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Biotech / Medical : Pharma News Only (pfe,mrk,wla, sgp, ahp, bmy, lly) -- Ignore unavailable to you. Want to Upgrade?

To: Anthony Wong who wrote (824)	9/18/1998 5:33:00 PM
From: Anthony Wong	Read Replies (1) \| Respond to of 1722

Verdict out: Viagra is good for Asians too By Stella O. Gonzales Philippine Daily Inquirer September 19, 1998 SINGAPORE-The results are out and the verdict is much the same as earlier clinical trials conducted on American men: Viagra is an effective, well-tolerated drug treatment for impotent Asian men. Now it's up to Asian governments to decide whether they will allow the sale of the much-ballyhooed drug in their countries. A report made yesterday during the 4th Asian Congress on Urology at the Raffles City Convention Center here said 86 percent of 127 erectile dysfunction patients from the Philippines, Singapore and Malaysia who participated in the trial reported improvement in erection after 12 weeks. A similar test, this time on 130 patients from Hong Kong, Indonesia and Thailand, reported 81 percent improved erections. Viagra, manufactured by Pfizer, has been approved for sale in Thailand and Australia. Among other countries awaiting approval from local regulation agencies are Japan and those who conducted the Asian clinical trials. It has been estimated that 3.5 million Filipino men are suffering from erectile dysfunction. In Asia, one in two men over 40 years old suffer from it and nearly half of the sufferers have a specific underlying physical cause. The average age of the impotent Asian man is 46 years. The worldwide estimate is 100 million impotent men. The Asian Sildenafil Efficacy and Safety Study (ASSESS) by Viagra (generic name: Sildenafil) manufacturer Pfizer used 690 patients from the six countries mentioned above plus Taiwan, where testing is ongoing. ASSESS Participants were all Asians, aged 18 years or older, were clinically diagnosed to have erectile dysfunction, are not receiving any other treatment for ED, and have a stable relationship with a female partner. They were grouped into two--one taking Viagra (not more than once daily) one hour before sexual intercourse, the other a placebo. It was a randomized, double-blind test where even the doctors who gave the medicine did not know who received Viagra and who got the placebo. The results from the Asian countries were turned over to Pfizer's central research group in New York. ASSESS-1 included the Philippines, Singapore and Malaysia while ASSESS-2 covered Hong Kong, Indonesia and Thailand. In the Philippines, 67 patients took placebo and 66 Viagra. Individual results of the Philippine clinical trial conducted by Doctors Benjamin Mendoza, Reynaldo de la Cruz, Telesforo Gana and German Jose Albano are not known. They have been incorporated into the results of ASSESS-1. Of the 127 patients in ASSESS-1 who took Viagra, 86 percent reported improved erections while 33 percent who took placebo also reported an improvement. Of the 130 patients in ASSESS-2 who took Viagra, 81 percent reported improved erections while 28 percent in the placebo group reported an improvement. In ASSESS-1, there was a 74-percent success at attempted sexual intercourse among Viagra users; in ASSESS-2, 68 percent. Common side effects There was no reported incident of a heart attack or stroke among those who took Viagra. One patient receiving Viagra experienced severe angina pectoris which was not considered to be related to the treatment. One placebo patient suffered an accidental injury to the hand. (Clinical trial protocol requires the reporting of all ailments even if these are not related to the drug-taking). In ASSESS-1, the most common side effect among those who took Viagra was headache (11 percent of active group), vasodilation (7.9 percent), rhinitis (4.7 percent), mylagia (3.1 percent), visual disturbances (3.1 percent), paresthesia (1.6 percent), and dyspepsia (1.6 percent). Incidentally, even those in the placebo group reported similar side effects with 7.9 percent reporting headaches, 4.7 percent vasodilation, 1.6 percent rhinitis, and 0.8 percent dyspepsia. In ASSESS-2, reported side effects are flushing (15 percent), headache (10 percent), dizziness (7 percent), rhinitis (5 percent) abnormal vision (5 percent). Dr. Akmal Taher of the urology division of University of Indonesia's Faculty of Medicine told the conference that the results ''are not surprising, considering the extensive clinical trials already conducted in the US and from experience in other countries.'' Dato Dr. Tan Hui Meng, consultant urologist at the Subang Jaya Medical Center in Malaysia, said specialists like him ''welcome any new treatments which will help the many millions of men who suffer from it.'' The Asian clinical trial was a rare occasion when a multinational drug company conducted extensive local tests on a drug even if the US Food and Drug Administration had already approved its sale. inquirer.net