scholarly journals Statins for primary prevention and rhabdomyolysis: A nationwide cohort study in France

2018 ◽  
Vol 26 (5) ◽  
pp. 512-521 ◽  
Author(s):  
Joël Coste ◽  
Cécile Billionnet ◽  
Annie Rudnichi ◽  
Jacques Pouchot ◽  
Rosemary Dray-Spira ◽  
...  
Keyword(s):  
Cardiovascular Disease ◽  
Cohort Study ◽  
Survival Analysis ◽  
Primary Prevention ◽  
Hazard Ratio ◽  
Lipid Lowering ◽  
Control Analysis ◽  
High Potency ◽  
Time Control ◽  
Overall Risk

Aims The purpose of this study was to investigate the risk of rhabdomyolysis in subjects initiating statin therapy for primary prevention of cardiovascular disease, focusing on the type of statin, dose and time since initiation. Methods and results A nationwide cohort study using French hospital discharge and claims databases was performed, studying subjects from the general population 40–75 years in 2009, with no history of cardiovascular disease and no lipid-lowering drugs during the preceding three-year period, followed for up to seven years. The primary outcome was hospitalization for rhabdomyolysis. Event-free survival analysis and case-time-control analysis were both performed, separately by gender. The cohort included 8,236,667 subjects, 969,460 of whom initiated a lipid-lowering drug for cardiovascular disease primary prevention. During 18,407,391 person-months exposed to statins, 168 events were observed, corresponding to an incidence of rhabdomyolysis of 1.10 per 10,000 person-years (1.54 in men vs 0.81 in women); 10/168 cases were fatal, and 18/168 and 57/168 cases occurred during the first month and first trimester of treatment, respectively. Survival analysis did not reveal any increased overall risk (hazard ratio = 1.02 (0.83–1.25) in men and 0.76 (0.60–0.96) in women). However, exposure to high-potency statins was associated with an increased risk in men (hazard ratio = 1.93 (1.27–2.94)). Rosuvastatin 20 mg (in men and women) and simvastatin 40 mg (in men) were associated with hazard ratios > 5. Case-time-control analyses showed similar patterns of risk. Drug interactions did not appear to significantly contribute to rhabdomyolysis events in this study. Conclusion Although the overall risk of statin-associated rhabdomyolysis in the context of primary prevention was not increased, the first months of treatment and the use of high-potency statins represent at-risk situations, which require appropriate monitoring, especially in men.

scholarly journals Association between refill adherence to lipid-lowering medications and the risk of cardiovascular disease and mortality in Swedish patients with type 2 diabetes mellitus: a nationwide cohort study

BMJ Open ◽  
2018 ◽  
Vol 8 (3) ◽  
pp. e020309 ◽  
Author(s):  
Sofia Axia Karlsson ◽  
Christel Hero ◽  
Ann-Marie Svensson ◽  
Stefan Franzén ◽  
Mervete Miftaraj ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Cardiovascular Disease ◽  
Type 2 Diabetes Mellitus ◽  
Primary Prevention ◽  
Secondary Prevention ◽  
Exposure Period ◽  
Lipid Lowering ◽  
Refill Adherence

ObjectivesTo analyse the association between refill adherence to lipid-lowering medications, and the risk of cardiovascular disease (CVD) and mortality in patients with type 2 diabetes mellitus.DesignCohort study.SettingNational population-based cohort of Swedish patients with type 2 diabetes mellitus.Participants86 568 patients aged ≥18 years, registered with type 2 diabetes mellitus in the Swedish National Diabetes Register, who filled at least one prescription for lipid-lowering medication use during 2007–2010, 87% for primary prevention.Exposure and outcome measuresRefill adherence of implementation was assessed using the medication possession ratio (MPR), representing the proportion of days with medications on hand during an 18-month exposure period. MPR was categorised by five levels (≤20%, 21%–40%, 41%–60%, 61%–80% and >80%). Patients without medications on hand for ≥180 days were defined as non-persistent. Risk of CVD (myocardial infarction, ischaemic heart disease, stroke and unstable angina) and mortality by level of MPR and persistence was analysed after the exposure period using Cox proportional hazards regression and Kaplan-Meier, adjusted for demographics, socioeconomic status, concurrent medications and clinical characteristics.ResultsThe hazard ratios for CVD ranged 1.33–2.36 in primary prevention patients and 1.19–1.58 in secondary prevention patients, for those with MPR ≤80% (p<0.0001). The mortality risk was similar regardless of MPR level. The CVD risk was 74% higher in primary prevention patients and 33% higher in secondary prevention patients, for those who were non-persistent (p<0.0001). The mortality risk was 6% higher in primary prevention patients and 18% higher in secondary prevention patients, for non-persistent patients (p<0.0001).ConclusionsHigher refill adherence to lipid-lowering medications was associated with lower risk of CVD in primary and secondary prevention patients with type 2 diabetes mellitus.

