Post-marketing surveillance study of the efficacy and safety of vardenafil among patients with erectile dysfunction in primary care

Kim, C M; Kim, Y S; Sunwoo, Sung; Cho, B; Rho, Mannque; Yang, Yun Jun; Kim, C H; Shin, Ho Cheol; Lee, Sang Yeoup; Kim, D H

doi:10.1038/sj.ijir.3901544

Cited by 14 publications

(7 citation statements)

References 21 publications

(36 reference statements)

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“…Vardenafil also showed good safety across all patient subgroups. The overall incidence of AEs in the present analysis (3.6%) was similar to that observed for the individual REALISE study populations from Germany (1.4%) [26], Indonesia (2.9%) [23], and Korea (5.2%) [32], and was very low in comparison with the incidence of AEs seen with vardenafil use in other clinical trials (13–45%) [13,18,19,33,34]. The most frequently reported AEs were transient and mild, and were typical of those noted previously with vardenafil and other PDE5 inhibitors.…”

Section: Discussionsupporting

confidence: 87%

The Real-Life Safety and Efficacy of Vardenafil (REALISE) Study: Results in Men from Europe and Overseas with Erectile Dysfunction and Cardiovascular or Metabolic Conditions

Ahlen

Zumbé

Stauch

et al. 2010

The Journal of Sexual Medicine

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Introduction The Real-Life Safety and Efficacy of vardenafil study is an international, open-label, prospective, noncomparative, noninterventional study in men with erectile dysfunction (ED). Aim To determine the safety and efficacy of vardenafil in a large international pool of men with ED (aged ≥18 years) and associated underlying conditions (N=73,946), in a real-life setting. Methods Patients attended an initial physician visit and one to two follow-up visits. Data were acquired by physician interviews and patient diaries and recorded in case report forms (CRFs). Data were pooled from 47 countries in Europe, Asia-Pacific, Latin America, and the rest of the world (excluding the United States and Japan for methodological reasons). Results were stratified by baseline ED severity, body mass index (BMI), and the presence of hypertension, diabetes, lipid metabolism disorder, or cardiovascular disease (CVD). Main Outcome Measures CRFs and patient questionnaires containing questions on overall improvement of erection, satisfaction with efficacy, and desire to continue vardenafil use. Results Many participants had hypertension (32.0%), diabetes (22.1%), lipid metabolism disorder (14.6%), or CVD (42.2%). High percentages of patients reported improvements in erectile function, irrespective of baseline ED severity (mild, 97.0%; moderate, 96.2%; severe, 85.5%), BMI (<25, 94.1%; ≥25 and <30, 94.6%; ≥30, 92.9%), or the presence of hypertension (93.6%), diabetes (92.6%), lipid metabolism disorder (94.7%), or CVD (93.3%). Over 90% of patients, including those with underlying conditions, reported being “satisfied” or “very satisfied” with vardenafil efficacy, and stated their intention to continue vardenafil use after the end of the study period. The incidence of adverse events was low, and 97.0% of patients were either “satisfied” or “very satisfied” with vardenafil tolerability. Conclusions These data from a worldwide population of men with ED and associated underlying conditions show that vardenafil is effective and well-tolerated for the treatment of ED in a real-life setting, supporting its use as a first-line ED therapy.

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Section: Discussionsupporting

confidence: 87%

The Real-Life Safety and Efficacy of Vardenafil (REALISE) Study: Results in Men from Europe and Overseas with Erectile Dysfunction and Cardiovascular or Metabolic Conditions

Ahlen

Zumbé

Stauch

et al. 2010

The Journal of Sexual Medicine

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“…Headache, facial flushing, nasal congestion and dyspepsia are the most common adverse events (19,21–23). Postmarketing surveillance of PDE5 inhibitors has provided additional data that, in general, indicate a safety profile consistent with that reported in premarketing clinical studies (24–30). However, there are some gaps in the knowledge base.…”

Section: Introductionsupporting

confidence: 62%

Safety of sildenafil citrate: review of 67 double-blind placebo-controlled trials and the postmarketing safety database

