Statin Use Research Articles

Impact of High-Intensity Statin on Atrial Fibrillation After Off-Pump Coronary Artery Bypass.

There is uncertainty regarding the impact of high-intensity statins on postoperative outcomes in patients undergoing surgical myocardial revascularization. This study was conducted to evaluate the impact of high-intensity statin treatment on the occurrence rate of new-onset postoperative atrial fibrillation (POAF) after off-pump coronary artery bypass grafting (OPCAB). Six hundred thirteen patients (66.8±9.8 years, male:female = 476:137) who underwent isolated OPCAB were retrospectively enrolled. Hypertension (n = 409, 66.7%), diabetes mellitus (n = 343, 59.6%) and chronic kidney disease (n = 138, 22.5%) were common comorbidities. Statins and beta-blockers were administered to all patients until the day of surgery and resumed within 6 hours after surgery. Risk factors associated with POAF were analyzed, including the use of high-intensity statins (atorvastatin 40 mg-80 mg or rosuvastatin 20 mg), as well as baseline characteristics and preoperative risk factors. High-intensity statins were used in 158 patients (25.8%). POAF occurred in 184 patients (30.0%). The use of high-intensity statins was not correlated with preoperative levels of low-density lipoprotein (P = 0.135) or high sensitivity C-reactive protein (P = 0.365). Multivariate logistic regression analysis revealed that the use of high-intensity statins was significantly associated with a reduced occurrence of POAF (P = 0.022, odds ratio [95% confidence interval] = 0.592 [0.378-0.926]). Age, acute coronary syndrome, insulin-dependent diabetes mellitus and chronic kidney disease were also significantly associated with POAF. Preoperative administration of high-intensity statins was associated with a 41% reduction in the occurrence rate of POAF in patients who underwent OPCAB.

Recent trends of low-density lipoprotein cholesterol control and lipid-lowering therapy in patients with atherosclerotic cardiovascular disease in Taiwan: 2015–2020

ObjectiveThis study aimd to assess recent trends in the control of low-density lipoprotein cholesterol (LDL-C) and the utilization of lipid-lowering drugs (LLD) among patients with atherosclerotic cardiovascular disease (ASCVD) in Taiwan. MethodsPatients with ASCVD and without a history of hemorrhagic stroke were identified from the Taiwanese Secondary Prevention for patients with AtheRosCLErotic disease (T-SPARCLE) Registry. ASCVD patients were stratified into four categories: those who ever had acute coronary syndrome (ACS), those who underwent percutaneous coronary intervention or coronary artery bypass grafting (PCI/CABG) without ACS, those who ever had an ischemic stroke (IS) without ACS or PCI/CABG, and other ASCVD cases. We assessed their latest recorded LDL-C levels for the periods 2015–16, 2017–18, and 2019–20. LLD therapy patterns were presented as monotherapy, dual therapy, or combination therapy of three or more drugs, with statin use classified by intensity. ResultsWe identified 3831 ASCVD patients in 2015–16, 3531 in 2017–18, and 1231 in 2019–20. LLD utilization rose from 58.4% in 2015–16 to 73.2% in 2019–20. The proportions of patients achieving LDL-C goals in 2015–16, 2017–18, and 2019–20 were 21.5%, 25.8%, and 33.3% in the ACS cohort (goal <70 mg/dL); 20.4%, 26.1%, and 39.0% in the PCI/CABG cohort (goal <70 mg/dL); 54.4%, 58.5%, and 58.9% in the IS cohort (goal <100 mg/dL); and 60.0%, 65.5%, and 67.0% in the other ASCVD cohort (goal <100 mg/dL), respectively. Over half of the patients were prescribed moderate-intensity statins. Statin use, age, history of diabetes mellitus, and hypertension were important factors for attaining LDL-C goal in ACS patients. ConclusionDespite improvements in LDL-C management observed over recent years, significant gaps remain in guideline adherence, especially for patients with ACS or PCI/CABG in Taiwan, with over 60% not meeting LDL-C targets. Intensifying efforts to align clinical practice with guidelines are imperative.

Advancing Community Care and Access to Follow-Up after Acute Kidney Injury Hospitalization: A Randomized Clinical Trial.

