2007
DOI: 10.1159/000100908
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Safety of Rosuvastatin: Update on 16,876 Rosuvastatin-Treated Patients in a Multinational Clinical Trial Program

Abstract: Background: The safety and tolerability of rosuvastatin were assessed using data from 16,876patients who received rosuvastatin 5–40 mg in a multinational phase II/III/IIIb/IV program, representing 25,670 patient-years of continuous exposure to rosuvastatin. Methods: An integrated database, consisting of 33 trials whose databases were locked up to and including September 16, 2005, was used to examine adverse events and laboratory data. Results: In placebo-controlled trials, adverse events irrespective of causal… Show more

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Cited by 78 publications
(44 citation statements)
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“…Lower targets for LDL-C remain controversial, will need to be evaluated in prospective settings, and may not be achievable among patients with very elevated LDL-C. Nonetheless, the JUPITER trial data provide reassurance regarding the safety of treating with rosuvastatin at very low levels of LDL-C. Safety findings among patients attaining LDL-C Ͻ50 mg/dl were consistent with the established safety profile of rosuvastatin (24). Elevation of ALT and dipstick proteinuria and hematuria were more frequent with rosuvastatin than with placebo, but within the rosuvastatin group, were not more frequent among subjects attaining LDL-C Ͻ50 mg/dl.…”
Section: Numbers and Rates (Per 100 Person-years) Of Treatment-emergementioning
confidence: 78%
“…Lower targets for LDL-C remain controversial, will need to be evaluated in prospective settings, and may not be achievable among patients with very elevated LDL-C. Nonetheless, the JUPITER trial data provide reassurance regarding the safety of treating with rosuvastatin at very low levels of LDL-C. Safety findings among patients attaining LDL-C Ͻ50 mg/dl were consistent with the established safety profile of rosuvastatin (24). Elevation of ALT and dipstick proteinuria and hematuria were more frequent with rosuvastatin than with placebo, but within the rosuvastatin group, were not more frequent among subjects attaining LDL-C Ͻ50 mg/dl.…”
Section: Numbers and Rates (Per 100 Person-years) Of Treatment-emergementioning
confidence: 78%
“…Evidence from a rosuvastatin clinical trials database suggests that treatmentrelated discontinuation rates were lower (2.9%) for patients receiving rosuvastatin 5-40 mg/day than for patients receiving placebo (4.3%). 73 However, in the 2-year open-label ASTEROID study (n = 507, all statin-naïve) discontinuation rates because of drug-related muscle pain or weakness for rosuvastatin 40 mg/day were 3.7%. 76 It is noteworthy that adverse events may be more common in clinical practice as trial participants are usually younger, healthier and more closely monitored than patients in usual clinical practice.…”
Section: Intensive-dose Statinsmentioning
confidence: 99%
“…Although the evidence for the long-term safety of rosuvastatin is limited, a rosuvastatin clinical trials database (comprising data from 33 phase II/ III clinical trials) 73 suggests that rates of myopathy (< 0.03%), myositis (< 0.3%) and elevated ALT levels greater than three times the upper limit of normal (< 0.2%) are uncommon at doses of ≤ 40 mg/day. Although no deaths have been attributed to rosuvastatin (< 40 mg/day), one case of rhabdomyolysis has been found in a patient who received rosuvastatin 20 mg/day and concomitant gemfibrozil treatment.…”
Section: Intensive-dose Statinsmentioning
confidence: 99%
“…The doses of statins used in the current study are widely used and have well-characterised safety and tolerability profiles [14,15]. Co-administration of atorvastatin or rosuvastatin at these commonly used doses with aleglitazar had no apparent effect on the safety profile of any of the three compounds in healthy volunteers in this short-term study.…”
Section: Discussionmentioning
confidence: 79%