scholarly journals Assessing gaps in cholesterol treatment guidelines for primary prevention of cardiovascular disease based on available randomised clinical trial evidence: The Rotterdam Study

2017 ◽  
Vol 25 (4) ◽  
pp. 420-431 ◽  
Author(s):  
Jelena Pavlović ◽  
Philip Greenland ◽  
Jaap W Deckers ◽  
Maryam Kavousi ◽  
Albert Hofman ◽  
...  
Keyword(s):  
Cardiovascular Disease ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Primary Prevention ◽  
Randomised Clinical Trial ◽  
Lipid Lowering ◽  
Randomised Clinical Trials ◽  
Atherosclerotic Cardiovascular Disease ◽  
Intermediate Risk ◽  
Clinical Trial Evidence

Background The purpose of this study was to determine how American College of Cardiology/American Heart Association (ACC/AHA) 2013 and European Society of Cardiology 2016 guidelines for the primary prevention of atherosclerotic cardiovascular disease (CVD) compare in reflecting the totality of accrued randomised clinical trial evidence for statin treatment at population level. Methods From 1997–2008, 7279 participants aged 45–75 years, free of atherosclerotic cardiovascular disease, from the population-based Rotterdam Study were included. For each participant, we compared eligibility for each one of 11 randomised clinical trials on statin use in primary prevention of CVD, with recommendations on lipid-lowering therapy from the ACC/AHA and European Society of Cardiology (ESC) guidelines. Atherosclerotic cardiovascular disease incidence and cardiovascular disease mortality rates were calculated. Results The proportion of participants eligible for each trial ranged from 0.4% for ALLHAT-LLT to 30.8% for MEGA. The likelihood of being recommended for lipid-lowering treatment was lowest for those eligible for low-to-intermediate risk RCTs (HOPE-3, MEGA, and JUPITER), and highest for high-risk individuals with diabetes (MRC/BHF HPS, CARDS, and ASPEN) or elderly PROSPER. Eligibility for an increasing number of randomised clinical trials correlated with a greater likelihood of being recommended lipid-lowering treatment by either guideline ( p < 0.001 for both guidelines). Conclusion Compared to RCTs done in high risk populations, randomised clinical trials targeting low-to-intermediate risk populations are less well-reflected in the ACC/AHA, and even less so in the ESC guideline recommendations. Importantly, the low-to-intermediate risk population targeted by HOPE-3, the most recent randomised clinical trial in this field, is not well-captured by the current European prevention guidelines and should be specifically considered in future iterations of the guidelines.

scholarly journals Ultra-processed food intake and risk of cardiovascular disease: prospective cohort study (NutriNet-Santé)

BMJ ◽  
2019 ◽  
pp. l1451 ◽  
Author(s):  
Bernard Srour ◽  
Léopold K Fezeu ◽  
Emmanuelle Kesse-Guyot ◽  
Benjamin Allès ◽  
Caroline Méjean ◽  
...  
Keyword(s):  
Cardiovascular Disease ◽  
Cohort Study ◽  
Disease Risk ◽  
Saturated Fatty Acids ◽  
Cerebrovascular Diseases ◽  
Incidence Rates ◽  
Hazard Ratio ◽  
Sensitivity Analyses ◽  
Processed Foods ◽  
Processed Food

