Abstract 149: Impact of Baseline 10-year Cardiovascular Risk on Benefit and Harm of Intensive Treatment in SPRINT

Hypertension ◽  
2017 ◽  
Vol 70 (suppl_1) ◽  
Author(s):  
Robert A Phillips ◽  
Jiaqiong Xu ◽  
Leif E Peterson ◽  
Joseph A Diamond ◽  
Adam E Schussheim

We investigated the impact of baseline CV risk on outcomes in SPRINT. Using the ACC/AHA CVD risk algorithm, we stratified the SPRINT population into quartiles of baseline 10-year CV risk. Within each quartile, Cox proportional hazards models were used to examine the effect of intensive treatment vs. standard of care on the SPRINT CV outcomes, all-cause mortality and serious adverse events (SAEs). Number needed to treat (NNT) and number needed to harm (NNH) were calculated for each quartile. There were 9,323 participants with available baseline ACC/AHA 10-year risk scores. In each quartile of risk, the hazard ratio (HR) favored intensive treatment. For CV outcomes, NNT decreased from 91 in the 1 st quartile to 38 in the 4 th quartile. For all-cause mortality, NNT decreased from 333 in the 1 st quartile to 45 in the 4 th quartile. Although incidence of all SAEs increased with each quartile in both treatment groups (p for trend <0.0001), there was no difference in incidence of SAEs between the treatment groups in each quartile. However, SAEs classified as hypotension were more frequent in the 4 th quartile for the intensive treatment group (incremental increase 1.8%, NNH = 55) and SAEs classified as acute kidney injury or acute renal failure were significantly more frequent in the 2 nd , 3 rd and 4 th quartiles for the intensively treated group (incremental increase 1.7%, 2.4% and 2.1%; NNH 59, 42 and 48, respectively). Therefore, those with greatest baseline CVD risk got the most benefit from intensive BP treatment but were at greater risk for hypotension and renal injury. This analysis may help providers and patients make decisions regarding the intensity of BP treatment to prevent death and CV events.

2019 ◽  
Vol 17 (3) ◽  
pp. 298-306 ◽  
Author(s):  
Charalambos Vlachopoulos ◽  
Dimitrios Terentes-Printzios ◽  
Konstantinos Aznaouridis ◽  
Nikolaos Ioakeimidis ◽  
Panagiotis Xaplanteris ◽  
...  

Background: Recent data advocate adoption of a more intensive treatment strategy for management of blood pressure (BP). </P><P> Objective: We investigated whether the overall effects of the Systolic Blood Pressure Intervention Trial (SPRINT) are applicable to cardiovascular disease (CVD) patients. </P><P> Methods: In a post hoc analysis we analyzed data from SPRINT that randomly assigned 9361 individuals to a systolic BP (SBP) target of <120 mmHg (intensive treatment) or <140 mmHg (standard treatment). 1562 patients had clinically evident CVD (age=70.3±9.3 years, 24% females) at study entry and were followed for 3.1 years. Further, we assessed the effect of low (<150 mmHg) baseline SBP on outcome. </P><P> Results: In CVD patients, there was no benefit from the intensive treatment regarding all endpoints, except for a marginally significant benefit on all-cause mortality (hazard ratio [HR]: 0.67; 95% confidence interval [CI], 0.45 to 1.00; p=0.0509). Further, while there was no increase in serious adverse events (SAE) in the intensive group, there was increased risk for study-related SAE, acute renal failure and electrolyte abnormalities. In patients with low baseline SBP there was a beneficial effect on allcause mortality (HR: 0.56; 95% CI: 0.33 to 0.96; p=0.033), but with greater stroke incidence (HR: 2.94; 95% CI: 1.04 to 8.29; p=0.042). </P><P> Conclusion: We confirm the beneficial effect of the intensive strategy in SPRINT study on all-cause mortality and the harmful effect on specific adverse outcomes in patients with CVD. However, in patients with low baseline SBP stroke may increase.


