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International Braz J Urol : Official... 2021To describe the otorhinolaryngological adverse effects of the main drugs used in urological practice. (Review)
Review
PURPOSE
To describe the otorhinolaryngological adverse effects of the main drugs used in urological practice.
MATERIALS AND METHODS
A review of the scientific literature was performed using a combination of specific descriptors (side effect, adverse effect, scopolamine, sildenafil, tadalafil, vardenafil, oxybutynin, tolterodine, spironolactone, furosemide, hydrochlorothiazide, doxazosin, alfuzosin, terazosin, prazosin, tamsulosin, desmopressin) contained in publications until April 2020. Manuscripts written in English, Portuguese, and Spanish were manually selected from the title and abstract. The main drugs used in Urology were divided into five groups to describe their possible adverse effects: alpha-blockers, anticholinergics, diuretics, hormones, and phosphodiesterase inhibitors.
RESULTS
The main drugs used in Urology may cause several otorhinolaryngological adverse effects. Dizziness was most common, but dry mouth, rhinitis, nasal congestion, epistaxis, hearing loss, tinnitus, and rhinorrhea were also reported and varies among drug classes.
CONCLUSIONS
Most of the drugs used in urological practice have otorhinolaryngological adverse effects. Dizziness was most common, but dry mouth, rhinitis, nasal congestion, epistaxis, hearing loss, tinnitus, and rhinorrhea were also reported. Therefore, doctors must be aware of these adverse effects to improve adherence to the treatment and to minimize damage to the health of patients.
Topics: Adrenergic alpha-Antagonists; Doxazosin; Humans; Male; Pharmaceutical Preparations; Prazosin; Prostatic Hyperplasia; Tadalafil; Tamsulosin
PubMed: 33566468
DOI: 10.1590/S1677-5538.IBJU.2021.99.06 -
Journal of Travel Medicine 2012
Topics: Acetazolamide; Altitude Sickness; Carbolines; Carbonic Anhydrase Inhibitors; Humans; Hypertension, Pulmonary; Male; Mountaineering; Tadalafil
PubMed: 22943266
DOI: 10.1111/j.1708-8305.2012.00646.x -
Clinical Cancer Research : An Official... Mar 2022We hypothesize that the addition of the phosphodiesterase-5 inhibitor tadalafil to the PD-1 inhibitor nivolumab, is safe and will augment immune-mediated antitumor... (Randomized Controlled Trial)
Randomized Controlled Trial
PURPOSE
We hypothesize that the addition of the phosphodiesterase-5 inhibitor tadalafil to the PD-1 inhibitor nivolumab, is safe and will augment immune-mediated antitumor responses in previously untreated squamous cell carcinoma of the head and neck (HNSCC).
PATIENTS AND METHODS
We conducted a two-arm multi-institutional neoadjuvant randomized trial in any-stage resectable HNSCC (NCT03238365). Patients were stratified at randomization by human papillomavirus (HPV) status. Patients in both arms received nivolumab 240 mg intravenously on days 1 and 15 followed by surgery on day 28. Those in the combination therapy arm also received tadalafil 10 mg orally once daily for 4 weeks. Imaging, blood, and tumor were obtained pretreatment and posttreatment for correlative analysis.
RESULTS
Neoadjuvant therapy was well-tolerated with no grade 3 to 5 adverse events and no surgical delays. Twenty-five of 46 (54%) evaluable patients had a pathologic treatment response of ≥20%, including three (7%) patients with a complete pathologic response. Regardless of HPV status, tumor proliferation rate was a negative predictor of response. A strong pretreatment T-cell signature in the HPV-negative cohort was a predictor of response. Tadalafil altered the immune microenvironment, as evidenced by transcriptome data identifying enriched B- and natural killer cell gene sets in the tumor and augmented effector T cells in the periphery.
CONCLUSIONS
Preoperative nivolumab ± tadalafil is safe in HNSCC and results in more than 50% of the patients having a pathologic treatment response of at least 20% after 4 weeks of treatment. Pretreatment specimens identified HPV status-dependent signatures that predicted response to immunotherapy while posttreatment specimens showed augmentation of the immune microenvironment with the addition of tadalafil.
