scholarly journals Efficacy, Safety, Cost, and Clinical Outcomes After the Switch to Generic Rosuvastatin Compared with Consistent Brand-Name Atorvastatin Treatment.

Author(s):  
Mu-shiang Huang ◽  
Chun-I Wu ◽  
Pei-Fang Su ◽  
Ping-Yen Liu

Abstract Background: The efficacy, safety, and clinical outcomes for patients switch to generic rosuvastatin, compared with patients taking other brand-name atorvastatin, is unclear. Method: We retrospectively collected electronic medical records from January 1, 2013, to December 31, 2020, of patients who switched medication, because of hospital policy, from brand-name to generic rosuvastatin after March 14, 2018. we only considered patients who had taken the medication at least 1 year prior to and 1 year after that date. We also collected records of patients who consistently used brand-name atorvastatin during the same period. The efficacy of lipid control, potential adverse effects, clinical outcomes of major cardiovascular events (MACE), and medical expenses were compared between the 2 groups. Propensity score matching (PSM) was conducted to balance potential cofounders. Result: After 1:1 PSM, 592 patients were enrolled in the rosuvastatin and atorvastatin groups, and no significant difference was observed in their total cholesterol (TC) level difference (−4.38 ± 23.0 vs. −3.72 ± 26.95 mg/dL, P = 0.702), low-density lipoprotein (LDL-C) (−2.38 ± 19.89 vs. −2.42 ± 23.63 mg/dL, P = 0.976), or glycated hemoglobin (−0.05% ± 0.7% vs. −0.08% ± 0.76%, P = 0.543). No significant differences were noted in their cumulative MACE (2.70% vs. 3.89%, log-rank P = 0.265) after the switch date, and each person in the generic group had a 16% average reduction in their medical expenses. Conclusion: Switching to generic rosuvastatin led to comparable lipid-lowering efficacy, safety, and clinical outcomes and fewer medical expenses compared with consistently using brand-name atorvastatin.

2021 ◽  
Author(s):  
Mu-shiang Huang ◽  
Chun-I Wu ◽  
Pei-Fang Su ◽  
Ping-Yen Liu

Abstract Background: The efficacy, safety, and clinical outcomes for patients switch to generic rosuvastatin, compared with patients taking other brand-name atorvastatin, is unclear. Method: We retrospectively collected electronic medical records from January 1, 2013, to December 31, 2020, of patients who switched medication, because of hospital policy, from brand-name to generic rosuvastatin after March 14, 2018. we only considered patients who had taken the medication at least 1 year prior to and 1 year after that date. We also collected records of patients who consistently used brand-name atorvastatin during the same period. The efficacy of lipid control, potential adverse effects, clinical outcomes of major cardiovascular events (MACE), and medical expenses were compared between the 2 groups. Propensity score matching (PSM) was conducted to balance potential cofounders. Result: After 1:1 PSM, 592 patients were enrolled in the rosuvastatin and atorvastatin groups, and no significant difference was observed in their total cholesterol (TC) level difference (−4.38 ± 23.0 vs. −3.72 ± 26.95 mg/dL, P = 0.702), low-density lipoprotein (LDL-C) (−2.38 ± 19.89 vs. −2.42 ± 23.63 mg/dL, P = 0.976), or glycated hemoglobin (−0.05% ± 0.7% vs. −0.08% ± 0.76%, P = 0.543). No significant differences were noted in their cumulative MACE (2.70% vs. 3.89%, log-rank P = 0.265) after the switch date, and each person in the generic group had a 16% average reduction in their medical expenses. Conclusion: Switching to generic rosuvastatin led to comparable lipid-lowering efficacy, safety, and clinical outcomes and fewer medical expenses compared with consistently using brand-name atorvastatin.


