Moderate Statin Research Articles

Statins and Mortality of Patients After Transcatheter Aortic Valve Implantation: A Systematic Review and Meta-analysis.

While TAVI is widely used, optimal medical therapy to reduce the mortality rate after transcatheter aortic valve implantation (TAVI) is still unclear. We performed a systematic review and meta-analysis to evaluate the impact of statins on mortality following TAVI. Present systematic review of the literature was performed using Medline, Embase, Scopus, and Web of Science; all studies reported all-cause mortality in patients who underwent TAVI and received or did not receive statin therapy. Data were analyzed using random-effects models. Seventeen articles (21380 patients) were included in the meta-analysis. Statin therapy was associated with a reduction of all-cause mortality (Hazard ratio [HR] = .78, 95% Confidence interval [CI] .68-.89, P < .001). Moderate between-study heterogeneity was observed (I2 = 45.2). High-intensity statin therapy was more effective than low or moderate intensity statin therapy in reduction of all-cause mortality (Risk ratio [RR] = .62, 95% CI 0.45-.85, P = .003, I2 = .0). Statin therapy could reduce the mid-term all-cause mortality rate following TAVI. However, all included studies were observational and, therefore, randomized controlled trials are still needed to assess the effect of statin therapy on mortality after TAVI.

Serum Lipoprotein(a) and 3-Year Outcomes in Patients Undergoing Percutaneous Coronary Intervention

We aimed at addressing the association between serum lipoprotein (a) levels and clinical outcomes of consecutive patients undergoing PCI. We used consecutive patients undergoing PCI at the Heart Center University of Freiburg, Bad Krozingen in Germany between January 2005 and November 2013. A total of 6679 patients (men [n = 5391] and women [n = 1288]) with mean age of 67.5 (± 11.1) years were assessed at baseline and prospectively followed for 3 years. Lp(a) measurement was performed at hospital admission as a routine laboratory parameter. Approximately 30% of PCI patients showed an elevated Lp(a) value of more than 50 mg/dL. In total, 736 Patients died during the follow-up, thereof 189 (11.3%) in the first quartile, 186 (10.7%) in the second quartile, 183 (11.5%) in the third quartile and 178 (10.7%) in the last quartile (P value 0.843 from LogRank test). The MACE rate showed consistent results with 409 (24.4%), 385 (22.1%), 395 (24.7%) and 419 (25.3%) in the different respective quartiles (P value 0.125 from LogRank test). In this large non-selected cohort of patients undergoing PCI followed by moderate intensity statin therapy, higher Lp(a) levels were not associated with worse clinical outcomes during a follow-up of 3 years.

Association between statin use and the prognosis of patients with acute myocardial infarction complicated with diabetes.

BackgroundType 2 diabetes leads to an increase in the prevalence of lipid abnormalities, which increases the risk of cardiovascular disease. Therefore, current guidelines generally recommend the use of moderate or high-intensity statins in patients with type 2 diabetes. There are still few studies on the overall risk benefit balance of statins for acute myocardial infarction (AMI) patients with diabetes. Compared with other types of lipid-lowering drugs, the advantage of statins for the prognosis of patients with AMI has not yet been determined. We investigated the effects of statins and non-statins on intensive care unit (ICU) and inpatient mortality in patients with AMI and diabetes.MethodsThis study retrospectively collected all patients with AMI and diabetes in the Medical Information Mart Intensive Care-IV database. We assessed ICU and in-hospital mortality rates during hospitalization in both groups. The clinical end point was in-hospital mortality and ICU mortality. Kaplan-Meier and Cox proportional-hazards regression models were applied to analyze the correlation between the two groups and the outcomes.ResultsData on 1,315 patients with AMI and diabetes were collected, among which 1,211 used statins during hospitalization. The overall in-hospital mortality of patients with AMI and diabetes was 17.2%, and the total ICU mortality was 12.6%. The in-hospital mortality was lower for the statin group than for the non-statin group (13.9% and 55.8%, respectively). Kaplan-Meier survival curves demonstrated that survival probability was higher in the statin group than in the non-statin group. In the cohort without hyperlipidemia, the statin group had lower risks of ICU death (HR = 0.12, 95% CI = 0.04–0.40) and in-hospital death (HR = 0.36, 95% CI = 0.16–0.84) compared with the non-statin group.ConclusionsStatins can significantly reduce ICU and in-hospital mortality rates in patients with AMI and diabetes. Even in the population without hyperlipidemia, statins can still reduce the mortality in patients with AMI and diabetes.