Topics: Head and Neck Neoplasms; Humans; Neoadjuvant Therapy; Nivolumab; Papillomavirus Infections; Squamous Cell Carcinoma of Head and Neck; Tadalafil; Treatment Outcome; Tumor Microenvironment
PubMed: 34911681
DOI: 10.1158/1078-0432.CCR-21-1816 -
Chemical & Pharmaceutical Bulletin 2018Tadalafil (TD), a phosphodiesterase-5 (PDE-5) inhibitor with poor oral bioavailability. The aim of the study was to prepare and characterize three crystalline polymorphs...
Tadalafil (TD), a phosphodiesterase-5 (PDE-5) inhibitor with poor oral bioavailability. The aim of the study was to prepare and characterize three crystalline polymorphs of TD (II, III, and IV) and the tadalafil amorphous form (TD-AM). TD polymorphs and TD-AM were prepared and characterized by polarized light microscope (PLM), scanning electron microscopy (SEM), differential scanning calorimetry (DSC), thermal gravimetric analysis (TGA), X-ray powder diffractometry (XRPD), and Fourier-transform (FT)IR, followed by the dissolution testing, physical stabilities and polymorphic transformation studies. TD-I and TD-II were found to be enantiotropically related, while TD-III was monotiotropically related to TD-I with heat release. Among all studied polymorphs, TD-AM demonstrated an extremely high intrinsic dissolution rate with most prolonged higher saturated concentration during dissolution, while TD-II, TD-III, and TD-IV converted to TD-I easily by supersaturation-mediated phase transformation. Upon heating under 60°C for 3 h and storing at long-term stability condition for 3 months, no phase transformation was detected for TD-I, TD-III, and TD-AM, while TD-II and TD-IV easily transformed to TD-I and TD-III, respectively. The higher intrinsic dissolution rate, prolonged supersaturated state during dissolution and favorable physical stability of TD-AM made it to be a very promising candidate for further product development.
Topics: Crystallization; Molecular Conformation; Particle Size; Polymers; Solubility; Surface Properties; Tadalafil
PubMed: 30504628
DOI: 10.1248/cpb.c18-00450 -
Therapeutics and Clinical Risk... 2015The evidence suggests that combination therapy for benign prostatic hyperplasia (BPH)-lower urinary tract symptoms (LUTS) using an α-blocker and a 5α-reductase... (Review)
Review
The evidence suggests that combination therapy for benign prostatic hyperplasia (BPH)-lower urinary tract symptoms (LUTS) using an α-blocker and a 5α-reductase inhibitor has become well accepted. The combination of daily tadalafil and an α-blocker has also demonstrated benefit. This paper addresses combination therapy with daily tadalafil and finasteride for the treatment of BPH-LUTS. Our results demonstrate that use of tadalafil and finasteride represents a logical extension of combination therapies. We analyze a landmark study by Casabé et al that demonstrates improved voiding symptoms as assessed by International Prostate Symptom Scores with a combination of tadalafil and finasteride compared with finasteride and placebo. Study patients had moderate to severe LUTS and prostate volumes >30 g. The additional benefit of improved erectile function as assessed by International Index of Erectile Function-erectile function domain scores with the addition of tadalafil was a secondary benefit. We propose that the ideal patient for combination therapy with tadalafil and finasteride has a prostate volume >30 g and desires additional benefit over monotherapy. For these men, improved erectile function without sexual side effects was a secondary benefit.
PubMed: 25848297
DOI: 10.2147/TCRM.S80353 -
American Journal of Men's Health 2023Lower urinary tract symptoms (LUTS) secondary to benign prostrate hyperplasia (BPH) are common geriatric diseases, and its incidence rises with age. The treatment of BPH... (Meta-Analysis)
Meta-Analysis
A Systematic Review and Meta-Analysis of the Efficacy and Safety of Tamsulosin Plus Tadalafil Compared With Tamsulosin Alone in Treating Males With Lower Urinary Tract Symptoms Secondary to Benign Prostrate Hyperplasia.
