Long-term treatment with pitavastatin is effective and well tolerated by patients with primary hypercholesterolemia or combined dyslipidemia.

Objectives: The primary objective was to assess the safety and tolerability of pitavastatin 4mg once daily during 52 weeks treatment. The secondary objectives were to assess the effect on lipid and lipoprotein fractions and ratios, and LDL-C target attainment.

Methods: Patients with primary hypercholesterolemia or combined dyslipidemia who had previously received pitavastatin, atorvastatin or simvastatin for 12 weeks during double-blind phase III studies received open-label pitavastatin 4mg once daily for up to 52 weeks.

Results: Investigators at 72 sites enrolled 1353 patients who received at least one dose of pitavastatin 4mg; 155 (11.5%) patients discontinued treatment during the 52-week follow up. The proportion of patients achieving NCEP and EAS LDL-C targets at week 52 was 74.0% and 73.5% respectively. The reduction in LDL-C levels seen during the double-blind studies was sustained, while HDL-C levels rose continually during follow up, ultimately increasing by 14.3% over the initial baseline. Changes in other efficacy parameters (triglycerides, total cholesterol, non-HDL-C, Apo-A1 and Apo-B, high sensitivity C-reactive protein, oxidised LDL) and ratios (total cholesterol: HDL-C, non-HDL-C:HDL-C and Apo-B:Apo-A1) were sustained during 52-weeks treatment compared with the end of the double-blind studies. Pitavastatin was well tolerated: 4.1% of patients withdrew from the study due to treatment emergent adverse events (TEAEs) and none of the serious adverse events were considered treatment-related. No clinically significant abnormalities were associated with pitavastatin in routine laboratory variables, urinalysis, vital signs or 12-lead ECG. There were no reports of myopathy, myositis or rhabdomyolysis. The most common TEAEs were: increased creatine phosphokinase (5.8%), nasopharyngitis (5.4%) and myalgia (4.1%).

Conclusion: Pitavastatin 4mg once daily was effective and well tolerated during 52-weeks treatment in patients with primary hypercholesterolemia or combined dyslipidemia. Around three-quarters of patients achieved NCEP and EAS LDL-C targets at week 52, HDL-C levels rose continually during follow up, while changes in other efficacy parameters were sustained over the year-long study.