Potential of Mirabegron and its Extended-release Formulations for the Treatment of Overactive Bladder Syndrome

2020 ◽  
Vol 21 (2) ◽  
pp. 79-88 ◽  
Author(s):  
Pankaj Mandpe ◽  
Bala Prabhakar ◽  
Pravin Shende
Keyword(s):  
Clinical Trials ◽  
Overactive Bladder ◽  
Adverse Effects ◽  
Symptomatic Relief ◽  
Phase Iii ◽  
Overactive Bladder Syndrome ◽  
Modified Release ◽  
Blurred Vision ◽  
Antimuscarinic Drugs ◽  
Tablet Dosage

Background: Overactive bladder syndrome is a broadly occurring urological disorder with a distressing impact on the quality of life. The commonly used antimuscarinic drugs show poor patient compliance because of unsatisfactory potency, tolerability and high occurrence of adverse effects such as dry mouth, blurred vision, constipation, dizziness etc. Mirabegron is the first approved β3-adrenoreceptor agonist, used as mono or in combination therapies for overactive bladder syndrome. Objective: The present review provides an insight into the mechanism, pharmacokinetics, toxicokinetics, clinical trials and the development of various conventional and modified-release dosage forms of mirabegron for the treatment of overactive bladder syndrome. Results: The clinical trials of phase II and phase III of mirabegron demonstrated symptomatic relief from the overactive bladder without disturbing the micturition cycle. To date, mirabegron showed promising results for safety, tolerability and efficacy in patients with overactive bladder syndrome. The modified-release tablet dosage form of mirabegron appear to be a proficient and suitable replacement for antimuscarinics and revealed the tremendous potential to overcome the adverse effects of conventional antimuscarinic drugs like Oxybutyline chloride ER, Detrol LA, VESIcare, etc. Conclusion: Mirabegron shows a distinct mode of action, i.e., targeting β3-adrenoreceptors and improving bladder storage without altering void contractions. The limited side effects, high safety, efficacy and tolerability of mirabegron present an adequate substitute to antimuscarinics. However, long-term analysis and clinical studies are prerequisites for assessing the safety, tolerability and efficacy profile of mirabegron.

Long-term clinical use of mirabegron in patients with overactive bladder syndrome

2020 ◽  
Vol 13 (4) ◽  
pp. 460-464
Author(s):  
Tomasz Wiatr ◽  
Piotr Chłosta
Keyword(s):  
Overactive Bladder ◽  
Term Treatment ◽  
Overactive Bladder Syndrome ◽  
Invasive Treatment ◽  
Treatment Development ◽  
Non Invasive ◽  
Antimuscarinic Drugs ◽  
Adrenoceptor Agonist ◽  
Long Term Treatment

Overactive bladder syndrome (OAB) is defined by the International Continence Society (ICS) as urinary urgency with increased daytime frequency and nocturia in the absence of proven infection or any other pathology, usually with or without urgency incontinence. Pharmacotherapy with antimuscarinic drugs is highly effective, but more than 60% of patients discontinue the treatment. Development of mirabegron, a β3-adrenoceptor agonist (β3-AR), has become an expected pharmacotherapy option for the non-invasive treatment of overactive bladder. The available studies show that long-term treatment with 50 mg mirabegron in patients with OAB is associated with reducing the severity of symptoms. Data from clinical trials show that mirabegron provides efficacy similar to antimuscarinic drugs, but with a better tolerance profile.

Uncommon Adverse Effects of Deoxycholic Acid Injection for Submental Fullness: Beyond the Clinical Trials

2020 ◽  
Vol 24 (6) ◽  
pp. 619-624
Author(s):  
Kristy C. Metzger ◽  
Erika L. Crowley ◽  
Dorota Kadlubowska ◽  
Melinda J. Gooderham
Keyword(s):  
Clinical Trials ◽  
Adverse Effects ◽  
Deoxycholic Acid ◽  
Case Reports ◽  
Case Series ◽  
Phase Iii ◽  
Patient Counselling ◽  
Medical Environment ◽  
Phase Iii Clinical Trials ◽  
Health Canada

Deoxycholic acid (BELKYRATM, Allergan, Markham, ON, Canada) is a minimally invasive injectable treatment approved by Health Canada for the nonsurgical reduction of submental fullness. Multiple phase III clinical trials have proven the efficacy and safety of deoxycholic acid. In the clinical trials, the most common adverse events (AEs) reported, such as injection site pain, numbness, swelling, bruising and induration, were transient and mild-to-moderate in severity. Additional postmarketing AEs have been reported in the literature. In this study, we reviewed the uncommon reported events and aimed to increase clinician awareness of the potential adverse effects for patient counselling of risks and benefits, identify AEs of procedures that may be performed outside of the medical environment, and identify factors that increase the risk of an adverse event. Beyond the clinical trials, real-world case reports and case series have been reported for the AEs of alopecia, transient neuropraxia, vascular occlusive events/vascular injury, and skin necrosis. Dermatologists need to be aware of these risks, for the treatment and management of their own patients and for those patients who may be treated outside the medical clinic environment that present for medical management of these AEs.

scholarly journals Drugs and future candidates

2013 ◽  
Vol 5 (5-S2) ◽  
pp. 131
Author(s):  
Karl-Erik Andersson
Keyword(s):  
Overactive Bladder ◽  
Adverse Effects ◽  
Line Treatment ◽  
First Line ◽  
Bladder Filling ◽  
Antimuscarinic Drugs ◽  
Overall Effectiveness ◽  
First Line Treatment

Antimuscarinic drugs are still first-line treatment for the symptomsof overactive bladder (OAB) and are associated with good initialresponse rates. Adverse effects and decreasing efficacy overthe longer term do, however, limit their overall effectiveness. Assuch, alternatives to antimuscarinics are needed. The recognitionof the functional contribution of the urothelium, the spontaneousmyocyte activity during bladder filling, and the diversity of nervetransmitters involved in the symptoms of the OAB has sparkedinterest in pharmacologic manipulation of both peripheral andcentral pathophysiology. Some of the treatments currently underinvestigation are discussed in this review.