Lower urinary tract symptoms (LUTS) secondary to benign prostrate hyperplasia (BPH) are common geriatric diseases, and its incidence rises with age. The treatment of BPH and LUTS is becoming a burden for health care. The meta-analysis was performed to evaluate the efficacy and safety of combination therapy (tamsulosin plus tadalafil) compared with tamsulosin alone in treatment of males with LUTS/BPH. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses were utilized to conduct this study. There were several databases available for literature retrieval, including Medline, Embase, PubMed, Scopus, Web of Science databases, and Cochrane Controlled Trials Register. To improve the comprehensiveness of the search, related references were also searched. Finally, six randomized controlled trials including 441 patients were included. The combination therapy had significant improvements in total International Prostate Symptom Score ( < .0001), quality of life score ( = .003), maximum urine flow rate ( < .00001), and International Index of Erectile Function ( < .00001) compared with the tamsulosin monotherapy, but there was no obvious difference in postvoid residual volume ( = .06). In terms of safety, the combination group had comparable rates of discontinuation due to adverse events ( = .19) than the monotherapy group except for pain symptoms ( < .0001). The combination of tamsulosin and tadalafil provided a preferable therapeutic effect compared with the tamsulosin alone in treating males with BPH/LUTS, and both therapy regimens were well tolerated by the patients.
Topics: Male; Humans; Aged; Tamsulosin; Tadalafil; Prostatic Hyperplasia; Hyperplasia; Quality of Life; Erectile Dysfunction; Drug Therapy, Combination; Treatment Outcome; Lower Urinary Tract Symptoms; Randomized Controlled Trials as Topic
PubMed: 36842963
DOI: 10.1177/15579883231155096 -
Pediatric Pulmonology Mar 2022To describe the safety and tolerability of treatment with ambrisentan and tadalafil in pediatric pulmonary hypertension (PH). (Observational Study)
Observational Study
OBJECTIVE
To describe the safety and tolerability of treatment with ambrisentan and tadalafil in pediatric pulmonary hypertension (PH).
STUDY DESIGN
This retrospective observational two-center study included subjects (≤18 years of age) with PH receiving combination therapy with ambrisentan and tadalafil. Before initiating this therapy, many patients were on other therapies for PH. At baseline, patients either received no therapy or monotherapy with a phosphodiesterase 5 inhibitor (PDE5i) or endothelin receptor antagonist (ERA) (Group A), switched from a different PDE5i and ERA (Group B), or were on prostanoid therapy with or without a PDE5i and/or ERA (Group C and D). Demographics, symptoms, and adverse effects were collected. Pre- and postvalues for exercise capacity, hemodynamics, and biomarkers were compared.
RESULTS
There were 43 subjects (26 F, 17 M) ages 4-17.5 years (median 9.3) with World Symposium of PH group 1, 3, and 5. Significant improvements were seen in change scores at follow-up in the entire sample and Group A for 6-min walk distance: +37.0 (6.5-71.0) [p = 0.022], mean pulmonary artery pressure: -6.0 (-14.0 to -3.5) [p = .002], pulmonary vascular resistance: -1.7 (-6.2 to -1.0) [p = .003], NT-proBNP -32.9 (-148.9 to -6.7) [p = .025]. WHO functional class improved in 39.5% and was unchanged in 53.5%; PH risk scores improved in 16%; were unchanged in 56%; and declined in 14%. Three patients discontinued therapy (two headaches, one peripheral edema). Seven patients were hospitalized for worsening disease (2/7 had a Potts shunt placed, 2/7 had an atrial septostomy). There were no deaths or lung transplantation.
CONCLUSIONS
Combination therapy with ambrisentan and tadalafil was well-tolerated, with an acceptable safety profile in a select group of children. This therapy was associated with improved exercise capacity and hemodynamics in children who were treatment naïve or on monotherapy with a PH medication before the initiation of ambrisentan and tadalafil. Based on these early data, further study of combination therapy in pediatric PH is warranted.
