scholarly journals Efficacy of Transdermal Oxybutynin in the Treatment of Overactive Bladder Syndrome: Does It Make Sense Using It in 2017?

2018 ◽  
Vol 2018 ◽  
pp. 1-7 ◽  
Author(s):  
Raúl Vozmediano-Chicharro ◽  
Blanca Madurga ◽  
Pedro Blasco
Keyword(s):  
Overactive Bladder ◽  
Adverse Events ◽  
Application Site ◽  
Overactive Bladder Syndrome ◽  
Good Tolerability ◽  
Subgroup Analyses ◽  
Voiding Diary ◽  
Previously Treated ◽  
Clinical Records

Objectives. Evaluation of changes in symptoms among patients with overactive bladder syndrome treated with transdermal oxybutynin and tolerability after 12 months of follow-up. Methods. This was a multicenter, retrospective, single-cohort, observational study. Changes in symptoms were evaluated primarily with a 3-day voiding diary. Results were compared to baseline. Subgroup analyses were performed in patients previously treated for OAB or not and aged < 65 years versus ≥65 years. Results. Clinical records of 105 patients were examined; 92.4% were women. At 12 months, 58 patients continued to receive transdermal oxybutynin. Changes in symptoms according to the voiding diary were evaluated in 47 patients. Significant improvements from baseline were observed in urinary frequency (−2.6 voids/24 hours (95% CI: −3.5; −1.8), p<0.001); daily number of urgent episodes (−4.7 episodes/day (95% CI: −6.1; −3.6), p<0.001); and urge incontinence (−1.9 episodes/day (95% CI: −2.9; −1.3), p<0.001). No statistically significant differences were found in subgroup analyses. In total, 38.1% of patients had adverse events, primarily in the application site (27.6%). No severe systemic adverse events occurred. Only 6 patients (5.7%) reported dry mouth. Conclusions. Improved symptoms and good tolerability observed after 1 year of treatment with transdermal oxybutynin shows that it currently has a place in the treatment of OAB patients.

scholarly journals RNAi inhibition of angiopoietin-like protein 3 (ANGPTL3) with ARO-ANG3 mimics the lipid and lipoprotein profile of familial combined hypolipidemia

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
G.F Watts ◽  
C Schwabe ◽  
R Scott ◽  
P Gladding ◽  
D Sullivan ◽  
...  
Keyword(s):  
Adverse Events ◽  
Dose Response ◽  
Minimal Change ◽  
Funding Source ◽  
Private Company ◽  
Good Tolerability ◽  
Duration Of Action ◽  
Mixed Dyslipidemia ◽  
Genetic Deficiency

Abstract Background Elevated LDL-C and triglyceride rich lipoproteins (TRLs) are independent risk factors for cardiovascular disease (CVD). Genetic deficiency of angiopoietin-like protein 3 (ANGPTL3) is associated with reduced circulating levels of LDL-C, triglycerides (TGs), VLDL-C, HDL-C and reduced CVD risk, with no described adverse phenotype. ARO-ANG3 is a RNA interference drug designed to silence expression of ANGPTL3. Single doses of ARO-ANG3 have been shown to reduce ANGPTL3, TGs, VLDL-C and LDL-C in healthy volunteers (HVs, AHA 2019). We report the effects of multiple doses of ARO-ANG3 in HVs with a focus on the duration of action. Methods ARO-ANG3 was administered subcutaneously to HVs on days 1 and 29 at doses of 100, 200 or 300 mg (n=4 per group). Measured parameters included ANGPTL3, LDL-C, TGs, VLDL-C and HDL-C. Follow up is ongoing. Results All HVs have received both doses and follow-up is currently through week 16 (12 weeks after second dose). Mean nadir for ANGPTL3 levels occurred 2 weeks after the second dose (−83–93%) with minimal change for 200 and 300 mg but 16% recovery for 100 mg at week 16. Mean TGs and VLDL-C reached nadir earlier (3 wks, −61–65%) without apparent dose response and minimal change for any dose at wk 16. LDL-C nadir occurred 4–6 wks after the second dose (−45–54%), again with minimal evidence for dose response or change through wk 16. HDL-C was reduced 14–37% at wk 16. ARO-ANG3 was well tolerated without serious or severe adverse events or dropouts related to drug. The most common adverse events have been headache and upper respiratory infections. Conclusions Genetic deficiency of ANGPTL3 is a cause of familial combined hypolipemia and is associated with a decreased risk of CVD. Using RNAi to selectively suppress ANGPTL3 production reproduces these genetic effects with a duration of at least 12 weeks following a second dose and with good tolerability over 16 wks. ANGPTL3 inhibition results in lowering of LDL-C and TRLs which may confer protection against CVD in patients with atherogenic mixed dyslipidemia. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Arrowhead Pharmaceuticals