AbstractObjectiveTo assess the prospective associations between consumption of ultra-processed foods and risk of cardiovascular diseases.DesignPopulation based cohort study.SettingNutriNet-Santé cohort, France 2009-18.Participants105 159 participants aged at least 18 years. Dietary intakes were collected using repeated 24 hour dietary records (5.7 for each participant on average), designed to register participants’ usual consumption of 3300 food items. These foods were categorised using the NOVA classification according to degree of processing.Main outcome measuresAssociations between intake of ultra-processed food and overall risk of cardiovascular, coronary heart, and cerebrovascular diseases assessed by multivariable Cox proportional hazard models adjusted for known risk factors.ResultsDuring a median follow-up of 5.2 years, intake of ultra-processed food was associated with a higher risk of overall cardiovascular disease (1409 cases; hazard ratio for an absolute increment of 10 in the percentage of ultra-processed foods in the diet 1.12 (95% confidence interval 1.05 to 1.20); P<0.001, 518 208 person years, incidence rates in high consumers of ultra-processed foods (fourth quarter) 277 per 100 000 person years, and in low consumers (first quarter) 242 per 100 000 person years), coronary heart disease risk (665 cases; hazard ratio 1.13 (1.02 to 1.24); P=0.02, 520 319 person years, incidence rates 124 and 109 per 100 000 person years, in the high and low consumers, respectively), and cerebrovascular disease risk (829 cases; hazard ratio 1.11 (1.01 to 1.21); P=0.02, 520 023 person years, incidence rates 163 and 144 per 100 000 person years, in high and low consumers, respectively). These results remained statistically significant after adjustment for several markers of the nutritional quality of the diet (saturated fatty acids, sodium and sugar intakes, dietary fibre, or a healthy dietary pattern derived by principal component analysis) and after a large range of sensitivity analyses.ConclusionsIn this large observational prospective study, higher consumption of ultra-processed foods was associated with higher risks of cardiovascular, coronary heart, and cerebrovascular diseases. These results need to be confirmed in other populations and settings, and causality remains to be established. Various factors in processing, such as nutritional composition of the final product, additives, contact materials, and neoformed contaminants might play a role in these associations, and further studies are needed to understand better the relative contributions. Meanwhile, public health authorities in several countries have recently started to promote unprocessed or minimally processed foods and to recommend limiting the consumption of ultra-processed foods.Study registrationClinicalTrials.gov NCT03335644.

scholarly journals Cardiovascular effect of discontinuing statins for primary prevention at the age of 75 years: a nationwide population-based cohort study in France

2019 ◽  
Vol 40 (43) ◽  
pp. 3516-3525 ◽  
Author(s):  
Philippe Giral ◽  
Anke Neumann ◽  
Alain Weill ◽  
Joël Coste
Keyword(s):  
Cardiovascular Disease ◽  
Cohort Study ◽  
Primary Prevention ◽  
Cardiovascular Event ◽  
Structural Model ◽  
Medication Possession Ratio ◽  
Population Based ◽  
Cerebrovascular Event ◽  
Increased Risk ◽  
Time Varying Covariates

Abstract Aims The role of statin therapy in primary prevention of cardiovascular disease in persons older than 75 years remains a subject of debate with little evidence to support or exclude the benefit of this treatment. We assessed the effect of statin discontinuation on cardiovascular outcomes in previously adherent 75-year-olds treated for primary prevention. Methods and results A population-based cohort study using French national healthcare databases was performed, studying all subjects who turned 75 in 2012–14, with no history of cardiovascular disease and with a statin medication possession ratio ≥80% in each of the previous 2 years. Statin discontinuation was defined as three consecutive months without exposure. The outcome was hospital admission for cardiovascular event. The hazard ratio comparing statin discontinuation with continuation was estimated using a marginal structural model adjusting for both baseline and time-varying covariates (cardiovascular drug use, comorbidities, and frailty indicators). A total of 120 173 subjects were followed for an average of 2.4 years, of whom 17 204 (14.3%) discontinued statins and 5396 (4.5%) were admitted for a cardiovascular event. The adjusted hazard ratios for statin discontinuation were 1.33 [95% confidence interval (CI) 1.18–1.50] (any cardiovascular event), 1.46 (95% CI 1.21–1.75) (coronary event), 1.26 (95% CI 1.05–1.51) (cerebrovascular event), and 1.02 (95% CI 0.74–1.40) (other vascular event). Conclusion Statin discontinuation was associated with a 33% increased risk of admission for cardiovascular event in 75-year-old primary prevention patients. Future studies, including randomized studies, are needed to confirm these findings and support updating and clarification of guidelines on the use of statins for primary prevention in the elderly.

