Constipation Frequency: Rosuvastatin 5 mg vs 10 mg
Based on FDA labeling data, constipation occurs at similar rates with rosuvastatin 5 mg (2.1%) and 10 mg (2.1%), both comparable to placebo (2.4%). 1
Direct Comparison from Clinical Trial Data
The FDA-approved prescribing information for Crestor provides head-to-head constipation rates from placebo-controlled trials:
- Rosuvastatin 5 mg: 2.1% constipation rate
- Rosuvastatin 10 mg: 2.1% constipation rate
- Placebo: 2.4% constipation rate
These rates are essentially identical between the two doses and not elevated compared to placebo. 1
Context from Guidelines
The Canadian Working Group consensus on statin adverse effects notes that while constipation is among the reported gastrointestinal side effects of statins (along with dyspepsia, diarrhea, nausea, and abdominal cramps), meta-analyses of clinical trials indicate that the incidence of such adverse effects is not greater in statin-treated patients compared with control subjects who had not been exposed to statins. 2
Risk factors identified for gastrointestinal side effects include female sex, East Indian race, alcohol consumption, higher statin doses (specifically noted for lovastatin), secondary dyslipidemia, diabetes mellitus, and concurrent β-blocker use. 2
Clinical Implications
There is no clinically meaningful difference in constipation frequency between rosuvastatin 5 mg and 10 mg. The choice between these doses should be based on:
- LDL-C reduction goals
- Cardiovascular risk profile
- Other adverse effect considerations (myalgia rates are slightly higher with 10 mg: 2.1% vs 3.1% at 5 mg) 1
The 10 mg dose provides superior lipid-lowering efficacy without increasing constipation risk, though it may carry slightly higher rates of other adverse effects like myalgia. 3, 4