Immunogenicity and Safety Profile of COVID-19 Vaccines- A Systematic Review (Preprint)

2020 ◽  
Author(s):  
Reeju Maharjan ◽  
Aditya Bamboria ◽  
Neelam Asghar ◽  
Manish Shrestha ◽  
Syed W H Rizvi
Keyword(s):  
Clinical Trials ◽  
Adverse Effects ◽  
Systematic Reviews ◽  
Neutralizing Antibodies ◽  
Phase Iii ◽  
Effective Vaccine ◽  
Efficacy And Safety ◽  
Vaccine Candidates ◽  
One Year ◽  
Meta Analyses

BACKGROUND An effective vaccine will be important in controlling severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) pandemic. OBJECTIVE In this study, we aim to analyze the degree of immunogenicity that rises after administering different vaccines, and to study their efficacy. METHODS We systematically reviewed multiple vaccine candidates at different stages of clinical trials to prevent Coronavirus disease in 2019 (COVID-19). We reviewed literature from four major electronic databases (PubMed, MEDLINE, PubMed Central, and Google scholar) to identify studies on SARS-CoV-2 vaccine candidates. This article included studies that include clinical trials in multiple stages and systematic reviews published in 2020. We performed a quality assessment with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines for our articles. RESULTS We included a total of 19 articles. This review article has a total of 24,342 individuals. These studies show promising results regarding vaccines candidates, safety profiles, and immunogenicity with the effective generation of neutralizing antibodies and specific T-cell responses. Adverse effects range from mild to moderate, with no serious adverse effects reported. It is unclear how long the generated immunity will last, and a follow up of the study participants for an extended one-year period will be needed. CONCLUSIONS Ascertaining vaccines' efficacy and safety in vulnerable populations is essential for the general use of vaccine use. A number of these vaccines are currently under phase III or to enter phase III and may increase vaccines' efficacy and safety in different populations.

Antimuscarinic drugs in detrusor overactivity and the overactive bladder syndrome: motor or sensory actions?

2006 ◽  
Vol 98 (3) ◽  
pp. 503-507 ◽  
Author(s):  
STEVEN M. FINNEY ◽  
KARL-ERIK ANDERSSON ◽  
JAMES I. GILLESPIE ◽  
LAURENCE H. STEWART
Keyword(s):  
Overactive Bladder ◽  
Detrusor Overactivity ◽  
Overactive Bladder Syndrome ◽  
Antimuscarinic Drugs

scholarly journals Ipilimumab Pharmacotherapy in Patients with Metastatic Melanoma

2012 ◽  
Vol 6 ◽  
pp. CMO.S7245 ◽  
Author(s):  
Joanne M. Jeter ◽  
Lee D. Cranmer ◽  
Evan M. Hersh
Keyword(s):  
Monoclonal Antibody ◽  
Overall Survival ◽  
Clinical Trials ◽  
Adverse Effects ◽  
Metastatic Melanoma ◽  
Phase Iii ◽  
Preclinical Evaluation ◽  
Investigational Therapies ◽  
Alternative Means ◽  
Phase Iii Studies

Immune augmentation with ipilimumab, an anti-CTLA-4 monoclonal antibody, has joined the ranks of approved immunologic agents for the treatment of metastatic melanoma. Phase III studies of ipilimumab in metastatic melanoma have demonstrated an overall survival advantage as compared to other approved and investigational therapies. However, the adverse effects associated with this medication are unique and often require management with steroids or other immunosuppressants. In addition, the time to response differs with ipilimumab as compared to traditional chemotherapy, and alternative means of assessment of response have been proposed. In this review, we will summarize the basic science of this treatment, its preclinical evaluation, and the clinical trials leading to its approval. We will also discuss the details regarding its use, assessment of response to this drug and other immune-related therapies, and further directions for investigation.

Behavioral therapy versus drug therapy in individuals with idiopathic overactive bladder: A systematic review and meta-analysis

2019 ◽  
Vol 25 (5) ◽  
pp. 573-585 ◽  
Author(s):  
Valentina Lucia La Rosa ◽  
Thaís Duarte de Campos da Silva ◽  
Arielle Rosa de Oliveira ◽  
Taís Marques Cerentini ◽  
Patricia Viana da Rosa ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Drug Therapy ◽  
High Risk ◽  
Overactive Bladder ◽  
Randomized Clinical Trials ◽  
Behavioral Therapy ◽  
Risk Of Bias ◽  
Cochrane Library ◽  
Overactive Bladder Syndrome ◽  
Significant Difference

The aim of this study was to systematically review randomized clinical trials comparing the treatment of individuals with overactive bladder syndrome through the use of behavioral therapy versus drug therapy. A systematic electronic search of MEDLINE via PubMed, Embase, and Cochrane Library was performed, including studies indexed until August 2019. Five randomized clinical trials were included. The studies presented a high risk of bias. There was no significant difference between the evaluated treatments. Thus, behavioral therapy and drug therapy also promote the improvement of the symptoms of overactive bladder syndrome, and the behavioral therapy does not have significant adverse effects reported. Due to the high risk of bias in included studies, data should be interpreted with caution. Future studies with more comprehensive protocols may change the effect estimates of behavioral therapy on overactive bladder syndrome.

Sign in / Sign up

Export Citation Format

Share Document