Obicetrapib Lowers LDL-C in Patients Taking High Intensity Statins - Results from the ROSE Clinical Trial

Lead Author's Financial Disclosures New Amsterdam Pharma. Study Funding NewAmsterdam Pharma. Background/Synopsis Mendelian randomization studies have predicted that cholesteryl ester transfer protein (CETP) inhibition would reduce the risk of cardiovascular events. This was confirmed in REVEAL; by lowering LDL-C, anacetrapib was associated with a reduction in cardiovascular events. Early studies of the selective CETP inhibitor obicetrapib demonstrated LDL-C lowering up to 45% as monotherapy and 68% in combination with moderate intensity statin therapy. Objective/Purpose To assess the effects of obicetrapib on LDL-C and lipid parameters in patients treated with high intensity statins. Methods Patients (n=120) with an LDL-C ≥70 mg/dL, despite treatment with high intensity statins, were randomized to treatment with obicetrapib 5 or 10 mg or matching placebo for 8 weeks. The primary endpoint was the difference between groups in percent change in LDL-C from baseline to week 8. Secondary endpoints included changes in ApoB, non-HDL-C and HDL-C. Exploratory analyses evaluated differences in Friedewald and preparative ultracentrifugation measurement (PUC) of LDL-C. Safety assessment included biochemistry, vital signs, physical examinations, and adverse events. Results Patients had a median LDL-C of 88 mg/dL at baseline. Compared with placebo, obicetrapib produced greater dose-dependent lowering of LDL-C (up to 50.8%, P<0.0001), which was comparable between PUC and Friedewald measures. Obicetrapib also produced greater lowering of apoB (up to 29.8%, P<0.0001), non-HDL-C (up to 44.4%, P<0.0001), Lp(a) (up to 56.5%, P<0.0001) and raising of HDL-C (up to 165%, P<0.0001) in a dose-dependent fashion compared with placebo. Fewer patients in the obicetrapib arms (26%) experienced treatment-emergent adverse events than in the placebo arm (48%). No patients in either obicetrapib arm experienced a treatment-emergent SAE. There were no clinically significant changes in laboratory parameters, vital signs, or physical examinations in any study group. Conclusions Obicetrapib at doses of 5 and 10 mg produced robust decreases in LDL-C, ApoB, Lp(a) and Non-HDL-C and increases in HDL-C compared to placebo in patients treated with high intensity statins and was safe and well tolerated. New Amsterdam Pharma.

Obicetrapib Lowers LDL-C in Patients Taking High Intensity Statins - Results from the ROSE Clinical Trial

<h3>Lead Author's Financial Disclosures</h3> Nothing to disclose. <h3>Study Funding</h3> NewAmsterdam Pharma. <h3>Background/Synopsis</h3> Mendelian randomization studies have predicted that cholesteryl ester transfer protein (CETP) inhibition would reduce the risk of cardiovascular events. This was confirmed in REVEAL; by lowering LDL-C, anacetrapib was associated with a reduction in cardiovascular events. Early studies of the selective CETP inhibitor obicetrapib demonstrated LDL-C lowering up to 45% as monotherapy and 68% in combination with moderate intensity statin therapy. <h3>Objective/Purpose</h3> To assess the effects of obicetrapib on LDL-C and other lipid parameters in patients treated with high intensity statins. <h3>Methods</h3> Patients (n=120) with an LDL-C ≥70 mg/dL, despite treatment with high intensity statins, were randomized to treatment with obicetrapib 5 or 10mg or matching placebo for 8 weeks. The primary endpoint was the difference between groups in percent change in LDL-C from baseline to week 8. Secondary endpoints included changes in ApoB, non-HDL-C and HDL-C. Exploratory analyses evaluated differences in Friedewald and preparative ultracentrifugation measurement (PUC) of LDL-C. Safety assessment included biochemistry, vital signs, physical examinations, and adverse events. <h3>Results</h3> Patients had a median LDL-C of 88mg/dL at baseline. Compared with placebo, obicetrapib produced greater dose-dependent lowering of LDL-C (up to 50.8%, P<0.0001), which was comparable between PUC and Friedewald measures. Obicetrapib also produced greater lowering of apoB (up to 29.8%, P<0.0001) and non-HDL-C (up to 44.4%, P<0.0001) and raising of HDL-C (up to 165%, P<0.0001) in a dose-dependent fashion compared with placebo. (Table) Fewer patients in the obicetrapib arms (26%) experienced treatment emergent adverse events than in the placebo arm (48%). No patients in either obicetrapib arm experienced a treatment emergent SAE. There were no clinically significant changes in laboratory parameters, vital signs, or physical examinations in any study group. <h3>Conclusions</h3> Obicetrapib at doses of 5 and 10mg produced robust decreases in LDL-C, ApoB and Non-HDL-C and increases in HDL-C compared to placebo in patients treated with high intensity statins and was safe and well tolerated.

