Efficacy and Tolerability of Pitavastatin Versus Pitavastatin/Fenofibrate in High-risk Korean Patients with Mixed Dyslipidemia: A Multicenter, Randomized, Double-blinded, Parallel, Therapeutic Confirmatory Clinical Trial

Ihm, Sang Hyun; Chung, Woo Baek; Lee, Jong Min; Hwang, Byung‐Hee; Yoo, Ki Dong; Her, Sung Ho; Song, Woo Hyuk; Chae, In Ho; Park, Tae Ho; Kim, Ju Han; Jeon, Dong Woon; Cho, Byung Ryul; Kang, Seung Ho; Park, Sang Don; Lee, Jin Bae; Woo, Jeong Taek; Lee, Byung Wan; Han, Kyung Ah; Won, Kyung Heon; Kim, Hyo Soo; Yu, Jae Myung; Chung, Choon Hee; Kim, Hae Jin; Cho, Ho Chan; Seung, Ki Bae

doi:10.1016/j.clinthera.2020.08.002

Cited by 7 publications

(6 citation statements)

References 22 publications

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“…The results of a SAFARI trial indicated additional reduction in non-HDL-C with fenofibrate adjunct to simvastatin compared to statin monotherapy [ 35 ]. In a recent study, Ihm et al (2020) reported that, in patients with stable LDL-C and elevated TG levels, adding fenofibrate to pitavastatin led to a better reduction in non-HDL-C levels compared to pitavastatin monotherapy (treatment difference of 12.45% at 8 weeks in favor of combination treatment) [ 36 ].…”

Section: Discussionmentioning

confidence: 99%

“…In our study, adding fenofibrate to statin treatment led to a 38.9% reduction in serum CRP levels. Ihm et al, in the abovementioned clinical study, reported a reduction in CRP with a pitavastatin/fenofibrate combination [ 36 ]. There are several mechanisms of inflammatory process involvement in atherosclerotic plaque formation and destabilization, including macrophages, neutrophils, lymphocytes, interleukins, and chemokines [ 37 ].…”

Section: Discussionmentioning

confidence: 99%

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Effectiveness and Safety of Fenofibrate in Routine Treatment of Patients with Hypertriglyceridemia and Metabolic Syndrome

Ezhov,

Arutyunov

2023

Diseases

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Background: Multiple trials have demonstrated the efficacy of fenofibrate for the management of dyslipidemia. Real-world evidence may provide important insights into the effectiveness and safety of fenofibrate in patients with metabolic syndrome and elevated triglyceride (TG) levels, but such evidence is currently scarce. Materials and Methods: A non-interventional study was conducted among routine healthcare providers. Patients with TG levels of >2.3 mmol/L on stable statin therapy starting fenofibrate treatment were enrolled. Data on medical history, fenofibrate treatment, change in lipid levels, and C-reactive protein (CRP) were collected from medical records every 3 months for 6 to 7 months of observation. Results: Overall, 988 patients receiving fenofibrate were enrolled (median age [95% CI] 60 [26.0–86.0] years), and 46.4% of the participants were females. Most patients had concomitant cardiovascular disease. A baseline TG level of 3.6 ± 1.5 mmol/L was reduced by 50.1% to 1.7 ± 0.58 mmol/L at 6 months of treatment (p < 0.001). Baseline non-high-density lipoprotein cholesterol (non-HDL-C) levels decreased by 33.7% at 6 months. Total cholesterol and low-density lipoprotein levels by the end of follow-up were reduced by 24.7 and 25.5% (p < 0.001 for both). C-reactive protein level decreased more than 39% from baseline. Conclusions: Fenofibrate in a real-world setting significantly reduced TG, LDL-C, and non-HDL-C levels. In addition, a C-reactive protein level reduction of 39% was achieved.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Effectiveness and Safety of Fenofibrate in Routine Treatment of Patients with Hypertriglyceridemia and Metabolic Syndrome

Ezhov,

Arutyunov

2023

Diseases

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“…After 8 weeks of treatment, it was found that combination therapy was associated with greater reductions in serum non-HDL-C and LDL-C and increases in serum HDL-C (by –7.4%, –7.7% and +20.7%, respectively). Monotherapy and combination therapy were safe and well tolerated by patients [ 66 ]. It is worth noting that pitavastatin also improves the LDL-C subfraction profile, as it reduces the percentage of small LDL and oxidised LDL (oxLDL) [ 67 ].…”

