Effect of addition of pemafibrate and double dose of statin on small dense LDL cholesterol in statin-treated patients with type 2 diabetes and hypertriglyceridemia: a comparative Study

Authors
Category Primary study
Registry of TrialsJapan Primary Registry Network
Year 2020
INTERVENTION: After obtaining informed consent, patients with type 2 diabetes occurring with hypertriglyceridemia who have been taking statin for 3 months or more are randomly allocated to either group receiving pemafibrate 0.2 mg/day in addition to statin or group receiving doubling dose of statin. The patients are followed for 12 weeks. CONDITION: Hypertriglyceridemia PRIMARY OUTCOME: sd LDL‐C reduction rate SECONDARY OUTCOME: Absolute concentration and reduction rate of each item; 1. sd LDL‐C(Absolute concentration onlys); 2. Large LDL‐C; 3. LDL‐C; 4. HDL fractionation; 5. sd LDL‐C / Large LDL‐C; 6. LDL‐TG, LDL‐TG/LDL‐C; 7. TG, HDL‐C; 8. Non‐HDL‐C; 9. RLP‐C; 10. Toxic‐AGEs; 11. VLDL‐C (a formula); 12. ANGPTL2, ANGPTL3, ANGPTL4, ANGPTL8; 13. Apo A1, Apo A2, Apo B, Apo CII, Apo CIII, Apo E; 14. High sensitivity CRP; 15. AST, ALT, gamma‐GTP, ALP, CK, Creatinine; 16. Blood sugar, insulin, HOMA‐IR; 17. eGFR; 18. FIB‐4 index; 19. Cholinesterase; 20. HbA1c, Glycoalbumin; 21. HbA1c/Glycoalbumin; 22. Urine Albumin‐to‐Creatinine Ratio INCLUSION CRITERIA: 1. Age>=20 years old 2. Type 2 diabetes patients 3. Patients who have been taking below statins for 3 months or longer without changing Atorvastatin 5, 10 mg/day Pitavastatin 1, 2 mg/day Rosuvastatin 2.5 mg/day 4. 150mg/dL=
Epistemonikos ID: 12adf646885585d98abaf63179887c5ab07ffc1a
First added on: Aug 24, 2024