History of Viagra, Sildenafil citrate and studies
March 1998 is the registration date for Pfizer Inc.'s revaporized Viagra. The FDA approved Sildenafil Citrate for the treatment of erectile dysfunction in men. This substance is the main component of the preparation. This substance is also found in a number of other preparations, such as Kamini Oral Jelly and Kamagra Gold.
As of 2005, over 27 million men worldwide and over 17 million in America alone were receiving Viagra. This statistic comes from a dossier by Pfizer Inc. New York State. Long-term and such massive use of the drug is the best guarantee of drug safety. And numerous studies lasting at least a year only confirmed the complete safety of Sildenafil.
Reportedly, 1,358 men with erectile dysfunction participated in double-blind studies that lasted about a year, and over the following four years, 979 men continued to receive Sildenafil citrate at various doses (25, 50, and 100 mg).
After three years they were published in Carson et al. 2002: Padma-Narthan et al. Released in 2002, allowing full clarity on the final dates. It is important to note that the population included patients with erectile dysfunction with concomitant diseases such as arterial hypertension, diabetes mellitus, hyperlipidemia, history of coronary artery disease. The aim was to investigate the long-term safety of using sildenafil in men with ED. This was an open-label, long-term, 4-year study with different doses (25, 50, and 100 mg). However, men who previously participated in the study and continued to take the drug, or those who completed sildenafil treatment during the initial open-label extension, may not have participated in the longer extension study. Viagra was provided to the trial participants free of charge. The results of the study were reportedly recorded daily in the medication diaries, which were used to assess participation in the study. Since the start of the study, 1545 men have thus participated, bearing in mind that 1358 of the total number continued to participate in extended studies.
All procedures fully complied with all ethical requirements and standards of the competent human experimentation body (institutional or regional).