Rosuvastatin to Prevent Vascular Events in Men and Women with Elevated C-Reactive Protein
Samuel Eric Wilson in 50 Landmark Papers Every Vascular and Endovascular Surgeon Should Know, 2020
Increased levels of the inflammatory biomarker high-sensitivity C-reactive protein predict cardiovascular events. Since statins lower levels of high- sensitivity C-reactive protein as well as cholesterol, the authors hypothesized that people with elevated high-sensitivity C-reactive protein levels but without hyperlipidemia might benefit from statin treatment. They randomly assigned 17,802 apparently healthy men and women with low-density lipoprotein (LDL) cholesterol levels of less than 130 mg per deciliter and high-sensitivity C-reactive protein levels of 2.0 mg per liter or higher to rosuvastatin, 20 mg daily, or placebo and followed them for the occurrence of the combined primary endpoint of myocardial infarction, stroke, arterial revascularization, hospitalization for unstable angina, or death from cardiovascular causes. Rosuvastatin reduced LDL cholesterol levels by 50% and high-sensitivity C-reactive protein levels by 37%. The rosuvastatin group did not have a significant increase in myopathy or cancer but did have a higher incidence of physician-reported diabetes.
Statins in multiple sclerosis
Eli Minkoff, Eli Baker in Multiple Sclerosis Therapeutics, 2007
Statins are orally administered inhibitors of the enzyme 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase, which catalyzes the conversion of HMG-CoA to L-mevalonate, a key intermediate for cholesterol biosynthesis1 (Figure 32.1a). Since 1987, when lovastatin was the first statin to be approved in the United States for the treatment of hypercholesterolemia, statins have established themselves as safe and well-tolerated drugs. A number of statins have been approved for the treatment of dyslipidemia: simvastatin (Zocor®, Lipex®), mevastatin (Compactin®), lovastatin (Mevacor®, Altocor®) and pravastatin (Pravachol®) are natural fungal derivatives, whereas fluvastatin (Lescol®), cerivastatin (Baycol®), atorvastatin (Lipitor®) and rosuvastatin (Crestor®) are synthetic statins. All statins resemble HMG-CoA in chemical structure, and thereby competitively bind and inhibit HMGCoA reductase (Figure 32.1b). Although synthetic statins are considered the more potent agents, there is no significant difference in the recommended total daily dose between natural and synthetic statins.
NEBIVOLOL
Neil Shear in Litt's Drug Eruption and Reaction Manual, 2015
NELFINAVIR Trade name: Viracept (Pfizer) Indications: HIV infection Class: Antiretroviral, CYP3A4 inhibitor, Protease inhibitor, HIV Half-life: 3.5-5 hours Clinically important, potentially hazardous interactions with: abiraterone, afatinib, alfuzosin, amiodarone, amprenavir, aripiprazole, artemether / lumefantrine, atorvastatin, avanafil, barbiturates, benzodiazepines, cabazitaxel, cabozantinib, carbamazepine, chlordiazepoxide, ciclesonide, clonazepam, clorazepate, crizotinib, cyclosporine, darifenacin, dasatinib, delavirdine, diazepam, dihydroergotamine, eletriptan, eplerenone, ergot alkaloids, ergotamine, erlotinib, estrogens, eszopiclone, etravirine, eucalyptus, everolimus, fentanyl, fesoterodine, flurazepam, fluticasone propionate, indinavir, ivabradine, ixabepilone, lapatinib, lomitapide, lopinavir, lorazepam, maraviroc, methadone, methylergonovine, methysergide, midazolam, mifepristone, omeprazole, oral contraceptives, oxazepam, paclitaxel, pantoprazole, pazopanib, phenytoin, pimozide, ponatinib, primidone, progestogens, quazepam, quinidine, quinine, ranolazine, rifabutin, rifampin, rilpivirine, ritonavir, rivaroxaban, romidepsin, rosuvastatin, ruxolitinib, saquinavir, sildenafil, simeprevir, simvastatin, solifenacin, St John’s wort, sunitinib, tacrolimus, tadalafil, telithromycin, temazepam, temsirolimus, ticagrelor, tolterodine, tolvaptan, vardenafil, vemurafenib Pregnancy category: B Note: Protease inhibitors cause dyslipidemia which includes elevated triglycerides and cholesterol and redistribution of body fat centrally to produce the so-called ‘protease paunch’, breast enlargement, facial atrophy, and ‘buffalo hump’.
Acute renal failure with the combined use of rosuvastatin and fenofibrate
Published in Renal Failure, 2010
Hakan Buyukhatipoglu, Yusuf Sezen, Unal Guntekin, Idris Kirhan, Omer Faruk Dag
Among the lipid-lowering drugs, the statins and fibrates are the most commonly used agents. Either class of drug is considered relatively safe. Though a variety of albeit uncommon adverse side effects have been observed with both classes, most of these therapeutic complications can be managed without discontinuation of the offending drug. Sometimes, especially in patients with extremely high cholesterol and/or triglyceride levels, a combination regimen is deemed necessary. However, the combined use of lipid-lowering drugs increases the incidence and severity of adverse events. In this article, we report an unusual case of acute renal failure (ARF) in a patient who had been prescribed both a statin (rosuvastatin) and a fibrate (fenofibrate).
Rosuvastatin safety: lessons from the FDA review and post-approval surveillance
Published in Expert Opinion on Drug Safety, 2004
Rosuvastatin is the first statin approved by the regulatory authorities since the withdrawal of cerivastatin. Although highly efficacious, this new statin has generated considerable controversy regarding its safety. Rosuvastatin was approved for clinical use based on the largest pre-approval database for all statins prior to commercial use. In this database, rosuvastatin had a similar safety profile to other approved statins up to the highest approval dose of 40 mg. As with all statins, there is a marked increase in adverse effects when the dose is titrated from 40 to 80 mg, and rosuvastatin demonstrates a similar dose/toxicity relationship. In the pre-approval data trials on 80 mg, there was a 1.0% (n = 16) incidence of myopathy and 7 patients developed rhabdomyolysis. However the ≤ 40 mg doses had a myopathy rate similar to other statins. In the post-marketing surveillance for rosuvastatin, there have been reports of rhabdomyolysis, but the incidence rate, when corrected for prescription utilisation, is similar to other statins following initial approval.
Combination therapy with rosuvastatin and fenofibric acid for mixed dyslipidemia: overview of efficacy and safety
Published in Clinical Lipidology, 2010
Terry A Jacobson, Peter H Jones, Eli M Roth
Despite achieving optimal LDL-C levels with statin therapy, the risk of cardiovascular events persists in the majority of dyslipidemic patients. In particular, patients with mixed dyslipidemia, who have continued elevation of triglycerides and decreased HDL-C, have substantial residual cardiovascular risk. Thus, patients with multiple abnormal lipid parameters may require combination lipid drug therapy. Current guidelines recommend more intensive goals for LDL-C in high-risk patients, as well as combination treatment with agents that target triglycerides and HDL-C in these patients with mixed dyslipidemia. Clinical trials of rosuvastatin plus fenofibric acid suggest that this is an efficacious and safe strategy for the treatment of mixed dyslipidemia.
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