Association of Statin Usage and the Development of Diabetes Mellitus after Acute Pancreatitis

BackgroundPatients with acute pancreatitis (AP) have at least a 2-fold higher risk for developing postpancreatitis diabetes mellitus (PPDM). No therapies have prevented PPDM. Statins were demonstrated to possibly lower the incidence and severity of AP but have not been studied to prevent PPDM. MethodsData from a commercial insurance claim database (Optum Clinformatics) were used to assess the impact of statins on patients without pre-existing DM admitted for a first episode of AP in 118,479 patients. Regular statin usage was defined as filled statin prescriptions for at least 80% of the year prior to AP. The primary outcome was defined as PPDM. We constructed a propensity score and applied inverse probability of treatment weighting to balance baseline characteristics between groups. Using Cox proportional hazards regression modeling, we estimated the risk of PPDM, accounting for competing events. ResultsWith a median of 3.5 years of follow-up, the 5-year cumulative incidence of PPDM was 7.5% (95% confidence interval [CI], 6.9% to 8.0%) among regular statin users and 12.7% (95% CI, 12.4% to 12.9%) among nonusers. Regular statin users had a 42% lower risk of developing PPDM compared with nonusers (hazard ratio, 0.58; 95% CI, 0.52 to 0.65; P < .001). Irregular statin users had a 15% lower risk of PPDM (hazard ratio, 0.85; 95% CI, 0.81 to 0.89; P < .001). Similar benefits were seen with low, moderate, and high statin doses. ConclusionsIn a large database-based study, statin usage reduced the risk of developing DM after acute pancreatitis. Further prospective studies with long-term follow-up are needed to study the impact of statins on acute pancreatitis and prevention of PPDM.

Lipid profile of patients treated with evolocumab in Spanish hospital nephrology units (RETOSS NEFRO)

Background and objectiveTo describe the clinical characteristics, the reasons for initiating therapy and the effects of treatment in the initial phase of evolocumab availability in the Nephrology Units of Spain. Material and MethodsRetrospective, observational and multicentric study that included patients initiating treatment with evolocumab (from February 2016 to August 2018), in 15 Nephrology Units in Spain. The demographic and clinical characteristics of the patients, the lipid lowering treatment and the evolution of the lipid profiles between 24 weeks pre-initiation and 12±4 weeks post-initiation of evolocumab were reviewed. Results60 patients were enrolled: 53.3% women; mean (SD) age, 56.9 (12.8) years, 45.0% with familial hypercholesterolemia (FH) (5.0% homozygous and 40.0% heterozygous) and 65.0% with atherosclerotic cardiovascular disease. The mean (SD) eGFR was 62.6 (30.0) ml/min/1.73m2 (51.7% of patients had eGFR <60ml/min/1.73m2 [CKD stage>2]), 50.0% had proteinuria (>300mg/g) and 10.0% had nephrotic syndrome. Other CV risk factors were hypertension (75.0%), diabetes (25.0%), and smoking (21.7%). A 40.0% of patients were statin intolerant. At evolocumab initiation, 41.7% of patients were on a high intensity statin, 18.3% on moderate intensity statin and 50.0% were receiving ezetimibe. Mean (SD) LDL-c at evolocumab initiation was 179.7 (62.9) mg/dL (53.4% of patients with LDL-c ≥160mg/dL and 29.3% ≥190mg/dL). After 12 weeks, evolocumab resulted in LDL-c reductions of 60.1%. At week 12, 90.0% of patients reached LDL-c levels <100mg/dL, 70.0% <70mg/dL, and 55.0% <55mg/dL, while mean eGFR levels and statin use remained stable. ConclusionIn Nephrology Units of Spain, evolocumab was predominantly prescribed in patients with FH, chronic renal disease (CRD>2) and secondary prevention, with LDL-c levels above those recommended by the guidelines. Evolocumab used in clinical practice significantly reduced the LDL-c levels in all patients included in the study.

Associations of statin use with 30-day adverse outcomes among 4 801 406 US Veterans with and without SARS-CoV-2: an observational cohort study

ObjectiveTo estimate associations of statin use with hospitalisation, intensive care unit (ICU) admission and mortality at 30 days among individuals with and without a positive test for SARS-CoV-2.DesignRetrospective cohort study.SettingUS...