2019 ◽  
Vol 4 ◽  
pp. 71 ◽  
Author(s):  
Priti Gupta ◽  
David Prieto-Merino ◽  
Vamadevan S. Ajay ◽  
Kalpana Singh ◽  
Ambuj Roy ◽  
...  

Introduction: Cardiovascular diseases (CVDs) are the leading cause of death in India. The CVD risk approach is a cost-effective way to identify those at high risk, especially in a low resource setting. As there is no validated prognostic model for an Indian urban population, we have re-calibrated the original Framingham model using data from two urban Indian studies. Methods: We have estimated three risk score equations using three different models. The first model was based on Framingham original model; the second and third are the recalibrated models using risk factor prevalence from CARRS (Centre for cArdiometabolic Risk Reduction in South-Asia) and ICMR (Indian Council of Medical Research) studies, and estimated survival from WHO 2012 data for India. We applied these three risk scores to the CARRS and ICMR participants and estimated the proportion of those at high-risk (>30% 10 years CVD risk) who would be eligible to receive preventive treatment such as statins. Results: In the CARRS study, the proportion of men with 10 years CVD risk > 30% (and therefore eligible for statin treatment) was 13.3%, 21%, and 13.6% using Framingham, CARRS and ICMR risk models, respectively. The corresponding proportions of women were 3.5%, 16.4%, and 11.6%. In the ICMR study the corresponding proportions of men were 16.3%, 24.2%, and 16.5% and for women, these were 5.6%, 20.5%, and 15.3%. Conclusion: Although the recalibrated model based on local population can improve the validity of CVD risk scores our study exemplifies the variation between recalibrated models using different data from the same country. Considering the growing burden of cardiovascular diseases in India, and the impact that the risk approach has on influencing cardiovascular prevention treatment, such as statins, it is essential to develop high quality and well powered local cohorts (with outcome data) to develop local prognostic models.


Circulation ◽  
2015 ◽  
Vol 131 (suppl_1) ◽  
Author(s):  
Duke Appiah ◽  
Pamela J Schreiner ◽  
Raegan W Durant ◽  
Sharina D Person ◽  
Catarina I Kiefe ◽  
...  

Introduction: Cardiovascular disease (CVD) mortality has decreased over recent decades, in part, due to changes in the prevalence of risk factors. However, few studies have explored the impact of the obesity epidemic on CVD risk prediction in young adults. Hypothesis: We assessed the hypothesis that BMI trends are positively associated with changes in 10-year AHA/ACC atherosclerotic cardiovascular disease (ASCVD) risk scores from young adulthood to middle age beyond the effect of other CVD risk factors included in the scores (age, sex, race, lipids, blood pressure, hypertension medication, diabetes, smoking). METHODS: Data were obtained from 2437 black and white men and women aged 18-30 years at baseline (1985-1986) enrolled in the Coronary Artery Risk Development in Young Adults (CARDIA) study with follow-up exams at year 0, 5, 10, 15, 20 and 25 (ages 43-55 years). Repeated-measures regression was used to model the association between ASCVD risk scores and time-varying BMI measures. RESULTS: The average 10-year ASCVD risk increased from 0.6% at baseline (mean age: 25.3) to 3.9% at year 25 (mean age: 50.3) with the change higher for men (blacks: 1.0 to 8.2%, whites: 0.3 to 4.6%) than women (blacks: 0.5 to 3.6%, whites: 1.2 to 1.4%). The overall prevalence of obesity at baseline and year 25 was 10% and 42% respectively. BMI trends were positively associated with 10-year change in ASCVD risk scores (0.12% per 1 kg/m2 increase, p<0.001). BMI adjustment minimally reduced risk scores trends with the greatest change between unadjusted and adjusted risk scores observed among black women (0.1 to 3.0%) (Figures A and B). CONCLUSION: In young adults, BMI trends are associated positively with 10-year changes in ASCVD risk independent of other risk factors. This adds to the evidence that weight control in early adulthood is an important predictor of lower future CVD risk.