Key Points A risk-guided intervention improved adherence to processes of care for AKI survivors.Further supports are necessary to improve uptake of processes of care for AKI survivors in primary care. Background AKI is associated with development and progression of CKD. Gaps in recommended care for CKD are common after AKI. Methods In this randomized controlled trial conducted in Alberta, Canada, we allocated adults hospitalized with Kidney Disease Improving Global Outcomes (KDIGO) stage 2 or greater AKI to a risk-guided, transition of care intervention versus usual practices at the time of hospital discharge. For people in the intervention group, we used a validated risk index to predict risk of severe CKD after AKI. People at low risk (&lt;1%) received patient education alone. People at medium risk received additional clinical guidance, provided to their primary care physician. People at high risk (&gt;10%) were referred to nephrology. The primary outcome was the proportion of patients who received treatment with an angiotensin-converting enzyme inhibitor (ACE-I) or angiotensin II receptor blocker (ARB), statin, and nephrology specialist follow-up within 90 days of discharge. Results One hundred fifty-five patients were recruited; the mean (SD) age was 60 (15) years, 91 (60%) were male, and 96 (62%) had eGFR &lt;60 ml/min per 1.73 m2 or urine albumin-creatinine ratio &gt;30 mg/g at discharge. The proportion of participants who received ACE-I/ARB, statin treatment, and nephrologist follow-up was 28% in the intervention group versus 3% in the usual care group (absolute risk difference [RD], 25%; 95% confidence interval [CI], 15% to 36%). The use of ACE-I or ARB in participants with urine albumin-creatinine ratio &gt;300 mg/g or diabetes was greater in the high-risk group with the intervention versus usual care (RD, 37%; 95% CI, 6% to 67%), as was statin use among those with CKD (RD, 30%; 95% CI, 5% to 56%) and nephrologist follow-up for those with sustained eGFR &lt;30 ml/min per 1.73 m2 at discharge (RD, 78%; 95% CI, 56% to 100%). Hyperkalemia was more frequent in the intervention group (RD, 10%; 95% CI, 9% to 19%). Conclusions A risk-guided intervention for patients hospitalized with AKI increased recommended processes of care for CKD for high-risk patients after hospital discharge. Clinical Trial registry name and registration number: Improving Post Discharge Care after Acute Kidney Injury (AFTER AKI), NCT02915575.

Impact of statin use in head and neck cancer: a nested case-control study.

Dyslipidemia and statin use are associated with an increased risk of various cancers. However, the association in head and neck cancer (HNC) remains unclear. Therefore, this study aimed to investigate the impact of dyslipidemia and statin use on the development of HNC. Using data from the Korean National Health Insurance Service-National Sample Cohort from 2002 to 2019, we compared two groups HNC patients (n = 1006) and matched control participants (n = 4024) after propensity score overlap weighted balancing. The odds ratios (ORs) for HNC development according to dyslipidemia and statin use duration were assessed using propensity score overlap-weighted multivariable logistic regression. Individuals with untreated dyslipidemia had significantly lower odds of developing HNC than those of normal participants (OR 0.70, 95% confidence interval [CI] 0.59-0.82). Conversely, patients with dyslipidemia who received statin therapy (< 60days) showed a nearly two-fold increase in the odds of HNC (OR 1.94, 95% CI 1.29-2.90). Long-term statin use (≥ 60days) aligned the odds with those of normal participants (OR 0.89, 95% CI 0.76-1.04). The adverse effect of short-term statin use on HNC development requires further study, and long-term statin use for dyslipidemia treatment does not increase the odds of HNC.

Atorvastatin and telmisartan do not reduce nasopharyngeal carriage of SARS-CoV-2 in mild or moderate COVID-19 in a phase IIb randomized controlled trial

Observational studies suggest a reduction in fatal or severe COVID-19 disease with the use of ACE2 inhibitors and statins. We implemented a randomized controlled tree-arm open label trial evaluating the benefits of adding telmisartan (TLM) or atorvastatin (ATV) to lopinavir boosted ritonavir (LPVr) on the SARS-CoV-2 nasopharyngeal viral load in patients with mild / moderate COVID-19 infection in Côte d’Ivoire. RT-PCR positive COVID-19 patients ≥ 18 years, with general or respiratory symptoms for less than 7 days were randomized (1:1:1) to receive LPVr (400 mg/100 mg twice daily), LPVr + TLM (10 mg once daily) or LPVr + ATV (20 mg once daily) for 10 days. The primary endpoint was viro-inflammatory success defined as a composite variable at day 11: Ct ≥ 40 and C-reactive protein < 27 mg/L. We randomized 294 patients: 96 to LPVr, 100 to LPVr + TLM, 98 to LPVr + ATV arms. Baseline characteristics were well balanced between arms. In the primary analysis (missing = failure), 46% patients in the LPVr arm reached viro-inflammatory success at day 11 vs 43% in the LPVr + TLM arm (p = 0.69) and 43% in the LPVr + ATV arm (p = 0.68). The median time from baseline to resolution of COVID-19 related symptoms was not different between arms. Nine patients were hospitalized: 2 in the LPVr arm, 5 in the LPVr + TLM arm and 2 in the LPVr + ATV arm and 4 patients died. Among adults with mild to moderate COVID-19 infection, the addition of telmisartan or atorvastatin, to the standard LPVr treatment is not associated with a better virological or clinical outcome.Trial registration: NCT04466241, registered on 10/07/2020

