This paper reviewed the safety and tolerability of vardenafil in the treatment of erectile dysfunction (ED), including the general, cardiovascular and ocular safety. Results from clinical trials and practice experience demonstrated that vadenafil had good safety and tolerability, whether for general ED population or for difficult-to-treat ED patients, whether as short-term treatment or as long-term therapy.
Drug Tolerance ; Erectile Dysfunction ; drug therapy ; Humans ; Imidazoles ; adverse effects ; therapeutic use ; Male ; Middle Aged ; Phosphodiesterase Inhibitors ; adverse effects ; therapeutic use ; Piperazines ; adverse effects ; therapeutic use ; Sulfones ; adverse effects ; therapeutic use ; Treatment Outcome ; Triazines ; adverse effects ; therapeutic use ; Vardenafil Dihydrochloride

Phosphodiesterase 5 inhibitors are recommended as first-line treatment of erectile dysfunction in many guidelines, because of their convenience, higher efficacy, and less side-effects. Since its first launch in 1998, sildenafil has been currently the best investigated phosphodiesterase 5 inhibitor with respect to long-term trails and quantity. Clinical trials showed the efficacy of sildenafil compared with placebo in many of the groups of patients who have ED, including those with cardiovascular disease, diabetes mellitus, depression, radical prostatectomy and dialysis. Typically the adverse effects reported in patients from clinical trials of sildenafil have been mild to moderate, and commonly include flushing and dyspepsia and transient visual disturbances. This article summarized recent reports on efficacy and safety of phosphodiesters 5 inhibitors in the treatment of erectile dysfunction.
Erectile Dysfunction ; drug therapy ; Humans ; Male ; Phosphodiesterase Inhibitors ; adverse effects ; therapeutic use ; Piperazines ; adverse effects ; therapeutic use ; Purines ; adverse effects ; therapeutic use ; Safety ; Sildenafil Citrate ; Sulfones ; adverse effects ; therapeutic use

Erectile dysfunction is a common ailment in middle-aged and old men. The management of ED has entered a new stage since sildenafil was used to treat ED in 1998. Sildenafil became the first-line treatment for its efficacy and safety. In recent years, new PDE5 inhibitors--vardenafil and tadalafil came into market in succession, providing more options available for oral therapy. This review is about the development of preclinical and clinical medicine research on the three PDE5 inhibitors, and provide information for clinical choices.
Erectile Dysfunction ; drug therapy ; Humans ; Male ; Phosphodiesterase Inhibitors ; adverse effects ; therapeutic use ; Piperazines ; adverse effects ; therapeutic use ; Purines ; adverse effects ; therapeutic use ; Sildenafil Citrate ; Sulfones ; adverse effects ; therapeutic use

Since the worldwide introduction of sildenafil in 1998, 23 million patients with ED have been treated with the drug, and the accumulated experiences have proved its safety and efficacy. This article presents a review about the action mechanism and metabolic process of sildenafil, with a particular focus on the application of sildenafil to ED diagnosis, the curative effect of its daily use on ED, the standard treatment, combined therapy and progressive protocol with sildenafil for ED and its complications, along with such safety aspect as its effect on the sight.
Drug Therapy, Combination ; Erectile Dysfunction ; drug therapy ; Humans ; Male ; Phosphodiesterase Inhibitors ; adverse effects ; therapeutic use ; Piperazines ; adverse effects ; therapeutic use ; Purines ; adverse effects ; therapeutic use ; Sildenafil Citrate ; Sulfones ; adverse effects ; therapeutic use

BACKGROUNDAcute gout is an intensely painful, inflammatory arthritis. Although the non-steroidal anti-inflammatory drugs (NSAIDs) are widely used for this condition, the efficacy is based on only a few studies, particularly in China. We tried to assess the safety and efficacy of etoricoxib in the treatment of acute gouty arthritis in China.