Circulation ◽  
2007 ◽  
Vol 116 (suppl_16) ◽  
Author(s):  
Bernhard Schwaab ◽  
Annika Waldmann ◽  
Alexander Katalinic ◽  
Britta Poppe ◽  
Abdolhamid Sheikhzadeh ◽  
...  

Background: The evidence of cardiac Rehab is not fully settled as meta-analysis mostly included studies without acute revascularisation and modern preventive medication. Method: In a multicentre randomised controlled trial, 1.474 patients (pts.) with acute CAD were included to investigate the impact of telemedicine on chronic CAD: 679 pts. were included immediately at discharge from the hospital (Hosp), 795 pts. after three week in-patient Rehab. All pts. had acute coronary angiography and were followed for one year. As Hosp pts. were included 11,3 ± 3 days (median 11) earlier than Rehab pts., events in the Hosp group were counted from day 12. Results: Rehab pts. were older (64 ±10 vs. 62 ±10 years; p<.001), had more congestive heart failure (64 vs. 40%, p<.001), renal insufficiency (10 vs. 7%, p=.036), hypercholesterolemia (79 vs. 74%, p=.023), and carotid stenosis (8 vs. 4%, p=.004). Telemedicine device prescription, gender, atrial fibrillation, peripheral artery disease, diabetes, hypertension, education and social status were similar in groups. After one year, Rehab pts. had more β-blockers (88 vs. 75%, p<.001), ACE-inhibitors (81 vs. 70%, p<.001), lower LDL-C (102 ±35 vs. 121 ±47 mg/dl, p<.001) and a higher proportion of non-smokers (62 vs. 56%, p=.024). There was no difference in platelet inhibition, anticoagulation and statin therapy (81 vs. 79%). The primary combined endpoint of all-cause mortality, acute myocardial infarction (AMI), coronary revascularisation and hospitalisation occurred in 32.6% of Rehab pts. and in 38.7% of Hosp pts. (p=.014; absolute risk reduction (ARR) 0.0615, relative risk reduction (RRR) 16%, number needed to treat (NNT) 17). AMI (1.8 vs. 3.8%, p=.015; ARR 0.0207, RRR 54%, NNT 49) was reduced. Revascularisation (4.2 vs. 5.4%), hospitalisation (33.6 vs. 38.0%) and all-cause mortality (2.1 vs. 2.4%) were similar between groups. After multivariate analysis, the primary endpoint was still significant: OR 0.716 (95% CI 0.575–0.892; p=0.003) giving a RRR of 28% in favour of Rehab therapy. Conclusion: Although Rehab pts. were sicker at entry, cardiac Rehab substantially reduced relevant clinical endpoints within one year. With a very low NNT, Rehab is highly effective and should be advised to all suitable patients with acute CAD.


BJGP Open ◽  
2020 ◽  
Vol 4 (1) ◽  
pp. bjgpopen20X101012
Author(s):  
Morten Charles ◽  
Niels Henrik Bruun ◽  
Rebecca Simmons ◽  
Else-Marie Dalsgaard ◽  
Daniel Witte ◽  
...  

