Demographics and baseline disease characteristics were balanced between the treatment arms in all trials. Abdominal pain may occur. The trial included 2230 patients randomized 2:1 to receive either Nexletol (n = 1488) or placebo (n = 742) as add-on to a maximally tolerated lipid lowering therapy. Before you start taking Nexletol, tell your healthcare provider about all your medical conditions, including if you: Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. There is no clinical experience with Nexletol overdose. What is NEXLETOL and how is it used? A very serious allergic reaction to this drug is rare. Patients on simvastatin 40 mg/day or higher were excluded from the trial. Increase in Liver Enzymes: Increases in hepatic transaminases (AST and/or ALT) were observed with Nexletol. Twenty-nine percent (29%) of patients had diabetes at baseline. Males were dosed for 28 days prior to mating and females were dosed 14 days prior to mating through gestation day 7. Gout was reported in 1.5% of patients treated with Nexletol and 0.4% of patients treated with placebo. Overall, the mean age at baseline was 66 years (range: 24 to 88 years), 61% were ≥ 65 years old, 27% women, 2% Hispanic, 96% White, 3% were Black, and 1% Asian. An increased incidence of liver hepatocellular adenomas and hepatocellular adenomas combined with carcinomas, thyroid gland follicular cell adenoma and follicular cell adenomas combined with carcinomas, and pancreatic islet cell adenomas combined with carcinomas were observed in male rats at the dose of 30 mg/kg/day (exposure equivalent to the maximum recommended human dose (MRHD), based on AUC). Call your doctor for medical advice about side effects. are pregnant. Lowering "bad" cholesterol may help to decrease the risk of heart disease and help prevent strokes and heart attacks. Bempedoic acid is used along with a proper diet and other medications to help lower "bad" cholesterol (such as LDL) in the blood. Nexletol is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-C. Patients were stratified by presence of HeFH and by baseline statin intensity. Nexletol is a prescription medicine used along with diet and other lipid-lowering medicines in the treatment of adults with: heterozygous familial hypercholesterolemia (HeFH). Study 2 was a multi-center, randomized, double-blind, placebo-controlled, 52-week trial in patients with HeFH and/or ASCVD. This is not expected to result in lower efficacy. Total ezetimibe (ezetimibe and its glucuronide form) and ezetimibe glucuronide AUC and Cmax increased approximately 1.6- and 1.8-fold, respectively. Tendon rupture can happen while you are taking Nexletol. Pharmacokinetic data indicate that bempedoic acid is absorbed with a median time to maximum concentration of 3.5 hours when administered as Nexletol 180 mg tablets. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. Bempedoic acid was not teratogenic when given orally at doses of 60 and 80 mg/kg/day, resulting in 11 and 12 times the systemic exposure in humans at the maximum recommended human dose (MRHD) of 180 mg to pregnant rats and rabbits, respectively. In clinical trials, tendon rupture occurred in 0.5% of patients treated with Nexletol versus 0% of placebo-treated patients and involved the rotator cuff (the shoulder), biceps tendon, or Achilles tendon. How Long Does Coronavirus Live On Surfaces? The mean baseline LDL-C was 120.4 mg/dL. Increase in Creatinine and Blood Urea Nitrogen: Overall, there was a mean increase in serum creatinine of 0.05 mg/dL compared to baseline with Nexletol at Week 12. All rights reserved. In addition, treatment of hyperlipidemia is not generally necessary during pregnancy. High-density lipoprotein (HDL) and triglycerides (TG) were examined as exploratory endpoints and were not included in the statistical hierarchy. Data sources include IBM Watson Micromedex (updated 2 Nov 2020), Cerner Multum™ (updated 2 Nov 2020), ASHP (updated 23 Oct 2020) and others. Last month, a new kind of medication called bempedoic acid (Nexletol) was approved for use by the FDA as a novel way to lower cholesterol. In Canada - Call your doctor for medical advice about side effects. Canada residents can call a provincial poison control center. In vitro metabolic interaction studies suggest that bempedoic acid, as well as its active metabolite and glucuronide forms are not metabolized by and do not interact with cytochrome P450 enzymes. It is unknown if this medication passes into breast milk. Maximally tolerated lipid lowering therapy was defined as a maximally tolerated statin dose alone or in combination with other lipid-lowering therapies. Tell your doctor right away if you have any serious side effects, including: toe/joint pain, difficulty urinating (for example, due to enlarged prostate). Overall, the mean age at baseline was 64 years (range: 28 to 91 years), 51% were ≥ 65 years old, 36% women, 8% Hispanic, 94% White, 5% were Black, and 1% Asian. For additional results see Table 2 and Figure 1. Efficacy of Nexletol was evaluated at Week 12. known heart disease who need additional lowering of "bad" cholesterol (LDL-C) levels. How long have you been taking Nexletol 180 Mg Tablet Antihyperlipidemic - ATP-Citrate Lyase (ACLY) Inhibitor? Increases to more than 3× the upper limit of normal (ULN) in AST occurred in 1.4% of patients treated with Nexletol versus 0.4% of placebo patients, and increases to more than 5× ULN occurred in 0.4% of Nexletol-treated versus 0.2% of placebo-treated patients. The mean baseline LDL-C was 103.2 mg/dL. Does this new medication add something special? This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use. Store Nexletol in the original package at room temperature between 68°F to 77°F (20°C to 25°C). Tendon rupture occurred within weeks to months of starting Nexletol. Consult your doctor before breast-feeding. Take this medication by mouth with or without food as directed by your doctor, usually once daily. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment. Keep taking this medication even if you feel well. You and your healthcare provider should decide if you will take Nexletol or breastfeed. The mean bempedoic acid AUC in subjects with mild renal impairment (n = 8) were 1.5-fold higher compared to those with normal renal function (n = 6). The efficacy of Nexletol was investigated in two multi-center, randomized, double-blind, placebo-controlled trials that enrolled 3009 adult patients with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who were on maximally tolerated statin therapy. No adverse development effects were observed when bempedoic acid was given to pregnant rabbits during the period of organogenesis (gestation day 6 to 18) at doses up to 80 mg/kg/day (12 times MRHD). Figure 1: Mean Percent Change from Baseline in LDL-C Over 52 Weeks in Patients with HeFH and/or ASCVD on Maximally Tolerated Statin Treated with Nexletol and Placebo (Study 1 and Study 2). Compared to patients with normal hepatic function, the bempedoic acid mean Cmax and AUC were decreased by 11% and 22%, respectively, in patients with mild hepatic impairment and by 14% and 16%, respectively, in patients with moderate hepatic impairment. It is used with other cholesterol-lowering drugs. No overall differences in safety or effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients.
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