Topics: Adolescent; Antihypertensive Agents; Child; Child, Preschool; Drug Therapy, Combination; Familial Primary Pulmonary Hypertension; Humans; Hypertension, Pulmonary; Phenylpropionates; Phosphodiesterase 5 Inhibitors; Pulmonary Arterial Hypertension; Pyridazines; Retrospective Studies; Tadalafil; Treatment Outcome
PubMed: 34921523
DOI: 10.1002/ppul.25796 -
Urologia Internationalis 2017To compare the efficacy and safety between tadalafil once-a-day and tadalafil on-demand dosing regimen in patients with ED. (Meta-Analysis)
Meta-Analysis Review
INTRODUCTION
To compare the efficacy and safety between tadalafil once-a-day and tadalafil on-demand dosing regimen in patients with ED.
MATERIALS AND METHODS
A systematic search of Medline, Embase, and Cochrane Library was performed to identify all randomized controlled trials (RCTs) that compared tadalafil used a once-a-day with an on-demand dosing regimen for erectile dysfunction. A secondary hand-search was performed in relevant journals, references, and the grey literature. Meta-analyses were performed using Review Manager version 5.3.0.
RESULTS
Six RCTs involving a total of 1,534 patients were included in this review. All studies reported the International Index of Erectile Function-Erectile Function domain score and the results of the meta-analysis showed no difference between the groups. The overall pooled estimated weighted mean differences (WMD) was 0.97 (95% CI -0.37 to 2.32; p = 0.16). Meta-analyses of Sexual Encounter Profile questions 2 and 3 (SEP-2 and SEP-3) showed that the once-a-day dosing regimen was superior to the on-demand regimen with statistical significance. The WMD of SEP-2 and SEP-3 were 10.32 (95% CI 3.16-17.48; p = 0.005) and 11.07 (95% CI 2.57-19.56; p = 0.01), respectively. Both dosing regimens of tadalafil showed similar complication rates. The meta-analyses of adverse events showed no significant differences.
CONCLUSIONS
The efficacy rates of tadalafil once-a-day and on-demand were similar. No significant difference in safety was found between the 2 dose regimens of tadalafil.
Topics: Chi-Square Distribution; Drug Administration Schedule; Erectile Dysfunction; Humans; Male; Odds Ratio; Penile Erection; Phosphodiesterase 5 Inhibitors; Randomized Controlled Trials as Topic; Recovery of Function; Risk Factors; Tadalafil; Time Factors; Treatment Outcome; Urological Agents
PubMed: 28628914
DOI: 10.1159/000477496 -
Therapeutic Advances in Respiratory... Jun 2017Pulmonary arterial hypertension (PAH) is a progressive disease defined by an elevation in pulmonary arterial pressure that can lead to right heart failure and death.... (Review)
Review
Pulmonary arterial hypertension (PAH) is a progressive disease defined by an elevation in pulmonary arterial pressure that can lead to right heart failure and death. Ambrisentan is a selective endothelin receptor antagonist approved for the treatment of idiopathic, heritable PAH and connective tissue disease-associated PAH. Ambrisentan has been shown to improve exercise capacity and hemodynamics with an acceptable side-effect profile. It has also proven to be safely used in combination with other PAH-specific medications, especially with phosphodiesterase-5 inhibitors. In the recent randomized trial, AMBITION, it was shown that upfront combination therapy of ambrisentan and tadalafil significantly decreased the risk of clinical failure compared with monotherapy. This review describes the drug profile of ambrisentan and its safety and efficacy in the treatment of PAH.
Topics: Animals; Antihypertensive Agents; Drug Therapy, Combination; Humans; Hypertension, Pulmonary; Phenylpropionates; Pyridazines; Randomized Controlled Trials as Topic; Tadalafil
PubMed: 28425346
DOI: 10.1177/1753465817696040