BackgroundThere is no long-term evidence on the effectiveness of training for motivational interviewing in diabetes treatment.AimWithin a trial of intensive treatment of people with screen-detected diabetes, which included training in motivational interviewing for GPs, the study examined the effect of the intervention on incident cardiovascular disease (CVD) and all-cause mortality.Design & settingIn the ADDITION-Denmark trial, 181 general practices were cluster randomised in a 2:1:1 ratio to: (i) to screening plus routine care of individuals with screen-detected diabetes (control group); (ii) screening plus training and support in intensive multifactorial treatment of individuals with screen-detected diabetes (intensive treatment group); or (iii) screening plus training and support in intensive multifactorial treatment and motivational interviewing for individuals with screen-detected diabetes (intensive treatment plus motivational interviewing group). The study took place from 2001–2009.MethodAfter around 8 years follow-up, rates of first fatal and non-fatal CVD events and all-cause mortality were compared between screen-detected individuals in the three treatment groups.ResultsCompared with the routine care group, the risk of CVD was similar in the intensive treatment group (hazard ratio [HR] 1.11, 95% confidence interval [CI] = 0.82 to 1.50) and the intensive treatment plus motivational interviewing group (HR 1.26, 95% CI = 0.96 to 1.64). The incidence of death was similar in all three treatment groups.ConclusionTraining of GPs in intensive multifactorial treatment, with or without motivational interviewing, was not associated with a reduction in mortality or CVD among those with screen-detected diabetes.


2020 ◽  
Vol 70 (700) ◽  
pp. e765-e771
Author(s):  
Alexander Pate ◽  
Richard Emsley ◽  
Tjeerd van Staa

BackgroundIn 2014, the National Institute for Health and Care Excellence (NICE) changed the recommended threshold for initiating statins from a 10-year risk of cardiovascular disease (CVD) of 20% to 10% (Clinical Guideline 181), making 4.5 million extra people eligible for treatment.AimTo evaluate the impact of this guideline change on statin prescribing behaviour.Design and settingA descriptive study using data from Clinical Practice Research Datalink (CPRD), a primary care database in England.MethodPeople aged 25–84 years being initiated on statins for the primary prevention of CVD were identified. CVD risk predictions were calculated for every person using data in their medical record (calculated risks), and were extracted directly from their medical record if a QRISK score was recorded (coded risks). The 10-year CVD risks of people initiated on statins in each calendar year were compared.ResultsThe average ‘calculated risk’ of all people being initiated on statins was 20.65% in the year before the guideline change, and 20.27% after. When considering only the ‘coded risks’, the average risk was 21.85% before the guideline change, and 18.65% after. The proportion of people initiating statins that had a coded risk score in their medical record increased significantly from 2010–2017.ConclusionCurrently available evidence, which only considers people with coded risk scores in their medical record, indicates the guideline change had a large impact on statin prescribing. However, that analysis likely suffers from selection bias. This new evidence indicates only a modest impact of the guideline change. Further qualitative research about the lack of response to the guideline change is needed.


2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1155.1-1155
Author(s):  
D. Gerasimova ◽  
E. Gerasimova ◽  
T. Popkova ◽  
A. Melkumyan