Risk of Opioid Overdose Associated with Concomitant Use of Methadone and Statins.

Methadone has a high potential for risky drug-drug interactions that can lead to opioid overdose, yet evidence on the magnitude of this risk remains limited. Since methadone is transported via P-glycoprotein (P-gp), the use of statins that inhibit P-gp may elevate methadone plasma concentrations, potentially leading to opioid overdose. We explored this hypothesis by examining whether concomitant use of methadone and P-gp-inhibiting statins was associated with opioid overdose. Using Medicaid claims data from 2003 to 2020, we conducted a cohort study among new concomitant users of methadone and statins. We compared overdose rates among individuals exposed to P-gp-inhibiting statins (simvastatin, atorvastatin, or lovastatin) vs. those exposed to rosuvastatin (negative control), adjusting for baseline covariates. We identified 69,263 individuals newly exposed to methadone and a statin of interest; the overall incidence rate of opioid overdose was 26.0 per 1,000 person-years. Adjusted hazard ratios (HRs) for methadone + P-gp-inhibiting statins consistently showed no association, ranging from 0.76 (95% CI = 0.48-1.22) for atorvastatin to 0.78 (95% CI = 0.50-1.22) for simvastatin, compared with methadone + rosuvastatin. Similar results were observed in sensitivity analysis that treated all P-gp-inhibiting statins as a single exposure group, as well as analyses stratified by baseline diagnosis of opioid use disorder or overdose, the duration of baseline methadone use, and calendar year intervals. Our findings suggest that concomitant use of methadone with simvastatin, atorvastatin, or lovastatin is not associated with the risk of opioid overdose compared to concomitant use of methadone and rosuvastatin.

Diabetic adverse events associated with three commonly used statins: a disproportionality analysis based on the FDA adverse event reporting system database

ABSTRACT Background The increasing prevalence of statin use for cardiovascular disease management has raised concerns regarding their safety profile, particularly regarding the potential risk of diabetes. Our study aims to analyze diabetic adverse event reports related to statins using a large pharmacovigilance database to provide timely insights into this significant issue. Methods We analyzed data from the FDA Adverse Event Reporting System (FAERS) database from 2004 to 2023. Disproportionality analyses were performed to detect signals of diabetic adverse events associated with the three most commonly prescribed statins: atorvastatin, rosuvastatin, and simvastatin. Results We identified 11,364 cases of statin-related diabetic adverse events across the three statins. Disproportionality analyses revealed a significant association between these statins and four specific diabetic adverse events: type 2 diabetes mellitus, impaired glucose tolerance, diabetic neuropathy, and diabetic retinal edema. Notable sex differences emerged, with females exhibiting an overall significantly higher propensity for diabetes-related adverse events. Conclusions Our study is timely and relevant as it addresses growing concerns about the safety of widely prescribed statins and their association with diabetes. By highlighting these critical issues, the study seeks to contribute valuable insights to practitioners, ultimately guiding better clinical practices and enhancing pharmacovigilance efforts.