Statin Prescription Patterns and Associated Factors Among Patients with Type 2 Diabetes Mellitus Attending Diabetic Clinic at Muhimbili National Hospital, Dar es Salaam, Tanzania.

PurposeTo determine statin prescription patterns and associated factors among type 2 diabetes patients attending the diabetic clinic at Muhimbili National Hospital (MNH) in Dar es Salaam, Tanzania.Patients and MethodsA hospital-based cross-sectional study involving outpatients was conducted from September 2020 to November 2020. Statin prescription history (both type and dosage) was obtained from patients as well as from the electronic medical records for determination of patterns. Participants were categorized as moderate or high risk for cardiovascular disease whereas prescription patterns were categorized as moderate and high intensity statins. Logistic regression was used to examine association, control confounders and effect modifier whereby p <0.05 was considered statistically significant.ResultsOf 400 patients who were approached for the study, 395 (98.8%) were eligible for statin prescriptions. The mean (±SD) age of the study participants was 58.1±10.3 years, out of which 371 (93.9%) belonged to the age group ≥40 years. Two-thirds(241 61.0%) of the patients were female. About two-thirds(257; 69.4%) of patients had health insurance coverage. Statins were prescribed in 47.3% of the participants. Moderate intensity statin was the only pattern prescribed. In the adjusted model, insurance coverage (OR: 0.056; 95% CI: 0.03–0.12), and hypertension (OR: 0.259; 95% CI: 0.12–0.54) were associated with an increased likelihood of being prescribed a moderate intensity statin.ConclusionA significant number of patients at MNH diabetic clinic were not on statins despite qualifying for the prescription. The findings call for further studies on reasons for low statin prescription practices in this tertiary facility.

Moderate-intensity statin use for primary prevention for more than 5 years is associated with decreased all-cause mortality in 75 years and older

ObjectiveEvidence regarding the primary preventive effects of statin in the elderly is inadequate. This study aimed to determine the duration and intensity of statins beneficial in adults aged ≥75 years for primary prevention. MethodsThis is a retrospective longitudinal study, using the National Health Insurance Corporation-Senior Cohort data from 2002 to 2015. Exact block matching was used to select comparable subjects from statin users and non-users. ResultThe study subjects consisted of 685 pairs of statin non-users and users (total number of 1,370). During the follow-up (mean 8.7 years) period, the adjusted HR for mortality compared to non-user was 0.95 (p = 0.71) in low intensity statin users and 0.80 (p = 0.002) in the moderate intensity statin groups. The adjusted HR for MACE (Major Adverse Cardiovascular Events) compared to non-users was 1.10 (p = 0.39) in the low intensity statin group and 1.29 (p = 0.001) in the moderate intensity statin group. The risk of MACE disappeared five years after in moderate intensity statin users. Moderate intensity statin use was significantly associated with an increased risk of NODM (New Onset Diabetes Mellitus) (HR 1.50, p < 0.001) for up to three years, but the risk faded away after five years (HR 0.90, p = 0.52). ConclusionModerate intensity statins taken for five or more years for primary prevention would be associated with low risk of all-cause mortality in the 75+ years old. This result may support the evidence that initiation of statin for primary prevention in patients aged over 75 years is beneficial and tolerable.

Comparison of the Four Major US Guidelines for Lipid Lowering Therapy for the Primary Prevention of ASCVD in Patients with Diabetes

<h3>Lead Author's Financial Disclosures</h3> Nothing to disclose. <h3>Study Funding</h3> None. <h3>Background/Synopsis</h3> Four US organizations (AHA/ACC, ADA, NLA, and AACE/ACE) have guidelines on statin and other lipid-lowering medication use for the primary prevention of ASCVD in patients with diabetes mellitus (DM). While all four guidelines recommend moderate to high-intensity statin as first-line therapy, the NLA and AACE/ACE have LDL-C goals based on risk and advocate non-statin LDL cholesterol lowering drugs for patients who need additional LDL-C lowering. <h3>Objective/Purpose</h3> To compare the four major guidelines in a contemporary cohort of patients with DM in a large cardiology practice. <h3>Methods</h3> We identified 8,834 patients (age > 20) with DM and no history of ASCVD who had at least one office visit between December 2019 and November 2020. Patient clinical characteristics, laboratory data, and medications were extracted from their electronic health record (EHR). Patients were considered to have met the AHA/ACC and ADA guidelines if they were aged 40 to 75 and were on a moderate or high-intensity statin. Adherence to the NLA and AACE/ACE guidelines was assessed among the 7,212 patients with DM (81.6%) who had an LDL-C value recorded in the EHR. Patients were stratified into high (LDL-C goal < 100 mg/dL) and very high-risk (LDL-C goal < 70 mg/dL) groups based on additional risk factors. <h3>Results</h3> The mean age of the study patients was 67.8 +/- 12.1 years, 50.4% were female and 70.1% were white. Among the 7,212 patients with an LDL-C in the EHR, 90.2% were stratified as very high-risk by the NLA and 98.8% by the AACE/ACE guidelines. Of the very high-risk patients not at their LDL-C goal, 69.9% were not on a high intensity statin and 92.6% not on any intestinal blocking agent. <h3>Conclusions</h3> In a contemporary cohort of primary prevention patients with DM seen in a cardiology practice almost all are very high risk and almost 60% have not achieved their NLA or AACE/ACE guideline directed LDL-C goal. Although the AHA/ACC and ADA guidelines are less stringent, over 25% have not met these goals. The use of non-statin LDL-C lowering drugs was low. Strategies are needed to improve guideline directed lipid lowering therapy in these high-risk patients.

