scholarly journals Reduced cardiovascular morbidity in patients with hemophilia: results of a 5-year multinational prospective study

2021 ◽  
Author(s):  
Paul Van Der Valk ◽  
Michael Makris ◽  
Kathelijn Fischer ◽  
Robert C Tait ◽  
Pratima Chowdary ◽  
...  
Keyword(s):  
Risk Reduction ◽  
Risk Model ◽  
Absolute Risk ◽  
Absolute Risk Reduction ◽  
Clotting Factor ◽  
Cvd Risk ◽  
Multicenter Observational Study ◽  
Clotting Factor Concentrates ◽  
Prospective Multicenter Observational Study

Hemophilia is a congenital bleeding disorder caused by low clotting factor VIII or IX levels. Life expectancy of people with hemophilia (PWH) has increased with the availability of clotting factor concentrates. At the same time, the incidence of cardiovascular disease (CVD) has increased. In retrospective studies there are conflicting data if, despite this increase, the incidence is still lower than in the general population. We prospectively compared the incidence of CVD in PWH with the predicted incidence. This prospective, multicenter, observational study included adult PWH (>30y) from the Netherlands and United Kingdom (UK). They were followed for a 5-year period and CVD incidence was compared with a predicted event rate based on the QRISK2-2011 CVD risk model. The primary endpoint was the observed fatal and nonfatal CVD incidence after 5 years compared to the estimated events and in relation to severity of hemophilia. The study included 709 patients, of whom 687 (96.9%) completed 5 years follow up or reached an endpoint. For 108 patients the QRISK score could not be calculated at inclusion. For the remaining 579 fewer CVD events were observed than predicted: 9 versus 24 (RR 0.38; 95% CI: 0.18 - 0.80 p=0.01), corresponding with an absolute risk reduction of 2.4%. Severe hemophilia treated on demand had the highest risk reduction. There was no statistical significant relation between severity of hemophilia and incidence of CVD. In hemophilia a lower than predicted CVD incidence was found, supporting the theory that hemophilia protects against CVD. The study is registered at www.clinicaltrials.gov (identification number NCT01303900).

Abstract 001: Effects of Intensive Blood Pressure Control in Adults With and Without Albuminuria: Results From the SPRINT Trial

Circulation ◽  
2018 ◽  
Vol 137 (suppl_1) ◽  
Author(s):  
Alex Chang
Keyword(s):  
Blood Pressure ◽  
High Risk ◽  
Primary Outcome ◽  
Absolute Risk ◽  
Absolute Risk Reduction ◽  
High Risk Population ◽  
Number Needed To Treat ◽  
Cvd Risk ◽  
Intensive Blood Pressure

Background: Albuminuria is strongly associated with elevated risk of cardiovascular disease (CVD). While the Systolic Blood Pressure Intervention Trial (SPRINT) showed that intensive blood pressure (BP) lowering reduces CVD in high-risk non-diabetic adults, it is unclear whether this effect varies by albuminuria status. Methods: SPRINT randomized non-diabetic adults with elevated blood pressure and increased CVD risk to a systolic BP (SBP) goal of <120 or <140 mmHg. Albuminuria (>=30 mg/g) was measured by albumin/creatinine ratio (ACR) at baseline. Outcomes examined included the primary composite CVD outcome (myocardial infarction, other acute coronary syndromes, stroke, heart failure, or death from CVD) and all-cause death. Results: A total of 8913/9361 (95.2%) participants had baseline ACR data; 51.9%, 28.7%, and 19.4% had baseline ACR < 10, 10-29.9, and >=30 mg/g, respectively. The primary composite outcome occurred in 4.0%, 6.7%, and 11.2% of individuals with baseline ACR <10, 10-29.9, and >=30 mg/g, respectively. The effect of intensive BP lowering on the primary outcome was similar in patients with albuminuria (HR 0.74, 95% CI: 0.55-0.99) and without albuminuria (HR 0.73, 95% CI: 0.59-0.91; p for interaction = 0.77). Intensive BP lowering reduced risk of stroke in patients with albuminuria (HR 0.45, 95% CI: 0.24-0.85) but not patients without albuminuria (1.13, 95% CI: 0.73-1.74; p for interaction = 0.03). Absolute risk reduction was particularly high in those with albuminuria, with a number needed to treat (NNT) of 32 to prevent 1 primary outcome and a NNT of 37 to prevent 1 death from any cause at 3 years of follow-up. By comparison, the NNT to prevent 1 primary outcome was 72 for ACR < 30 mg/g at 3 years of follow-up. Conclusions: The effect of Intensive BP lowering reduces CVD risk similarly in non-diabetic adults with and without albuminuria. Given the high CVD risk in patients with albuminuria, this high-risk population may particularly benefit from efforts to intensify BP control.

