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

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

OBJECTIVETo evaluate the efficacy and safety of olmesartan medoxomil compared with losartan potassium in patients with mild to moderate essential hypertension.

METHODThis is a randomized, double-blind, double-dummy, active-controlled, parallel, multi-center study. After a 2-week placebo run-in period, a total of 287 eligible subjects were randomized at 1:1 ratio to receive olmesartan medoxomil 20 mg or losartan potassium 50 mg, once daily for 8 weeks. The blood pressure was assessed after 4 weeks treatment. If the subject's seating diastolic blood pressure (SeDBP) was still >or=90 mm Hg, the dosage was doubled for another 4 weeks; for those subjects whose SeDBP was <90 mm Hg after 4-week treatment, the initial dosage remained unchanged and the treatment continued until completion of the study.

RESULTS(1) The mean trough reduction in SeDBP from baseline in olmesartan group was significantly greater than that in losartan group after 4 weeks (11.72 mm Hg vs 9.23 mm Hg, P=0.004) and 8 weeks treatment (12.94 mm Hg vs 11.01 mm Hg, P=0.035). (2) The number and percentage of responders in olmesartan group (81, 65.3%) were statistically higher than those (68, 52.7%) in losartan group (P=0.028) after 4 weeks treatment and were similar between the two groups after 8 weeks treatment (P>0.05). (3) Individual and overall trough/peak ratios of DBP and SBP in 24-hour ambulatory blood pressure monitoring were higher in olmesartan group than losartan group. The hypotensive effect of olmesartan was more durable than losartan at 24 hour interval. (4) The incidence of study drug-related adverse events (AEs) in olmesartan group (10.5%) was similar as that in losartan group (13.9%, P>0.05). Most of these AEs were mild and transient.

CONCLUSIONThis study shows that olmesartan medoxomil, at oral dose of 20 mg-40 mg once daily was effective and safe for hypertension treatment and the hypotensive effect was superior to losartan potassium (50 mg-100 mg once daily).

Adolescent ; Adult ; Aged ; Antihypertensive Agents ; administration & dosage ; China ; Double-Blind Method ; Female ; Humans ; Hypertension ; drug therapy ; physiopathology ; Imidazoles ; adverse effects ; therapeutic use ; Losartan ; adverse effects ; therapeutic use ; Male ; Middle Aged ; Olmesartan Medoxomil ; Tetrazoles ; adverse effects ; therapeutic use

OBJECTIVETo investigate the effect and safety of zoledronic acid (Zoledex) in patients with cancer-induced hypercalcemia.

METHODSSeventeen patients with cancer-induced hypercalcemia (corrected blood calcium > 2.70 mmol/L) were treated intravenously by 4 mg zoledex within 15 minutes on the first day. The corrected blood calcium was observed every 4 days in the following 28 days.

RESULTSThe response rate was 94.1% (16/17). The mean corrected blood calcium became normal after the first dose of zoledex (P < 0.01). The lowest value was found on the fourteenth day after treatment. The main side effects consisted of fever (29.4%, 5/17), hypocalcemic tetany (11.8%, 2/17) and arythmia (5.9%, 1/17).

CONCLUSIONZoledex is effective and safe in the treatment of patient with cancer-induced hypercalcemia.

Adult ; Aged ; Aged, 80 and over ; Bone Density Conservation Agents ; adverse effects ; therapeutic use ; Diphosphonates ; adverse effects ; therapeutic use ; Female ; Humans ; Hypercalcemia ; drug therapy ; etiology ; Imidazoles ; adverse effects ; therapeutic use ; Male ; Middle Aged ; Neoplasms ; complications ; Safety

Vardenafil is a new type of PDE5 inhibitor (PDE5I) with great inhibiting potential on PDE5 (IC50: 0.01 nmol/L) for enhancing erectile function. International and domestic clinical studies showed it to be safe and effective in treating ED with mild temporary side effects such as headache, dizziness, flushing and rhinitis. In this paper we reviewed the cardiovascular safety of vardenafil. Studies showed that clinical dosage of vardenafil could decrease the systematic arterial blood pressure mildly (< 10 mmHg) , however, it did not interact in a potentially hazardous way with antihypertensive or antianginal therapy, with the exception of organic nitrates. Vardenafil slightly prolonged the QT interval (QTc) in cardiac repolarization, but with no evidence to prove that it could cause arrhythmia in clinical studies. The rates and categories of cardiovascular adverse events of vardenafil therapy were not significantly different from placebo in 5 clinical trials. Present studies demonstrated that clinical dosage of vardenafil appeared generally well tolerated in most patients with chronic and stable cardiovascular disease and it was an ideal drug for the first line treatment of ED.
Adult ; Blood Pressure ; drug effects ; Erectile Dysfunction ; drug therapy ; Heart ; drug effects ; Humans ; Imidazoles ; adverse effects ; therapeutic use ; Male ; Middle Aged ; Phosphodiesterase Inhibitors ; adverse effects ; therapeutic use ; Piperazines ; adverse effects ; therapeutic use ; Safety ; Sulfones ; adverse effects ; therapeutic use ; Triazines ; adverse effects ; therapeutic use ; Vardenafil Dihydrochloride

OBJECTIVETo evaluate the efficacy and safety of long-term on-demand use of vardenafil in the treatment of erectile dysfunction (ED).

