Statin Use In Patients Research Articles

Association of Statin Therapy Initiation With Diabetes Progression

Statin therapy has been associated with increased insulin resistance; however, its clinical implications for diabetes control among patients with diabetes is unknown. To assess diabetes progression after initiation of statin use in patients with diabetes. This 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. Treatment initiation with statins (statin users) or with H2-blockers or proton pump inhibitors (active comparators). Diabetes 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. From 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. This 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.

Effectiveness of statins in patients with stroke due to cervical artery dissection: A preliminary study

BackgroundStatin therapy has become one of the most important advances in stroke secondary prevention. Nevertheless, statin therapy in patients who present an ischemic stroke following cervical artery dissection (CAD) has not yet been supported by clinical evidence. This study aimed to investigate the effect of statins on neurological outcomes after a stroke due to CAD. MethodsWe conducted a prospective cohort study including consecutive patients diagnosed with a stroke due to CAD. Subjects were classified into non-statin, simvastatin 20mg, simvastatin 40mg, and high-potency statin groups. After 2 years, the functional outcome, stroke recurrence, major cardiovascular events, and mortality were assessed. ResultsAmong the 54 patients included in our cohort, there were 16 (29.6%) patients without statins, 22 (40.7%) with simvastatin 20mg, 12 (22.2%) with simvastatin 40mg and 4 (7.5%) with high-potency statins. Using simvastatin 40mg was associated with a significantly lower incidence of stroke recurrence. Patients with simvastatin 40mg and high-potency statins presented the best functional recovery throughout the follow-up (p<.01). DiscussionThe use of statins in patients with CAD-related stroke may improve functional outcomes in specific cases. Statins do not prevent stroke recurrence and major cardiovascular events in this type of stroke.

Efficacy of Statin Therapy in Patients with Hospital Admission for COVID-19.

PurposeCOVID-19 is characterized by dysfunctional immune responses and metabolic derangements, which in some, lead to multi-organ failure and death. Statins are foundational lipid-lowering therapeutics for cardiovascular disease and also possess beneficial immune-modulating properties. Because of these immune-modulating properties, some have suggested their use in COVID-19. We sought to investigate the association between statin use and mortality in patients hospitalized with COVID-19.MethodsFive thousand three hundred seventy-five COVID-19 patients admitted to Mount Sinai Health System hospitals in New York between February 27, 2020, and December 3, 2020, were included in this analysis. Statin use was classified as either non-user, low-to-moderate-intensity user, or high-intensity user. Multivariate Cox proportional hazards models were used to evaluate in-hospital mortality rate. Considered covariates were age, sex, race, and comorbidities.ResultsCompared to non-statin users, both low-to-moderate-intensity (adjusted hazard ratio; aHR 0.62, 95% confidential intervals; CI 0.51–0.76) and high-intensity statin users (aHR 0.53, 95% CI 0.43–0.65) had a reduced risk of death. Subgroup analysis of 723 coronary artery disease patients showed decreased mortality among high-intensity statin users compared to non-users (aHR 0.51, 95% CI 0.36–0.71).ConclusionsStatin use in patients hospitalized with COVID-19 was associated with a reduced in-hospital mortality. The protective effect of statin was greater in those with coronary artery disease. These data support continued use of statin therapy in hospitalized patients with COVID-19. Clinical trials are needed to prospectively determine if statin use is effective in lowering the mortality in COVID-19 and other viral infections.Supplementary InformationThe online version contains supplementary material available at 10.1007/s10557-021-07263-2.

Statin Use Reduces Mortality in Patients Who Develop Major Complications After Transcarotid Artery Revascularization

Statins are often used for primary and secondary prevention of cardiovascular events. Multiple studies have demonstrated a significant reduction in perioperative complications after carotid endarterectomy for patients taking statins. However, data for statin use for patients undergoing transcarotid artery revascularization (TCAR) are limited. We evaluated the effects of statin use on the postoperative outcomes after TCAR.

