Unique ID issued by UMIN | UMIN000047737 |
---|---|
Receipt number | R000054422 |
Scientific Title | Efficacy and safety of pemafibrate in high risk patients with coronary artery disease |
Date of disclosure of the study information | 2022/05/13 |
Last modified on | 2022/11/21 20:07:11 |
Clinical test to examine the efficacy and
safety of pemafibrate
PEMA Trial
Efficacy and safety of pemafibrate in high
risk patients with coronary artery disease
PEBE Trial
Japan |
Hypertriglyceridemia
Medicine in general | Cardiology | Endocrinology and Metabolism |
Adult |
Others
NO
To examine the efficacy and safety with pemafibrate treatment compared with those of bezafibrate
Efficacy
Others
Others
Not applicable
To examine a percent change in the fasting
serum triglyceride levels from baseline to the study endpoint after the 24-week treatment with bezafibrate or pemafibrate.
To examine a percent change in the fasting serum HDL-C and ApoA-1 levels from baseline
to study endpoint.
Interventional
Cross-over
Randomized
Individual
Open -no one is blinded
Active
2
Treatment
Medicine |
Patients were randomly assigned in a 1:1 ratio to two treatments: bezafibrate of 400 mg/day or pemafibrate of 0.2 mg/day for the first 24-week treatment period.
Patients were randomly assigned in a 1:1 ratio to two treatments: bezafibrate of 400 mg/day or pemafibrate of 0.2 mg/day for the first 24-week treatment period.
20 | years-old | < |
75 | years-old | >= |
Male and Female
Eligible patients were men and postmenopausal women aged 20-75 years with dyslipidemia
treated with statin and CAD who showed
fasting serum TG levels of > 150 mg/dL and HDL-C levels of < 50 mg/dL in men or < 55 mg/dL in women at entry.
1.patients who required additional
medication for dyslipidemia during the
study period
2.fasting serum TG levels of over than 1000 mg/dl
3.type 1 diabetes mellitus or uncontrolled type 2 DM (HbA1c level of over than 8.5%)
4.familiar hypercholesterolemia
5.chronic kidney disease showing a serum
creatinine level of over than 1.5 mg/dL
6.history or complication of gallbladder
disease, cholelithiasis, pancreatitis, and malignant tumor
7.aspartate aminotransferase (AST) or alanine aminotransferase (ALT) elevation to a level more than two times the upper limit of normal (ULN) range
8.uncontrolled hypertension (systolic blood pressure BP ofover tahn 160 mmHg or diastolic BP of over than 100 mmHg)
9.hemoglobin level of less than 12g/dL in men or less than 11 g/dL in women
11.recent myocardial infarction or cerebrovascular disorder within 3 months before
the study
12.hospitalization for worsening heart failure within 3 months
13.use of ezetimibe and supplements
containing eicosapentaenoic acid, and/or
docosahexaenoic acid within 3 months
before the study.
Patients were also prohibited from using agents that affect lipid metabolism,such as
thiazolidinedione, insulin,oral
corticosteroid, or protease inhibitor.
60
1st name | Akihiro |
Middle name | |
Last name | Nakamura |
Iwate Prefectural Central Hospital
Department of Cardiology
020-0066
1-4-1 Ueda, Morioka, Japan
0196531151
akihiro-nakamura@pref.iwate.jp
1st name | Akihiro |
Middle name | |
Last name | Nakamura |
Iwate Prefectural Central Hospital
Department of Cardiology
020-0066
1-4-1 Ueda, Morioka, Japan
0196531151
akihiro-nakamura@pref.iwate.jp
Department of Cardiology, Iwate Prefectural Centgral Hospital
Iwate Prefectural Centgral Hospital
Local Government
Iwate Prefectural Central Hospital
1-4-1 Ueda, Morioka, Japan
0196531151
akihiro-nakamura@pref.iwate.jp
NO
岩手県立中央病院 循環器内科
2022 | Year | 05 | Month | 13 | Day |
https://www.jstage.jst.go.jp/article/jat/advpub/0/advpub_63659/_pdf/-char/en
Published
https://www.jstage.jst.go.jp/article/jat/advpub/0/advpub_63659/_pdf/-char/en
60
The %Change in TG and Apo A-I levels was significantly greater with pemafibrate than with bezafibrate (-46.1% vs. -34.7%, p<0.001; 9.2% vs. 5.7%, p=0.018, respectively). %Change in HDL-C levels was not significantly different between the two treatments. %Change in liver enzyme levels was markedly decreased with pemafibrate than with bezafibrate.
2022 | Year | 11 | Month | 21 | Day |
The mean age was 63 years, and 92% (n=55)
of the patients were men. The mean body mass index was 27 kg/m2, and 77% (n=46) of the patients met the Japanese criteria for MetS. Approximately 40% (n=24) of the patients had type 2 DM and 80% (n=48) had hypertension. Nearly half of the patients (n=31, 52%) received rosuvastatin as statin therapy.
Of 78 patients initially screened, 60 were
enrolled and randomized with 30 patients per treatment. All 60 patients completed the study and were included in both analysis sets.
The incidence rates of AEs were 37% (n=22) and 43% (n=26) with bezafibrate and pemafibrate treatments, respectively. Treatment related AEs occurred in one patient in each treatment group: thickening of the gallbladder with bezafibrate treatment and hot flash with pemafibrate treatment.
In the bezafibrate treatment group, SAEs occurred in five patients, of which two were related to the treatment: worsening renal function and acute cholecystitis. Conversely, in the pemafibrate treatment group, SAEs occurred in six patients, but none were related to the treatment. There were no treatment discontinuations because of AEs or SAEs.
The primary efficacy endpoint was a percent
change (%Change) in the fasting serum TG levels from baseline to the study endpoint after the 24-week treatment with bezafibrate or pemafibrate. The baseline and study endpoint were defined as measurements before and after the 24-week treatment, respectively.
The secondary efficacy endpoints were %Change in the fasting serum HDL-C and Apo A-I levels from baseline to the study endpoint.
Completed
2019 | Year | 10 | Month | 30 | Day |
2019 | Year | 10 | Month | 30 | Day |
2020 | Year | 02 | Month | 01 | Day |
2021 | Year | 07 | Month | 30 | Day |
2022 | Year | 05 | Month | 12 | Day |
2022 | Year | 11 | Month | 21 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054422
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