JW Pharmaceutical said more countries have recognized that its cholesterol-lowering drug Livalo (ingredient: pitavastatin) did not increase the risk of new-onset diabetes.
The drugmaker said on Friday the number of countries recognizing Livalo’s safety against diabetes has increased from 10 to 21.
|JW Pharmaceutical’s hyperlipidemia treatment Livalo|
Livalo is the only statin-class medication that won such a recognition based on post-marketing surveillance and clinical data. Starting with the U.K. in March 2016, nine other countries -- Portugal, Greece, Germany, Spain, Sweden, the Netherlands, Italy, Taiwan, and Indonesia – had guaranteed its diabetes-free efficacy until June last year.
Eleven more countries offered official recognition -- France, Ireland, Austria, Norway, Finland, Poland, Georgia, Kazakhstan, Armenia, Russia and Ukraine.
The results were based on the J-PREDICT study, which showed that pitavastatin lowered the risk of diabetes by 18 percent compared to placebo, and a meta-analysis of a study conducted with 15 pitavastatin drugs.
Presented by Tokyo Medical University Professor Masato Odawara in 2014, the J-PREDICT was a follow-up study of 1,269 patients with impaired glucose tolerance hyperlipidemia using statin drugs for five years from 2007. The study introduced pitavastatin as an alternative to conventional medicines such as atorvastatin, rosuvastatin, pravastatin, and simvastatin, which had diabetes risk issues in long-term use.
The KAMIR study on statin drugs in Korean patients with acute myocardial infarction confirmed that Livalo had a low incidence of new-onset diabetes, compared to atorvastatin or rosuvastatin.
“Various studies have shown that pitavastatin is the only statin drug that is effective in dyslipidemia without raising blood sugar levels. The drug’s prescription sales are increasing,” an official at JW Pharmaceutical said. “We expect this trend will spread to more countries.”