LB760 Statin use in patients with pre-existing inflammatory myopathies

Systemic autoimmune myopathies (SAM) are a group of rare rheumatic diseases associated with high morbidity and disability. Recent studies have shown a high prevalence of hyperlipidemia in patients with SAM. While statins are commonly used lipid-lowering medications, the safety of statin use in patients with SAM is still unclear. The objective of this study was to evaluate the safety of statin use in patients with pre-existing SAM. We performed a single-center retrospective cohort study of adult patients with clinically diagnosed SAM between 2008-2018.

The Association Between the Use of Statins and Clinical Outcomes in Patients with COVID-19: A Systematic Review and Meta-analysis.

PurposePreviously, we have reported potential clinical benefits with the use of statins in patients with coronavirus disease 2019 (COVID-19) in a meta-analysis, where there was a significantly reduced hazard for a fatal or severe course of illness with the use of statins, but the meta-analysis was limited by the small number of studies included, with small heterogeneity among studies, due to the unavailability of more studies at the point of literature search. We aimed to perform an updated systematic review and meta-analysis to summarize the existing evidence on the effect of statins on the clinical outcomes of patients with COVID-19.MethodsElectronic databases, including PubMed, Google Scholar, and Scopus, and preprint servers were searched (last updated June 3, 2021) to identify studies investigating the association between the use of statins in patients with COVID-19 and the development of severe disease and/or mortality. Random-effects model meta-analyses were performed to estimate the pooled odds ratio (OR) or hazard ratio (HR) with 95% confidence intervals (CIs). The outcomes of interest were (1) all-cause mortality and (2) a composite endpoint of severe illness of COVID-19.ResultsUpon systematic literature search, we identified 35 studies, of which 32 studies reported the outcome of all-cause mortality and 15 studies reported the composite endpoint of severe COVID-19 illness between statin users versus non-statin users with COVID-19. Our meta-analysis revealed that the use of statins was associated with a significantly lower risks of all-cause mortality (HR = 0.70, 95% CI 0.58–0.84, n = 21,127, and OR = 0.63, 95% CI 0.51–0.79, n = 115,097) and the composite endpoint of severe illness (OR = 0.80, 95% CI 0.73–0.88, n = 10,081) in patients with COVID-19, compared to non-use of statins, at the current sample size.ConclusionStatin use is associated with a better prognosis in patients with COVID-19. Our findings provide a rationale to investigate the use of statins among patients with COVID-19 in large scale clinical trials.

Reduction of Myocardial Infarction and All-Cause Mortality Associated to Statins in Patients Without Obstructive CAD

ObjectivesThe aim of this work was to evaluate the prognostic impact of statin therapy in symptomatic patients without obstructive CAD. BackgroundInformation on the prognostic impact of post–coronary computed tomographic angiography (CTA) statin use in patients with no or nonobstructive coronary artery disease (CAD) is sparse. MethodsPatients undergoing CTA with suspected CAD in western Denmark from 2008 to 2017 with <50% coronary stenoses were identified. Information on post-CTA use of statin therapy and cardiovascular events were obtained from national registries. ResultsThe study included 33,552 patients, median aged 56 years, 58% female, with no (n = 19,669) or nonobstructive (n = 13,883) CAD and a median follow-up of 3.5 years. The absolute risk of the combined end point of myocardial infarction (MI) or all-cause mortality was directly associated with the CAD burden with an event rate/1,000 patient-years of 4.13 (95% CI: 3.69-4.61) in no, 7.74 (95% CI: 6.88-8.71) in mild (coronary artery calcium score [CACS] 0-99), 13.72 (95% CI: 11.61-16.23) in moderate (CACS 100-399), and 32.47 (95% CI: 26.25-40.16) in severe (CACS ≥400) nonobstructive CAD. Statin therapy was associated with a multivariable adjusted HR for MI and death of 0.52 (95% CI: 0.36-0.75) in no, 0.44 (95% CI: 0.32-0.62) in mild, 0.51 (95% CI: 0.34-0.75) in moderate, and 0.52 (95% CI: 0.32-0.86) in severe nonobstructive CAD. The estimated numbers needed to treat to prevent the primary end point were 92 (95% CI: 61-182) in no, 36 (95% CI: 26-58) in mild, 24 (95% CI: 15-61) in moderate, and 13 (95% CI: 7-86) in severe nonobstructive CAD. Residual confounding may persist, but not to an extent explaining all of the observed risk reduction associated with statin treatment. ConclusionsThe risk of MI and all-cause mortality in patients without obstructive CAD is directly associated with the CAD burden. Statin therapy is associated with a reduction of MI and all-cause death across the spectrum of CAD, however, the absolute benefit of treatment is directionally proportional with the CAD burden.