Optimal risk thresholds for prescribing statins as primary prevention of cardiovascular disease in Iranian general population: a benefit-harm modelling study

PurposeThe use of statins for the primary prevention of cardiovascular diseases (CVD) is associated with various beneficial outcomes, alongside certain undesirable effects. This study aims to determine optimal risk thresholds above which statin therapy yields a net benefit, considering both the positive effects and potential adverse effects, as well as their probabilities and patient preferences.MethodsQuantitative benefit-harm balance modeling was applied to the Iranian general population aged 40 to 75 years with no history of CVD. The analysis utilized data from prior studies, including statin effect estimates for different outcomes from a meta-analysis, patient preferences obtained from an Iranian survey, and baseline incidence rates of adverse outcomes sourced from the Global Burden of Disease study for Iran. Outcomes were defined as angina, myocardial infarction, fatal coronary heart disease, fatal or non-fatal stroke, and heart failure. Benefit-harm balance indices were calculated for various combinations of age, sex, and 10-year CVD risk.ResultsStatin therapy was found to be advantageous at a lower 10-year CVD risk threshold in men (18–23%) compared to women (24–28%). Furthermore, individuals aged 40–45 years exhibited a lower risk threshold (18% in men, 24% in women) than those aged 70–75 years (23% in men, 28% in women).ConclusionThe desirable 10-year risk thresholds for statin prescription in the primary prevention of CVD vary by age and gender, ranging from 18 to 28%, encompassing a spectrum of outcomes from angina to CVD mortality. These results suggest hard-CVD risk thresholds of 7.5% to 10% for both sexes.

Hypercholesterolemia and Alzheimer's Disease: Unraveling the Connection and Assessing the Efficacy of Lipid-Lowering Therapies.

This article examines the relationship between cholesterol levels and Alzheimer's disease (AD), beginning with the early observation that individuals who died from heart attacks often had brain amyloid deposition. Subsequent animal model research proved that high cholesterol could hasten amyloid accumulation. In contrast, cholesterol-lowering treatments appeared to counteract this effect. Human autopsy studies reinforced the cholesterol-AD connection, revealing that higher cholesterol levels during midlife significantly correlated with higher brain amyloid pathology. This effect was especially pronounced in individuals aged 40 to 55. Epidemiological data supported animal research and human tissue observations and suggested that managing cholesterol levels in midlife could reduce the risk of developing AD. We analyze the main observational studies and clinical trials on the efficacy of statins. While observational data often suggest a potential protective effect against AD, clinical trials have not consistently shown benefit. The failure of these trials to demonstrate a clear advantage is partially attributed to multiple factors, including the timing of statin therapy, the type of statin and the appropriate selection of patients for treatment. Many studies failed to target individuals who might benefit most from early intervention, such as high-risk patients like APOE4 carriers. The review addresses how cholesterol is implicated in AD through various biological pathways, the potential preventive role of cholesterol management as suggested by observational studies, and the difficulties encountered in clinical trials, particularly related to statin use. The paper highlights the need to explore alternate therapeutic targets and mechanisms that escape statin intervention.

Separating Risk Prediction: Myocardial Infarction vs. Ischemic Stroke in 6.2M Screenings.

Traditional cardiovascular disease risk prediction models generate a combined risk assessment for myocardial infarction (MI) and ischemic stroke (IS), which may inadequately reflect the distinct etiologies and disparate risk factors of MI and IS. We aim to develop prediction models that separately estimate the risks of MI and IS. Our analysis included 6,242,404 individuals over 40 years old who participated in a cardiovascular health screening examination in 2009. Potential predictors were selected based on a literature review and the available data. Cox proportional hazards models were used to construct 5-year risk prediction models for MI, and IS. Model performance was assessed through discrimination and calibration. During a follow-up of 39,322,434.39 person-years, 89,140 individuals were diagnosed with MI and 116,259 with IS. Both models included age, sex, body mass index, smoking, alcohol consumption, physical activity, diabetes, hypertension, dyslipidemia, chronic kidney disease, and family history. Statin use was factored into the classification of dyslipidemia. The c-indices for the prediction models were 0.709 (0.707-0.712) for MI, and 0.770 (0.768-0.772) for IS. Age and hypertension exhibited a more pronounced effect on IS risk prediction than MI, whereas smoking, body mass index, dyslipidemia, and chronic kidney disease showed the opposite effect. The models calibrated well for low-risk individuals. Our findings underscore the necessity of tailored risk assessments for MI and IS to facilitate the early detection and accurate identification of heterogeneous at-risk populations for atherosclerotic cardiovascular disease.