2020 ◽  
Author(s):  
Huan Liu ◽  
Zhipeng Zhou ◽  
Yanqing Wu ◽  
Jingsong Xu

Abstract BANKGROUND: Mortality from coronary artery disease continues to rise, and secondary prevention and treatment are particularly important. OBJECTIVE: The objective of this study is to evaluate low-density lipoprotein cholesterol (LDL-C) levels in patients after percutaneous coronary intervention (PCI), to describe how treatment outcomes for individual patients changed over time and to examine the potential impact of lipid control rates through population LDL-C levels changes.METHODS: This retrospective study was conducted in patients who underwent PCI between July 2017 and June 2019. The main results included LDL-C levels after PCI. To assess the outcome of prevention, three separate measures of LDL-C were considered: baseline, first follow-up, and final follow-up, and LDL-C control rates were analyzed according to different guidelines. we examine the impact of 0.1mmol/l decreases or increases in population LDL-C levels on LDL-C control.RESULTS: Data were analyzed for 423 patients (mean age, 62 ±10 years), and the baseline LDL-C level was 3.11 ± 0.99 mmol/l. 51.5% of the patients achieved the Chinese Lipids Guidelines treatment goal, 22% and 11.6% of the patients achieved the 2016 ESC Lipids Guidelines and 2019 ESC Lipids Guidelines treatment goal at the final follow-up period respectively. LDL-C levels fluctuated during the follow-up period, and the long-term maintenance results could not be guaranteed after PCI. Population LDL-C levels changes in lifestyle could have a very large impact on LDL-C control in China.CONCLUSION: LDL-C control with statins is not ideal in patients after PCI, which is far from the requirements of the latest guidelines. Although clinicians understand the lipid-lowering effect of statins, they should not give up active lifestyle changes, and should strengthen the comprehensive management of blood lipid control.


2020 ◽  
Vol 16 (5) ◽  
pp. 361-371 ◽  
Author(s):  
Anandita Agarwala ◽  
Anne C Goldberg

Bempedoic acid (ETC-1002) is a novel, first-in-class, oral, small molecule that inhibits cholesterol biosynthesis in the same pathway as statins, thereby lowering low-density lipoprotein cholesterol (LDL-C) by upregulating LDL receptors. Preclinical and completed Phase II and III clinical trials have demonstrated promising results regarding its safety and efficacy across a variety of patient characteristics including statin intolerance and on a background of lipid-lowering therapy. Bempedoic acid is currently being evaluated in a cardiovascular outcomes trial to evaluate its effect on major cardiovascular events in patients with or at high risk for cardiovascular disease and with statin intolerance. In this review, we will discuss the history and development of bempedoic acid, relevant clinical trials, and its potential role as a lipid-lowering medication in the context of other currently available lipid-lowering therapies.


2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
A Ryabikov ◽  
E Mazdorova ◽  
M Shapkina ◽  
E Avdeeva ◽  
G Simonova ◽  
...  

Abstract Background Despite of guidelines for management of dyslipidemias (DLP) and the availability of effective and safe lipid lowering drugs (LLD), about one half of CVD patients do not reach the target lipid levels. The knowledge on DLP management in Russian population is limited. Objective To analyze the frequency and profile of LLD therapy in subjects with DLP and cardiometabolic diseases in a contemporary Russian population. Methods A random population sample of men and women 55–84 years old (n=3898) was examined in 2015–17 in the Russian arm of the HAPIEE project. A composite dysmetabolic group included DLP (total cholesterol, TC ≥5 mmo/l or low-density lipoprotein cholesterol, LDLC ≥3 mmol/l or triglycerides, TG ≥1.7 mmol/l) and/or coronary heart disease (CHD) and/or diabetes mellitus type 2 (DM2). Regular medication intake for 12 months was coded by ATC. Results In studied population sample 88% of subjects had dysmetabolic disorders (DLP - 83.1%, CHD - 14.9%, DM2- 20.8%); among them 32.8% subjects received LLD therapy (21.2% in men vs. 39.4% in women, p<0.001) and 17.1% did not report the status of LLD receiving. The frequency of LLD use in CHD group was 48,3%, in DM2 – 35,0%, in DLP – 29.4%. Among named LLD, statins were predominantly used (98%). Lipids control was achieved among subjects with CHD in 18.3% (37.9% among those receiving LLD); among DM2 - in 9.0% (25.6%); among DLP without CHD or DM2 – in 7.3% (24.8%). Conclusion In an urban population sample aged 55–84 examined in 2015–17, more than one half of subjects with dysmetabolic disorders (CHD, DM2, DLP) did not receive LLD. Among those receiving lipid-lowering therapy, the lipid control was achieved in about 40% of participants with CHD, and in every forth participant with DM2 or DLP. The lack of lipid control is likely to contribute high rate of atherosclerotic CVD in studied population. FUNDunding Acknowledgement Type of funding sources: Foundation. Main funding source(s): Russian Foundation of Basic Research; Russian Academy of Sciences


Author(s):  
Anandita Agarwala ◽  
Nathan Bekele ◽  
Elena Deych ◽  
Michael W. Rich ◽  
Aliza Hussain ◽  
...  