Abstract 10160: Population Eligible for PCSK9i in Spain: A Real-World Analysis

Background: Cardiovascular (CV) diseases are the leading cause of mortality globally. Reducing low-density lipoprotein cholesterol (LDL-C) is a proven strategy to decrease risk of acute CV events. The study aimed to estimate a PCSK9i-eligible population in Spain. Methods: We conducted a retrospective cohort study based on real-world data from the IQVIA Spanish Electronic Medical Records primary care database. Adult (≥18 y.o.) patients registered in the database between 2014 and 2020, diagnosed with myocardial infarction (MI), unstable angina (UA), ischemic stroke (IS), transient ischemic attack (TIA) or peripheral artery disease (PAD) and with at least 1 measurement of LDL-C or total cholesterol were included in the study and followed up for up to 12 months from the initial diagnosis. Results: The study included 9,516 patients; mean (SD) age was 67.7 (12.5) years, 63.9% were male and mean LDL-C was 117.3 (38.8) mg/dL. In the study population 28.5% of patients suffered an MI as most severe event during the study period, 10.0% had UA, 18.7% were diagnosed with IS, 13.6% with TIA, and 29.3% with PAD. At the time of last available LDL-C assessment (≥3 months after diagnosis), 64.4% of patients were on lipid lowering therapy (LLT). Of those, 45.4% were on high-intensity LLT (high-intensity statins with/without ezetimibe or PCSK9 inhibitors), 46.9% on moderate-intensity statins, and 7.7% on low-Intensity LLT (low-intensity statins, ezetimibe alone or non-statin LLT). Overall, 12.9% of treated patients achieved LDL-C levels &lt;55 mg/dL; this proportion was the highest among those on high-intensity statins and any statin combined with ezetimibe (63.2%), followed by patients on moderate intensity statins (32.6%) and those on low-intensity LLTs (3.1%). A total of 17.1% of patients receiving optimized LLT had an LDL-C&gt;100 mg/dL (LDL-C reimbursement threshold for PCSK9i in Spain). Conclusions: More than 85% of patients at very-high risk of cardiovascular events in our cohort do not achieve LDL-C &lt;55 mg/dL recommended by 2019 ESC/EAS guidelines for management of dyslipidemia. More than 17% of the patients have LDL-C &gt;100 mg/dL despite being treated with maximally tolerated LLT and, therefore, would be eligible for using PCSK9i within Spanish reimbursement criteria.

Abstract 10669: The Association of Statin Dose and Mortality Risk Across Chronic Kidney Disease Stages in 665,858 United States Veterans

Rationale: Statin therapy is associated with lower mortality risk in both general and chronic kidney disease (CKD) populations. While statin therapy is recommended for CKD patients, the intensity of statin doses remains disputed. Thus, we examined the relationship of different statin doses with all-cause and cardiovascular (CVD) mortality across CKD stages. Methods: The cohort consists of 665,858 US Veterans with statin prescriptions between 2004-2014 who were followed until 2014. Statin intensity was categorized into low, moderate, and high dose based on ACC/AHA guidelines. Statin dosage and all-cause/CVD mortality associations were estimated using Cox proportional hazards models adjusting for comorbidities, labs, history of percutaneous coronary intervention and coronary artery bypass grafting across CKD stages. Results: Cohort mean age is 62+/-12 years with 6% females and 18% Blacks. Median [IQR] of eGFR is 79[64,93] mL/min/1.73m2 with 80% non-CKD. At baseline, 38%, 59%, and 3% patients were taking a low, moderate, and high dose of statin. A lower to null risk of all-cause and CVD mortality were found in low statin dose patients (ref: moderate statin dose) for all CKD stages. Furthermore, the association of low statin dose with all-cause mortality incrementally declined as CKD stages progressed. A null association of high statin dose with mortality risk was observed for all stages, with the exception of CKD stage 5/ESRD patients, where a 30% and 39% higher all-cause and CVD mortality risk were observed. [Figure] Conclusion: A low statin dose was associated with lower CVD mortality risk compared to a moderate dose in non-CKD patients. Yet, a high dose was associated with higher all-cause and CVD death risk in CKD stage5/ESRD patients. Statin therapy is known to improve patient outcomes; however, different intensities of statin should be applied when dealing with patients with different CKD stages as advanced stages of CKD may require adjustment in statin dosing.

