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Author: Admin | 2025-04-28
Rosuvastatin calcium and > Placebo in aTrial (% of Patients ) Adverse Reactions Rosuvastatin calcium 40 mg N=700 Placebo N=281 Myalgia 12.7 12.1 Arthralgia 10.1 7.1 Headache 6.4 5.3 Dizziness 4.0 2.8 Increased CPK 2.6 0.7 Abdominal pain 2.4 1.8 ALT > 3x ULN* 2.2 0.7 *Frequency recorded as abnormal laboratory value 2Adverse reactions by MedDRA preferred term. In a clinical trial, 17,802 participants were treatedwith rosuvastatin 20 mg (n=8901) or placebo (n=8901) for a mean duration of 2years. A higher percentage of rosuvastatin-treated patients versus placebo-treatedpatients, 6.6% and 6.2%, respectively, discontinued study medication due to anadverse event, irrespective of treatment causality. Myalgia was the most commonadverse reaction that led to treatment discontinuation.There was a significantly higher frequency of diabetesmellitus reported in patients taking rosuvastatin (2.8%) versus patients takingplacebo (2.3%). Mean HbA1c was significantly increased by 0.1% in rosuvastatin-treatedpatients compared to placebo-treated patients. The number of patients with a HbA1c > 6.5% at the end of the trial was significantly higher inrosuvastatin-treated versus placebotreated patients [see WARNINGS ANDPRECAUTIONS].Adverse reactions reported in ≥ 2% of patients andat a rate greater than placebo are shown in Table 3.Table 3: Adverse Reactions3 Reported in ≥ 2% of Patients Treated with Rosuvastatin calcium and > Placebo in aTrial (% of Patients ) Adverse Reactions Rosuvastatin calcium 20 mg N=8901 Placebo N=8901 Myalgia 7.6 6.6 Arthralgia 3.8 3.2 Constipation 3.3 3.0 Diabetes mellitus 2.8 2.3 Nausea 2.4 2.3 3Treatment-emergent adverse reactions by MedDRA preferred term. Postmarketing ExperienceThe following adverse reactions have been identifiedduring postapproval use of rosuvastatin calcium: arthralgia, fatal andnon-fatal hepatic failure, hepatitis, jaundice, thrombocytopenia, depression,sleep disorders (including insomnia and nightmares), peripheral neuropathy andgynecomastia. Because these reactions are reported voluntarily from apopulation of uncertain size, it is not always possible to reliably estimatetheir frequency or establish a causal relationship to drug exposure.There have been rare reports of immune-mediatednecrotizing myopathy associated with statin use [see WARNINGS ANDPRECAUTIONS].There have been rare postmarketing reports of cognitiveimpairment (e.g., memory loss, forgetfulness, amnesia, memory impairment,confusion) associated with statin use. These cognitive issues have been reportedfor all statins. The reports are generally nonserious, and reversible uponstatin discontinuation, with variable times
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