Background Black men and women are at higher risk for, and suffer greater morbidity and mortality from, atherosclerotic cardiovascular disease (ASCVD) compared with adults of European Ancestry (EA). Black patients with familial hypercholesterolemia are at particularly high risk for ASCVD complications because of lifelong exposure to elevated levels of low‐density‐lipoprotein cholesterol. Methods and Results This retrospective study analyzed ASCVD prevalence and risk factors in 808 adults with heterozygous familial hypercholesterolemia from 5 US‐based lipid clinics, and compared findings in Black versus EA patients. Multivariate logistic regression models were used to determine the strongest predictors of ASCVD as a function of race. No significant difference was noted in the prevalence of ASCVD in Black versus EA patients with familial hypercholesterolemia (39% versus 32%, respectively; P =0.15). However, Black versus EA patients had significantly greater prevalence of modifiable risk factors, including body mass index (mean, 32±7 kg/m 2 versus 29±6 kg/m 2 ; P <0.001), hypertension (82% versus 50%; P <0.001), diabetes (39% versus 15%; P <0.001), and current smoking (16% versus 8%; P =0.006). Black versus EA patients also had significantly lower usage of statins (61% versus 73%; P =0.004) and other lipid‐lowering agents. In a fully adjusted multivariate model, race was not independently associated with ASCVD (odds ratio, 0.92; 95% CI, 0.60–1.49; P =0.72). Conclusions The strongest predictors of ASCVD in Black patients with familial hypercholesterolemia were hypertension and cigarette smoking. These data support wider usage of statins and other lipid‐lowering therapies and greater attention to modifiable risk, specifically blood pressure management and smoking cessation.


2021 ◽  
Vol 10 (2) ◽  
pp. 73-78
Author(s):  
D. Yu. Sedykh ◽  
O. N. Hryachkova ◽  
V. V. Kashtalap ◽  
O. L. Barbarash

Aim. To study the features of clinical and anamnestic characteristics and treatment of patients with hypertriglyceridemia (HTG) using the data of the lipid control center of Kemerovo.Methods. The single-center retrospective study is based on the data of patients dynamic observation (n = 100) in the Dyslipidemia Registry of Kuzbass in 2019. A comparative analysis of clinical and anamnestic characteristics, lipidogram parameters and therapy was performed at the time when the patients were included in the study and after 6–12 months in patients with HTG (the criterion was the level of triglycerides (TG) above 1.69 mmol/L) and in patients without it. Indications for consulting a lipidologist were high cholesterol (levels of total cholesterol (TC) ˃7.5 mmol/L or low-density lipoprotein cholesterol ˃4.9 mmol/L or TG˃5 mmol/L), requirement of the high dose and/or combination therapy of lipid-lowering drugs; medical history of cardiovascular diseases and/or revascularization of vascular bed in patients under 55 years of age; suspected intolerance to lipid-lowering therapy due to the developed side effects; the issue of lipid-lowering therapy in complex clinical situations.Results. Among the patients who visited a lipidologist in 2019, mixed hypertriglyceridemia was noted in 56 (56%) of cases, while 44 (44%) patients had other lipid metabolism disorders without increased levels of TG. A distinctive feature of patients with mixed hypertriglyceridemia is the lower incidence of myocardial infarctions (p = 0.029) and lower number of coronary stents (p = 0.018) in the medical history, despite the initially higher levels of TC (p = 0.005) and TG (p = 0.000). According to the results of 6–12 months observation, a significant decrease in TC (p = 0.001) and TG (p = 0.044) levels during the lipid-lowering therapy was revealed due to the addition of fenofibrate (p = 0.000) to all groups of patients who were monitored by a lipidologist.Conclusion. The patients with dyslipidemia and HTG are a complex category of patients who require combined lipid-lowering therapy, which can only be prescribed by a lipidologist. 


Food Research ◽  
2021 ◽  
Vol 5 (6) ◽  
pp. 141-149
Author(s):  
N.S. Mohd Isa ◽  
J.S. Ng ◽  
F. Tufail Ahmad ◽  
M.N.I. Kassim ◽  
Norhayati H. ◽  
...  