Section: Pitavastatin – Basic Information and Lipid-lowering Effectmentioning

confidence: 99%

Position paper of the Polish Expert Group on the use of pitavastatin in the treatment of lipid disorders in Poland endorsed by the Polish Lipid Association

Banach,

Surma,

Kapłon-Cieślicka

et al. 2023

Arch Med Sci

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LDL-C is the basic lipid parameter that should be measured to determine CV risk and determines the aim and LLT target. LLT improves cardiovascular prognosis and prolongs life in both primary and secondary cardiovascular prevention. Despite the availability of effective lipid-lowering drugs and solid data on their beneficial effects, the level of LDL-C control is highly insufficient. This is related to physician inertia and patients' fear of side effects. The development of lipidology has made drugs available with a good safety profile and enabling personalisation of therapy. Pitavastatin, the third most potent statin, is characterised by a lower risk of muscle complications and NOD due to its being metabolised differently. Thus, pitavastatin is a good therapeutic option in patients at high risk of diabetes or with existing diabetes, and in patients at cardiovascular risk. This Position Paper indicates the place of using pitavastatin in the treatment of lipid disorders.

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“…These disparities are mainly because of differences in types of the definition used for dyslipidemia in each country, lipid assays used, prescription rates of lipid-lowering drugs, year of investigation, age distribution of patients, ethnic differences, regional variations, and socioeconomic status [7]. Furthermore, a residual risk for atherosclerotic cardiovascular disease (ASCVD) persists when raised TG and lowered HDL-C levels are uncontrolled with statins [10]. Therefore, to improve the awareness and treatment rates and to reduce the prevalence of dyslipidemia and associated CV risk, country-specific epidemiological surveys and management guidelines in accordance with the national settings are recommended.…”

Section: Introduction Epidemiology Of Dyslipidemia In the Asian Regionmentioning

confidence: 99%

Role of Fenofibrate Use in Dyslipidemia and Related Comorbidities in the Asian Population: A Narrative Review

Deerochanawong,

Kim,

Chang

2024

Diabetes Metab J

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Hypertriglyceridemia and decreased high-density lipoprotein cholesterol (HDL-C) persist despite statin therapy, contributing to residual atherosclerotic cardiovascular disease (ASCVD) risk. Asian subjects are metabolically more susceptible to hypertriglyceridemia than other ethnicities. Fenofibrate regulates hypertriglyceridemia, raises HDL-C levels, and is a recommended treatment for dyslipidemia. However, data on fenofibrate use across different Asian regions are limited. This narrative review summarizes the efficacy and safety data of fenofibrate in Asian subjects with dyslipidemia and related comorbidities (diabetes, metabolic syndrome, diabetic retinopathy, and diabetic nephropathy). Long-term fenofibrate use resulted in fewer cardiovascular (CV) events and reduced the composite of heart failure hospitalizations or CV mortality in type 2 diabetes mellitus. Fenofibrate plays a significant role in improving irisin resistance and microalbuminuria, inhibiting inflammatory responses, and reducing retinopathy incidence. Fenofibrate plus statin combination significantly reduced composite CV events risk in patients with metabolic syndrome and demonstrated decreased triglyceride and increased HDL-C levels with an acceptable safety profile in those with high CV or ASCVD risk. Nevertheless, care is necessary with fenofibrate use due to possible hepatic and renal toxicities in vulnerable individuals. Long-term trials and real-world studies are needed to confirm the clinical benefits of fenofibrate in the heterogeneous Asian population with dyslipidemia.

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Efficacy and Tolerability of Pitavastatin Versus Pitavastatin/Fenofibrate in High-risk Korean Patients with Mixed Dyslipidemia: A Multicenter, Randomized, Double-blinded, Parallel, Therapeutic Confirmatory Clinical Trial

Abstract: Purpose: Dyslipidemia is an important risk factor for cardiovascular disease (CVD). Statins are known to effectively reduce not only low-density lipoprotein cholesterol (LDL-C) level but also death and nonfatal myocardial infarction due to coronary heart disease.

Cited by 7 publications

References 22 publications

Effectiveness and Safety of Fenofibrate in Routine Treatment of Patients with Hypertriglyceridemia and Metabolic Syndrome

Effectiveness and Safety of Fenofibrate in Routine Treatment of Patients with Hypertriglyceridemia and Metabolic Syndrome

Position paper of the Polish Expert Group on the use of pitavastatin in the treatment of lipid disorders in Poland endorsed by the Polish Lipid Association

Role of Fenofibrate Use in Dyslipidemia and Related Comorbidities in the Asian Population: A Narrative Review

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