METHODSWe conducted a questionnaire investigation among 891 ED patients treated by on-demand use of oral vardenafil at 20 mg every 3 days from March 2007 to January 2010, covering the general information of the patients, their need for and attitudes towards the treatment, clinical efficacy and adverse events of the drug, and satisfaction of the patients and their partners after 12 weeks of treatment.

RESULTSTreatment and follow-up were completed in 700 patients, of whom 504 (72%) achieved sufficient hardness and duration of penile erection and overall sexual satisfaction, 84 (12%) admitted to improvement of erectile hardness and duration but not adequate satisfaction, and the other 112 (16%) experienced no significant changes. Significant differences were found in IIEF-5 scores, Rigiscan test results and partners TSS scores before and after the treatment (P < 0.05). Most frequent adverse events included flushing (15%), dizziness and headache (10%), dyspepsia (3%), and nasal congestion (1%).

CONCLUSIONLong-term on-demand use of oral vardenafil, in addition to its safety and good tolerance, can effectively improve the erectile function of ED patients, their success rate of sexual intercourse, and overall quality of sexual life.

Adult ; Erectile Dysfunction ; drug therapy ; Follow-Up Studies ; Humans ; Imidazoles ; adverse effects ; therapeutic use ; Male ; Piperazines ; adverse effects ; therapeutic use ; Sulfones ; adverse effects ; therapeutic use ; Treatment Outcome ; Triazines ; adverse effects ; therapeutic use ; Vardenafil Dihydrochloride ; Vasodilator Agents ; adverse effects ; therapeutic use ; Young Adult

OBJECTIVETo evaluate the efficacy and safety of vardenafil on men with erectile dysfunction (ED) of various etiologies.

METHODSA total of 88 men with mild to severe erectile dysfunction were enrolled in the randomized, double-blind, placebo-controlled, fixed-dose trial of 12 weeks of treatment with either placebo or 5, 10 and 20 mg of vardenafil.

RESULTSThis study indicated that vardenafil dosages of 5, 10 and 20 mg were significantly superior to placebo for the treatment of ED, on the basis of the primary study endpoints of the EF domain score of the IIEF, diary-recorded success rates for penetration and maintenance of erection during the intercourse and the GAQ. Vardenafil was well tolerated. The incidence of adverse events was higher for vardenafil than for placebo.

CONCLUSIONOral vardenafil therapy has a high efficacy and a low incidence of adverse events for ED patients with mixed etiologies.

Administration, Oral ; Adult ; Aged ; Double-Blind Method ; 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 ; Triazines ; adverse effects ; therapeutic use ; Vardenafil Dihydrochloride

Erectile dysfunction (ED) usually exists in combination with depression in men. The comorbidity of the two diseases may bring more troubles to patients, so it is important to find an effective treatment. Recently, DRIVER (Depression Related Improvement with Vardenafil for Erectile Response) trials showed that, phosphodiesterase 5 (PDE 5) inhibitor vardenafil could improve not only erectile function but also depressive symptoms and quality of life in men with ED and depression. Vardenafil was generally safe and well tolerated.
Adult ; Aged ; Aged, 80 and over ; Depressive Disorder ; complications ; drug therapy ; Erectile Dysfunction ; complications ; drug therapy ; Humans ; Imidazoles ; adverse effects ; therapeutic use ; Male ; Middle Aged ; Phosphodiesterase Inhibitors ; adverse effects ; therapeutic use ; Piperazines ; adverse effects ; therapeutic use ; Quality of Life ; Sulfones ; adverse effects ; therapeutic use ; Treatment Outcome ; Triazines ; adverse effects ; therapeutic use ; Vardenafil Dihydrochloride

Vardenafil is an oral, potent, highly selective phosphodiesterase 5 (PDE5) inhibitor. It improves erectile function significantly regardless of the etiology and severity of erectile dysfunction (ED) or the age of the patients. Its onset time leading to successful intercourse is as short as 10 minutes after administered orally, and in most patients it works persistently. Adverse reactions are generally transient and mild to moderate in nature. So vardenafil is both effective and safe for men with ED.
Double-Blind Method ; 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

The prevalence of erectile dysfunction (ED) is higher in hypertension patients than in non-hypertension men. Because doctors worry about the severe adverse events of drug combination, they tend to be reluctant to prescribe ED medicines for patients. Vardenafil, as a novel and highly selective phosphodiesterase 5 inhibitor, has been proved by many clinical trials to be quite safe for the cardiovascular system. A recent large-scale clinical trial showed that vardenafil could improve erectile function in ED men with hypertension, with sure safety and no significant clinical changes in the index of hypertension or heart rate.
Adult ; Aged ; Erectile Dysfunction ; complications ; drug therapy ; Humans ; Hypertension ; complications ; 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