Role of the Pharmacotherapeutic Monitoring Service (PMS) of the Community Pharmacy in the detection and resolution of adverse reactions to statins linked to possible diagnostic errors in elderly patients

The Medication Review in the Pharmacotherapeutic Follow-up Service (PFS) seems to be an effective method to study long-term drug safety in the outpatient setting. The adverse drug reactions (ADRs) that are not immediately obvious are difficult to identify and sometimes can be confused with a more common condition. Misdiagnosis by not associating the symptoms of AMR to its pharmacological cause causes its masking and hinders its detection. Detect in the SFT service the diagnostic errors related to the non-detection of adverse reactions to statins. The data obtained from the medication review at the Pharmacotherapeutic Follow-up Service (PFS) were pooled for analysis. The patients who received the service were selected with the "DLGM screening" tool, an acronym "Diagnosis load Generated by Medications", that allows us to describe adverse drug reactions (ADRs), when their symptoms are attributed to a pathology, without considering medication as a possible underlying cause.Only the results of patients over 60 years of age, who after a prolonged period of statin use gradually presented musculoskeletal disorders (MSD) and other symptoms theoretically described as possible ADRs, are shown. In 66 % of the cases, corresponding to 14 patients out of a total of 21 studied, the physician modified the treatment and in 92% of these cases there was improvement and a decrease of the consumption of analgesics drug, anti-inflammatory and other drugs used to treat ADR symptoms. DLGM screening identified hidden AMRs in 62 % of patients.

Use of cholesterol-lowering medications in relation to risk of primary liver cancer in the Clinical Practice Research Datalink.

Although the relation between statin use and liver cancer risk has been extensively examined, few studies have examined other cholesterol-lowering medications in relation to liver cancer risk. The authors examined five classes of nonstatin medications and liver cancer risk. A nested case-control including 3719 cases and 14,876 matched controls was conducted within the Clinical Practice Research Datalink. Additional matches on type 2 diabetes and chronic liver disease were also implemented. The medications examined included cholesterol absorption inhibitors, bile acid sequestrants, fibrates, niacin, and omega-3 fatty acids. Conditional logistic regression estimated odds ratios and 95% confidence intervals. Cholesterol absorption inhibitor use was associated with reduced liver cancer risk in the overall analysis (odds ratio, 0.69; 95% confidence interval, 0.50-0.96) and in analyses based on type 2 diabetes and chronic liver disease status. Although bile acid sequestrant use was associated with increased liver cancer risk in the overall analysis (odds ratio, 5.31; 95% confidence interval, 3.53-7.97), the results of the analyses based on type 2 diabetes and chronic liver disease status were inconsistent. [Correction added on 19 August 2024, after first online publication: In the preceding sentence, the value '3.534' has been changed to '3.54'.]. No associations were observed for the other medications. Cholesterol absorption inhibitors may be associated with reduced liver cancer risk. Whether bile acid sequestrant use was associated with increased risk was only partially supported in the current study.

Impact of statins on incidence of gastrointestinal bleeding events among patients with continuous-flow left ventricular assist devices.

Patients with continuous flow left ventricular assist devices (CF-LVADs) are at increased risk of gastrointestinal bleeding (GIB). Statins are commonly prescribed in LVAD patients for cardiovascular disease prevention. However, their impact on GIB events is controversial. Importantly, literature regarding statins impact on GIB in CF-LVAD patients is lacking. A single-center, retrospective review of adult patients who underwent CF-LVAD implantation between May 2016 and January 2020 was performed. Patients were categorized based on statin use throughout the study period. The primary outcome was the composite of arteriovenous malformation confirmed GIB and major GIB events for up to 1-year post-LVAD implantation. Of 123 patients included in the final analysis, 66 (54%) received statin therapy during the study period. No difference was observed in the primary outcome between the statin and control groups (RR: 1.73; 95% CI: 0.75-3.98; p=0.20). Multivariable Cox regression revealed that older age and higher baseline creatinine were associated with an increased risk of GIB within 1-year of CF-LVAD implantation. Among patients with CF-LVADs, there was no significant difference in the incidence of major GIB events associated with the use of statin therapy. Further studies are needed to assess whether a true association exists.

Statin Therapy Reduces Radiation-Induced Cardiotoxicity in Patients With Breast Cancer Receiving Adjuvant Radiotherapy.