Giuliano

Jackson

Montorsi

et al. 2009

International Journal of Clinical Practice

140

101

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Summary Aim: To review special safety topics associated with sildenafil and to document the tolerability of 50‐ and 100‐mg doses, overall and by age, in men with erectile dysfunction (ED). Methods: Data were collated from 67 double‐blind placebo‐controlled (DBPC) trials (> 14,000 men) conducted by the manufacturer and from the manufacturer’s postmarketing safety database (39,277 patients). The DBPC data were stratified by dose, starting dose and age (≥ 65 and ≥ 75 years). Special safety topics included cardiovascular risk, priapism, non‐arteritic anterior ischaemic optic neuropathy (NAION), impaired renal and hepatic function, drug interactions (i.e. nitrates, cytochrome P3A4 inhibitors, other ED therapies and α‐blockers) and incorrect use. Results: Sildenafil was well tolerated at a dose of 50 or 100 mg in men with ED, overall, in those aged ≥ 65 years, and in those aged ≥ 75 years. Analyses of the databases did not reveal any causal link between sildenafil and cardiovascular events, or any new safety risks relating to cardiovascular events, priapism, NAION, hearing loss or drug interactions. In the small number of men with moderate impairment of renal function or hepatic function who were treated with sildenafil in DBPC trials, the safety profile was similar to that in men with no impairment of renal or hepatic function. Overdose with sildenafil was rare in the ED population. No new safety issues, emerging trends or adverse reactions were identified in conjunction with overdose, dependence, abuse or misuse. Conclusion: This collated review confirms generally the good tolerability and established safety profile of sildenafil 50 and 100 mg in men with ED and reveals no new safety issues.

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“…The most common visual disturbances are increased blue tinge in the visual image and an increased sensitivity to light 242–244 . The rate of occurrence for these symptoms is low; in 3–11% of men taking sildenafil 25–100 mg 241 , 0.3–2% of vardenafil 245, 246 , and 0.1% of tadalafil users 247 . The symptoms tend to be mild, transient, dose-dependent, and completely reversible.…”

Section: The No-gc-1-cgmp Pathway As a Target For Glaucoma Therapeuticsmentioning

confidence: 99%

The nitric oxide-guanylate cyclase pathway and glaucoma

2018

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Glaucoma is a prevalent optic neuropathy characterized by the progressive dysfunction and loss of retinal ganglion cells (RGCs) and their optic nerve axons, which leads to irreversible visual field loss. Multiple risk factors for the disease have been identified, but elevated intraocular pressure (IOP) remains the primary risk factor amenable to treatment. Reducing IOP however does not always prevent glaucomatous neurodegeneration, and many patients progress with the disease despite having IOP in the normal range. There is increasing evidence that nitric oxide (NO) is a direct regulator of IOP and that dysfunction of the NO-Guanylate Cyclase (GC) pathway is associated with glaucoma incidence. NO has shown promise as a novel therapeutic with targeted effects that: 1) lower IOP; 2) increase ocular blood flow; and 3) confer neuroprotection. The various effects of NO in the eye appear to be mediated through the activation of the GC- guanosine 3:5'-cyclic monophosphate (cGMP) pathway and its effect on downstream targets, such as protein kinases and Ca channels. Although NO-donor compounds are promising as therapeutics for IOP regulation, they may not be ideal to harness the neuroprotective potential of NO signaling. Here we review evidence that supports direct targeting of GC as a novel pleiotrophic treatment for the disease, without the need for direct NO application. The identification and targeting of other factors that contribute to glaucoma would be beneficial to patients, particularly those that do not respond well to IOP-dependent interventions.

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Post-marketing surveillance study of the efficacy and safety of vardenafil among patients with erectile dysfunction in primary care

Cited by 14 publications

References 21 publications

The Real-Life Safety and Efficacy of Vardenafil (REALISE) Study: Results in Men from Europe and Overseas with Erectile Dysfunction and Cardiovascular or Metabolic Conditions

The Real-Life Safety and Efficacy of Vardenafil (REALISE) Study: Results in Men from Europe and Overseas with Erectile Dysfunction and Cardiovascular or Metabolic Conditions

Safety of sildenafil citrate: review of 67 double-blind placebo-controlled trials and the postmarketing safety database

The nitric oxide-guanylate cyclase pathway and glaucoma

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