To evaluate the efficacy and safety of aildenafil citrate, an oral phosphodiesterase type 5 inhibitor, in the treatment of erectile dysfunction.
Integrated analyses were made of 8-week, randomized, double-blind, placebo-controlled phase 2 clinical trials involving 250 men with mild-to-severe erectile dysfunction of various etiologies who received aildenafil citrate 30 or 60 mg (n = 167) or placebo (n = 83).
The statistic results of International Index of Erectile Function, Patient Sexual Encounter Profile (SEP) diaries and Global Assessment Question (GAQ) were significantly higher in the aildenafil citrate patients than in the placebo controls. The main drug-related adverse events were flushing, headache, dizziness and naupathia, which were mild and could be self-relieved. Conclusion: The aildenafil citrate therapy significantly ameliorated erectile function and was well tolerated by a wide range of patients with erectile dysfunction.
"Aildenafil was found to be present in two herbal supplements (VII and VIII) at levels of 49 and 46 mg per dose unit, respectively. Patent and scientific literature showed that the pharmacological effects and potency of aildenafil were similar to those of sildenafil (Liu 2005; He et al. 2006; Guo et al. 2007; Wang et al. 2007). Because the dose levels found for aildenafil with these herbal supplements exceeded the lowest commercially available sildenafil dose of a registered drug (Table 3), these supplements were considered to produce significant pharmacological effects. "
[Show abstract][Hide abstract] ABSTRACT: Herbal food supplements, claiming to enhance sexual potency, may contain deliberately added active pharmacological ingredients (APIs) that can be used for the treatment of erectile dysfunction (ED). The aim of this study was to determine whether herbal food supplements on the Dutch market indeed contain APIs that inhibit phosphodiesterase type 5 (PDE-5) inhibitors, such as sildenafil and analogous PDE-5 inhibitors. Herbal food supplements intended to enhance sexual potency (n = 71), and two soft drinks, were sampled from 2003 up to and including 2012. In 23 herbal supplements, nine different PDE-5 inhibitors were identified; in a few cases (n = 3), more than one inhibitor was indentified. The presence of these APIs was however not stated on the label. The concentrations of PDE-5 inhibitors per dose unit were analysed. Furthermore, the potential pharmacologically active properties of the detected PDE-5 inhibitors were estimated by using data from the scientific and patent literature regarding (1) in vitro PDE-5 activity, (2) reported effective doses of registered drugs with PDE-5 inhibitor activity and (3) similarity to other structural analogues. It was concluded that 18 of the 23 herbal food supplements, when used as recommended, would have significant pharmacological effects due to added APIs. Adequate use of existing regulation and control measures seems necessary to protect consumers against the adverse effects of these products.
Food Additives and Contaminants - Part A Chemistry, Analysis, Control, Exposure and Risk Assessment 11/2013; 30(12). DOI:10.1080/19440049.2013.848294 · 1.80 Impact Factor
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