Effect of Radiotherapy After Breast-Conserving Surgery for Ductal Carcinoma in Situ: 20 Years Follow-Up in the Randomized SweDCIS Trial

2014 ◽  
Vol 32 (32) ◽  
pp. 3613-3618 ◽  
Author(s):  
Fredrik Wärnberg ◽  
Hans Garmo ◽  
Stefan Emdin ◽  
Veronica Hedberg ◽  
Linda Adwall ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Risk Reduction ◽  
Ductal Carcinoma In Situ ◽  
Carcinoma In Situ ◽  
Ductal Carcinoma ◽  
Absolute Risk ◽  
Absolute Risk Reduction ◽  
Breast Conserving Surgery

Purpose Four randomized studies show that adjuvant radiotherapy (RT) lowers the risk of subsequent ipsilateral breast events (IBEs) after breast-conserving surgery (BCS) for ductal carcinoma in situ (DCIS) by approximately 50% after 10 to 15 years. We present 20 years of follow-up data for the SweDCIS trial. Patients and Methods Between 1987 and 1999 1,046 women were randomly assigned to RT or not after BCS for primary DCIS. Results up to 2005 have been published, and we now add another 7 years of follow-up. All breast cancer events and causes of death were registered. Results There were 129 in situ and 129 invasive IBEs. Absolute risk reduction in the RT arm was 12.0% at 20 years (95% CI, 6.5 to 17.7), with a relative risk reduction of 37.5%. Absolute reduction was 10.0% (95% CI, 6.0 to 14.0) for in situ and 2.0% (95% CI, −3.0 to 7.0) for invasive IBEs. There was a nonstatistically significantly increased number of contralateral events in the RT arm (67 v 48 events; hazard ratio, 1.38; 95% CI, 0.95 to 2.00). Breast cancer–specific death and overall survival were not influenced. Younger women experienced a relatively higher risk of invasive IBE and lower effect of RT. The hazard over time looked different for in situ and invasive IBEs. Conclusion Use of adjuvant RT is supported by 20-year follow-up. Modest protection against invasive recurrences and a possible increase in contralateral cancers still call for a need to find groups of patients for whom RT could be avoided or mastectomy with breast reconstruction is indicated.

Use of pre-operative calcium and vitamin D supplementation to prevent post-operative hypocalcaemia in patients undergoing thyroidectomy: a systematic review

2021 ◽  
pp. 1-6
Author(s):  
A S Khatiwada ◽  
A S Harris
Keyword(s):  
Systematic Review ◽  
Vitamin D ◽  
Clinical Trials ◽  
Total Thyroidectomy ◽  
Risk Reduction ◽  
Operative Treatment ◽  
Absolute Risk ◽  
Absolute Risk Reduction ◽  
Vitamin D Supplementation ◽  
Absolute Reduction

Abstract Objective This systematic review aimed to establish the evidence behind the use of pre-operative calcium, vitamin D or both calcium and vitamin D to prevent post-operative hypocalcaemia in patients undergoing thyroidectomy. Method This review included prospective clinical trials on adult human patients that were published in English and which studied the effects of pre-operative supplementation with calcium, vitamin D or both calcium and vitamin D on the rate of post-operative hypocalcaemia following total thyroidectomy. Results Seven out of the nine trials included reported statistically significantly reduced rates of post-operative laboratory hypocalcaemia (absolute risk reduction, 13–59 per cent) and symptomatic hypocalcaemia (absolute reduction, 11–40 per cent) following pre-operative supplementation. Conclusion Pre-operative treatment with calcium, vitamin D or both calcium and vitamin D reduces the risk of post-operative hypocalcaemia and should be considered in patients undergoing total thyroidectomy.

