scholarly journals Effectiveness of blood pressure–lowering treatment by the levels of baseline Framingham risk score: A post hoc analysis of the Systolic Blood Pressure Intervention Trial (SPRINT)

2019 ◽  
Vol 21 (12) ◽  
pp. 1813-1820 ◽  
Author(s):  
Ling Zhang ◽  
Xiuting Sun ◽  
Lizhen Liao ◽  
Shaozhao Zhang ◽  
Huimin Zhou ◽  
...  
BMJ Open ◽  
2018 ◽  
Vol 8 (7) ◽  
pp. e021685 ◽  
Author(s):  
Frederick Warner ◽  
Sanket S Dhruva ◽  
Joseph S Ross ◽  
Pranammya Dey ◽  
Karthik Murugiah ◽  
...  

ObjectivesTo understand the discrepancy between the published 10-year cardiovascular risk and 10-year cardiovascular risk generated from raw data using the Framingham Risk Score for participants in the Systolic Blood Pressure Intervention Trial (SPRINT).DesignSecondary analysis of SPRINT data published inThe New England Journal of Medicine(NEJM) and made available to researchers in late 2016.SettingSPRINT clinical trial sites.ParticipantsStudy participants enrolled into SPRINT.ResultsThe number of SPRINT study participants identified as having ≥15% 10-year cardiovascular risk was not consistent with what was reported in the original publication. Using the data from the trial, the Framingham Risk Score indicated ≥15% 10-year cardiovascular risk for 7089 participants compared with 5737 reported in the paper, a change from 61% to 76% of the total study population.ConclusionsThe analysis of the clinical trial data by independent investigators identified an error in the reporting of the risk of the study population. The SPRINT trial enrolled a higher risk population than was reported in the initial publication, which was brought to light by data sharing.


2019 ◽  
Vol 6 (6) ◽  
pp. 356-363 ◽  
Author(s):  
Christina Byrne ◽  
Manan Pareek ◽  
Muthiah Vaduganathan ◽  
Tor Biering-Sørensen ◽  
Arman Qamar ◽  
...  

Abstract Aims The 2018 ESC/ESH guidelines for hypertension recommend differential management of patients who are <65, 65–79, and ≥80 years of age. However, it is unclear whether intensive blood pressure lowering is well-tolerated and modifies risk uniformly across the age spectrum. Methods and results SPRINT randomized 9361 high-risk adults without diabetes and age ≥50 years with systolic blood pressure 130–180 mmHg to either intensive or standard antihypertensive treatment. The primary efficacy endpoint was the composite of acute coronary syndromes, stroke, heart failure, or death from cardiovascular causes. The primary safety endpoint was composite serious adverse events. We assessed whether age modified the efficacy and safety of intensive vs. standard blood pressure lowering using Cox proportional-hazards regression and restricted cubic splines. In all, 3805 (41%), 4390 (47%), and 1166 (12%) were <65, 65–79, and ≥80 years. Mean age was similar between the two study groups (intensive group 67.9 ± 9.4 years vs. standard group 67.9 ± 9.5 years; P = 0.94). Median follow-up was 3.3 years. In multivariable models, age was linearly associated with the risk of stroke (P < 0.001) and non-linearly associated with the risk of primary efficacy events, death from cardiovascular causes, death from any cause, heart failure, and serious adverse events (P < 0.001). The safety and efficacy of intensive blood pressure lowering were not modified by age, whether tested continuously or categorically (P > 0.05). Conclusion In SPRINT, the benefits and risks of intensive blood pressure lowering did not differ according to the age categories proposed by the ESC/ESH guidelines for hypertension. Trial Registration SPRINT (Systolic Blood Pressure Intervention Trial); ClinicalTrials.gov Identifier: NCT01206062, https://clinicaltrials.gov/ct2/show/NCT01206062.


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