WOKINGHAM, England, March 23, 2011 /PRNewswire/ -- Kowa Pharmaceutical Europe welcomes the first regional launch of its statin, Livazo (pitavastatin) in Lebanon, where it will be marketed by Beirut-based Algorithm, under an exclusive license.
Aimed at patients with primary hyperlipidemia and / or mixed dyslipidemia,(1) Lebanon will be the first market for Livazo outside the Far East and the USA. Algorithm will launch Livazo in the rest of the Middle East and North Africa from 2012 onwards.
Livazo is a potent statin that combines effective control on LDL-cholesterol (LDL-C) and triglycerides (TG), long-term incremental HDL-cholesterol (HDL-C) increase and, due to its novel structure, is less likely to have drug-drug interactions.(2) Its effectiveness has been demonstrated in several Phase III clinical studies:
- Livazo safely and effectively reduced LDL-C and achieved European Atherosclerosis Society (EAS) guideline targets in the majority of patients with primary hyperlipidemia or mixed dyslipidemia, similar to reductions seen with atorvastatin(3) and simvastatin(4) - Livazo 2 mg and 4 mg demonstrated comparable efficacy to commonly prescribed statins with 2 mg Livazo demonstrating statistically significant superior efficacy compared with simvastatin 20 mg in lowering LDL-C, non high-density lipoprotein cholesterol (non-HDL-C) and total cholesterol (TC)(4) - Livazo effectively reduced LDL-C in the elderly(5) and also improved LDL-C and other parameters of lipid metabolism in patients at higher cardiovascular risk(2) - Livazo was superior to pravastatin in improving LDL-C in elderly patients (65 years)(5) - Livazo demonstrated a gradual and sustained increase in HDL-C over the long-term, supported by data from a 52 week extension study(6)
"We welcome innovative treatments such as Livazo, which not only lowers LDL-C effectively but also addresses HDL residual risk and so has the potential to increase the proportion of patients achieving treatment targets," said Professor Ibrahim Salti, Professor of Medicine and Head of the Division of Endocrinology and Metabolism at the American University of Beirut in Lebanon. "Pitavastatin has shown good efficacy in metabolic syndrome patients without effect on HbA1C levels, as well as in elderly patients. The low drug-drug interaction makes it an attractive option for clinically complex patients on multiple medications."
High cholesterol levels are a major risk factor for heart disease, the number one cause of death globally.(7) In Lebanon, about one sixth of all adults has high blood cholesterol, but only two fifths of these receive medical treatment for it.(8)
The overall safety and tolerability of pitavastatin are consistent with other commonly prescribed statins. In Phase III studies comparing pitavastatin with atorvastatin(3), simvastatin(4) and pravastatin(5), the overall safety profile of pitavastatin was demonstrated, with low incidences of adverse events. All three doses of pitavastatin (1, 2 and 4 mg) demonstrated a comparable safety profile to 10, 20 and 40 mg of pravastatin(5), which is considered to be the statin least likely to cause adverse drug reactions or drug-drug interactions. Additionally, pitavastatin has demonstrated a long-term safety profile (to 52 weeks),(6) comparable to that of simvastatin or atorvastatin.(9,10)
Drummond Paris, President of Kowa Research Europe, said: "The launch of Livazo in Lebanon represents a milestone for Kowa as our first product in this region. It will be the first of many launches in Europe, the Middle East and North Africa during 2011. We are keen to offer the benefits of Livazo to patients across the globe."
References 1. Livazo Summary of Product Characteristics 2. Ose L. Pitavastatin: finding its place in therapy. Ther Adv Chronic Dis. 2011. Published online before print. January 26, 2011, doi: 10.1177/2040622310389227 3. Budinski D, Arneson V, Hounslow N, Gratsiansky N. Pitavastatin compared with atorvastatin in primary hypercholesterolemia or combined dyslipidemia. Clin. Lipidol. 2009;4:291-302 4. Ose L, Budinski D, Hounslow N, Arneson V. Comparison of pitavastatin with simvastatin in primary hypercholesterolaemia or combined dyslipidaemia. Curr Med Res Opin 2009;25: 2755-64 5. Stender S, Hounslow N. Robust efficacy of pitavastatin and comparable safety to pravastatin. Atherosclerosis Suppl. 2009; 10:e945 6. Ose L, Budinski D, Hounslow N, Arneson V: Long-term treatment with pitavastatin is effective and well tolerated by patients with primary hypercholesterolemia or combined dyslipidemia. Atherosclerosis 2010; 202-208 7. World Health Organization. Cardiovascular diseases fact sheet. Accessed on 14 February, 2011. http://www.who.int/mediacentre/factsheets/fs317/en/index.html. 8. Rady, A. Is lifestyle affecting the risk of non-communicable diseases in Lebanon? Human & Health 2010;13:15-17 9. Data on file (study 309) 10. Data on file (study 310)