Evaluation of Statin Use and Prescribing in Patients with Chronic Kidney Disease Not Receiving Treatment with Kidney Transplant or Dialysis

Chronic kidney disease (CKD) is a risk factor for cardiovascular disease. The Kidney Disease Improving Global Outcomes 2013 guidelines and the Canadian Cardiovascular Society 2016 guidelines recommend statins for primary prevention of cardiovascular disease in CKD patients aged 50 years or older who are not receiving treatment with kidney transplant or dialysis. To evaluate statin use for patients in the Vancouver General Hospital Kidney Care Clinic (VGH KCC) and to gain insight into the KCC nephrologists' practices and perspectives regarding the prescribing of statins for patients with CKD. The study comprised 2 parts. Part 1 consisted of a cross-sectional study of all statin-eligible patients in the VGH KCC followed by a retrospective chart review. In the chart review, data were collected for 250 statin users and 250 non-users. Logistic regression analyses were performed to determine associations between demographic variables and statin use or non-use. Part 2 was an electronic survey of VGH KCC nephrologists. Of the 813 statin-eligible patients, 512 (63%) were taking a statin. Patients were approximately 5 times more likely to be receiving statin therapy when it was indicated for secondary versus primary prevention (adjusted odds ratio 4.64, 95% confidence interval 2.95-7.47). Eight of the 9 KCC nephrologists completed the survey, and 7 (87.5%) of these respondents indicated that they never or rarely prescribed statins themselves to KCC patients for primary prevention. However, the same number reported that they sometimes or often suggested statin initiation to family physicians. Three of the respondents indicated agreement with guideline recommendations, but many stated that the decision for statin initiation should be individualized to the patient. Strategies to improve statin prescribing rates that were endorsed by respondents included educating family physicians, creating preprinted orders and laboratory requisitions for statin initiation, providing educational materials about statins to patients, and implementing a protocol for KCC pharmacists to counsel patients about statins. Many statin-eligible VGH KCC patients were not receiving statin therapy, and most of the KCC nephrologists considered statin prescribing as a role for family physicians. Within the KCC, future directions will be to develop a standardized approach to identify patients who would benefit from statin therapy, and to implement strategies to improve statin prescribing rates in appropriate patients.

Communicating personalised statin therapy-effects as 10-year CVD-risk or CVD-free life-expectancy: does it improve decisional conflict? Three-armed, blinded, randomised controlled trial

ObjectiveTo determine whether communicating personalised statin therapy-effects obtained by prognostic algorithm leads to lower decisional conflict associated with statin use in patients with stable cardiovascular disease (CVD) compared with standard...

Outcomes of Preinjury Use of Statins in Patients with Traumatic Brain Injury: A Systematic Review and Meta-analysis

No completely effective pharmacotherapies have been developed to improve the outcomes of traumatic brain injury (TBI). Given the reporting of cohort studies suggesting that preinjury statin use may reduce TBI-associated mortality, this study aimed to evaluate the effects of statin use in patients with TBI. This study was performed according to the PRISMA guidelines. The PubMed, Embase, Cochrane Central, Web of Science, and China National Knowledge Infrastructure databases were searched from inception until April 13, 2021, using a search strategy that included 2 main terms: "statins" and "traumatic brain injury." The outcomes were mortality, hospital length of stay, and intensive care unit length of stay, which were evaluated using a random-effects model and represented by the pooled risk ratio with 95% confidence intervals. The search results identified 7 eligible studies, with a total of 111,935 patients with brain injury. Preinjury statin use in patients with TBI was associated with a significantly decreased risk of mortality compared with that in nonusers (risk ratio, 0.75; 95% confidence interval, 0.59-0.94; I2= 53%). Subgroup analysis showed that statin withdrawal might increase mortality. Sensitivity analysis showed that the results were stable and robust. Preinjury statin use may contribute to mortality reduction in patients with TBI, whereas statin withdrawal might increase mortality. In clinical management, statin use should not be discontinued after TBI.