scholarly journals Amblyopia screening effectiveness at 3–4 years old: a cohort study

2021 ◽  
Vol 6 (1) ◽  
pp. e000599
Author(s):  
Sandra Guimaraes ◽  
Andreia Soares ◽  
Cristina Freitas ◽  
Pedro Barros ◽  
Ricardo Dourado Leite ◽  
...  
Keyword(s):  
Risk Reduction ◽  
Treatment Effectiveness ◽  
Absolute Risk ◽  
Absolute Risk Reduction ◽  
Number Needed To Screen ◽  
History Of ◽  
Disease Study ◽  
New Diagnosis ◽  
Screening Effectiveness ◽  
Timely Referral

ObjectiveTo study the effectiveness of amblyopia screening at ages 3–4.Methods and AnalysisFrom a population with no previous screening, a cohort of 2300 children with 3–4 years old attending school (91% of children this age attend school in Portugal), were submitted to a complete ophthalmological evaluation. Amblyopia was diagnosed, treated and followed. Amblyopia prevalence, treatment effectiveness, absolute risk reduction (ARR), number needed to screen (NNS) and relative risk reduction (RRR) were estimated.ResultsPast/present history of amblyopia was higher than 3.1%–4.2%, depending on amblyopia definition normatives. Screening at age 3–4, had estimated ARR=2.09% (95% CI 1.50% to 2.68%) with a reduced risk of amblyopia in adulthood of 87% (RRR). NNS was 47.8 (95% CI 37.3 to 66.7). Treatment effectiveness of new diagnosis was 88% (83% if we include children already followed). 91% of new amblyopia diagnoses were refractive (of which 100% surpassed amblyopia Multi-Ethnic Pediatric Eye Disease Study criteria after treatment), while most strabismic amblyopias were already treated or undertreatment. Only 30% of children with refractive amblyopia risk factors that were not followed by an ophthalmologist, ended up having amblyopia at age 3–4. Eye patch was needed equally in new-diagnosis versus treated-earlier refractive amblyopia.ConclusionsScreening amblyopia in a whole-population setting at age 3–4 is highly effective. For each 48 children screened at age 3–4, one amblyopia is estimated to be prevented in the future (NNS). Screening earlier may lead to overdiagnosis and overtreatments: Treating all new diagnosis before age 3–4 would have a maximal difference in ARR of 0.3%, with the possible burden of as much as 70% children being unnecessary treated before age 3–4.Involving primary care, with policies for timely referral of suspicious/high-risk preverbal children, plus whole screening at age 3–4 seems a rational/effective way of controlling amblyopia.

Prevalence of underlying malignancies in complex cysts of the breast

2021 ◽  
pp. 1-7
Author(s):  
J.C.W.L. Gerets ◽  
M. Kool ◽  
P.C.G. Simons ◽  
F. Aarts ◽  
F.J. Vogelaar
Keyword(s):  
Healthcare Costs ◽  
Disease Burden ◽  
Watchful Waiting ◽  
Absolute Risk ◽  
Absolute Risk Reduction ◽  
Patient Characteristics ◽  
Number Needed To Treat ◽  
Single Center ◽  
Underlying Malignancy

INTRODUCTION: The management of complex cysts of the breast is an ongoing topic of discussion. The aim of this study was to determine the prevalence of underlying malignancy in radiologically diagnosed complex cysts, and to assess whether watchful waiting could be the preferred method to safely manage complex cysts of the breast. SUBJECTS AND METHODS: A single-center retrospective study was performed between May 2003 and November 2019 in the VieCuri Medical Centre. Women with a radiologically diagnosed complex cyst of the breast were included. Prevalence of underlying malignancy was calculated, as were absolute risk reduction and number needed to treat in order to diagnose malignancy. In addition, patient characteristics were compared to determine characteristics associated with malignancy. RESULTS: Of 78 radiologically diagnosed complex cysts of the breast, five (6,4%) were found to be malignant. The number needed to treat was calculated at 12,8 (absolute riks reduction 0,078). Age (P = 0,003) was associated with malignancy. CONCLUSION: Complex cysts of the breast could be managed more conservatively. Patient characteristics can be used to assess the eligibility for radiological follow-up. This, in turn, would lead to a lower NNT and possibly a decrease in disease burden and healthcare costs.