To evaluate the efficacy of statin therapy in reducing major adverse cardiovascular event (MACE) risk among patients with breast cancer undergoing breast-conserving surgery and adjuvant whole breast radiotherapy. A retrospective cohort study was conducted using data from the Taiwan Cancer Registry Database linked to the National Health Insurance Research Database. Patients diagnosed with left-sided early breast invasive ductal carcinoma between 2016 and 2019 were included. Propensity score matching was employed to compare MACE risk between statin users and nonusers. Cox regression models were used to estimate adjusted hazard ratios (aHRs) for MACE, considering cumulative defined daily doses and daily defined doses of statins. Among 1481 patients undergoing breast-conserving surgery and adjuvant whole breast radiotherapy, statin use significantly reduced MACE risk (aHR, 0.34 [95% CI, 0.25-0.44]). Hydrophilic statins, particularly rosuvastatin and pravastatin, demonstrated the greatest risk reduction. Higher cumulative defined daily doses and daily intensity doses of statins were associated with lower MACE risk, indicating a dose-response relationship. The 5-year cumulative incidence of MACE was significantly lower in statin users compared with nonusers (12.24% versus 31.70%). Statin therapy is associated with a reduced risk of MACE in patients with breast cancer undergoing breast-conserving surgery and adjuvant whole breast radiotherapy. Hydrophilic statins rosuvastatin and pravastatin exhibit the most pronounced cardioprotective effects. These findings suggest a potential role for statins in mitigating cardiovascular complications in this population and highlight the need for further research to optimize statin therapy in survivors of breast cancer undergoing radiotherapy.

Lifetime effects and cost-effectiveness of statin therapy for older people in the United Kingdom: a modelling study

BackgroundCardiovascular disease (CVD) risk increases with age. Statins reduce cardiovascular risk but their effects are less certain at older ages. We assessed the long-term effects and cost-effectiveness of statin therapy...

Association between statin use and immune-related adverse events in patients treated with immune checkpoint inhibitors: analysis of the FAERS database.

Understanding the risk relationship between statin use and immune-related adverse events (irAEs) in patients undergoing immune checkpoint inhibitors (ICIs) therapy is crucial for optimizing oncological management. This study aimed to investigate whether the use of statins increases the risk of irAEs in patients receiving ICI therapy. This study primarily utilized data from FAERS database. Multivariable logistic regression was the principal method of analysis, and the Benjamini-Hochberg procedure was employed to adjust for multiple hypothesis testing. In a group of 145,214 patients undergoing ICI therapy, 9,339 reported using statin medications. Multivariable analysis indicated an increased risk of irAEs among statin users (OR 1.199, 95% CI: 1.141-1.261; FDR p < 0.001) in comparison to those not using statins. Notably, increased risks were observed particularly in patients diagnosed with lung, pancreatic, and renal cancers. The link between statin usage and increased irAEs risk remained consistent across various ICIs treatments. Statin medication usage is linked to an elevated probability of experiencing irAEs in patients enrolled in ICI therapy. In cancer patients receiving immune checkpoint inhibitors, careful consideration of statin use is essential to avoid potentially increased irAEs risk. These findings provide critical guidance for clinicians in developing treatment strategies that balance therapeutic efficacy and safety in oncological management.

Diabetes Risk Factors in People With HIV Receiving Pitavastatin Versus Placebo for Cardiovascular Disease Prevention : A Randomized Trial.

REPRIEVE (Randomized Trial to Prevent Vascular Events in HIV) led to new guidelines for statin use among people with HIV (PWH) with low to moderate risk for atherosclerotic cardiovascular disease (ASCVD). Little is known about the natural history of diabetes mellitus (DM) or mechanisms contributing to statin effects on DM among this population. To determine the contribution of known DM risk factors to excess risk for DM with pitavastatin in REPRIEVE. Phase 3, primary ASCVD prevention trial over a median of 5.6 years of follow-up. (ClinicalTrials.gov: NCT02344290). Global, multicenter trial. 7731 PWH aged 40 to 75 years with low to moderate ASCVD risk (by the pooled cohort equations from the American College of Cardiology and American Heart Association) without DM at study entry. Random 1:1 assignment to pitavastatin, 4 mg daily, or placebo. New-onset DM was determined at each visit by clinical diagnosis requiring initiation of medication treatment for DM. The incidence of new-onset DM was assessed in relation to predefined demographic and metabolic risk factors, stratified by treatment group. Treatment effects of pitavastatin on progression to new DM in key subgroups were determined. Participants with at least 3 DM risk factors (vs. no risk factors) had increased risk for DM in each treatment group (incidence rate, 3.24 per 100 person-years [PY] vs. 0.34 per 100 PY [pitavastatin] and 2.66 per 100 PY vs. 0.27 per 100 PY [placebo]). The incidence of DM was highest in South Asia. In adjusted analyses, high body mass index, prediabetes, and metabolic syndrome components were strongly associated with new-onset DM (all P < 0.005). Pitavastatin was the only statin assessed; DM was assessed clinically. Metabolic risk factors, including prediabetes and obesity, contributed to new-onset DM in statin- and placebo-treated participants. A clinically significant effect of pitavastatin on DM was seen primarily among those with multiple risk factors for DM at entry. Strategies targeting key metabolic risk factors, like obesity and prediabetes, may help protect against DM among PWH. National Heart, Lung, and Blood Institute of the National Institutes of Health.

