Dataset Information

Role of Traditional Cardiovascular Risk Factors after Initiation of Statin Therapy: A PharmLines Inception Cohort Study.

ABSTRACT:

Background

Multiple studies and meta-analyses examined the role of traditional risk factors for cardiovascular events in statin treatment-naive patients. Nowadays, millions receive such therapy for the primary prevention of cardiovascular events (CVE).

Objective

CVEs still occur in patients on primary preventive statin therapy. Therefore, further risk stratification within these patients is urgently needed.

Methods

Using the unique linkage between biomedical data and prescription data from the PharmLines Initiative, we assessed the role of several risk factors used in cardiovascular risk models, using a time-dependent Cox PH model, in the occurrence of drug treatment of CVEs after initiation of statin therapy.

Results

Among 602 statin therapy starters, 11% received drug treatment for CVE within an average follow-up period of 832 days. After multivariable modelling, cholesterol levels and blood pressure at baseline were no longer associated, whereas self-reported diabetes and increasing age were highly associated with the outcome when on statin therapy (hazard ratio (HR): 3.01, 95% confidence interval (95% CI): 1.48-6.12 and 1.04; 95% CI: 1.01-1.07, respectively). Males, smokers, and nonadherent patients had increased risks (HR 1.6, 1.12, and 1.18, resp.), though not statistically significant.

Conclusion

Drug treatment for CVEs after statin initiation is increased in patients with diabetes type 2, in aged patients, males, smokers, and those with poor adherence, while there was no association with baseline cholesterol levels and blood pressure. These factors should be taken into account during the monitoring of statin therapy and may lead to changes in statin treatment or risk-related lifestyle factors.

SUBMITTER: Steenhuis D

PROVIDER: S-EPMC9155967 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Role of Traditional Cardiovascular Risk Factors after Initiation of Statin Therapy: A PharmLines Inception Cohort Study.

Steenhuis Dennis D de Vos Stijn S Bos Jens J Hak Eelko E

Cardiovascular therapeutics 20220524

<h4>Background</h4>Multiple studies and meta-analyses examined the role of traditional risk factors for cardiovascular events in statin treatment-naive patients. Nowadays, millions receive such therapy for the primary prevention of cardiovascular events (CVE).<h4>Objective</h4>CVEs still occur in patients on primary preventive statin therapy. Therefore, further risk stratification within these patients is urgently needed.<h4>Methods</h4>Using the unique linkage between biomedical data and prescr ...[more]

PMID: 35676913

Similar Datasets

Project description:ImportanceStatin therapy has been associated with increased insulin resistance; however, its clinical implications for diabetes control among patients with diabetes is unknown.ObjectiveTo assess diabetes progression after initiation of statin use in patients with diabetes.Design, setting, and participantsThis was a retrospective matched-cohort study using new-user and active-comparator designs to assess associations between statin initiation and diabetes progression in a national cohort of patients covered by the US Department of Veterans Affairs from fiscal years 2003-2015. Patients included were 30 years or older; had been diagnosed with diabetes during the study period; and were regular users of the Veterans Affairs health system, with records of demographic information, clinical encounters, vital signs, laboratory data, and medication usage.InterventionsTreatment initiation with statins (statin users) or with H2-blockers or proton pump inhibitors (active comparators).Main outcomes and measuresDiabetes progression composite outcome comprised the following: new insulin initiation, increase in the number of glucose-lowering medication classes, incidence of 5 or more measurements of blood glucose of 200 mg/dL or greater, or a new diagnosis of ketoacidosis or uncontrolled diabetes.ResultsFrom the 705 774 eligible patients, we matched 83 022 pairs of statin users and active comparators; the matched cohort had a mean (SD) age of 60.1 (11.6) years; 78 712 (94.9%) were men; 1715 (2.1%) were American Indian/Pacific Islander/Alaska Native, 570 (0.8%) were Asian, 17 890 (21.5%) were Black, and 56 633 (68.2 %) were White individuals. Diabetes progression outcome occurred in 55.9% of statin users vs 48.0% of active comparators (odds ratio, 1.37; 95% CI, 1.35-1.40; P < .001). Each individual component of the composite outcome was significantly higher among statin users. Secondary analysis demonstrated a dose-response relationship with a higher intensity of low-density lipoprotein-cholesterol lowering associated with greater diabetes progression.Conclusions and relevanceThis retrospective matched-cohort study found that statin use was associated with diabetes progression, including greater likelihood of insulin treatment initiation, significant hyperglycemia, acute glycemic complications, and an increased number of prescriptions for glucose-lowering medication classes. The risk-benefit ratio of statin use in patients with diabetes should take into consideration its metabolic effects.