scholarly journals New Male Users of Lipid-Lowering Drugs for Primary Prevention of Cardiovascular Disease: The Impact of Treatment Persistence on Morbimortality. A Longitudinal Study

2020 ◽  
Vol 17 (20) ◽  
pp. 7653
Author(s):  
Isabel Aguilar-Palacio ◽  
María José Rabanaque ◽  
Lina Maldonado ◽  
Armando Chaure ◽  
José María Abad-Díez ◽  
...  
Keyword(s):  
Cardiovascular Disease ◽  
Primary Prevention ◽  
Smoking Status ◽  
Lipid Lowering ◽  
Major Adverse Cardiovascular Events ◽  
Treatment Persistence ◽  
Effect Of Treatment ◽  
Lowering Drug ◽  
The Impact ◽  
Prevention Of Cardiovascular Disease

The objective of this study was to analyse persistence to lipid-lowering drug use for primary prevention of cardiovascular disease (CVD) in a new users cohort, to explore all-cause and cardiovascular related morbidity, comorbidity and mortality in this group and, finally, to study the relationship between persistence and morbimortality. We selected subjects who started lipid-lowering treatment for primary prevention of CVD between 1 January 2010 and 31 December 2017 (N = 1424), and classified them as treatment-persistent or -nonpersistent. Bivariate analyses were performed to compare sociodemographic and clinical variables, morbimortality and time to event between groups. The association between morbidities was explored using comorbidity network analysis. The effect of persistence was analysed using logistic regression and Cox survival analyses. Only 38.7% of users were persistent with treatment. Persistent and nonpersistent users had similar sociodemographic and clinical profiles, although differed in age, smoking status, and glycemia. Comorbidity networks revealed that the number of co-occurring diagnoses was higher in nonpersistent than persistent users. Adjusted analyses indicated a protective effect of treatment persistence, especially against major adverse cardiovascular events (MACE), but this effect was not statistically significant. Observational studies are crucial to characterize real-world effectiveness.

scholarly journals Cardiovascular Disease and All-Cause Mortality in Male Twins With Discordant Cardiorespiratory Fitness: A Nationwide Cohort Study

2020 ◽  
Vol 189 (10) ◽  
pp. 1114-1123
Author(s):  
Marcel Ballin ◽  
Anna Nordström ◽  
Peter Nordström
Keyword(s):  
Cardiovascular Disease ◽  
Cohort Study ◽  
Confidence Interval ◽  
Cardiorespiratory Fitness ◽  
Military Service ◽  
Lower Risk ◽  
Hazard Ratio ◽  
Familial Factors ◽  
All Cause Mortality

Abstract Whether genetic and familial factors influence the association between cardiorespiratory fitness (CRF) and cardiovascular disease (CVD) is unknown. Two cohorts were formed based on data from 1,212,295 men aged 18 years who were conscripted for military service in Sweden during 1972–1996. The first comprised 4,260 twin pairs in which the twins in each pair had different CRF (≥1 watt). The second comprised 90,331 nonsibling pairs with different CRF and matched on birth year and year of conscription. Incident CVD and all-cause mortality were identified using national registers. During follow-up (median 32 years), there was no difference in CVD and mortality between fitter twins and less fit twins (246 vs. 251 events; hazard ratio (HR) = 1.00, 95% confidence interval (CI): 0.83, 1.20). The risks were similar in twin pairs with ≥60-watt difference in CRF (HR = 0.96, 95% CI: 0.57, 1.64). In contrast, in the nonsibling cohort, fitter men had a lower risk of the outcomes than less fit men (4,444 vs. 5,298 events; HR = 0.83, 95% CI: 0.79, 0.86). The association was stronger in pairs with ≥60-watt difference in CRF (HR = 0.65, 95% CI: 0.59, 0.71). These findings indicate that genetic and familial factors influence the association of CRF with CVD and mortality.

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