METHODSA randomized, double-blind, active comparator study was conducted at 10 sites in China. Patients (n = 178; ≥ 18 years of age) with acute gouty attack (< 48 hours) were treated for 5 days with etoricoxib (120 mg/d; n = 89) or indometacin (75 mg twice daily; n = 89). The primary efficacy end point was self-assessed pain in the affected joint (0-4 point Likert scale) from days 2 - 5. Secondary end points included investigator assessments of tenderness and swelling, patient/ investigator global assessments of response to therapy, and patients discontinuing treatment. Safety was assessed by adverse events (AEs).

RESULTSEtoricoxib and indometacin had comparable primary and secondary end points. Mean change difference from baseline from days 2 - 5 was 0.03 (95% confidence interval (CI) -0.19 to 0.25; P = 0.6364), which fell within the prespecified comparative bounds of -0.5 to 0.5. No severe AEs were associated with etoricoxib use. Non-severe AEs were mainly digestive and general, and most (73.7%) were mild, although they caused withdrawal of two subjects in the etoricoxib group, due to bilateral renal calculi and uronephrosis of the left kidney (unrelated to etoricoxib) and fever and chills (potentially etoricoxib-related). Overall, AEs were similar, although the absolute number of AEs in the etoricoxib group (n = 31) was less than the indometacin group (n = 34).

CONCLUSIONSEtoricoxib (120 mg once daily) is effective in treating acute gout, is generally safe and well-tolerated, and is comparable in efficacy to indometacin (75 mg twice daily).

Adult ; Aged ; Arthritis, Gouty ; drug therapy ; Cyclooxygenase Inhibitors ; adverse effects ; therapeutic use ; Double-Blind Method ; Female ; Humans ; Indomethacin ; adverse effects ; therapeutic use ; Male ; Middle Aged ; Pyridines ; adverse effects ; therapeutic use ; Sulfones ; adverse effects ; therapeutic use

OBJECTIVETo observe the clinical efficacy and safety of sildenafil in the treatment of high altitude heart disease associated with severe pulmonary arterial hypertension (PAH) in children.

METHODSFifty children (aged 2 months to 2 years) with high altitude heart disease associated with severe PAH, who were continuously transferred to the Intensive Care Unit between January 2011 and October 2013, were randomly assigned to observation and control groups. The control group was given conventional treatment, while the observation group received oral sildenafil [1 mg/(kg . d)] three times daily for 7-10 days in addition to the conventional treatment. Before and after treatment, hemodynamics, blood gas, routine blood parameters, and blood biochemical parameters were recorded.

RESULTSAfter treatment, the observation group had a significantly higher decrease in mean pulmonary artery pressure and significantly higher increases in arterial partial pressure of oxygen, cardiac output, cardiac index, and oxygenation index compared with the control group (P<0.05). In the observation group, there were no significant changes in mean arterial pressure, routine blood parameters and blood biochemical parameters (P>0.05), and no obvious adverse reactions were found.

CONCLUSIONSFor children with high altitude heart disease associated with severe PAH, sildenafil can effectively reduce pulmonary artery pressure and improve cardiac function and does not cause adverse reactions. This therapy has good safety according to the preliminary evaluation.

Altitude ; Familial Primary Pulmonary Hypertension ; Female ; Heart Diseases ; drug therapy ; Humans ; Hypertension, Pulmonary ; complications ; physiopathology ; Infant ; Male ; Piperazines ; adverse effects ; therapeutic use ; Purines ; adverse effects ; therapeutic use ; Sildenafil Citrate ; Sulfones ; adverse effects ; therapeutic use ; Vasodilator Agents ; adverse effects ; therapeutic use

Erectile dysfunction (ED) is one of the most popular and disturbing sexual problems, which impairs patients' health and affects their quality of life. Sildenafil citrate, the first oral PDE-5 inhibitor in the world, has established its efficacy and safety credit in both doctors and ED patients. The authors reviewed the results of related studies in the last decade and made deeper insights into the use of sildenafil citrate in such aspects as the general drug tolerance and its influence on the cardiovascular system, potentiality of concomitant diseases with co-administration of other drugs, long-term safety, and ocular and genital safety.
Erectile Dysfunction ; drug therapy ; Evidence-Based Medicine ; Humans ; Male ; Phosphodiesterase Inhibitors ; adverse effects ; therapeutic use ; Piperazines ; adverse effects ; therapeutic use ; Purines ; adverse effects ; therapeutic use ; Retrospective Studies ; Sildenafil Citrate ; Sulfones ; adverse effects ; therapeutic use

