Constipation with Pitavastatin
Constipation is not a common side effect of pitavastatin, occurring in approximately 2.2% of patients taking the 4 mg dose, which is only slightly higher than placebo (1.9%). 1
Incidence Data from Clinical Trials
In controlled clinical studies of adults with primary hyperlipidemia, constipation occurred in 3.6% of patients on pitavastatin 1 mg, 1.5% on 2 mg, and 2.2% on 4 mg, compared to 1.9% in the placebo group 1
The FDA drug label identifies constipation as an adverse reaction occurring at ≥2% frequency and at a rate greater than or equal to placebo, but it remains relatively uncommon compared to other gastrointestinal effects 1
Comparison with Other Statins
Pitavastatin's gastrointestinal side effect profile is generally favorable compared to other statins in the class 2, 3
The most common treatment-related adverse events with pitavastatin are musculoskeletal (myalgia 3.1% at 4 mg) rather than gastrointestinal in nature 1
In the large LIVES post-marketing surveillance study of approximately 20,000 patients, gastrointestinal adverse events were not among the most commonly reported side effects 4
Clinical Context
Diarrhea (1.9% at 4 mg) is actually slightly less common than constipation with pitavastatin, and both occur at low rates 1
The overall discontinuation rate due to adverse reactions with pitavastatin is low (3.7% at 4 mg), with constipation not being a leading cause of treatment discontinuation 1
Pitavastatin was generally well tolerated in clinical trials of up to 60 weeks' duration, with a tolerability profile similar to atorvastatin and simvastatin 3
Practical Implications
If constipation occurs with pitavastatin, it should not be assumed to be drug-related given the similar incidence to placebo, and other causes should be evaluated 1
The low incidence of gastrointestinal side effects makes pitavastatin a reasonable option for patients who have experienced GI intolerance with other statins 2, 5