Browsing by Subject "Hydroxymethylglutaryl-CoA reductase inhibitors"
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Item A multistate transition model for statin‐induced myopathy and statin discontinuation(Wiley, 2021) Zhu, Yuxi; Chiang, Chien-Wei; Wang, Lei; Brock, Guy; Milks, M. Wesley; Cao, Weidan; Zhang, Pengyue; Zeng, Donglin; Donneyong, Macarius; Li, Lang; Biostatistics and Health Data Science, Richard M. Fairbanks School of Public HealthThe overarching goal of this study was to simultaneously model the dynamic relationships among statin exposure, statin discontinuation, and potentially statin-related myopathic outcomes. We extracted data from the Indiana Network of Patient Care for 134,815 patients who received statin therapy between January 4, 2004, and December 31, 2008. All individuals began statin treatment, some discontinued statin use, and some experienced myopathy and/or rhabdomyolysis while taking the drug or after discontinuation. We developed a militate model to characterize 12 transition probabilities among six different states defined by use or discontinuation of statin and its associated myopathy or rhabdomyolysis. We found that discontinuation of statin therapy was common and frequently early, with 44.4% of patients discontinuing therapy after 1 month, and discontinuation is a strong indicator for statin-induced myopathy (risk ratio, 10.8; p < 0.05). Women more likely than men (p < 0.05) and patients aged 65 years and older had a higher risk than those aged younger than 65 years to discontinue statin use or experience myopathy. In conclusion, we introduce an innovative multistate model that allows clear depiction of the relationship between statin discontinuation and statin-induced myopathy. For the first time, we have successfully demonstrated and quantified the relative risk of myopathy between patients who continued and discontinued statin therapy. Age and sex were two strong risk factors for both statin discontinuation and incident myopathy.Item Donor Simvastatin Treatment Is Safe and Might Improve Outcomes After Liver Transplantation: A Randomized Clinical Trial(Wolters Kluwer, 2022) Pagano, Duilio; Bosch, Jaime; Tuzzolino, Fabio; Oliva, Elisabetta; Ekser, Burcin; Zito, Giovanni; Cintorino, Davide; di Francesco, Fabrizio; Petri, Sergio Li; Ricotta, Calogero; Bonsignore, Pasquale; Calamia, Sergio; Magro, Bianca; Trifirò, Gianluca; Alduino, Rossella; Barbara, Marco; Conaldi, Pier Giulio; Gallo, Alessia; Venuti, Francesca; Luca, Angelo; Gruttadauria, Salvatore; Surgery, School of MedicineBackground: The current curative approaches for ischemia/reperfusion injury on liver transplantation are still under debate for their safety and efficacy in patients with end-stage liver disease. We present the SIMVA statin donor treatment before Liver Transplants study. Methods: SIMVA statin donor treatment before Liver Transplants is a monocentric, double-blind, randomized, prospective trial aiming to compare the safety and efficacy of preoperative brain-dead donors' treatment with the intragastric administration of 80 mg of simvastatin on liver transplant recipient outcomes in a real-life setting. Primary aim was incidence of patient and graft survival at 90 and 180 d posttransplant; secondary end-points were severe complications. Results: The trial enrolled 58 adult patients (18-65 y old). The minimum follow-up was 6 mo. No patient or graft was lost at 90 or 180 d in the experimental group (n = 28), whereas patient/graft survival were 93.1% ( P = 0.016) and 89.66% ( P = 0.080) at 90 d and 86.21% ( P = 0.041) and 86.2% ( P = 0.041) at 180 d in the control group (n = 29). The percentage of patients with severe complications (Clavien-Dindo ≥IIIb) was higher in the control group, 55.2% versus 25.0% in the experimental group ( P = 0.0307). The only significant difference in liver tests was a significantly higher gamma-glutamyl transferase and alkaline phosphatase at 15 d ( P = 0.017), ( P = 0.015) in the simvastatin group. Conclusions: Donor simvastatin treatment is safe, and may significantly improve early graft and patient survival after liver transplantation, although further research is mandatory.Item Effects of Statin Treatment on Outcomes after Traumatic Brain Injury(Liebert, 2018) Whyte, John; Ketchum, Jessica M.; Bogner, Jenny; Brunner, Robert C.; Hammond, Flora M.; Zafonte, Ross; Whiteneck, Gale G.; Weintraub, Alan; Physical Medicine and Rehabilitation, School of MedicineNeuroprotective treatments that have shown promise in reducing secondary injury and improving recovery in animal models of traumatic brain injury (TBI) have not been found effective to date in humans. One reason may be the delay after injury in initiating treatment. Statin medications are among the promising neuroprotective agents in animal models, and their presence in the bloodstream of many individuals at the time of injury might optimize their clinical impact. This observational study conducted by a subset of centers participating in the National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR)-funded TBI Model System program sought to examine the effects of taking statin medication at the time injury on functional outcomes. Participants >50 years of age were prospectively enrolled during patient rehabilitation. Demographic data, cardiovascular history, and brain injury history were obtained through chart abstraction and interview. Prescription medication use in the year prior to enrollment was determined from a national pharmacy search service. Propensity scoring was used to create 49 pairs of participants who were well matched on demographic and clinical attributes but discordant for statin use. The treated and untreated participants did not differ on initial