High lipid levels especially low-density-lipoprotein cholesterol (LDL-c) are associated with increased risk of cardiovascular (CVD) and coronary heart disease (CHD). Both black seed (Nigella sativa L.) and honey are well-known in the hypolipidemic potential and have CVD protective effects. In the present study, LDL-c uptake of the black seed and honey mixture was tested on HepG2 cells. Antioxidant activities of black seed and honey mixtures were determined through the 2, 2’-diphenyl-1-picrylhydrazyl (DPPH) assay. The anticancer potential of black seed and honey mixtures in HepG2 cells was performed using 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide (MTT) cytotoxicity assay. Black seed possessed the highest antioxidant activities with EC50 6.54 mg/mL as compared to honey with EC50 value 9.56 mg/mL while the black seed and honey mixture have EC50 between black seed and honey. From the results obtained, no synergistic effect was observed in the mixtures as the EC50 values were within the range of black seed and honey. Furthermore, no significant difference (p>0.05) among ratios (1:1, 2:1 and 1:2). However, the decrease in cell proliferation was the highest in black seed and honey mixture at 1:1 ratio (p<0.05) than individually treated black seed and honey. Thus, the black seed and honey mixture at ratio 1:1 was the most potent anticancer agent with an IC50 value of 7.44 μg/mL. The present study illustrated that black seed and honey mixtures possess a lipid-lowering effect via LDL-c uptake in HepG2 cells (p<0.05). The highest LDL-c uptake was observed at 15 μg/mL with the treatment of black seed and honey mixture at 1:2 ratio which was 294.4%. Further studies should be conducted on primary human liver cells to further justify the correlation between the antioxidant level and LDLc uptake mechanism of black seed and honey mixtures.


2014 ◽  
Vol 41 (1) ◽  
pp. 136-146 ◽  
Author(s):  
Manel Pladevall ◽  
George Divine ◽  
Karen E. Wells ◽  
Ken Resnicow ◽  
L. Keoki Williams

Purpose The purpose of this study was to assess whether providing medication adherence information with or without motivational interviewing improves diabetes and lipid control. Methods Study participants were adult members of a health system in southeast Michigan, were using both oral diabetes and lipid-lowering medications, and had glycated hemoglobin (A1C) or low-density lipoprotein cholesterol (LDL-C) levels not at goal. Participants were randomly assigned to receive usual care (UC), n = 567; have medication adherence information (AI) provided to their physician, n = 569; or have AI and receive motivational interviewing (MI) though trained staff (AI + MI), n = 556. Primary outcomes were A1C and LDL-C levels at 18 months post randomization. Results Primary outcomes were not significantly different between patients in the AI or AI + MI study arms when compared with UC. Similarly, neither oral diabetes nor lipid-lowering medication adherence was significantly different between groups. Patient participation in the AI + MI arm was low and limit the interpretation of the study results, but post hoc analysis of the AI + MI study arm showed that the number of MI sessions received was positively associated with only oral diabetes medication adherence. Conclusion Neither AI nor MI significantly improved diabetes and lipid control when compared with UC. Moreover, patient participation appeared to be a particular barrier for MI.


2019 ◽  
Vol 20 (10) ◽  
pp. 1029-1040 ◽  
Author(s):  
Xinjie Lu

Background:One of the important factors in Low-Density Lipoprotein (LDL) metabolism is the LDL receptor (LDLR) by its capacity to bind and subsequently clear cholesterol derived from LDL (LDL-C) in the circulation. Proprotein Convertase Subtilisin-like Kexin type 9 (PCSK9) is a newly discovered serine protease that destroys LDLR in the liver and thereby controls the levels of LDL in plasma. Inhibition of PCSK9-mediated degradation of LDLR has, therefore, become a novel target for lipid-lowering therapy.Methods:We review the current understanding of the structure and function of PCSK9 as well as its implications for the treatment of hyperlipidemia and atherosclerosis.Results:New treatments such as monoclonal antibodies against PCSK9 may be useful agents to lower plasma levels of LDL and hence prevent atherosclerosis.Conclusion:PCSK9's mechanism of action is not yet fully clarified. However, treatments that target PCSK9 have shown striking early efficacy and promise to improve the lives of countless patients with hyperlipidemia and atherosclerosis.


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