Association Between Statin Medication and Asthma/Asthma Exacerbation in a National Health Screening Cohort

Statins, which are a type of 3-hydroxy-3-methylglutaryl-CoA inhibitor, have multiple therapeutic effects, including anti-inflammatory and immunomodulatory properties. Despite positive preclinical data on statin use in patients with asthma, clinical trials and epidemiological studies have yielded conflicting results. To evaluate the association between statin use and an asthma diagnosis in all participants and the effects of statins on asthma-related outcomes among patients with asthma using a national health screening cohort. Patients with asthma and control participants matched for age group, sex, income, and region of residence were selected from the Korean National Health Insurance Service-Health Screening Cohort data. This case-control study comprised 88,780 people with asthma and the same number of control participants. Asthma exacerbation (AE) was defined as an emergency department visit, a history of hospitalization due to asthma, or the use of systemic steroids for 2 weeks. Conditional and unconditional logistic regression analyses were used to evaluate the effect of the previous use of statins on an asthma diagnosis or AE after adjusting for multiple covariates. A significant association between a statin prescription and an asthma diagnosis was not observed in this cohort (adjusted odds ratio, 1.01; 95% CI, 0.98-1.03; P= .633 for 1 year of statin prescription). Among the patients with asthma, 16.54% (n= 14,687) were categorized into the AE group and the others (n= 74,093) were categorized into the no AE group. A statin prescription was associated with fewer AEs in patients with asthma (adjusted odds ratio, 0.89; 95% CI, 0.84-0.93; P < .001 for 1 year of statin prescription). Statin use was associated with a reduced risk of asthma-related emergency department visits, hospitalizations, and systemic steroid use in patients with asthma in this cohort study.

Prevalence and Factors Associated With Statin Use Among Patients With Nonalcoholic Fatty Liver Disease in the TARGET-NASH Study

Patients with nonalcoholic fatty liver disease (NAFLD) are at an increased risk of cardiovascular disease. Hydoxy-3-methyglutaryl-coenzyme reductase inhibitors, statins, reduce the risk of cardiovascular events.1 Studies have shown that statins are safe among patients with liver disease, including those with compensated cirrhosis,2 and their use is associated with lower mortality, hepatic decompensation, and possibly hepatocellular carcinoma.3,4 Despite these data, statins are under prescribed among patients with liver disease due to concerns about hepatotoxicity.5 This study aimed to assess prevalence and patient factors associated with indicated statin use in patients with NAFLD in a real-world cohort.

Statins for treatment of chronic liver disease.

Statins are a class of lipid lower medications used primarily in patients with high-risk cardiovascular disease. Since their development, statins have been considered to be harmful in patients with liver disease, and many of the prescribing information labels consider them to be contraindicated in patients with active liver disease. However, recent studies have shown the contrary, warranting further investigation and discussion. This review aims to describe the latest literature on the mechanism, safety profile and potential benefits of statins use on the natural history of chronic liver disease (CLD) progression and its complications. A number of recently published studies have added to the existing body of literature supporting the concept that statins are safe and likely to be beneficial for treating patients with CLD. Patients with CLD including hepatitis B virus infection, hepatitis C virus infection, nonalcoholic fatty liver disease and alcohol on statins have been shown to have a lower rate of decompensating events, lower incidence of hepatocellular cancer, a lower rate of infections, and increased survival. However, the majority of the available literature supporting statin use in patients with liver disease comes from retrospective observational studies with high potential for bias. Statins appear to be safe in patients with compensated cirrhosis, and evidence suggests that they may reduce fibrosis, even in patients with advanced fibrosis and cirrhosis. Further high-quality research on this topic is needed to fully delineate the effect of statins in patients with liver disease.

