks [Q3W] vs weekly [QW]) is that higher single doses may cause rapid increases in Hb levels. Dose adjustment rules may provide physicians with guidance on how to minimize these risks; however, defining appropriate rules can be challenging. Methods: To evaluate the ability of dose reduction rules to discriminate between natural Hb variability and inappropriate Hb increases, we performed a pooled analysis of 5 randomized, double-blind studies involving Q3W and QW darbepoetin alfa (Aranesp®; DA) vs placebo. In these studies, 2335 eligible patients (pts) had cancer and anemia, were undergoing chemotherapy, and had received ≥1 dose of study drug. AE categories of interest in this analysis were hypertension, seizure, ischemic myocardial infarction, and embolism/thrombosis (arterial and venous). Three definitions for excessive rate-of-rise in Hb were compared as triggers for dose reduction: ≥1-g/dL increase in 14 days; ≥1.5-g/dL in 21 days; or ≥2-g/dL in 28 days. Results: Of the 3 definitions evaluated for excess rate-of-rise in Hb concentration, the 2-g/dL increase in 28 days best discriminated pts receiving DA treatment from placebo pts (see Table). The 1-g/dL increase in 14 days rule did not discriminate well between inappropriate Hb increases related to ESP therapy and natural Hb variability (ie, placebo). These results suggest that a 2-g/dL increase in 28 days may be associated with an increased risk of thrombotic events in pts receiving DA therapy compared with pts receiving placebo, after adjusting for thrombotic event history and ECOG performance status; the 1-g/dL increase in 14 days rule was not associated with an increased risk of thrombotic events in a similar analysis. No significant differences in the exposure-adjusted incidence rate of embolism/thrombosis events were observed between the DA extended-dose and 2.25-μg/kg QW groups, regardless of the definitions used. Conclusions: The 2-g/dL increase in 28 days definition discriminates natural Hb variability and excess rate-of-rise that may be associated with cardiovascular/thromboembolic AEs. The 1-g/dL increase in 14 days rule resulted in an excessive rate of “false positives,” even in the absence of ESP therapy. Placebo DA QW 2.25 μg/kg All DA Q3W extended dosing All DA N = No. of pts evaluable for safety; E = Total 16 person-week exposure period; n = Pts who experienced event; R = Exposure-adjusted incidence rate based on the no. of pts with event in a 16-week time period (R=n/E). No. of pts (N) 379 1049 907 1956 Exposure adjusted time (E) 321.1 979.1 928.8 1908 Hb threshold, n (R) ≥ 13 g/dL at any time 23 (0.07) 344 (0.35) 233 (0.25) 577 (0.30) Excess rise in Hb, n (R) ≥ 1 g/dL in 14 days 212 (0.66) 796 (0.81) 690 (0.74) 1486 (0.78) ≥ 1.5 g/dL in 21 days 138 (0.43) 654 (0.67) 560 (0.60) 1214 (0.64) ≥ 2 g/dL in 28 days 83 (0.26) 487 (0.50) 390 (0.42) 877 (0.46)

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Temporal Trends in Incidence and Case Fatality of Intracerebral Hemorrhage: The Tromsø Study 1995-2012

Cerebrovascular Diseases Extra ◽

10.1159/000447719 ◽

2016 ◽

Vol 6 (2) ◽

pp. 40-49 ◽

Cited By ~ 7

Author(s):

Maria Carlsson ◽

Tom Wilsgaard ◽

Stein Harald Johnsen ◽

Anne Merete Vangen-Lønne ◽

Maja-Lisa Løchen ◽

...

Keyword(s):

Intracerebral Hemorrhage ◽

Incidence Rate ◽

Temporal Trends ◽

Case Fatality ◽

Incidence Rates ◽

Adjusted Incidence Rate ◽

Adjusted Incidence ◽

Incident Cases ◽

Over Time ◽

Age And Sex

Background: The aim of this study was to explore temporal trends in incidence and case fatality rates of intracerebral hemorrhage (ICH) over the last two decades in a Norwegian municipality. Methods: Incident cases of primary ICH were registered in the period from 1995 through 2012 in 32,530 participants of the longitudinal population-based Tromsø Study. Poisson regression models were used to obtain incidence rates over time in age- and sex-adjusted and age- and sex-specific models. Case fatality rates were calculated and age- and sex-adjusted trends over time were estimated using logistic regression. Results: A total of 226 ICHs were registered. The age- and sex-adjusted incidence rate [95% confidence interval (CI)] in the overall population was 0.42 (0.37-0.48) per 1,000 person-years. Age-adjusted incidence rates were 0.53 (0.43-0.62) in men and 0.33 (0.26-0.39) in women. In individuals aged <75 years, the age- and sex-adjusted incidence rate was 0.27 (0.22-0.32) and in individuals aged ≥75 years, it was 2.42 (1.95-2.89) per 1,000 person-years. There was no significant change in incidence rates over time. The incidence rate ratio (95% CI) in the overall population was 0.73 (0.47-1.12) in 2012 compared with 1995. The overall 30-day case fatality (95% CI) was 23.9% (18.3-29.5) and did not change substantially over time [odds ratio in 2012 vs. 1995 = 0.83 (95% CI 0.27-2.52)]. Conclusion: No significant changes in incidence and case fatality rates of ICH were observed during the last two decades.

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MO514CARDIORENAL OUTCOMES AND MORTALITY IN PATIENTS WITH TYPE 2 DIABETES MELLITUS: A MULTINATIONAL PROSPECTIVE COHORT STUDY (PROVALID)

Nephrology Dialysis Transplantation ◽

10.1093/ndt/gfab087.0034 ◽

2021 ◽

Vol 36 (Supplement_1) ◽

Author(s):

Stefanie Thöni ◽

Felix Keller ◽

Sara Denicolo ◽

Susanne Eder ◽

Laszlo Rosivall ◽

...

