Rosuvastatin Calcium (Page 3 of 8)
6.1 Clinical Studies Experience
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in clinical practice.
In the rosuvastatin controlled clinical trials database (placebo or active-controlled) of 5394 patients with a mean treatment duration of 15 weeks, 1.4% of patients discontinued due to adverse reactions. The most common adverse reactions that led to treatment discontinuation were:
- abdominal pain
The most commonly reported adverse reactions (incidence ≥2%) in the Rosuvastatin controlled clinical trial database of 5394 patients were:
- abdominal pain
Adverse reactions reported in ≥ 2% of patients in placebo-controlled clinical studies and at a rate greater than placebo are shown in Table 1. These studies had a treatment duration of up to 12 weeks.
Table 1. Adverse Reactions 1 Reported in ≥ 2% of Patients Treated with Rosuvastatin and > Placebo in Placebo-Controlled Trials (% of Patients)
Rosuvastatin 5 mg N = 291
Rosuvastatin 10 mg N = 283
Rosuvastatin 20 mg N = 64
Rosuvastatin 40 mg N = 106
Total Rosuvastatin 5 mg to 40 mg N = 744
Placebo N = 382
1 Adverse reactions by COSTART preferred term.
Other adverse reactions reported in clinical studies were abdominal pain, dizziness, hypersensitivity (including rash, pruritus, urticaria, and angioedema) and pancreatitis. The following laboratory
abnormalities have also been reported: dipstick-positive proteinuria and microscopic hematuria [see Warnings and Precautions (5.4)] ; elevated creatine phosphokinase, transaminases, glucose, glutamyl transpeptidase, alkaline phosphatase, and bilirubin; and thyroid function abnormalities.
In a clinical trial, involving 981 participants treated with rosuvastatin 40 mg (n=700) or placebo (n=281) with a mean treatment duration of 1.7 years, 5.6% of subjects treated with rosuvastatin versus 2.8% of placebo-treated subjects discontinued due to adverse reactions. The most common adverse reactions that led to treatment discontinuation were: myalgia, hepatic enzyme increased, headache, and nausea.
Adverse reactions reported in ≥ 2% of patients and at a rate greater than placebo are shown in Table 2.
Table 2. Adverse Reactions 1 Reported in ≥ 2% of Patients Treated with Rosuvastatin and > Placebo in a Trial (% of Patients)
|Adverse Reactions|| |
Rosuvastatin 40 mg N = 700
|ALT > 3x ULN 2||2.2||0.7|
1 Adverse reactions by MedDRA preferred term.
2 Frequency recorded as abnormal laboratory value.
In a clinical trial, 17,802 participants were treated with rosuvastatin 20 mg (n = 8,901) or placebo (n = 8,901) for a mean duration of 2 years. A higher percentage of rosuvastatin-treated patients versus placebo-treated patients, 6.6% and 6.2%, respectively, discontinued study medication due to an adverse event, irrespective of treatment causality. Myalgia was the most common adverse reaction that led to treatment discontinuation.
There was a significantly higher frequency of diabetes mellitus reported in patients taking rosuvastatin (2.8%) versus patients taking placebo (2.3%). Mean HbA1c was significantly increased by 0.1% in rosuvastatin-treated patients compared to placebo-treated patients. The number of patients with a HbA1c > 6.5% at the end of the trial was significantly higher in rosuvastatin-treated versus placebo-treated patients [ see Warnings and Precautions (5.5) ]. Adverse reactions reported in ≥ 2% of patients and at a rate greater than placebo are shown in Table 3.
Table 3. Adverse Reactions 1 Reported in ≥ 2% of Patients Treated with Rosuvastatin and > Placebo in a Trial (% of Patients)
|Adverse Reactions|| |
Rosuvastatin 20 mg N = 8,901
Placebo N = 8,901
1 Treatment-emergent adverse reactions by MedDRA preferred term.
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