New data presented on 15 June 2009 showed that pitavastatin may provide a new treatment option for patients with dyslipidaemia and complex issues, such as those on multiple medications, as evidenced by a study supporting pitavastatin’s potential for low drug-drug interaction. The data were presented by Kowa at the XV International Symposium on Atherosclerosis in Boston, US.
The study was conducted to evaluate the effect of pitavastatin on warfarin. Warfarin has a narrow therapeutic index and is known to have potentially serious interactions with a wide range of medications and food products. The results of the study demonstrated no significant drug-drug interaction between pitavastatin and warfarin.
“This study provides compelling evidence that pitavastatin may make cardiovascular risk reduction simpler, especially in more clinically complex patients taking multiple medications,” said Roger E Morgan, chief medical officer, Kowa Research Institute. “The results presented today suggest pitavastatin may be an effective medication to manage dyslipidaemia in these vulnerable populations.”
An open-label add-on study was conducted to determine the potential for drug interaction following daily administration of pitavastatin 4mg on the steady-state pharmacodynamic (PD) and pharmacokinetic (PK) profiles of warfarin and to assess the safety and tolerability of coadministration of warfarin and pitavastatin in 24 healthy adult subjects. Once a target INR (measures coagulation of sample blood against a normal measurement) of 1.2 to 2.2 was achieved for each subject with warfarin monotherapy through day 14, pitavastatin 4mg was introduced and coadministered with warfarin through day 21.
The results of the study demonstrated that the steady-state PD and PK profiles of warfarin were unaffected by the coadministration of pitavastatin, and thus no significant drug-drug interaction was observed. In addition, pitavastatin 4mg in combination with warfarin was safe and well tolerated by healthy subjects when compared with warfarin administration alone.
“The study shows that pitavastatin may fill an unmet need in the current statin market for patients with dyslipidaemia that face complex clinical issues such as potential drug interactions,” said Morgan. “We feel that pitavastatin is a unique and effective medication for this targeted population, and we are looking forward to bringing pitavastatin to the market.”
Pitavastatin is a fully synthetic and highly potent inhibitor of HMG-CoA reductase used for primary hypercholesterolaemia and combined dyslipidaemia. Pitavastatin has a unique cyclopropyl group on the base structure common to the statin class. Since its 2003 launch in Japan, pitavastatin has accumulated millions of patient-years of exposure. Kowa has filed a New Drug Application for pitavastatin with the FDA and has filed in Europe in August 2008, using the decentralised authorisation procedure. Once approved, pitavastatin will be available in three dosage strengths (1, 2 and 4mg).