Keyword(s):

Risk Factors ◽

The Netherlands ◽

Incidence Rate ◽

Composite Endpoint ◽

Incidence Rates ◽

European Countries ◽

All Cause Mortality ◽

Adjusted Incidence Rate ◽

Adjusted Incidence

Abstract Background and Aims PROVALID is a prospective, observational, multinational cohort study in 4000 patients with type 2 diabetes mellitus. Our aim was to determine the incidence rate of renal and cardiovascular endpoints, as well as all-cause-mortality in different European countries and to identify risk factors associated with the investigated outcomes. Method Potential risk factors associated with the investigated outcomes were identified by calculation of the incidence rate ratio. Crude and adjusted incidence rates for every country were estimated using generalized linear (poisson) regression models and corresponding 95 % confidence intervals were computed. Incidence rates were adjusted for different risk factors including age, sex, estimated GFR, albuminuria, HbA1c, LDL, HDL, total cholesterol, systolic blood pressure, BMI and cardiovascular and renal comorbidities; among these several show significant impact on outcomes. The renal outcome was a composite of a sustained decline in the estimated GFR of at least 40%, a sustained increase in albuminuria of at least 30 % including the progression from normo- to micro- or macroalbuminuria, end-stage kidney disease, or death from renal causes. The cardiovascular composite endpoint was death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke. Results 3461 participants of four European countries (Austria 18 %, Hungary 41 %, Netherlands 26 % and Scotland 15 %) with a mean follow up time of 3.9 years were included into this study. Participants from Poland were excluded due to missing follow-up data. In total, 9.2 % and 6.4 % participants reached the renal and cardiovascular composite endpoint, respectively. 7.0 % of the participants died within this timeframe. The adjusted incidence rate for the renal endpoint ranged from 14.5 to 25.3 (per 1000 patient-years) with no significant differences between countries. On average, the incidence rate was lower in Scotland (IR, 14.5; 95 % CI, 8.7 to 22.5) and in the Netherlands (IR, 15.7; 95 % CI, 10.9 to 21.8) compared to Hungary (IR, 25.3; 95 % CI, 20.7 to 30.6) and Austria (IR 21.3; 95 % CI, 16.2 to 27.5). The adjusted incidence rate for the cardiovascular endpoint ranged from 7.0 to 20.3 and was significantly lower in Hungary (IR, 7.0; 95 % CI, 5.1 to 9.3) and the Netherlands (IR, 7.6; 95 % CI, 4.4 to 12.2) compared to Austria (IR, 16.7; 95 % CI, 12.4 to 22.1) and Scotland (IR, 20.3; 95 % CI, 13.8 to 28.9). The adjusted incidence rate for all-cause-mortality ranged from 4.2 to 15.9 and was significantly lower in the Netherlands (IR, 4.2; 95 % CI, 2.2 to 7.6) compared to Scotland (IR, 15.9; 95 % CI, 10.9 to 22.6). No significant difference in the incidence rates between Austria (IR, 9.8; 95 % CI, 7.0 to 13.4) and Hungary (IR, 9.3; 95 % CI, 6.8 to 12.4) was found. Conclusion After adjustment for known risk factors, incidence rates of cardiovascular endpoints, as well as all-cause-mortality still vary significantly between four European countries. This may be due to manifold reasons. Further analysis of the national therapeutic practice pattern within the PROVALID cohort may provide additional information.

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The incidence of venous thromboembolism in patients with overt hyperthyroidism

Thrombosis and Haemostasis ◽

10.1160/th11-10-0691 ◽

2012 ◽

Vol 107 (03) ◽

pp. 417-422 ◽

Cited By ~ 16

Author(s):

Danka J. F. Stuijver ◽

Olaf M. Dekkers ◽

Bregje van Zaane ◽

Eric Fliers ◽

Suzanne C. Cannegieter ◽

...

Keyword(s):

Venous Thromboembolism ◽

General Population ◽

Incidence Rate ◽

Multinodular Goiter ◽

Primary Outcome ◽

Incidence Rates ◽

Clinical Implications ◽

Toxic Adenoma ◽

Increased Risk ◽

Overt Hyperthyroidism

SummaryHyperthyroidism is associated with several changes in the haemostatic system resulting in a hypercoagulable state. It is uncertain at this stage whether this leads to an increased risk of venous thromboembolism (VTE). The aim of this retrospective cohort study was to determine the risk of VTE in all patients with overt hyperthyroidism and to compare this to the risk of VTE in the general population. In three hospitals in the Netherlands, patients with biochemically confirmed hyperthyroidism caused by Graves’ disease, multinodular goiter or toxic adenoma were included. All available electronic and handwritten records were examined. Primary outcome was the occurrence of VTE within six months before and until six months after the diagnosis of hyperthyroidism. We included a total of 587 patients. Five patients experienced a VTE during the study period, resulting in an incidence rate of 8.7 (95% CI 2.8 – 20.2) per 1,000 person-years. Three of these five patients had a first VTE (incidence rate for first VTE was 5.3 [95% CI 1.1 – 15.6] per 1,000 person-years). Incidence rates of VTE in the general population are between 0.6 and 1.6 per 1,000 person-years for first VTE and 0.7 and 1.8 per 1,000 person-years for all VTE. In conclusion, the incidence rate of VTE in patients with hyperthyroidism appears to be high. Future prospective studies are needed to further explore this possible association and to address its clinical implications.

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