Development and validation of a nomogram to predict acute postoperative urinary retention in ischemic stroke patients following femoral artery puncture.

Acute postoperative urinary retention (POUR) is a common complication in patients with ischemic stroke following femoral artery puncture (FAP), leading to discomfort, delayed hospital discharge, and increased patient morbidity. The relevant risk factors are unclear; thus, a predictive tool is required to guide treatment decisions. To develop and validate a nomogram to predict acute POUR in patients with ischemic stroke following FAP. We retrospectively collected cases from 1729 patients with ischemic stroke from the electronic record system of Jiangmen Central Hospital from January 2021 to December 2023. A total of 731 patients were randomly divided into development (n = 511, 70%) and validation (n = 220, 30%) groups. Univariate and multivariate logistic regression analyses with backward stepwise regression were used to select the predictive variables, and a nomogram was developed. The discrimination was evaluated based on the area under the curve (AUC). Calibration was assessed using calibration plots and the Hosmer-Lemeshow test. Clinical applications were evaluated using decision curve analysis (DCA). The incidence of acute POUR was 12.72%. Preoperative statin use within 24 h, operation type, intraoperative infusion, postoperative water intake within 3 h, postoperative pain, and postoperative anxiety were included in the nomogram. The AUC values were 0.764 [95% confidence interval (CI): 0.705-0.825] in the development group and 0.741 (95% CI: 0.615-0.856) in the validation group. The calibration plots showed good calibration. The p values in the Hosmer-Lemeshow tests were 0.962 and 0.315 for the development and validation groups, respectively. The DCA showed that patients could benefit from this nomogram. A nomogram was developed to successfully predict acute POUR in patients with ischemic stroke following FAP. This nomogram is a convenient and effective tool for clinicians to aid in the prevention and early intervention of acute POUR.

7668 Rhabdomyolysis Associated with Severe Hypothyroidism

Abstract Disclosure: H. Soe: None. P. Mikkilineni: None. Background: Over 70% of the patients with newly diagnosed hypothyroidism can present with muscle complaints such as weakness, fatigability, cramps, myalgia. However, rhabdomyolysis, which is the rapid breakdown of skeletal muscle cells, is the rare presentation. Clinical Case: A 70-year old male patient with history of rheumatoid arthritis, hyperlipidemia, prior CVA (left hemispheric subcortical stroke) 6 months ago without residual deficit presented to the hospital with poor oral intake and generalized muscle weakness for 3 weeks. He was unable to get out of bed without assistance and also needed adult diapers. Found to have new-onset severe hypothyroidism with TSH 228 uIU/ml (Ref: 0.350-4.940) and FT4 &amp;lt;0.40 ng/dL (Ref: 0.70-1.50), positive TPO antibody 197 IU/ml (Ref: 0-34). No prior thyroid labs were available and no known history of thyroid disorder was recorded. He has never been on Amiodarone or Lithium before. On physical exam, he was alert and oriented. There was no goiter or palpable thyroid nodule. There was no focal neurological deficit and no peripheral edema. There were no other signs and symptoms pertinent to hypothyroidism except mild bradycardia (HR 56-60) and borderline low blood pressure. AM cortisol was 10.1 ug/dL (Ref: 3.7-19.4). EKG showed low-voltage sinus bradycardia. Echocardiogram was normal. Urinalysis was positive for large blood but only 3 RBCs were present which raised the suspicion of rhabdomyolysis. Creatinine kinase (CK) was 15,584 IU/L (Ref: 30-200). Other laboratory studies were significant for acute renal failure with mild hyperkalemia and mild hypocalcemia, also transaminitis; BUN 130 mg/dl (Ref: 8-26), Creatinine 9.51 mg/dl (Ref: 0.72-1.25), eGFR 5 ml/min/1.73 m2 (Ref: &amp;gt;59), AST 435 IU/L (Ref: 5-34), ALT 269 IU/L (Ref: &amp;lt;55), ALP 171 IU/L (Ref: 40-150). On medication review, he was started on Atorvastatin 80 mg daily during prior admission for CVA 6 months ago. He received IV fluids, s/p 1 dose of Hydrocortisone 100 mg IV, Levothyroxine IV 200 mcg, followed by Levothyroxine IV 50 mcg daily x 3 days and switched to Levothyroxine PO 100 mcg daily (weight-based dose). Atorvastatin was on hold. He became anuric during the hospital course and received 2-3 sessions of hemodialysis. 3-4 days later, CK was trending down to 3000 IU/L, FT4 improved to 0.54 ng/dl and there was also significant improvement in kidney and liver functions. The patient was diagnosed with acute renal failure secondary to rhabdomyolysis associated with severe hypothyroidism caused by Hashimoto's thyroiditis, in the setting of high dose statin use. Conclusion: Clinicians should raise the suspicion of rhabdomyolysis in a patient with severe hypothyroidism, especially in patients with recent high dose statin use as rhabdomyolysis can be a rare and fatal complication of severe hypothyroidism, in the presence of precipitating factors. Presentation: 6/2/2024

