Efficacy and safety of pemafibrate in patients with hypertriglyceridemia in clinical settings: A retrospective study

Katakura, Yukino; Shimoda, Masashi; Ohnishi, Mana; Kusano, Takashi; Dan, Kazunori; Isobe, Hayato; Wamata, Ryo; Iwamoto, Yuichiro; Fushimi, Yoshiro; Sanada, J.; Obata, Atsushi; Kimura, Tomohiko; Tatsumi, Fuminori; Nakanishi, Shuhei; Mune, Tomoatsu; Kaku, Kohei; Kaneto, Hideaki

doi:10.1016/j.numecd.2023.02.011

Cited by 3 publications

(1 citation statement)

References 39 publications

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“… 7 , 8 , 9 , 10 , 11 , 12 Unlike the other PPARα agonists, pemafibrate is mainly eliminated via the liver, and its blood concentration is not significantly increased in patients with reduced renal function. 4 , 13 In recent real‐world studies of patients receiving pemafibrate in Japan, 51% 14 and 58% 15 of patients were also treated with statins indicating a medical need for the combination. Pemafibrate is currently under investigation for the treatment of non‐alcoholic steatohepatitis with positive results in a recent phase II trial in patients with non‐alcoholic fatty liver disease.…”

Section: Introductionmentioning

confidence: 99%

Drug–drug interactions between pemafibrate and statins on pharmacokinetics in healthy male volunteers: Open‐label, randomized, 6‐sequence, 3‐period crossover studies

Kamimura,

Hounslow,

Suganami

et al. 2024

Clinical Translational Sci

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Elevated triglyceride levels are associated with an increased risk of cardiovascular events despite guideline‐based statin treatment of low‐density lipoprotein cholesterol. Peroxisome proliferator‐activated receptor α (PPARα) agonists exert a significant triglyceride‐lowering effect. However, combination therapy of PPARα agonists with statins poses an increased risk of rhabdomyolysis, which is rare but a major concern of the combination therapy. Pharmacokinetic interaction is suspected to be a contributing factor to the risk. To examine the potential for combination therapy with the selective PPARα modulator (SPPARMα) pemafibrate and statins, drug–drug interaction studies were conducted with open‐label, randomized, 6‐sequence, 3‐period crossover designs for the combination of pemafibrate 0.2 mg twice daily and each of 6 statins once daily: pitavastatin 4 mg/day (n = 18), atorvastatin 20 mg/day (n = 18), rosuvastatin 20 mg/day (n = 29), pravastatin 20 mg/day (n = 18), simvastatin 20 mg/day (n = 20), and fluvastatin 60 mg/day (n = 19), involving healthy male volunteers. The pharmacokinetic parameters of pemafibrate and each of the statins were similar regardless of coadministration. There was neither an effect on the systemic exposure of pemafibrate nor a clinically important increase in the systemic exposure of any of the statins on the coadministration although the systemic exposure of simvastatin was reduced by about 15% and its open acid form by about 60%. The HMG‐CoA reductase inhibitory activity in plasma samples from the simvastatin and pemafibrate combination group was about 70% of that in the simvastatin alone group. In conclusion, pemafibrate did not increase the systemic exposure of statins, and vice versa, in healthy male volunteers.

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Section: Introductionmentioning

confidence: 99%

Drug–drug interactions between pemafibrate and statins on pharmacokinetics in healthy male volunteers: Open‐label, randomized, 6‐sequence, 3‐period crossover studies

Kamimura,

Hounslow,

Suganami

et al. 2024

Clinical Translational Sci

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PPARs in atherosclerosis: The spatial and temporal features from mechanism to druggable targets

Zheng,

Shao,

Zheng

et al. 2024

Journal of Advanced Research

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Relieved Depressive State and Glycemic Control in Type 2 Diabetes (T2D) Patient Treated by Imeglimin (Twymeeg)

Okada¹,

Bando

Iwatsuki³

et al. 2023

Asp Biomed Clin Case Rep

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The patient is a 66-year-old female being treated for hypertension. She developed a cerebral vascular accident (CVA) in October 2019, and was subsequently diagnosed with type 2 diabetes (T2D) due to an HbA1c level of 9.8%. She began a low carbohydrate diet (LCD) and started taking oral hypoglycemic agents (OHAs) such as metformin and linagliptin. From July 2021, she occasionally experienced anxiety and palpitations, leading to a diagnosis of reactive depression (adjustment disorder). Despite treatment with etizolam as needed, these symptoms persisted. In December 2022, due to an increase in HbA1c levels to 7.7%, metformin was switched to imeglimin (Twymeeg). By April 2023, her HbA1c had decreased to 6.9%, and she reported a sustained sense of well-being without psychosomatic symptoms.

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Efficacy and safety of pemafibrate in patients with hypertriglyceridemia in clinical settings: A retrospective study

Cited by 3 publications

References 39 publications

Drug–drug interactions between pemafibrate and statins on pharmacokinetics in healthy male volunteers: Open‐label, randomized, 6‐sequence, 3‐period crossover studies

Drug–drug interactions between pemafibrate and statins on pharmacokinetics in healthy male volunteers: Open‐label, randomized, 6‐sequence, 3‐period crossover studies

PPARs in atherosclerosis: The spatial and temporal features from mechanism to druggable targets

Relieved Depressive State and Glycemic Control in Type 2 Diabetes (T2D) Patient Treated by Imeglimin (Twymeeg)

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