Abstract TMP92: Higher Risk of Ischemic Events in Secondary Prevention for Patients With Persistent Versus Paroxysmal Atrial Fibrillation: The SAMURAI-NVAF Study

Stroke ◽  
2016 ◽  
Vol 47 (suppl_1) ◽  
Author(s):  
Masatoshi Koga ◽  
Sohei Yoshimura ◽  
Yasuhiro Hasegawa ◽  
Satoshi Shibuya ◽  
Yasuhiro Ito ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Secondary Prevention ◽  
Clinical Outcomes ◽  
Chads2 Score ◽  
Multicenter Observational Study ◽  
Hemorrhagic Events ◽  
Anticoagulated Patients ◽  
Prospective Multicenter Observational Study ◽  
Ischemic Events

Background and purpose: The discrimination between paroxysmal and persistent atrial fibrillations (AF) has not been considered to guide secondary stroke prevention, because it remains unclear whether patients with persistent AF are at higher risk compared with paroxysmal AF, particularly in secondary prevention. We aimed to assess the differences in clinical outcomes between mostly anticoagulated patients with persistent vs. paroxysmal AF who had ischemic stroke or TIA. Methods: Using interim data of 1192 nonvalvular AF (NVAF) patients with acute ischemic stroke or TIA who were registered in the SAMURAI-NVAF study (an ongoing prospective, multicenter, observational study) to determine choice of anticoagulantion therapy and clinical outcomes, we divided patients into those with paroxysmal AF and those with persistent AF. We compared clinical outcomes between the 2 groups. Results: The median follow-up period was 1.0 year (IQR 0.3-2.0). Of the 1192 patients, 434 (191 women, 77.3±10.0 y.o.) and 758 (336, 77.9±9.9) were assigned to the paroxysmal AF group and persistent AF group, respectively. Of each group, 220 (50.7%) and 442 (58.3%) were anticoagulated with warfarin and 199 (45.9%) and 276 (36.4%) were so with non-vitamin K antagonist oral anticoagulant (NOAC) (p=0.004). As for primary outcomes, 30 (6.2%/person-year) and 78 (9.9) ischemic events, respectively [hazard ratio adjusted for sex, age, initial NIHSS, CHADS2 score, creatinine clearance, anticoagulation with warfarin (vs. NOAC) (HR) 0.65; 95% CI 0.42-0.98], and 18 (4.9%/person-year) and 31 (3.8) hemorrhagic events, respectively (HR 0.97, 0.52-1.75), occurred during follow-up. As for secondary outcomes, the person-year rate of ischemic stroke or TIA was 3.9% and 8.4%, respectively (HR 0.46, 0.27-0.76), that of intracranial hemorrhage was 1.6% and 1.7%, respectively (HR 0.97, 0.36-2.37), and that of death was 11.1% and 15.7%, respectively (HR 0.90, 0.64-1.26). Conclusions: Among patients with prior ischemic stroke or TIA, those with persistent AF had a higher risk of ischemic events, and ischemic stroke or TIA compared with those with paroxysmal AF. The prevention of progress to persistent AF from paroxysmal AF may be beneficial for secondary prevention in patients with NVAF.

Abstract P297: Long-Term Benefit Comparison of Absolute Risk Reduction versus Absolute Risk to Prioritize Statin Therapy

Circulation ◽  
2018 ◽  
Vol 137 (suppl_1) ◽  
Author(s):  
Ciaran N Kohli-Lynch ◽  
Andrew E Moran ◽  
George Thanassoulis ◽  
Allan D Sniderman ◽  
Yiyi Zhang ◽  
...  
Keyword(s):  
Risk Factor ◽  
Statin Therapy ◽  
Risk Reduction ◽  
Treatment Initiation ◽  
Absolute Risk ◽  
Treatment Strategies ◽  
Absolute Risk Reduction ◽  
Statin Treatment ◽  
Policy Model