Association between antecedent statin use and decreased mortality in hospitalized patients with COVID-19

The coronavirus disease 2019 (COVID-19) can result in a hyperinflammatory state, leading to acute respiratory distress syndrome (ARDS), myocardial injury, and thrombotic complications, among other sequelae. Statins, which are known to have anti-inflammatory and antithrombotic properties, have been studied in the setting of other viral infections, but their benefit has not been assessed in COVID-19. This is a retrospective analysis of patients admitted with COVID-19 from February 1st through May 12th, 2020 with study period ending on June 11th, 2020. Antecedent statin use was assessed using medication information available in the electronic medical record. We constructed a multivariable logistic regression model to predict the propensity of receiving statins, adjusting for baseline sociodemographic and clinical characteristics, and outpatient medications. The primary endpoint includes in-hospital mortality within 30 days. A total of 2626 patients were admitted during the study period, of whom 951 (36.2%) were antecedent statin users. Among 1296 patients (648 statin users, 648 non-statin users) identified with 1:1 propensity-score matching, statin use is significantly associated with lower odds of the primary endpoint in the propensity-matched cohort (OR 0.47, 95% CI 0.36–0.62, p < 0.001). We conclude that antecedent statin use in patients hospitalized with COVID-19 is associated with lower inpatient mortality.

Statin use in patients with elevated serum hepatic transaminases at baseline: A meta-analysis

AimsClinical trials showed that statin therapy decreased cardiovascular events without significantly raising the level of transaminases. However, the information in subjects with altered liver test at baseline is more limited. The objectives of this meta-analysis were to analyze the liver safety and cardiovascular benefit when using a statin-based lipid-lowering treatment compared to a less intensive treatment or placebo, in subjects with abnormal liver tests at baseline. Data synthesisWe performed a meta-analysis including randomized trials of statin-based lipid-lowering therapy versus less intensive lipid-lowering therapy or placebo, reporting worsening hepatic test (>3 ULN) and cardiovascular events in patients with abnormal liver tests at baseline. The random-effects model was performed. This meta-analysis was performed according to PRISMA guidelines. Five eligible trials, including 2548 patients were identified and considered eligible for the analyses. A more intensive statin-based lipid-lowering therapy were associated with a similar occurrence of serious alteration of liver tests (OR: 0.90, 95% confidence interval: 0.21–3.99; I2: 64%) compared to less intensive or placebo treatments. Likewise, more intensive lipid-lowering strategies were associated with a significant reduction in major cardiovascular events (OR: 0.34, 95% confidence interval: 0.17–0.70; I2: 66%). ConclusionsIn this study, a more intensive statin-based lipid-lowering treatment, compared with less intensive treatment or placebo, showed a similar incidence of worsening transaminases levels in patients with abnormal liver tests at baseline. Also, a reduction in cardiovascular events was observed when a more intensive lipid-lowering therapy was used.

Statin use in patients with liver disease - overview and results from a retrospektive observational study

Statin use in patients with liver disease - overview and results from a retrospektive observational study

The impact of statin use prior to intensive care unit admission on critically ill patients with sepsis.