8261 Achievement of Diabetes Treatment Goals in Mexico from 2016 to 2022

Abstract Disclosure: D. Ramirez Garcia: None. C.A. Fermin Martinez: None. P.N. Mendez Labra: None. N.E. Antonio Villa: None. J.A. Seiglie: None. O.Y. Bello-Chavolla: None. Background: Optimal diabetes care involves achieving goals with treatment in key metabolic parameters including HbA1c, blood pressure (BP), low density lipoprotein cholesterol (LDL-C) levels, and smoking cessation. Evaluation of diabetes care in Mexico has been incomplete, with previous studies focusing primarily on glycemic control, but not on a comprehensive analysis of combined treatment targets. Objective: To estimate achievement of diabetes treatment goals (HbA1c [A], BP [B], LDL-C [C], smoking cessation [N], and combined targets [AB, BC, AC, ABC, ABCN]) using data from nationally representative surveys from 2016-2022 among individuals with diagnosed diabetes in Mexico. Methods: We analyzed serial cross-sectional National Health and Nutrition Surveys from 2016-2022. A total of 2,689 adults with diagnosed diabetes ≥20 years were identified amongst 21,248 adults ≥20 years. Weighted prevalence estimates were obtained for glycemic control (HbA1c &amp;lt;7% in those &amp;lt;65 years, and &amp;lt;7.5% in those ≥65 years), BP control (&amp;lt;130/80 mmHg), LDL-C control (&amp;lt;70 mg/dL), smoking cessation, and combined targets. We also fitted logistic regression models to estimate the odds of achieving treatment targets according to age, sex, educational level, indigenous identity, and survey cycle. Results: In 2022, the prevalence of HbA1c, BP, and LDL-C control among individuals with diagnosed diabetes in Mexico was 41.2% (95% CI 30.5-52.0%), 46.0% (95% CI 36.5-55.5%), and 17% (95% CI 10.2-25.2%), respectively. Non-smoking prevalence was 92.4% (95% CI 88.6-96.2%). Combined target achievement was low, with a prevalence of 10.8% (95%CI 6.2-15.5%) for BC and 4% (95% CI 1.7-6.3%) for ABCN. The proportion of goal achievement was relatively stable across 2016-2022 for every parameter analyzed, except for LDL-C. LDL-C had the lowest proportion of control across all cycles, although a gradual increase was observed: 8.1% (95% CI 4-12.3%) in 2016 to 17% (95% CI 10.2-25.2%) in 2022. The increase in LDL-C control coincides with greater prevalence of statin use across survey cycles. Men had lower odds of achieving ABCN combined control (OR 0.49, 95%CI 0.45-0.54) than women. Similarly, compared with individuals &amp;lt;45 years, participants 45-64 years (OR 0.36, 95%CI 0.32-0.40) and ≥65 years (OR 0.41 95%CI 0.35-0.47) had lower odds of achieving composite control. Conclusions: Achievement of diabetes treatment goals in Mexico is suboptimal. Less than half of individuals with diagnosed diabetes achieve HbA1c or BP goals, less than a fifth achieve LDL-C control, and only 1 in 20 individuals achieve ABCN control. Greater efforts are needed to the improve the comprehensive care of individuals with diabetes in Mexico. Presentation: 6/3/2024