Zydena® Cleared as Safe for Patients with Diabetes, Hypertension

Dong-A Pharmaceutical (President and CEO Won-Bae Kim) announced that the clinical trial on Zydena®'s efficacy and safety in treating erectile dysfunctions of hypertension and diabetes patients has been successfully concluded. The trial was conducted over the period of 10 months or so from June 2006 to this March on 135 hypertension patients in eight hospitals including Seoul University Hospital and 156 diabetes patients in seven hospitals including Korea University Anam Hospital. Efficacy of Zydena®, the results showed, reported no continuous or severe post-dose symptoms, rendering the drug’s safety also excellent. As for hypertension patients, those with erectile dysfunctions taking anti-hypertension treatments were the trial targets. The results revealed that in the test of IIEF EF (International Index of Erectile Function) to evaluate erectile functions, Zydena® showed significant improvements compared to its placebo (18.00 points for the placebo, 22.94 points for 100mg of Zydena®, and 24.33 points for 200mg of Zydena® out of the total of 30). In terms of the success rate of intra-vagina insertion being measured by the SEP (Sexual Encounter Profile) Q2, Zydena® showed significant improvements vis-à-vis the placebo (69.31% for the placebo, 83.27% for 100mg and 91.92% for 200mg). Also in SEP Q3 measuring the erectile duration, it showed the same competency (33.14% for the placebo, 63.25% for 100mg and 76.65% for 200mg). Moreover, in the GAQ (Global Assessment Question), Zydena® showed higher satisfaction results compared to the placebo (41.2% for the placebo, 78.8% for 100mg and 85.2% for 200mg). In the case of diabetes patients, Zydena® showed significant improvements compared to its placebo in IIEF EF (14.22 points for the placebo, 20.31 points for 100mg and 22.19 points for 200mg), SEP Q2 (48.99% for the placebo, 76.88% for 100mg and 86.67% for 200mg), SEP Q3 (22.60% for the placebo, 51.13% for 100mg and 63.00% for 200mg) and satisfaction (30.9% for the placebo, 65.5% for 100mg and 83.9% for 200mg). No severe side effects occurred in this trial, and side effects such as headache and blushing disappeared in short period. Professor Park, Nam-Cheol (president of Pusan Adrological Society) at Pusan National University Hospital, who led the trial said, “The frequency of erectile dysfunction among hypertension and diabetes patients is higher than that among general patients. The effects and safety of Zydena® in this clinical were much more satisfactory than expected. This trial would give an opportunity to doctors and patients to have a wider scope of choices in erectile dysfunction treatments.” One official at Dong-A Pharmaceutical said, “This trial, once again, scientifically proves excellent effects and safety of Zydena® for erectile dysfunction among those with hypertension and diabetes. Especially for those taking anti-hypertension treatments, its efficacy and safety turned out outstanding, which will be good new to the patients concerned about its side effects.” # # # About Dong-A Pharmaceutical Dong-A is Korea’s leading pharmaceutical company. Based on its corporate philosophy that the greatest value is life, Dong-A strives to be a responsible corporate citizen that contributes to the health and welfare of humankind. Over the past 42 years, Dong-A has maintained a reputation as a trustworthy producer of quality pharmaceutical products, and has risen to become the number one drug company in Korea. It is expanding its overseas presence on the strength of its new drug and biopharmaceutical products. Dong-A Socio Group includes Dong-A Otsuka, a beverage company, and Yongma Logis, a 3PL sp

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