To evaluate the impact of pre-intensive care unit admission (pre-ICU) statin use on all-cause in-hospital mortality and ICU length of stay (LOS). Retrospective cohort study. Adult ICUs at tertiary hospitals. Adult critically ill patients diagnosed with sepsis admitted to the ICUs. The exposure was pre-ICU statin prescription (statin users); unexposed represented absence of pre-ICU prescription (non-users). We used the 2001-2012 Medical Information Mart for Intensive Care-III (MIMIC-III) database to determine average treatment effect (ATE) of pre-ICU statin use on 30-day ICU mortality, ICU LOS, and 30-day in-hospital mortality using the Augmented Inverse Propensity Weighted technique (AIPW), after adjusting for confounding factors (age, race, health insurance, corticosteroids use, vital signs, laboratory tests, and Sequential Organ Failure Assessment score (SOFA). We measured 30-day ICU mortality as deaths within 30days of admission to the ICU, and ICU LOS was measured in fractional days. A 30-day in-hospital mortality was measured as death within 30days of hospital admission. A total of 8200 patients with sepsis were identified; 19.8% (1623) were statin users, and 80.2% (6577) were non-users. Most were Caucasian, aged 80years and above, and male. After adjusting for confounding factors, pre-ICU statin use decreased 30-day ICU mortality (ATE, -0.026; 95% confidence interval [CI], -0.048 to -0.009); ICU LOS (ATE, -0.369; 95% Cl, -0.849 to -0.096); and 30-day in-hospital mortality (ATE, -0.039; 95% CI, -0.084 to -0.026) on average compared with non-statin use, respectively. In a stratified analysis, the result for ICU LOS (ATE, -0.526; 95% CI, -0.879 to -0.241) and 30-day in-hospital mortality (ATE, -0.023; 95% CI, -0.048 to -0.002) was consistent among patients admitted to the medical ICU. Among patients with sepsis admitted to the medical ICU, pre-ICU statin use is causally associated with a decrease in 30-day ICU mortality, ICU LOS, and 30-day in-hospital mortality compared to non-use. This study adds to the totality of evidence on the pleiotropic effect of statin use in patients with sepsis.

Efficacy of statins on renal function in patients with chronic kidney disease: a systematic review and meta-analysis

Background Studies have shown that the use of statins could significantly improve lipid profiles; however, it remains controversial whether the use of statins could improve renal function in patients with chronic kidney disease (CKD). Therefore, we conducted a meta-analysis of randomized controlled trials (RCTs) to evaluate the effects of statins on renal function in patients with CKD. Methods We systematically searched PubMed, EMBASE, and the Cochrane Library databases for eligible RCTs from inception to October 2020. Pooled effect estimates were assigned as weighted mean differences (WMDs) with 95% confidence intervals (CIs) using the random-effects model. Results We selected 33 RCTs that recruited 37,391 patients with CKD patients. The summary results suggested that statin use significantly reduced urinary albumin (WMD: −2.04; 95%CI: −3.53 to −0.56; p = .007) and protein (WMD: −0.58; 95%CI: −0.95 to −0.21; p = .002) excretions and increased creatinine clearance (WMD: 0.86; 95%CI: 0.32–1.41; p = .002). However, there were no significant differences between statin and control groups in terms of changes in estimated glomerular filtration rate (WMD: 0.38; 95%CI: −0.04 to 0.79; p = .075), and serum creatinine levels (WMD: −0.07; 95%CI: −0.25, 0.12; p = .475). Conclusions We found that statin use in patients with CKD may slow CKD progression by lowering urinary albumin and protein excretions or increasing creatinine clearance. Further large-scale RCTs should be conducted to evaluate the long-term effects of statins on renal outcomes. Abbreviations: CKD: chronic kidney disease; RCT: randomized controlled trials; WMD: weighted mean differences; CI: confidence intervals; ACEI: angiotensin-converting enzyme inhibitors; eGFR: estimated glomerular filtration rate

Abstract 15098: New-Onset Diabetes Mellitus Risk in Statin Users Depends on Baseline HemoglobinA1c Value - Results of VA Database Analysis

