U. S. FDA Approves Broad New Labels for NEXLETOL and . . . - DAIC April 1, 2024 — Esperion announced that the United States Food and Drug Administration (FDA) has approved broad new label expansions for NEXLETOL (bempedoic acid) Tablets and NEXLIZET (bempedoic acid and ezetimibe) Tablets based on positive CLEAR Outcomes data that include indications for cardiovascular risk reduction and expanded LDL-C lowering in both primary and secondary prevention
Broader Adoption of SGLT2 Inhibitors in Clinical Practice Over the past decade, the indications for sodium-glucose cotransporter 2 (SGLT2) inhibitors for kidney and cardiovascular risk reduction have expanded, driven by clinical trial evidence demonstrating their efficacy among individuals with chronic kidney disease (CKD), heart failure, diabetes, and
NEXLIZET® NEXLETOL® Other Outcomes Trial Information The most common adverse reactions in the cardiovascular outcomes trial for bempedoic acid, a component of NEXLIZET and NEXLETOL, at an incidence of ≥2% and 0 5% greater than placebo were hyperuricemia, renal impairment, anemia, elevated liver enzymes, muscle spasms, gout, and cholelithiasis
Esperion Showcases New Data from CLEAR Outcomes Highlighting . . . “These new analyses from CLEAR Outcomes further strengthen the evidence base supporting NEXLETOL as a proven therapy for cardiovascular risk reduction - especially for patients who cannot tolerate statin therapy,” said Sheldon Koenig, President and Chief Executive Officer of Esperion “The consistency of benefit observed in high-risk populations, including those with autoimmune or
U. S. FDA Approves Broad New Labels for Esperion’s NEXLETOL . . . Esperion (NASDAQ: ESPR) today announced that the United States Food and Drug Administration (FDA) has approved broad new label expansions for NEXLETOL ® (bempedoic acid) Tablets and NEXLIZET ® (bempedoic acid and ezetimibe) Tablets based on positive CLEAR Outcomes data that include indications for cardiovascular risk reduction and expanded LDL-C lowering in both primary and secondary
U. S. FDA Approves Broad New Labels for Esperion’s NEXLETOL . . . U S FDA approves broad new labels for NEXLETOL® (bempedoic acid) Tablets and NEXLIZET® (bempedoic acid and ezetimibe) Tablets to prevent heart attacks and cardiovascular procedures in both primary and secondary prevention patients, regardless of statin use
SGLT2 Inhibitors: What They Are, Uses Side Effects SGLT2 inhibitors also lower the risk of heart failure flare-ups How do SGLT2 inhibitors work? SGLT2 is a protein in your kidneys that reabsorbs glucose Typically, when glucose in your blood flows through your kidneys, some glucose goes back into your bloodstream These medications block that process, so your kidneys don’t reabsorb glucose