P0446OUTCOMES OF CYCLOPHOSPHAMIDE FOR ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODIES-ASSOCIATED VASCULITIS: DIFFERENT PROTOCOLS, SINGLE-CENTER EXPERIENCE AND LITERATURE REVIEW

2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
José Agapito Fonseca ◽  
Inês Duarte ◽  
Joana Gameiro ◽  
Cristina Outerelo ◽  
Estela Nogueira ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Renal Replacement Therapy ◽  
Adverse Events ◽  
Replacement Therapy ◽  
Alveolar Hemorrhage ◽  
Single Center ◽  
Single Center Experience ◽  
Severe Infections ◽  
Clinical Records

Abstract Background and Aims Cyclophosphamide (CYC), associated with corticosteroids has been considered the mainstay of treatment for severe antineutrophil cytoplasmic antibody−associated vasculitis (AAV) for decades. This protocol is effective in 70-90% of patients resulting in drastic improvement in both renal and patient survival. Nevertheless, cyclophosphamide is associated with significant rates of adverse events, namely severe infections and malignancies. The authors present the single-center experience of the use of CYC for AAV treatment regarding clinical presentation, immunosuppression protocol, outcomes and adverse events, as well as a comparison with the main RCTs and studies using CYC for induction of remission of AAV. Method Retrospective analysis of clinical records of patients with AAV diagnosis (de novo or relapse) treated with CYC in the ward of the Nephrology Department of Centro Hospitalar Universitário Lisboa Norte between January 2006 and December 2019. Results Thirty patients with AAV diagnosis treated with CYC for induction of remission were identified. Average age was 69.4 ± 11.5 years. On admission, serum creatinine (SCr) was 5.03 mg/dL ± 2.24 mg/dL (eGFR 13.3 mL/min/1.73 m2 ± 11.1 mL/min/1.73 m2). Twenty patients (67%) required renal replacement therapy at admission and 12 (40%) had alveolar hemorrhage. The average Birmingham Vasculitis Activity Score (BVAS) was 27.5 ± 11.5. Immunosuppressive regimens varied considerably, as they were left to the clinician's consideration. Intravenous methylprednisolone pulses were performed in 29 (96.7%) patients, with total dose ranging from 1000 mg to 5000 mg. Cyclophosphamide was also prescribed at clinician’s choice, with only one patient receiving oral CYC and 29 patients receiving from 1 to 11 pulses in different doses. Plasma exchange was performed in 12 (40%) patients due to alveolar hemorrhage and/or rapidly progressive renal insufficiency. After induction of remission, twenty patients received maintenance therapy. On a 12-month follow-up, 9 (30%) patients were on renal replacement therapy and, in the remaining patients, mean SCr was 2.23 ± 0.98 mg/dL (eGFR 33.4 mL/min/1.73 m2 ± 19.8 mL/min/1.73m2). Fifteen (50%) patients experienced severe infection at 6 months, 3 (10.7%) patients developed malignancies and 7 (23.3%) patients died on a 12-month follow-up. Conclusion Our cohort of patients treated with CYC is unlike the population that underwent clinical trials. In our cohort, SCr at presentation was considerably higher, being only comparable to MEPEX and the control arm of RITUXVAS. The BVAS score of our patients was also significantly superior than all other studies. Furthermore, most clinical trials do not include patients with alveolar hemorrhage, present in 40% of the patients in our study, nor RRT requirement, present in 67% of our patients. The higher rate of severe infections and mortality registered in our cohort reflects the severity of the disease at presentation, but also highlights the importance of modifying immunosuppression to the population and the need for future regimens which can reduce the rate of adverse effects.

Implant-Driven Tibial Nerve Stimulation in the Treatment of Refractory Overactive Bladder Syndrome: 12-Month Follow-up

2006 ◽  
Vol 9 (2) ◽  
pp. 163-171 ◽  
Author(s):  
Floor van der Pal ◽  
Michael R. van Balken ◽  
John P. F. A. Heesakkers ◽  
Frans M. J. Debruyne ◽  
Bart L. H. Bemelmans
Keyword(s):  
Overactive Bladder ◽  
Nerve Stimulation ◽  
Tibial Nerve ◽  
Overactive Bladder Syndrome ◽  
Tibial Nerve Stimulation

Envafolimab (KN035) in advanced tumors with mismatch-repair deficiency.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 3021-3021
Author(s):  
Lin Shen ◽  
Jian Li ◽  
Yanhong Deng ◽  
Weijie Zhang ◽  
Aiping Zhou ◽  
...  
Keyword(s):  
Adverse Events ◽  
Mismatch Repair ◽  
Objective Response Rate ◽  
Interim Analysis ◽  
Response Rate ◽  
Objective Response ◽  
Open Label ◽  
Prior Therapy ◽  
Previously Treated