Project description:AimStatins may increase the risk of new-onset diabetes and adversely affect glycaemic control, but their effects on the glycemic response and mortality outcomes following commencement of insulin therapy in patients with Type 2 Diabetes (T2D) are unclear.MethodsA retrospective cohort study was conducted in 12,725 insulin initiators with T2D using The Health Improvement Network (THIN) UK database. Changes in HbA1c at 6, 12, 24 and 36 months, and the 5-year risk of mortality and (3-point) major adverse cardiovascular events (MACE), were compared between prior users (n = 10,682) and non-users (n = 2043) of statin therapy who were newly commenced on insulin treatment. Cox proportional hazard models were used to estimate the hazard ratios of the different outcomes.ResultsMean age of the cohort was 58.7 ± 14.0 years (51% male) and mean baseline HbA1c was 8.7 ± 1.8%. A greater initial reduction in HbA1c was observed following insulin initiation in the non-users of statins compared with the users, which was significant in the short term (-0.34% vs -0.26% at 6 months; mean diff = -0.09%, p = 0.004) but not in the long term: -0.31% versus -0.35% at 3 years (mean diff = 0.05%, p = 0.344). CV events (3-point MACE) were 878 versus 217 in statin users versus non-users (20.7 vs 30.9 per 1000 person-years; adjusted Hazard Ratio (aHR) 1.36 (95% CI 1.15-1.62; p < 0.0001). In a subgroup analysis of individual statins, HbA1c was higher throughout the study duration with all statins relative to non-users of statin therapy (p < 0.05). The aHRs for 3-point MACE for atorvastatin, simvastatin, rosuvastatin and pravastatin were 0.82 (95% CI 0.68-0.98), 0.67 (0.55-0.82), 0.56 (0.39-0.81) and 0.78 (0.60-1.01), respectively.ConclusionsFollowing initiation of insulin therapy in patients with T2D in routine care, concurrent use of a statin was associated with less good glycaemic control in the short-term but a much lower risk of major adverse CV events.

Project description:BackgroundRisk evaluation of atherosclerotic cardiovascular disease (ASCVD) remains the cornerstone of primary prevention. The cardiovascular risk assessment can guide the decision-making on various preventive measures such as initiating or deferring statin therapy. Thus, our study aimed to assess the physicians' knowledge, attitude, and practices regarding atherosclerotic cardiovascular diseases risk assessment. Also, we evaluated the physician-patient discussion and counseling practices before statin therapy initiation in concordance with recommendations from the latest clinical practice guideline.MethodsA cross-sectional study was conducted between November 2020 and January 2021. A self-administered questionnaire was distributed to 350 physicians (GPs, residents, specialists, and consultants). Two trained pharmacists distributed the questionnaires in 5 major tertiary governmental hospitals and more than ten private hospitals. Also, private clinics were targeted so that we get a representative sample of physicians at different workplaces.ResultsA total of 270 physicians filled the questionnaire out of 350 physicians approached, with 14 being excluded due to high missing data, giving a final response rate of 73%. Participants had suboptimal knowledge and practices with a high positive attitude toward atherosclerotic cardiovascular diseases risk assessment. The knowledge and practices were higher among consultants, participants from the cardiology department, those with experience years of more than nine years, and those who reported following a specific guideline for cholesterol management or using a risk calculator in their practice. Notably, the risk assessment and counseling practices were lower among physicians who reported seeing more patients per day.ConclusionPhysicians had overall low knowledge, suboptimal practices, and a high positive attitude toward cardiovascular risk assessment. Therefore, physicians' training and continuing medical education regarding cholesterol management and primary prevention clinical practice guidelines are recommended. Also, the importance of adherence to clinical practice guidelines and their impact on clinical outcomes should be emphasized.

Project description:ImportanceThe American College of Cardiology and the American Heart Association (ACC/AHA) cholesterol treatment guidelines have wide-scale implications for treating adults without history of atherosclerotic cardiovascular disease (ASCVD) with statins.ObjectiveTo estimate the cost-effectiveness of various 10-year ASCVD risk thresholds that could be used in the ACC/AHA cholesterol treatment guidelines.Design, setting, and participantsMicrosimulation model, including lifetime time horizon, US societal perspective, 3% discount rate for costs, and health outcomes. In the model, hypothetical individuals from a representative US population aged 40 to 75 years received statin treatment, experienced ASCVD events, and died from ASCVD-related or non-ASCVD-related causes based on ASCVD natural history and statin treatment parameters. Data sources for model parameters included National Health and Nutrition Examination Surveys, large clinical trials and meta-analyses for statin benefits and treatment, and other published sources.Main outcomes and measuresEstimated ASCVD events prevented and incremental costs per quality-adjusted life-year (QALY) gained.ResultsIn the base-case scenario, the current ASCVD threshold of 7.5% or higher, which was estimated to be associated with 48% of adults treated with statins, had an incremental cost-effectiveness ratio (ICER) of $37,000/QALY compared with a 10% or higher threshold. More lenient ASCVD thresholds of 4.0% or higher (61% of adults treated) and 3.0% or higher (67% of adults treated) had ICERs of $81,000/QALY and $140,000/QALY, respectively. Shifting from a 7.5% or higher ASCVD risk threshold to a 3.0% or higher ASCVD risk threshold was estimated to be associated with an additional 161,560 cardiovascular disease events averted. Cost-effectiveness results were sensitive to changes in the disutility associated with taking a pill daily, statin price, and the risk of statin-induced diabetes. In probabilistic sensitivity analysis, there was a higher than 93% chance that the optimal ASCVD threshold was 5.0% or lower using a cost-effectiveness threshold of $100,000/QALY.Conclusions and relevanceIn this microsimulation model of US adults aged 45 to 75 years [corrected], the current 10-year ASCVD risk threshold (≥7.5% risk threshold) used in the ACC/AHA cholesterol treatment guidelines has an acceptable cost-effectiveness profile (ICER, $37,000/QALY), but more lenient ASCVD thresholds would be optimal using cost-effectiveness thresholds of $100,000/QALY (≥4.0% risk threshold) or $150,000/QALY (≥3.0% risk threshold). The optimal ASCVD threshold was sensitive to patient preferences for taking a pill daily, changes to statin price, and the risk of statin-induced diabetes.

Dataset Information

Role of Traditional Cardiovascular Risk Factors after Initiation of Statin Therapy: A PharmLines Inception Cohort Study.

Background

Objective

Methods

Results

Conclusion

Publications

Role of Traditional Cardiovascular Risk Factors after Initiation of Statin Therapy: A PharmLines Inception Cohort Study.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets