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- ||| Stendra (avanafil) / IEH Biopharma, Menarini, Endo
Journal, Adverse events: Phosphodiesterase-5 inhibitors and hearing impairment: a disproportionality analysis using the US food and drug administration adverse event reporting system. (Pubmed Central) - Aug 12, 2024
Sildenafil had the highest reported cases (ROR: 3.03, 95% CI: 2.82-3.24, IC: 1.57, 95% CI: 1.34-1.80). These findings highlight a significant correlation between PDE-5i use and HIAEs, emphasizing the need for careful evaluation in clinical practice and providing appropriate guidance to patients before initiating treatment.
- | mirodenafil (AR1001) / ariBio, Samjin Pharma
Journal: Developing Topics. (Pubmed Central) - Aug 9, 2024
P2
Furthermore, AR1001 showed more pronounced activity in the modulation of GR and Wnt signaling among the various PDE-5 inhibitors. It is suggested that the multimodal activity of AR1001 contributes to the therapeutic effects of AR1001 observed in the phase 2 clinical trial in AD patients (NCT03625622).
- || silodosin / Generic mfg., vardenafil / Generic mfg., tadalafil / Generic mfg.
Clinical, Journal: Optimum combined MET according to tolerability with efficacy, Silodosin Tadalafil versus Silodosin Vardenafil for distal ureteric stone: a prospective, double blinded, randomized clinical trial. (Pubmed Central) - Aug 6, 2024
Both Silodosin-Tadalafil and Silodosin-Vardenafil therapies are effective in managing distal ureteric stones. However, the Silodosin-Tadalafil combination is associated with a significantly lower incidence of adverse events, making it a more tolerable option for patients.
- | Journal: Adulterated dietary supplements commercialized in Brazil: development of a screening method and a preliminary study of cytotoxicity. (Pubmed Central) - Jul 31, 2024
Subsequently, in vitro evaluations were performed of the potential cytotoxicity to evaluate the cell viability, DNA damage, determination of nitric oxide levels, and quantification of reactive oxygen species. Despite the necessity of further studies, the results indicate a relationship between the presence of adulterants in food supplements and a potential cytotoxic effect.
- | vardenafil / Generic mfg.
Journal: Possible Retinotoxicity of Long-term Vardenafil Treatment. (Pubmed Central) - May 19, 2024
Our results point towards the retinotoxicity of vardenafil, even without diabetes, which raises doubts about the retinal safety of long-term continuous vardenafil administration. This effect needs to be considered when approving PDE inhibitors for alternative indications.
- ||| sildenafil / Generic mfg., vardenafil / Generic mfg., tadalafil / Generic mfg.
Journal, Adverse events, Real-world evidence, Real-world: Differences in Ocular Adverse Events Associated with phosphodiesterase-5 inhibitors: a real-world pharmacovigilance study. (Pubmed Central) - May 13, 2024
This comprehensive pharmacovigilance study reveals distinct patterns of ocular adverse events associated with sildenafil, vardenafil, and tadalafil. These findings contribute to a better understanding of the safety profiles of PDE5 inhibitors and may guide healthcare professionals in clinical decision-making.
- Stendra (avanafil) / IEH Biopharma, Menarini, Endo, Miostat (carbachol) / Novartis
Phosphodiesterase (PDE) inhibition as a pharmacological option in OAB therapy: New molecular biological and functional aspects (Small Hall) - May 12, 2024 - Abstract #NORDKONGRESS2024NORDKONGRESS_23;
These findings contribute to a better understanding of the safety profiles of PDE5 inhibitors and may guide healthcare professionals in clinical decision-making. Contents Introduction: Phosphodiesterases (PDE) are key enzymes in the control of numerous organ and tissue functions, in urology the use of selective inhibitors of phosphodiesterase 5 (PDE5) in the indications Erectile Dysfunction (ED) (Avanafil, Sildenafil, Tadalafil, Vardenafil) and LUTS /BPS (Tadalafil) established...The organ bath technique was used to investigate the effects of selective inhibitors of PDEn 1, 2, 3 and 5 on the tonic contraction of isolated detrusor muscles induced by the muscarinic agonist carbachol (1
- || tadalafil / Generic mfg.
Retrospective data, Review, Journal: Which PDE5 inhibitor is the most effective in the treatment of erectile dysfunction in men with spinal cord injury? A systematic review and network meta-analysis. (Pubmed Central) - Mar 30, 2024
Within the grading of comparison network, tadalafil appeared to be the best PDE5i in the treatment of SCI-related ED. Further focused studies are warranted to confirm these findings and define optimal doses and duration of therapy.
- vardenafil / Generic mfg.
A randomised, placebo-controlled study to assess the efficacy & safety of twice-daily vardenafil in the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia (N01) - Jan 15, 2024 - Abstract #EAU2024EAU_2933;
- | vardenafil / Generic mfg.
Journal: Probing the mechanism by which the retinal G protein transducin activates its biological effector PDE6. (Pubmed Central) - Jan 2, 2024
for PDE6. These findings provide new insights into how the retinal G protein stimulates rapid catalytic turnover by PDE6 required for dim light vision.
- || Stendra (avanafil) / IEH Biopharma, Menarini, Endo
Review, Journal: Combination vardenifil and tadalifil drug induced liver injury; case report and review of the literature of liver injury associated with phosphodiesterase type 5 inhibitors. (Pubmed Central) - Nov 29, 2023
We report a patient who had taken vardenafil and tadalafil individually for several years without developing symptoms of liver injury...Biochemical pattern of liver injury is variable. PDE5I DILI is a rare event that can result in severe acute liver injury.
- | tadalafil / Generic mfg.
Journal: Identification of Emotional Spectrums of Patients Taking an Erectile Dysfunction Medication: Ontology-Based Emotion Analysis of Patient Medication Reviews on Social Media. (Pubmed Central) - Nov 29, 2023
The findings highlight the importance of emotions in shaping patient sentiment and satisfaction with medication treatment. Understanding these emotional dynamics can aid health care providers in better addressing patient needs and improving overall patient care.
- || sildenafil / Generic mfg., vardenafil / Generic mfg., tadalafil / Generic mfg.
Review, Journal: Analytical methods for the detection and characterization of unapproved phosphodiesterase type 5 inhibitors (PDE-5i) used in adulteration of dietary supplements- a review. (Pubmed Central) - Nov 28, 2023
Therefore, the above-mentioned techniques may not be adequate to characterize the analogues. Additional work involving chiroptical methods, two-dimensional (2D) NMR experiments and X-ray crystallography are likely to be required in the future.
- || Stendra (avanafil) / IEH Biopharma, Menarini, Endo
Review, Journal: The relationship between the history of PDE5-inhibitors assumption and melanoma: a systematic review. (Pubmed Central) - Nov 20, 2023
Current literature still reports contrasting data regarding the association between PDE5-is assumption and increased risk of melanoma, but a possible association is described, bringing attention to higher risk melanoma category of patients. More clinical studies are needed to clarify the impact of PDE5-is in the development and progression of melanoma.
- | Stendra (avanafil) / IEH Biopharma, Menarini, Endo
Journal: Oral phosphodiesterase type 5 inhibitors and priapism: A VigiBase analysis. (Pubmed Central) - Nov 4, 2023
More clinical studies are needed to clarify the impact of PDE5-is in the development and progression of melanoma. PDE5i use shows disproportionate priapism signals which are higher in young patients.
- | Stendra (avanafil) / IEH Biopharma, Menarini, Endo
Journal: The spreading information of YouTube videos on Phosphodiesterase 5 inhibitors: a worrisome picture from one of the most consulted internet source. (Pubmed Central) - Oct 21, 2023
The overall quality of the PDE5-is contents provided is sadly unsatisfactory. Nowadays, YouTube
- | vardenafil / Generic mfg.
Journal: A novel vardenafil analog in a healthcare product: Preparation, characterization, and quantification. (Pubmed Central) - Oct 9, 2023
Our developed quantitative method could meet practical needs. The high positive rate (16.67%) in 30 samples suggested that the related regulators should be alert to O-propyl vardenafil in routine test since it has not been detected ever before.
- | tadalafil / Generic mfg.
Journal: Erectile Dysfunction Pharmacotherapy Utilization after 60Gy in 20 Fractions Volumetric Modulated Arc Therapy to the Prostate. (Pubmed Central) - Oct 3, 2023
The high positive rate (16.67%) in 30 samples suggested that the related regulators should be alert to O-propyl vardenafil in routine test since it has not been detected ever before. In this limited analysis, pre-treatment use of ED medication and mean dose to penile shaft predicted for worsening ED after treatment with modestly hypofractionated radiotherapy for prostate cancer.
- | sildenafil / Generic mfg., vardenafil / Generic mfg., tadalafil / Generic mfg.
Journal: PDE5 inhibitor drugs for use in dementia. (Pubmed Central) - Sep 28, 2023
In this limited analysis, pre-treatment use of ED medication and mean dose to penile shaft predicted for worsening ED after treatment with modestly hypofractionated radiotherapy for prostate cancer. Potent phosphodiesterase-5 (PDE5) inhibitors are in clinical use as vasodilators.In animals PDE5 inhibitors enhance synaptic function and cognitive ability.In humans the PDE5 inhibitor sildenafil is associated with reduced risk of Alzheimer's disease.Licensed PDE5 inhibitors have potential for repurposing in dementia.Prospective clinical trials of PDE5 inhibitors are warranted.
- | vardenafil / Generic mfg.
Preclinical, Journal: Neuromodulatory effect of vardenafil on aluminium chloride/D-galactose induced Alzheimer's disease in rats: emphasis on amyloid-beta, p-tau, PI3K/Akt/p53 pathway, endoplasmic reticulum stress, and cellular senescence. (Pubmed Central) - Sep 26, 2023
The modulation of phosphatidylinositol-3-kinase/protein kinase B/p53 pathway and the reduction of nuclear factor kappa B level, the key regulator of senescence-associated secretory phenotype mediators release, with VAR treatment were also elucidated. Altogether, these findings insinuate the possible therapeutic benefits of VAR in AD management.
- | sildenafil / Generic mfg., vardenafil / Generic mfg., tadalafil / Generic mfg.
Journal: Proniosomal Gel-Loaded Phosphodiesterase Inhibitors (Sildenafil, Vardenafil, and Tadalafil): Prospects for Topical Penile Therapy of Tadalafil for Treatment of Erectile Dysfunction. (Pubmed Central) - Aug 25, 2023
No statistically significant (p > 0.05) differences in sexual performance or biochemical parameters (NO and cGMP levels) were recorded among orally and topically (tadalafil proniosomal gel) administered groups. These findings support tadalafil topical penile therapy as a promising alternative to the oral route.
- tadalafil / Generic mfg.
Erectile Dysfunction Pharmacotherapy Utilization after 60Gy in 20 Fractions Volumetric Modulated Arc Therapy to the Prostate (Hall B2; In Person Only; Screen: 3) - Aug 22, 2023 - Abstract #ASTRO2023ASTRO_1470;
Prior to treatment, 52 (25%) patients were on ED medication: 20 (9%) on sildenafil, 28 (13%) on tadalafil and 4 (8%) on vardenafil. In this limited analysis, pre-treatment use of ED medication and mean dose to penile shaft predicted for worsening ED after treatment with modestly hypofractionated radiotherapy for prostate cancer.
- | tamoxifen / Generic mfg.
Journal: A combination of phosphodiesterase type 5 inhibitor and tamoxifen for acute Peyronie's disease: the first clinical signals. (Pubmed Central) - Jul 31, 2023
In this limited analysis, pre-treatment use of ED medication and mean dose to penile shaft predicted for worsening ED after treatment with modestly hypofractionated radiotherapy for prostate cancer. No abstract available
- || sildenafil / Generic mfg., vardenafil / Generic mfg., tadalafil / Generic mfg.
Review, Journal: Phosphodiesterase-5 Inhibitors as Therapeutics for Cardiovascular Diseases: A Brief Review. (Pubmed Central) - Jul 24, 2023
PDE-5 inhibitors indicate the encouraging useful effects by ischemia/reperfusion injury, myocar-dial infarction, cardiac hypertrophy, cardiomyopathy and systolic and diastolic congestive heart failure. Therefore, this and similar reviews can help for additional clinical targeting in the therapy of cardiovascular diseases.
- AR1001 / ariBio
Protective Effects of AR1001 in Alzheimer (Virtual) - Jul 6, 2023 - Abstract #AAIC2023AAIC_7042;
P2
Furthermore, AR1001 showed more pronounced activity in the modulation of GR and Wnt signaling among the various PDE-5 inhibitors. It is suggested that the multimodal activity of AR1001 contributes to the therapeutic effects of AR1001 observed in the phase 2 clinical trial in AD patients (NCT03625622).
- AR1001 / ariBio
Protective Effects of AR1001 in Alzheimer (Virtual) - Jul 6, 2023 - Abstract #AAIC2023AAIC_4975;
P2
Furthermore, AR1001 showed more pronounced activity in the modulation of GR and Wnt signaling among the various PDE-5 inhibitors. It is suggested that the multimodal activity of AR1001 contributes to the therapeutic effects of AR1001 observed in the phase 2 clinical trial in AD patients (NCT03625622).
- AR1001 / ariBio
Protective Effects of AR1001 in Alzheimer (Virtual) - Jul 6, 2023 - Abstract #AAIC2023AAIC_2730;
P2
Furthermore, AR1001 showed more pronounced activity in the modulation of GR and Wnt signaling among the various PDE-5 inhibitors. It is suggested that the multimodal activity of AR1001 contributes to the therapeutic effects of AR1001 observed in the phase 2 clinical trial in AD patients (NCT03625622).
- AR1001 / ariBio
Protective Effects of AR1001 in Alzheimer (Virtual) - Jul 6, 2023 - Abstract #AAIC2023AAIC_511;
P2
Furthermore, AR1001 showed more pronounced activity in the modulation of GR and Wnt signaling among the various PDE-5 inhibitors. It is suggested that the multimodal activity of AR1001 contributes to the therapeutic effects of AR1001 observed in the phase 2 clinical trial in AD patients (NCT03625622).
- || vardenafil / Generic mfg.
PK/PD data, Journal: Pharmacokinetics comparison of vardenafil as administered by an intranasal spray formulation vs a 10-mg oral tablet. (Pubmed Central) - Jul 3, 2023
It is suggested that the multimodal activity of AR1001 contributes to the therapeutic effects of AR1001 observed in the phase 2 clinical trial in AD patients (NCT03625622). Our study indicated that the present VDF formulation, when administered intranasally, can achieve a more rapid but similar plasma concentration with only about one-third dose when compared with the oral administration.
- | Preclinical, Journal: Statins synergize with phosphodiesterase type 5 inhibitors but not with selective estrogen receptor modulators to prevent myofibroblast transformation in an in vitro model of Peyronie's disease. (Pubmed Central) - Jul 3, 2023
Our study indicated that the present VDF formulation, when administered intranasally, can achieve a more rapid but similar plasma concentration with only about one-third dose when compared with the oral administration. This is the first demonstration of an antifibrotic synergy between statins and PDE5 inhibitors.
- | vardenafil / Generic mfg.
Journal: Isolation and identification of a novel vardenafil analogue, propoxy-vardenafil, found as an adulterant in a health supplement. (Pubmed Central) - Jun 30, 2023
To the best of our knowledge, the analogue has not been reported and is even only ninth vardenafil analogue, which was confirmed that a n-propyloxy group had replaced the ethoxy group on the aromatic ring of vardenafil. Therefore, It is essential to pay more attention to vardenafil analogues in the routine inspection of health supplements.
- | sildenafil / Generic mfg., vardenafil / Generic mfg.
Journal: Multi-objective evolutionary optimization for dimensionality reduction of texts represented by synsets. (Pubmed Central) - Jun 22, 2023
The contribution of this study is two-fold: (i) to introduce different dimensionality reduction methods (lossless, low-loss and lossy) as an optimization problem that can be solved using MOEA and (ii) to provide an experimental comparison of lossless and low-loss schemes for text representation. The results obtained support the usefulness of the low-loss method to improve the efficiency of classifiers.
- | sildenafil / Generic mfg., vardenafil / Generic mfg., tadalafil / Generic mfg.
Journal: Determination of Phosphodiesterase Type-5 Inhibitors (PDE-5) in Dietary Supplements. (Pubmed Central) - May 31, 2023
The results of the quantitative analysis revealed similar findings between the two methods, with adulterant quantities found to be similar to or higher than those in approved medicinal products. This study demonstrated that the HPTLC method is a suitable and economical method for screening PDE-5 inhibitors as adulterants in dietary supplements intended for sexual activity enhancement.
- | vardenafil / Generic mfg.
Journal: Separation and structural elucidation of a novel vardenafil analogue as an adulterant in a natural health care dietary supplement. (Pubmed Central) - May 2, 2023
It was named morphardenafil as a morpholine ring has replaced the N-ethyl piperazine ring in vardenafil. A tablet of this dietary supplement contained about 50
- | Stendra (avanafil) / IEH Biopharma, Menarini, Endo
Journal: Oral phosphodiesterase type 5 inhibitors and male reproductive potential: an overview. (Pubmed Central) - Mar 30, 2023
Oral PDE5Is have in general stimulatory effects on sperm motility, while other semen parameters and hormone profiles showed varied results. In addition, oral PDE5Is have played a useful role in conditions related to distinctive male factor infertility, such as ED, temporary ED, ejaculatory failure alongside AR, and ejaculatory dysfunction in spinal cord lesions.
- | sildenafil / Generic mfg., vardenafil / Generic mfg.
Journal: The POWER saga from 2007 to 2022: An example of a sexual enhancement dietary supplement tainted by different adulterants and still on the market. (Pubmed Central) - Mar 20, 2023
Faced with this situation, the consumer should be better informed by establishing at the European level a public database of tainted dietary supplements on the model of that of the US Food and Drug Administration. It should indicate the product name, its photo, the adulterant name, and be easily accessible to everyone.
- tadalafil / Generic mfg.
Safety of PDE-5 Inhibitors for Erectile Dysfunction: Descriptive and Disproportionality Analyses of the FDA Adverse Event Reporting System (FAERS) Database from 2010 to 2022 () - Mar 9, 2023 - Abstract #ISPOR2023ISPOR_1217;
PDE-5 inhibitors demonstrate significant increased risks of reporting certain clinically important AEs. While these events are rare, it is imperative to continually monitor PDE-5 inhibitor use at the primary care to national surveillance levels to ensure safe utilization.
- || Review, Journal: Treating diabetes with combination of phosphodiesterase 5 inhibitors and hydroxychloroquine-a (Pubmed Central) - Feb 27, 2023
Phosphodiesterase 5 (PDE5) is a cGMP specific enzyme, which is the target of erectile dysfunction drugs including sildenafil, vardenafil, and tadalafil...The combination treatment activated Akt/mTOR cellular survival pathway, which was likely responsible for the salutary effects. Therefore, pretreatment with PDE5 inhibitor and HCQ may be a potentially useful therapy not only for controlling T2D but also reducing the rate and severity of COVID-19 infection in the vulnerable population of diabetics.
- sildenafil / Generic mfg., vardenafil / Generic mfg.
Computational approach for performing medicinal chemistry transformations within a 3D active site (Hall F-H (Indiana Convention Center)) - Feb 14, 2023 - Abstract #ACSSp2023ACS_SP_2801;
The methodology is outlined and a test study using a PDE5A-Sildenafil complex is performed. The results demonstrate that including pocket atoms and preserving key interactions help generate promising candidates that are relevant to the PDE5A receptor as well as a known PDE5A ligand (Vardenafil) from the original Sildenafil molecule.
- Expectations of partners of our patients undergoing penile rehabilitation programs after nerve-sparing prostatectomy (Yellow Area, Brown 2) - Dec 27, 2022 - Abstract #EAU2023EAU_2683;
- Major adverse cardiovascular events (MACE) related to phosphodiesterase 5 inhibitors (PDE5i): Analysis of real-life data from Eudra-Vigilance (EV) database (Yellow Area, Brown 2) - Dec 27, 2022 - Abstract #EAU2023EAU_2680;
- | vardenafil / Generic mfg.
Journal: Phosphodiesterase 5 Inhibitor Potentiates Epigallocatechin 3-O-Gallate-Induced Apoptotic Cell Death via Activation of the cGMP Signaling Pathway in Caco-2 Cells. (Pubmed Central) - Dec 23, 2022
In this study, we found that the phosphodiesterase 5 (PDE5) inhibitor, vardenafil (VDN), potentiates EGCG-induced apoptotic cell death in colon cancer cells...These results suggest that PDE5 inhibitors can be used to elevate cGMP levels to induce 67LR-mediated, cancer-specific cell death. Therefore, EGCG may be employed as a therapeutic candidate for colon cancer.
- | Stendra (avanafil) / Vivus, Menarini, Endo
Journal: Phosphodiesterase-5 inhibitors for Alzheimer's disease? (Pubmed Central) - Nov 18, 2022
Therefore, EGCG may be employed as a therapeutic candidate for colon cancer. No abstract available
- ||| sildenafil / Generic mfg., vardenafil / Generic mfg., tadalafil / Generic mfg.
Journal, Adverse events: Skin cancer signal associated with phosphodiesterase inhibitors: gaining insight through the FDA pharmacovigilance database. (Pubmed Central) - Nov 6, 2022
Vardenafil associated ROR and IC ranged from 23.38 (95% CI 15.20-35.96, IC 2.63) for metastatic malignant melanoma to 245.77 (95% CI 154.42-391.16, IC 2.10) for malignant melanoma stage III. This study supports the association between sildenafil, tadalafil, and vardenafil with skin cancer signal in erectile dysfunction (ED) patients.
- | vardenafil / Generic mfg.
Preclinical, Journal: Demonstration of Ameliorating Effect of Vardenafil Through Its Anti-Inflammatory and Neuroprotective Properties in Autism Spectrum Disorder Induced by Propionic Acid on Rat Model. (Pubmed Central) - Oct 25, 2022
Three chamber sociability and passive avoiding test, histopathological results, lactate levels derived from MRS, and biochemical biomarkers revealed significant differences among the PPAV and PPAS groups. We concluded that vardenafil improves memory and social behaviors and prevent loss of neuronal and Purkinje cell through its anti-inflammatory and neuroprotective effect.
- | vardenafil / Generic mfg.
Preclinical, Journal: The PDE5 inhibitor, vardenafil, ameliorates progressive pathological changes in a focal segmental glomerulosclerosis mouse model. (Pubmed Central) - Oct 21, 2022
Our data suggest that VAR exhibited reno-therapeutic effects via attenuating podocyte loss, preserving the integrity of the glomerular vasculature, and ameliorating fibrotic changes. These findings suggest that PDE5is might be a promising treatment modality for nephrotic syndrome.
- | sildenafil / Generic mfg., vardenafil / Generic mfg., tadalafil / Generic mfg.
Journal: Screening and Determination of Synthetic PDE-5 Inhibitors in Adulterated Sexual Enhancement Supplements. (Pubmed Central) - Oct 21, 2022
Of all sexual enhancement supplements, 13.9% (95% CI: 8.5-19.4) contained significant concentrations of sildenafil, tadalafil or vardenafil. While the study found relatively low levels of undeclared pharmaceutical ingredients in the sexual enhancement dietary supplements available on the UAE market, it is likely that patients with ED tend to consume multiple such supplements daily, thereby exposing themselves to highly elevated cumulative levels.
- | vardenafil / Generic mfg.
Preclinical, Journal: Vardenafil-Loaded Bilosomal Mucoadhesive Sponge for Buccal Delivery: Optimization, Characterization, and In Vivo Evaluation. (Pubmed Central) - Oct 15, 2022
In addition, VDF-loaded bilosomal buccal sponge triggered higher serum levels of cGMP, a biomarker of VDF in vivo efficacy, compared to oral VDF suspension. To sum up, bilosomes might represent a potential nanocarrier for buccal delivery of VDF, enhancing its oral bioavailability and therapeutic efficacy.
- || tadalafil / Generic mfg.
Review, Journal: Prostaglandins as a Topical Therapy for Erectile Dysfunction: A Comprehensive Review. (Pubmed Central) - Oct 11, 2022
Prostaglandins as a Topical Therapy for Erectile Dysfunction: A Comprehensive Review. Sex Med Rev 2022;10:764-781.
- || Stendra (avanafil) / Vivus, Menarini, Endo
Review, Journal: PDE5 inhibitors and male reproduction: Is there a place for PDE5 inhibitors in infertility clinics or andrology laboratories? (Pubmed Central) - Oct 5, 2022
Furthermore, some studies indicate that PDE5is influence positively the sperm capacity to undergo capacitation under biochemical conditions that are known to induce the sperm capacitation process. Additional research efforts are necessary in order to recommend unequivocally the usage of sildenafil, vardenafil, or avanafil for the alleviation of male infertility.