Is high dose pitavastatin better than low-dose?

This study compared the effects of treatment with high dose pitavastatin (Livalo) with low dose pitavastatin in Japanese adults with stable coronary artery disease (CAD). It was determined that high dose pitavastatin was more effective in preventing cardiovascular events than the low dose.

Pitavastatin is a type of drug called a statin. Statins lower LDL (bad cholesterol). High levels of LDL can increase the risk of cardiovascular events, such as heart attacks and strokes. People with CAD are often given a statin, as they are at higher risk of experiencing cardiovascular events.

Some research suggests that a high dose of a statin may be more effective than a low dose. However, little research has been done in people of Asian descent.

12,413 Japanese adults took part in this study. They had stable CAD, meaning they had no heart attacks, unstable angina (chest pain occurring at rest), or procedures on the heart in the last 3 months. They were randomly divided into two groups. 6,199 patients received a high dose of pitavastatin. 6,214 patients received a low dose. They were followed up with blood tests after 6 months, 12 months, and then yearly. The average total follow up was 3.9 years.

LDL was similar in both groups at the start of the study. At the end of the study, LDL was 14.7mg/dL lower in the high-dose group than in the low-dose group. Total cholesterol (good and bad), and triglycerides (type of fat in the blood) were lower and HDL (good cholesterol) higher in the high-dose group than the low-dose at the end of the study. 

CRP (a blood protein that indicates inflammation) was similar in both groups at the start of the study. After 6 months, CRP was reduced in the high-dose group but did not change in the low-dose group.

Those in the high-dose group were 19% less likely to experience a cardiovascular event (such as heart attack). Compared to the low-dose group, the high-dose group was 43% less likely to have a heart attack and 14% less likely to need a procedure to unblock or widen arteries. The mortality risk was 19% lower in the high-dose group than in the low-dose group. These results were similar whether a participant’s LDL levels were high or low at the start of the study.

Serious side effects occurred at a low rate, and were similar in both groups. Muscle complaints occured slightly more often in the high-dose group.

The study concluded that high dose pitavastatin was more effective than the low dose in reducing cardiovascular events, and that the high dose did not increase the risk of side effects.

The average age of participants in this study was 68 years, and 83% were male. All participants were Japanese. Thus the results may not apply equally to all those with CAD. The study was funded by the manufacturers of pitavastatin.