Statin and Icosapent Ethyl Use and Lipid Control in US Adults with Diabetes According to DM Risk Groups, Sex and Ethnicity in the NIH Precision Medicine Initiative All of Us Study

ObjectiveData on statin therapy intensity and icosapent ethyl use among adults with diabetes mellitus (DM) are limited. We studied statin intensity and icosapent ethyl use with lipid levels among US adults with DM across risk groups, sex and ethnicity. MethodsAmong adults ≥18 years of age with DM from the NIH Precision Medicine Initiative All of Us Study, we categorized risk groups as 1) low risk with ≤1 DM risk factor, 2) high risk with ≥2 DM risk factors, and 3) DM with known ASCVD. Risk factors included age >60 years, hypertension, LDL-C ≥160 mg/dL, cigarette smoking, and HDL-C <40 mg/dL (males) and <50 mg/dL (females). We examined the % of people on low, moderate, and high-intensity statin therapy and at LDL-C levels <70 mg/dL, 70-99 mg/dL, and ≥100 mg/dL. We also studied the % of people on icosapent ethyl and examined triglyceride (TG) levels <100 mg/dL, 100-149 mg/dL, and ≥150 mg/dL. ResultsOur 42,064 participants with DM included 27.1% non-Hispanic black and 21.7% Hispanic. Inadequate statin use and improperly controlled LDL-C remain common, with 33.8% of people on high-intensity statins having LDL-C levels ≥100 mg/dL. Additionally, 1.7% of those with TG levels ≥150 mg/dL were on icosapent ethyl. ConclusionsGuideline-recommended use of high intensity statins among our higher risk DM patients is lacking, with many having inadequately controlled LDL-C levels. Moreover, icosapent ethyl use remains low, even among those with high TG levels. Further provider and patient education need to be prioritized— especially among those at highest risk.

Cost variation analysis of statins available in India

Background: The current study aimed to find out the percentage cost variation among the various brands of statins marketed in India. Statins are HMG-CoA reductase inhibitors which are widely prescribed as blood cholesterol lowering agents and hence reduce illness and mortality in those who are at high risk of cardiovascular disease. There are numerous brands of statins are marketed in India.Methods: Cost of a particular drug manufactured by different companies in the same strength and the dosage form was obtained from the price list provided by the pharmaceutical companies in current index of medical specialities (CIMS) (42nd year January to April 2021). The difference in the maximum and the minimum price of the same drug manufactured by different pharmaceutical companies, cost ratio and the percentage variation in price were analysed.Results: The percentage cost variation of statins was seen highest with tablet atorvastatin 20 mg (564.06%), followed by combination of capsule atorvastatin 10 mg+aspirin 75 mg (325%) which was followed by combination of film coated tablet atorvastatin 10 mg+fenofibrate 160 mg (267.4%), tablet rosuvastatin 20 mg (171.1%), tablet lovastatin 10 mg (108.9%), combination of tablet rosuvastatin 10 mg+fenofibrate 160 mg (87.34%) and lowest was seen with tablet simvastatin 20 mg (6.0%).Conclusions: There is a very wide cost variation among different brands of statins marketed in India. The percentage cost variation was found to be the highest among the moderate intensity statins.