Introduction: Individuals with no established cardiovascular disease (CVD) are currently recommended preventive statin therapy based on 10-year absolute risk (AR) of CVD, and individuals with a 10-year AR ≥7.5% are recommended statins. However, individuals with elevated LDL cholesterol experience greater absolute CVD absolute risk reduction (ARR) from statin therapy compared with those with the same 10-year AR but with lower LDL. A previous study showed that ARR-based statin treatment would prevent more CVD events than AR-based treatment in the 10 years following treatment initiation. Objective: This study aimed to quantify the long-term benefits of treating patients based on ARR rather than AR. Methods: A microsimulation version of the CVD Policy Model, a decision-analytic state transition model, simulated intermediate-strength statin therapy in 40,000 CVD-free US adults (50% female) under a variety of treatment strategies. The model predicts health outcomes for individuals based on their age, sex, and risk factor profile, accounting for the competing risk of non-CVD mortality. Individuals entered the model aged 40 years, and a time horizon of 40 years was employed. Life year gains and CVD events prevented compared to no treatment were estimated for a range of 10-year ARR and AR treatment initiation thresholds. Results: At the same numbers of patient-years of treatment (PYoT), ARR consistently produced more life year gains than AR (Figure). A 10-year ARR threshold of ≥2.62% would lead to approximately the same PYoT as standard of care (10-year AR ≥7.5%) while preventing 60 additional CVD events and producing 421 additional life year gains in the cohort. Conclusion: Treating patients with statins based on ARR would yield significant health gains in the U.S. population compared to standard AR-based treatment strategies. The ARR strategy may also achieve greater adherence and uptake as it focuses on individuals with elevated levels of a modifiable risk factor.

Folic Acid and Folinic Acid for Reducing Side Effects in Patients Receiving Methotrexate for Rheumatoid Arthritis

2014 ◽  
Vol 41 (6) ◽  
pp. 1049-1060 ◽  
Author(s):  
Beverley Shea ◽  
Michael V. Swinden ◽  
Elizabeth Tanjong Ghogomu ◽  
Zulma Ortiz ◽  
Wanruchada Katchamart ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Trials ◽  
Folic Acid ◽  
Side Effects ◽  
Folinic Acid ◽  
Risk Reduction ◽  
Absolute Risk ◽  
Absolute Risk Reduction ◽  
Risk Of Bias ◽  
Serum Transaminase

Objective.To perform a systematic review of the benefits and harms of folic acid and folinic acid in reducing the mucosal, gastrointestinal, hepatic, and hematologic side effects of methotrexate (MTX); and to assess whether folic or folinic acid supplementation has any effect on MTX benefit.Methods.We searched the Cochrane Library, MEDLINE, EMBASE, and US National Institutes of Health clinical trials registry from inception to March 2012. We selected all double-blind, randomized, placebo-controlled clinical trials in which adult patients with rheumatoid arthritis (RA) were treated with MTX (dose ≤ 25 mg/week) concurrently with folate supplementation. We included only trials using low-dose folic or folinic acid (a starting dose of ≤ 7 mg weekly) because the high dose is no longer recommended or used. Data were extracted from the trials, and the trials were independently assessed for risk of bias using a predetermined set of criteria.Results.Six trials with 624 patients were eligible for inclusion. Most studies had low or unclear risk of bias for key domains. The quality of the evidence was rated as “moderate” for each outcome as assessed by the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) working group, with the exception of hematologic side effects, which were rated as “low.” There was no significant heterogeneity between trials, including where folic acid and folinic acid studies were pooled. For patients supplemented with any form of exogenous folate (either folic or folinic acid) while receiving MTX therapy for RA, a 26% relative (9% absolute) risk reduction was seen for the incidence of gastrointestinal side effects such as nausea, vomiting, or abdominal pain (RR 0.74, 95% CI 0.59 to 0.92; p = 0.008). Folic and folinic acid also appear to be protective against abnormal serum transaminase elevation caused by MTX, with a 76.9% relative (16% absolute) risk reduction (RR 0.23, 95% CI 0.15 to 0.34; p < 0.00001), as well as reducing patient withdrawal from MTX for any reason [60.8% relative (15.2% absolute) risk reduction, RR 0.39, 95% CI 0.28 to 0.53; p < 0.00001].Conclusion.The results support a protective effect of supplementation with either folic or folinic acid for patients with RA during treatment with MTX. There was a clinically important significant reduction shown in the incidence of GI side effects and hepatic dysfunction (as measured by elevated serum transaminase levels), as well as a clinically important significant reduction in discontinuation of MTX treatment for any reason.

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