Saroglitazar is noninferior to fenofibrate in reducing triglyceride levels in hypertriglyceridemic patients in a randomized clinical trial
Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved..
Saroglitazar, being a dual PPAR-α/γ agonist, has shown beneficial effect in diabetic dyslipidemia and hypertriglyceridemia. Fibrates are commonly used to treat severe hypertriglyceridemia. However, the effect of saroglitazar in patients with moderate to severe hypertriglyceridemia was not evaluated. We conducted a study to compare the efficacy and safety of saroglitazar (4 mg) with fenofibrate (160 mg) in patients with moderate to severe hypertriglyceridemia. This was a multicenter, randomized, double-blinded, double-dummy, active-control, and noninferiority trial in adult patients with fasting triglyceride (TG) levels of 500-1,500 mg/dl. The patients were randomized in a 1:1 ratio to receive daily dose of saroglitazar or fenofibrate for 12 weeks. The primary efficacy end point was the percent change in TG levels at week 12 relative to baseline. The study comprised of 41 patients in the saroglitazar group and 41 patients in the fenofibrate group. We found that the percent reduction from baseline in TG levels at week 12 was significantly higher in the saroglitazar group (least square mean = -55.3%; SE = 4.9) compared with the fenofibrate group (least square mean = -41.1%; SE = 4.9; P = 0.048). Overall, 37 treatment-emergent adverse events (AEs) were reported in 24 patients (saroglitazar: 13; fenofibrate: 11). No serious AEs were reported, and no patient discontinued the study because of AEs. We conclude that saroglitazar (4 mg) is noninferior to fenofibrate (160 mg) in reducing TG levels after 12 weeks of treatment, was safe, and well tolerated.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2022 |
|---|---|
| Erschienen: |
2022 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:63 |
|---|---|
| Enthalten in: |
Journal of lipid research - 63(2022), 7 vom: 15. Juli, Seite 100233 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Rodriguez-Gutierrez, Rene [VerfasserIn] |
|---|
| Links: |
|---|
| Anmerkungen: |
Date Completed 26.07.2022 Date Revised 22.08.2022 published: Print-Electronic Citation Status MEDLINE |
|---|
| doi: |
10.1016/j.jlr.2022.100233 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM34128176X |
|---|
| LEADER | 01000naa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM34128176X | ||
| 003 | DE-627 | ||
| 005 | 20231226011422.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231226s2022 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1016/j.jlr.2022.100233 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1137.xml |
| 035 | |a (DE-627)NLM34128176X | ||
| 035 | |a (NLM)35605678 | ||
| 035 | |a (PII)S0022-2275(22)00066-9 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Rodriguez-Gutierrez, Rene |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Saroglitazar is noninferior to fenofibrate in reducing triglyceride levels in hypertriglyceridemic patients in a randomized clinical trial |
| 264 | 1 | |c 2022 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 26.07.2022 | ||
| 500 | |a Date Revised 22.08.2022 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved. | ||
| 520 | |a Saroglitazar, being a dual PPAR-α/γ agonist, has shown beneficial effect in diabetic dyslipidemia and hypertriglyceridemia. Fibrates are commonly used to treat severe hypertriglyceridemia. However, the effect of saroglitazar in patients with moderate to severe hypertriglyceridemia was not evaluated. We conducted a study to compare the efficacy and safety of saroglitazar (4 mg) with fenofibrate (160 mg) in patients with moderate to severe hypertriglyceridemia. This was a multicenter, randomized, double-blinded, double-dummy, active-control, and noninferiority trial in adult patients with fasting triglyceride (TG) levels of 500-1,500 mg/dl. The patients were randomized in a 1:1 ratio to receive daily dose of saroglitazar or fenofibrate for 12 weeks. The primary efficacy end point was the percent change in TG levels at week 12 relative to baseline. The study comprised of 41 patients in the saroglitazar group and 41 patients in the fenofibrate group. We found that the percent reduction from baseline in TG levels at week 12 was significantly higher in the saroglitazar group (least square mean = -55.3%; SE = 4.9) compared with the fenofibrate group (least square mean = -41.1%; SE = 4.9; P = 0.048). Overall, 37 treatment-emergent adverse events (AEs) were reported in 24 patients (saroglitazar: 13; fenofibrate: 11). No serious AEs were reported, and no patient discontinued the study because of AEs. We conclude that saroglitazar (4 mg) is noninferior to fenofibrate (160 mg) in reducing TG levels after 12 weeks of treatment, was safe, and well tolerated | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a LDL/metabolism | |
| 650 | 4 | |a PPARs | |
| 650 | 4 | |a atherosclerosis | |
| 650 | 4 | |a cholesterol/metabolism | |
| 650 | 4 | |a dyslipidemias | |
| 650 | 4 | |a fatty acid metabolism | |
| 650 | 4 | |a lipids | |
| 650 | 4 | |a lipolysis | |
| 650 | 4 | |a obesity | |
| 650 | 4 | |a triglycerides | |
| 650 | 7 | |a Hypolipidemic Agents |2 NLM | |
| 650 | 7 | |a Phenylpropionates |2 NLM | |
| 650 | 7 | |a Pyrroles |2 NLM | |
| 650 | 7 | |a Triglycerides |2 NLM | |
| 650 | 7 | |a saroglitazar |2 NLM | |
| 650 | 7 | |a E0YMX3S4JD |2 NLM | |
| 650 | 7 | |a Fenofibrate |2 NLM | |
| 650 | 7 | |a U202363UOS |2 NLM | |
| 700 | 1 | |a González, Jose Gerardo |e verfasserin |4 aut | |
| 700 | 1 | |a Parmar, Deven |e verfasserin |4 aut | |
| 700 | 1 | |a Shaikh, Farheen |e verfasserin |4 aut | |
| 700 | 1 | |a Cruz-López, Pio |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Journal of lipid research |d 1960 |g 63(2022), 7 vom: 15. Juli, Seite 100233 |w (DE-627)NLM000005878 |x 1539-7262 |7 nnns |
| 773 | 1 | 8 | |g volume:63 |g year:2022 |g number:7 |g day:15 |g month:07 |g pages:100233 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1016/j.jlr.2022.100233 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 63 |j 2022 |e 7 |b 15 |c 07 |h 100233 | ||