Statin induced myalgia on high intensity statin in patients with Acute Coronary Syndrome

Abstract Background High intensity statins are recommended in patients with acute coronary syndrome. Statins inhibit atherosclerotic plaque formation in the coronary arteries and reducing the burden of ischemic heart disease, therefore decreasing the morbidity and mortality. Muscle symptoms are most common adverse effect of statins. Hence, the aim of this study is to determine the statin induced myalgia by the statin myalgia clinical score. Purpose To monitor the Statin induced myalgia on high intensity statin in patients with Acute Coronary Syndrome Methods This was an prospective observational study comprised of 418 patients with acute coronary syndrome who were commenced on high intensity statins (Rosuvastatin 20–40mg &amp; Atorvastatin 40–80). These patients were followed at 4 weeks, 8 weeks and 12 weeks subsequently and the clinical myalgia score (SAMS-CI) was calculated at each visit to determine the statin induced myalgia. SAMS-CI was categorized as unlikely (2–6), possible (7–8) and probable (9–11) Results From 418 patients, 327 were males and 91 were females. Mean age was 55.6±11.14. Only 19 (7.63±1.8) patients developed muscle symptoms on high intensity statins (Rosuvastatin 20 mg and Atorvastatin 40 mg) on SAMS-CI Score. 5 patients were unlikely to develop myalgia on SAMS-CI and continued with the same dosage without any new symptoms. 6 patients were possible on SAMS-CI, therefore the dosage of these patients were decreased to moderate intensity statin (Rosuvastatin 10mg, Atorvastatin 20 mg), their symptoms were resolved and continued with the moderate intensity statins. Furthermore, Statin was hold in 8 patients in the probable category for 4 weeks until the resolution of symptoms followed by moderate intensity statins. Conclusion Statin induced myalgia is more reported in old aged and female patients. Most of the patients can better tolerate the lower range of high intensity statins with the similar benefits and should be prescribed in every patient Funding Acknowledgement Type of funding sources: None.

Perfil clínico de los pacientes tratados con evolocumab en unidades hospitalarias de nefrología en España (RETOSS-NEFRO)

Background and objectiveTo describe the clinical characteristics, the reasons for initiating therapy and the effects of treatment in the initial phase of evolocumab availability in the Nephrology Units of Spain. Material and methodsRetrospective, observational and multicentric study that included patients initiating treatment with evolocumab (from February 2016 to August 2018), in 15 Nephrology Units in Spain. The demographic and clinical characteristics of the patients, the lipid lowering treatment and the evolution of the lipid profiles between 24 weeks pre-initiation and 12±4 weeks post-initiation of evolocumab were reviewed. ResultsSixty patients were enrolled: 53.3% women; mean (SD) age, 56.9 (12.8) years, 45.0% with familial hypercholesterolemia (FH) (5.0% homozygous and 40.0% heterozygous) and 65.0% with atherosclerotic cardiovascular (CV) disease. The mean (SD) eGFR was 62.6 (30.0)ml/min/1.73m2 (51.7% of patients had eGFR<60ml/min/1.73m2 [CKD stage>2]), 50.0% had proteinuria (>300mg/g) and 10.0% had nephrotic syndrome. Other CV risk factors were hypertension (75.0%), diabetes (25.0%), and smoking (21.7%). A 40.0% of patients were statin intolerant. At evolocumab initiation, 41.7% of patients were on a high-intensity statin, 18.3% on moderate intensity statin and 50.0% were receiving ezetimibe. Mean (SD) LDL-c at evolocumab initiation was 179.7 (62.9)mg/dL (53.4% of patients with LDL-c≥160mg/dL and 29.3%≥190mg/dL). After 12 weeks, evolocumab resulted in LDL-c reductions of 60.1%. At week 12, 90.0% of patients reached LDL-c levels <100mg/dL, 70.0% <70mg/dL, and 55.0% <55mg/dL, while mean eGFR levels and statin use were remained stable. ConclusionIn Nephrology Units of Spain, evolocumab was predominantly prescribed in patients with FH, chronic renal disease (CRD>2) and secondary prevention, with LDL-c levels above those recommended by the guidelines. Evolocumab used in clinical practice significantly reduced the LDL-c levels in all patients included in the study.

Switching, Persistence and Adherence to Statin Therapy: a Retrospective Cohort Study Using the Australian National Pharmacy Data.