Sildenafil is widely used to treat erectile dysfunction (ED). Because many patients with ED have cardiovascular diseases, doctors and patients are concerned over the safety of Sildenafil in patients with cardiovascular diseases. The review focuses on the safety of sildenafil for ED patients with cardiovascular diseases.
Cardiovascular Diseases ; complications ; Erectile Dysfunction ; complications ; drug therapy ; Humans ; Male ; Piperazines ; adverse effects ; therapeutic use ; Purines ; Sildenafil Citrate ; Sulfones ; Vasodilator Agents ; adverse effects ; therapeutic use

The rate of erectile dysfunction after radical retropubic prostatectomy is from 10% to 100%. The prevalence of erectile dysfunction after nerve-sparing radical prostatectomy is more than one third. In the patients who had undergone bilateral NS, 72% responded to sildenafil, 71.7% and 59.7% responded to 20 mg and 10 mg of vardenafil respectively. For all randomized patients who received tadalafil, the mean percentage of successful penetration attempts was 54% and the mean percentage of successful intercourse attempts was 41%. For the subgroup with evidence of postoperative tumescence these values were 69% and 52%, respectively. No head-to-head trials have been performed with sildenafil, vardenafil and tadalafil in treatment of erectile dysfunction after radical prostatectomy.
Carbolines ; therapeutic use ; Erectile Dysfunction ; drug therapy ; etiology ; Humans ; Imidazoles ; therapeutic use ; Male ; Phosphodiesterase Inhibitors ; therapeutic use ; Piperazines ; therapeutic use ; Prostatectomy ; adverse effects ; Purines ; therapeutic use ; Sildenafil Citrate ; Sulfones ; therapeutic use ; Tadalafil ; Triazines ; therapeutic use ; Vardenafil Dihydrochloride

Some patients with chronic obstructive pulmonary disease (COPD) have pulmonary hypertension (PH) that adversely affects survival. We performed a systematic review and meta-analysis to assess whether PH-specific therapies have an effect for stable COPD. Data sources were Medline, EMBASE, Cochrane Central Register of Controlled Trials, Korea med and references from relevant publications. Randomized prospective trials that compared PH specific therapy in COPD for more than 6 weeks with placebo were included. The outcomes were the exercise capacity and adverse events. Four randomized controlled trials involving 109 subjects were included in the analysis. Two trials involved bosentan, one sildenafil and one beraprost. The studies varied in duration of treatment from 3 to 18 months. In a pooled analysis of four trials, exercise-capacity was not significantly improved with PH-specific treatment for COPD (risk ratio, -5.1; 95% CI, -13.0 to 2.8). COPD with overt PH significantly improved the exercise capacity (mean difference, 111.6; 95% CI, 63.3 to 159.9) but COPD with PH unknown did not (mean difference, 26.6; 95% CI, -24.3 to 77.5). There was no significant difference in hypoxemia (mean difference, 2.6; 95% CI, -3.7 to 8.8). PH specific treatments have a significant effect in improving exercise capacity in COPD with overt PH.
Anoxia ; Antihypertensive Agents/adverse effects/*therapeutic use ; Clinical Trials as Topic ; Databases, Factual ; Epoprostenol/adverse effects/analogs & derivatives/therapeutic use ; Humans ; Hypertension, Pulmonary/complications/*drug therapy ; Piperazines/adverse effects/therapeutic use ; Pulmonary Disease, Chronic Obstructive/*etiology ; Purines/adverse effects/therapeutic use ; Questionnaires ; Risk Factors ; Sulfonamides/adverse effects/therapeutic use ; Sulfones/adverse effects/therapeutic use