Introduction: Statin use in non-diabetic patients is associated with an increased risk of development of new-onset diabetes mellitus (NODM). However, little is known if baseline hemoglobin A1c (HbA1c) can affect diabetogenic risks and mortality benefits of statin therapy. Methods: In a retrospective cohort study between 01/2011 and 12/2018 we collected the data of 152358 non-diabetic US veterans on statin and not on statin therapy who had available baseline HbA1c value and full demographic and clinical information prior to DM diagnosis. The risk of statin-induced DM and all-cause mortality rate were assessed in the whole cohort and based on baseline HbA1c categories: ≤5.6%, 5.7-5.9% and 6.0-6.4%. DM rate and mortality rate were calculated by Cox proportional hazards model adjusted for case-mix. Results: After mean follow up of 6.89 (SD 2.26) years in non-statin users and 3.85 (SD 2.29) years in statin users and adjustments for multiple covariates such as age, gender, ethnicity, obesity, hypertension (HTN), cardiovascular disease, and metformin use, we found that the rate of statin-induced DM depends on baseline HbA1c (Table 1). Analysis by HbA1c categories showed that NODM rate is inversely related to HbA1c level, while statin use in patients with HbA1c 6.0-6.4% was not associated with increased rate of NODM. We did not observe increase in all-cause mortality in statin users and statin users with HTN across HbA1c categories. Atorvastatin use was associated with decrease in all-cause mortality in HTN patients (Table 1). Conclusions: The results of this largest to date analysis of non-diabetic US veterans closely matched for baseline characteristics suggest that the rate of statin-induced DM depends on baseline HbA1c. The significant increase in NODM rate is only observed in patients with baseline HbA1c &lt;6.0% regardless of statin type prescribed. The increased NODM risk is not associated with all-cause mortality in statin users in general including patients with HTN.

Clinical factors, psychological factors and beliefs about statin use in patients with coronary heart disease and self-perceived muscle side-effects

Abstract Background Statin associated muscle symptoms (SAMS) are commonly reported and constitute the principal reason for statin non-adherence and/or discontinuation. Understanding the determinants of SAMS may enhance the clinical management and form the basis of interventions. The association between psychological distress and the beliefs about statin treatment and SAMS have previously not been investigated under randomized, controlled conditions. Purpose To compare clinical and psychological factors among coronary patients with confirmed SAMS and non-SAMS. Methods This pre-planned exploratory study included 71 consecutively recruited patients with self-perceived SAMS enrolled in the MUscle Side-Effect of atorvastatin in coronary patients (MUSE) randomized double-blinded crossover trial. Muscle symptom (pain, weakness, tenderness, stiffness and/or cramps) intensity was registered weekly in a patient diary using a 0 (no symptoms) to 10 (worst imaginable) cm visual-analogue scale (VAS). Confirmed SAMS was predefined as a 25% higher individual mean VAS-scores during 7-weeks treatment with atorvastatin 40 mg/day versus 7-weeks treatment with placebo, and ≥1cm absolute difference. Clinical factors (10 variables), psychological factors (5 variables) and beliefs about medicine (3 variables) were obtained from a questionnaire and a clinical examination at study start. Results Mean age was 63 (SD 9.5) years, 32% were women, and each participant had tried average 1.3 (SD 0.6, range 1 to 3) statins prior to study start. In all, 28% (n=20) had confirmed SAMS and 72% (n=51) had non-SAMS. There were no differences in mean VAS score at study start between the groups (mean VAS score 4.5 vs. 4.7, p=0.20). More patients with confirmed SAMS than non-SAMS (25% vs. 6%, p&amp;lt;0.001) did not use statin treatment at study start, and mean LDL-cholesterol level was borderline higher (2.8 vs. 2.3 mmol/L, p=0.06). Patients with confirmed SAMS had a weaker belief in their statin use compared to patients with non-SAMS (3.1 vs. 3.6, p&amp;lt;0.001) using a 5-category scale from 1 (weak belief) to 5 (strongest belief). There were no differences in the sociodemographic, clinical (pre-existing muscle skeletal disorders, somatic comorbidity, cardiovascular risk factors) or psychological (symptoms of anxiety or depression, type D personality, worry, insomnia) factors explored between patients with confirmed SAMS or with non-SAMS. There were no associations between these factors and increasing VAS scores in continuous analyses among patients with confirmed SAMS and non-SAMS. Conclusions Patients with statin dependent muscle side-effects reported a weaker belief on the necessity to take statins than patients with muscle complaints not caused by the statin. Otherwise, we found no differences in clinical or psychological factors between these populations. The results indicate that these factors do not distinguish patients with and without associated muscle symptoms in clinical practice. Funding Acknowledgement Type of funding source: Public hospital(s). Main funding source(s): Vestfold Hospital Trust, research grant