Glasgow Coma Score, time until commands were followed, duration of post-traumatic amnesia, or Functional Independence Measure (FIM) scores at rehabilitation admission, discharge, or 1 year post-injury, or on acute or rehabilitation hospital lengths of stay. Evidence of greater and lesser statin compliance was not associated with outcome. This study did not provide support for a clinically important benefit of statin use at the time of moderate to severe TBI.Item Quantifying Unmet Need in Statin-Treated Hyperlipidemia Patients and the Potential Benefit of Further LDL-C Reduction Through an EHR-Based Retrospective Cohort Study(Academy of Managed Care Pharmacy, 2019) Schleyer, Titus; Hui, Siu; Wang, Jane; Zhang, Zuoyi; Knapp, Kristina; Baker, Jarod; Chase, Monica; Boggs, Robert; Simpson, Ross J., Jr.; Medicine, School of MedicineBackground: Statins are effective in helping prevent cardiovascular disease (CVD). However, studies suggest that only 20%-64% of patients taking statins achieve reasonable low-density lipoprotein cholesterol (LDL-C) thresholds. On-treatment levels of LDL-C remain a key predictor of residual CVD event risk. Objectives: To (a) determine how many patients on statins achieved the therapeutic threshold of LDL-C < 100 mg per dL (general cohort) and < 70 mg per dL (secondary prevention cohort, or subcohort, with preexisting CVD); (b) estimate the number of potentially avoidable CVD events if the threshold were reached; and (c) forecast potential cost savings. Methods: A retrospective, longitudinal cohort study using electronic health record data from the Indiana Network for Patient Care (INPC) was conducted. The INPC provides comprehensive information about patients in Indiana across health care organizations and care settings. Patients were aged > 45 years and seen between January 1, 2012, and October 31, 2016 (ensuring study of contemporary practice), were statin-naive for 12 months before the index date of initiating statin therapy, and had an LDL-C value recorded 6-18 months after the index date. Subsequent to descriptive cohort analysis, the theoretical CVD risk reduction achievable by reaching the threshold was calculated using Framingham Risk Score and Cholesterol Treatment Trialists' Collaboration formulas. Estimated potential cost savings used published first-year costs of CVD events, adjusted for inflation and discounted to the present day. Results: Of the 89,267 patients initiating statins, 30,083 (33.7%) did not achieve the LDL-C threshold (subcohort: 58.1%). In both groups, not achieving the threshold was associated with patients who were female, black, and those who had reduced medication adherence. Higher levels of preventive aspirin use and antihypertensive treatment were associated with threshold achievement. In both cohorts, approximately 64% of patients above the threshold were within 30 mg per dL of the respective threshold. Adherence to statin therapy regimen, judged by a medication possession ratio of ≥ 80%, was 57.4% in the general cohort and 56.7% in the subcohort. Of the patients who adhered to therapy, 23.7% of the general cohort and 50.5% of the subcohort had LDL-C levels that did not meet the threshold. 10-year CVD event risk in the at-or-above threshold group was 22.78% (SD = 17.24%) in the general cohort and 29.56% (SD = 18.19%) in the subcohort. By reducing LDL-C to the threshold, a potential relative risk reduction of 14.8% in the general cohort could avoid 1,173 CVD events over 10 years (subcohort: 15.7% and 454 events). Given first-year inpatient and follow-up costs of $37,300 per CVD event, this risk reduction could save about $1,455 per patient treated to reach the threshold (subcohort: $1,902; 2017 U.S. dollars) over a 10-year period. Conclusions: Across multiple health care systems in Indiana, between 34% (general cohort) and 58% (secondary prevention cohort) of patients treated with statins did not achieve therapeutic LDL-C thresholds. Based on current CVD event risk and cost projections, such patients seem to be at increased risk and may represent an important and potentially preventable burden on health care costs. Disclosures: Funding support for this study was provided by Merck (Kenilworth, NJ). Chase and Boggs are employed by Merck. Simpson is a consultant to Merck and Pfizer. The other authors have nothing to disclose.Item Severe hypoglycemia in users of sulfonylurea antidiabetic agents and antihyperlipidemics(Wiley, 2016-05) Leonard, Charles E.; Bilker, Warren B.; Brensinger, Colleen M.; Han, Xu; Flory, James H.; Flockhart, David A.; Gagne, Joshua J.; Cardillo, Serena; Hennessy, Sean; Department of Medicine, IU School of MedicineDrug-drug interactions causing severe hypoglycemia due to antidiabetic drugs is a major clinical and public health problem. We assessed whether sulfonylurea use with a statin or fibrate was associated with severe hypoglycemia. We conducted cohort studies of users of glyburide, glipizide, and glimepiride plus a statin or fibrate within a Medicaid population. The outcome was a validated, diagnosis-based algorithm for severe hypoglycemia. Among 592,872 persons newly exposed to a sulfonylurea+antihyperlipidemic, the incidence of severe hypoglycemia was 5.8/100 person-years. Adjusted hazard ratios (HRs) for sulfonylurea+statins were consistent with no association. Most overall HRs for sulfonylurea+fibrate were elevated, with sulfonylurea-specific adjusted HRs as large as 1.50 (95% confidence interval (CI): 1.24-1.81) for glyburide+gemfibrozil, 1.37 (95% CI: 1.11-1.69) for glipizide+gemfibrozil, and 1.63 (95% CI: 1.29-2.06) for glimepiride+fenofibrate. Concomitant therapy with a sulfonylurea and fibrate is associated with an often delayed increased rate of severe hypoglycemia.