Background:Cardiovascular diseases (CVD) are the most common and socially significant comorbidities and the main cause of premature mortality in rheumatoid arthritis (RA). Appropriate RA therapy should not only suppress RA activity, but also reduce CVD risk.Objectives:To evaluate CVD risk and analyze its association with the use of conventional therapy in RA patients (pts).Methods:The study included 100 pts with RA (92 women and 8 men) aged 30 to 60 without established CVD. The median age was 49.5 [44.5;53] years, duration of RA was 144 [60;240] months, DAS28 was 4.4 [3.3;5.3] points. Eighty six RA pts (86%) treated with disease-modifying antirheumatic drugs (DMARDs) (methotrexate, n=55; leflunomide, n=12; hydroxychloroquine, n=8; sulfasalazine, n=11), including 33 pts (33%) in combination with glucocorticoids (GCs). Fourteen pts (14%) received monotherapy with GCs. Pts were divided into three treatment groups: DMARDs group, n=53; GCs group, n=14; DMARDs+GCs group, n=33. CVD risk was calculated with ASSIGN, QRISK3, and ERS-RA scales.Results:No differences were found between the groups when calculating CVD risk using ASSIGN (table 1). Estimated CVD risk by QRISK3 was lower in DMARDs group (4.9 [3.0; 7.7]) than in DMARDs+GCs group (7.1 [4.1; 13.6], p<0.05). High CVD risk on the ERS-RA scale was determined less frequently (13%) and median CVD risk was lower in DMARDs group (4.2 [2.2; 5.4]) than in GCs group (57%; 8.9 [4.8; 11.7], p<0.01) and DMARDs+GCs group (39%; 6.6 [3; 9.3], p<0.05, respectively). In DMARDs group, significant differences in CVD risk by ERS-RA were found in pts treated with hydroxychloroquine (2 [1.4; 5.8]) and leflunomid (6.2 [2.8; 12.3], p<0.05).Conclusion:RA pts treated with DMARDs have a reduced risk for CVD than pts treated with GCs or a combination of DMARDs and GCs. GCs significantly increase CVD risk. To clarify the impact of hydroxychloroquine and leflunomid on CVD risk, a study on a larger number of pts is required.Table 1.The impact of conventional antirheumatic therapy on CVD risk.TreatmentASSIGNQRISK3ERS-RAHigh CVD risk, %median[25-75 percentiles]High CVD risk,%median[25-75 percentiles]High CVD risk,%median[25-75 percentiles]DMARDs, n=53611 [6.5;14]24.9 [3;7.7] v13*v4.2 [2.2;5.4] *vGCs, n=1479.5 [7;13]76.6 [4.4;15.8]57*8.9 [4.8;11.7] *DMARDs+GCs, n=331510 [5;13.5]97.1 [4.1;13.6] v39v6.6 [3;9.3] vNote: * - p<0.01 between pts receiving DMARDs and GCs; v - p<0.05 between pts receiving DMARDs and DMARDs+GCs.Disclosure of Interests:None declared


2018 ◽  
Vol 21 (11) ◽  
pp. 1496-1505
Author(s):  
Phillipa K Reihana ◽  
Neville M Blampied ◽  
Julia J Rucklidge

Abstract Introduction Many smokers do not achieve abstinence using current smoking cessation options. This randomized controlled trial (RCT) investigated a novel nutritional supplement to assist with quitting smoking. Methods Following a baseline phase where cigarettes per day and nicotine dependence were measured, participants (n = 107) were randomized to placebo (n = 50) or micronutrient conditions (n = 57). A 4-week pre-quit phase permitted titration up to 12 capsules/day. During the quit phase (12 weeks), participants were registered with a public Quitline while consuming micronutrients or placebo. Carbon monoxide levels were measured to confirm smoking cessation. Results Forty-five (42%) participants completed the trial. Treatment and placebo groups did not differ on the primary outcome of continuous abstinence at 12 weeks using intention-to-treat analysis; however, 28% of the micronutrient-treated group had quit versus 18% for placebo (odds ratio [OR] = 1.78, 95% confidence interval [CI] = 0.71 to 4.48), with number needed to treat = 10. Comparison of cigarette consumption (cigarettes per day) between micronutrient and placebo groups showed that those taking micronutrients reported reduced consumption throughout the trial, notably at pre-quit weeks 1 and 4, and at quit phase week 4. There were no serious adverse events, blinding was successful, and there were no substantive group differences in side effects or dropout rate. Conclusion This is the first RCT investigating the impact of micronutrients on smoking reduction, finding that micronutrients reduced harm through reduction in number of cigarettes smoked relative to placebo. The small sample and high dropout rate limit confidence in the conclusions and generalizability of the study; however, assessed by number needed to treat, micronutrients are comparable to other smoking cessation treatments but with fewer side effects. Future research using larger and longer trials including cost-effectiveness and biomarker measures is encouraged. Implications Micronutrients are being increasingly studied for the treatment of psychiatric conditions, but direct application of micronutrients as a treatment for addictions is novel. There is extensive evidence that micronutrients alleviate stress. Given that tobacco smoking is often used to cope with stress, taking micronutrients may moderate the stress of withdrawal and increase the chance of a successful quit attempt. This study is the first known RCT to investigate the use of micronutrients to support smoking cessation. Treatments that are safe, effective, relatively inexpensive, and readily available are needed and micronutrient supplements offer one such possible alternative.