Statins are widely prescribed for the primary and secondary prevention of cardiovascular disease (CVD), but their effectiveness is dependent on the level of adherence and persistence. This study aimed to explore the patterns of switching, adherence and persistence among the Australian general population with newly dispensed statins. A retrospective cohort study was conducted using a random sample of data from the Australian national prescription claims data. Switching, adherence to and persistence with statins were assessed for people starting statins from 1 January 2015 to 31 December 2019. Switching was defined as either switching to another intensity of statin, to another statin or to a non-statin agent. Non-persistence to treatment was defined as discontinuation (i.e. ≥90days with no statin) of coverage. Adherence was measured using proportion of days covered (PDC), and patients with PDC < 0.80 were considered non-adherent. Cox proportional hazard models were used to compare discontinuation, switching and reinitiation between different statins. A cohort of 141,062 people dispensed statins and followed over a median duration of 2.5years were included. Of the cohort, 29.3% switched statin intensity, 28.4% switched statin type, 3.7% switched to ezetimibe and in 2.7%, ezetimibe was added as combination therapy during the study period. Overall, 58.8% discontinued statins based on the 90-day gap criteria, of whom 55.2% restarted. The proportion of people non-adherent was 24.0% at 6 months to 49.0% at 5 years. People on low and moderate intensity statins were more likely to discontinue compared to those on high-intensity statins (hazard ratio [HR] 1.20, 95% confidence interval [CI] 1.09-1.31), (HR 1.28, 95%CI 1.14-1.42), respectively. Compared to maintaining same statin type and intensity, switching statins, which includes up-titration (HR 0.77, 95%CI 0.70 to 0.86) was associated with less likelihood of discontinuation after reinitiation. Long-term persistence and adherence to statins remains generally poor among Australians, which limits the effectiveness of these medicines and the consequent health impact they may provide for individuals (and by extension, the population impact when poor persistence and adherence is considered in the statin-taking population). Switching between statins is prevalent in one third of statin users, although any clinical benefit of the observed switching trend is unknown. This, combined with the high volume of statin prescriptions, highlights the need for better strategies to address poor persistence and adherence.

Intensity of statin therapy and muscle symptoms: a network meta-analysis of 153 000 patients

ObjectiveTo estimate relative risk (RR) of statin-associated musculoskeletal symptoms by statin therapy intensity.SettingNetwork meta-analysis assessing multicentre randomised controlled trials (RCTs) across several countries.ParticipantsPubMed, Web of Science, Cochrane database and ClinicalTrials.gov...

Patient"s awareness of recommended LDL-C goals in primary prevention and observed achievement

Abstract Funding Acknowledgements Type of funding sources: None. Introduction The novel 2019 ESC/EAS Guidelines on lipids recommend more intensive reduction on LDL-C across CV risk categories in comparison with the 2016 edition. Purpose This cross-sectional observation study aims to assess whether patients on lipid lowering therapy, as a primary prevention measure, are aware of the new set goals and if they achieved them. Methods Patients, taking currently any statin as a primary prevention measure, visiting the Emergency Department of a tertiary hospital in northern Greece were invited to participate by answering a short questionnaire followed by a phone call to provide the exact lab results or other details. Results In total 412 eligible patients (54.1% female) were enrolled from January to October 2020 (mean age 61 ± 13 years old). Mean duration of statin prescription was about 8 years (7.8 ± 5 years). The majority (381, 92.5%) of patients reported lab tests yearly while most of them (394, 95.6%) were being followed up in outpatient clinics or private offices. Patients were allocated into CV categories: low (48, 11.7%), medium (239, 58.0%), high (108, 26.2%) and very high (17, 4.1%). The estimated 10-year risk of CV death was calculated using SCORE. Almost two thirds of the patients (282, 68.4%) were taking moderate intensity statins (as monotherapy) while one out of ten (45, 10.9%) was taking a statin plus ezetimibe combination. No patient was prescribed a PCSK9 inhibitor. Only two out of five (171, 41.5%) patients reached the LDL-C goal, though differences were noted between risk categories with almost half of the low and medium CV risk patients achieving the desired LDL-L level: low (23, 47.9%), medium (124, 51.9%), high (21, 19.4%) and very high (3, 17.6%). No significant difference was observed in terms of potency of statin. As expected, patients taking a statin and ezetimibe combination achieved lower LDL-C levels, with almost two thirds (31 out of 45 patients, 68.9%) reaching the goal. No information could be collected regarding why patients not reaching the goal were not offered a statin of higher potency and/or dosing, a combination with ezetimibe or a PCSK9 inhibitor. Disturbingly enough, none of the patient was aware that the LDL-C goals recommended by scientific societies had been lowered in 2019, while only 29 patients (7.0%) could recall discussing LDL-C goals with their physician. Moreover, merely three patients could remember the calculation of any CV risk score. The majority of the patients (379, 92.0%) reported that they would like to know their personal CV risk score and their LDL-C goal. Conclusions Greek primary prevention patients taking statins are overall unaware of the novel set LDL-C goals and it seems that they have not been offered a total CV risk score assessment. Hardly acceptable attainment of LDL-C goals was observed. Further research is warranted to assess the barriers that obstruct a satisfactory goal achievement. Abstract Figure.