2019 ◽  
Vol 4 ◽  
pp. 71 ◽  
Author(s):  
Priti Gupta ◽  
David Prieto-Merino ◽  
Vamadevan S. Ajay ◽  
Kalpana Singh ◽  
Ambuj Roy ◽  
...  

Introduction: Cardiovascular diseases (CVDs) are the leading cause of death in India. The CVD risk approach is a cost-effective way to identify those at high risk, especially in a low resource setting. As there is no validated prognostic model for an Indian urban population, we have re-calibrated the original Framingham model using data from two urban Indian studies. Methods: We have estimated three risk score equations using three different models. The first model was based on Framingham original model; the second and third are the recalibrated models using risk factor prevalence from CARRS (Centre for cArdiometabolic Risk Reduction in South-Asia) and ICMR (Indian Council of Medical Research) studies, and estimated survival from WHO 2012 data for India. We applied these three risk scores to the CARRS and ICMR participants and estimated the proportion of those at high-risk (>30% 10 years CVD risk) who would be eligible to receive preventive treatment such as statins. Results: In the CARRS study, the proportion of men with 10 years CVD risk > 30% (and therefore eligible for statin treatment) was 13.3%, 21%, and 13.6% using Framingham, CARRS and ICMR risk models, respectively. The corresponding proportions of women were 3.5%, 16.4%, and 11.6%. In the ICMR study the corresponding proportions of men were 16.3%, 24.2%, and 16.5% and for women, these were 5.6%, 20.5%, and 15.3%. Conclusion: Although the recalibrated model based on local population can improve the validity of CVD risk scores our study exemplifies the variation between recalibrated models using different data from the same country. Considering the growing burden of cardiovascular diseases in India, and the impact that the risk approach has on influencing cardiovascular prevention treatment, such as statins, it is essential to develop high quality and well powered local cohorts (with outcome data) to develop local prognostic models.


2021 ◽  
Vol 10 (12) ◽  
pp. 2713
Author(s):  
Vicente Martínez-Vizcaíno ◽  
Ana Díez-Fernández ◽  
Celia Álvarez-Bueno ◽  
Julia Martínez-Alfonso ◽  
Iván Cavero-Redondo

To jointly assess the safety and effectiveness of sodium-glucose cotransporter 2 inhibitors (SGLT2i) on cardiorenal outcomes and all-cause mortality in type 2 diabetes mellitus (T2DM) with or at high risk of cardiovascular disease (CVD). We performed a systematic review and network meta-analysis, systematically searching the MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials and Web of Science databases up to September 2020. Primary outcomes were composite major adverse cardiovascular events (MACEs), hospitalization for heart failure, all-cause mortality and a composite renal outcome. We performed a random effects network meta-analysis estimating the pooled hazard ratio (HR), risk ratio and number needed to treat (NNT). Six trials evaluating empagliflozin, canagliflozin, dapagliflozin and ertugliflozin met the inclusion/exclusion criteria, which comprised 46,969 patients, mostly with established CVD. Pooled estimates (95% CI) of benefits of SGLT2i in terms of HR and NNT were as follows: for all-cause mortality, 0.85 (0.75, 0.97) and 58 (28, 368); for MACE, 0.91 (0.85, 0.97) and 81 (44, 271); for hospitalization for heart failure, 0.70 (0.62, 0.78) and 32 (20, 55); and for composite renal outcome, 0.61 (0.50, 0.74) and 20 (11, 44). Pooled estimates for serious adverse events were 0.92 (95% CI 0.89, 0.95). In patients with T2DM at cardiovascular risk, ertugliflozin is a less potent drug than empagliflozin, canagliflozin or dapagliflozin to prevent cardiorenal events and all-cause mortality. In addition, our data endorse that empagliflozin is the best treatment option among SGLT2i for this type of patient, but the evidence is not consistent enough.


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