3021 Background: KN035 is a novel fusion protein of humanized anti-PD-L1 single domain antibody and human IgG1 Fc formulated for subcutaneous injection. This open-label phase II study evaluated the safety and antitumor activity of KN035 in patients with advanced microsatellite instability-high/mismatch repair-deficient (MSI-H/dMMR) cancer. Methods: The study included patients aged ≥18 years with previously treated MSI-H/dMMR colorectal cancer (CRC) or other advanced solid tumors. MSI-H/dMMR status was assessed centrally for CRC and gastric cancer (GC) and locally for other tumors. KN035 was administered at 150 mg once weekly until progression, unacceptable toxicity, or withdrawal. Tumor assessments were every 8 weeks. The primary endpoint was the objective response rate per RECIST v1.1 by independent radiology review. The primary efficacy population (PEP) included patients with CRC who failed fluoropyrimidine (F), oxaliplatin (O), and irinotecan (I) plus those with advanced GC who had failed at least one prior systemic treatment. This was a planned interim analysis performed after the first 50 patients in the PEP had at least two on-study tumor assessments (PEPi). Results: As of December 17, 2019, 103 patients with MSI-H/dMMR advanced cancers were enrolled at 25 centers in China. The PEPi included 39 patients with CRC and 11 with GC, with a median follow-up of 7.5 months. The overall population included 65 patients with CRC (24 had prior therapy with F and O or I), 18 with GC, and 20 with other tumors, with a median follow-up of 6.7 months. The confirmed objective response rate was 30% (95% CI: 17.9%, 44.6%) in the PEPi, 54.2% (95% CI: 32.8%, 74.4%) in the CRC patients who had prior therapy with F and O or I, and 34.0% (95% CI: 24.9%, 44.0%) in the overall population. Of patients who had an objective response at the interim analysis, 80% of those in the PEPi, 84.6% of CRC patients who had prior therapy with F and O or I, and 85.7% of those in the overall population were still responding at the time of data cutoff. Median progression-free survival was 6.6 months in both the PEPi and the overall population. Median overall survival was not reached in either population. Fourteen (13.6%) patients had grade 3–4 treatment-related adverse events. No grade 5 treatment-related adverse events, pneumonitis, or colitis were reported. Local injection-site reactions, all grade 1 or 2, were reported in nine patients. Conclusions: Envafolimab demonstrated durable anti-tumor activity with a manageable safety profile in patients with previously treated advanced MSI-H/dMMR cancer. Clinical trial information: NCT03667170 .

scholarly journals The effectiveness of combined topical product with fluocortolone pivalate and lidocaine for hemorrhoids: results of a multicenter observational study

2021 ◽  
Vol 20 (4) ◽  
pp. 70-86
Author(s):  
I. V. Kostarev ◽  
M. A. Agapov ◽  
V. S. Groshilin ◽  
L. G. Dvaladze ◽  
D. A. Tvorogov ◽  
...  
Keyword(s):  
Adverse Events ◽  
Initial Data ◽  
Lifestyle Changes ◽  
Good Tolerability ◽  
Multicenter Observational Study ◽  
Topical Product ◽  
Days Of Therapy ◽  
Patient Questionnaires ◽  
Almost All

AIM: to assess the changes in hemorrhoids symptoms and satisfaction with treatment against the background of treatment with a combined topical product Relief® Pro.PATIENTS AND METHODS: multicenter prospective non-interventional cohort study was done in 13 clinical centers in Russia. The study included patients aged 18 to 65 years with acute hemorrhoids of stages 1–2 treated with the combined product Relief® Pro (rectal suppositories, cream or a combination thereof). The follow-up period was up to 14 days (in the case of 2 visits to the clinical center after receiving the initial data). The analysis was performed on the basis of data obtained at Visit 2 (5–7 days of therapy) and Visit 3 (10–14 days of therapy) vs the initial data (Visit 1). Following criteria were used: the severity of hemorrhoid symptoms on the Sodergren scale, the severity of hemorrhoid symptoms (pain, bleeding, itching, edema, the presence of discharge, a feeling of discomfort), the size of the largest hemorrhoid node, the satisfaction of the doctor and the patient with treatment, assessment of the patient’s adherence to recommendations for lifestyle changes and treatment, evaluation of the use of the drug Relief® were evaluated as endpoints About the treatment process and patient preferences regarding the dosage form of the prescribed drug. In addition, adverse events were evaluated.RESULTS: the study included 1000 patients aged 18 to 65 years (men — 54.5%, women — 45.5%) Patients had grade 1 acute hemorrhoids (330 patients), grade 2 acute hemorrhoids (345 patients) and exacerbation of chronic hemorrhoids (325 patients). The drug Relief® Pro rectal cream was used by 333 patients; suppositories — 383 patients; joint therapy with both dosage forms — 284 patients. During follow-up (visits 2 and 3), positive dynamics was observed in patients — a decrease in the severity of hemorrhoid symptoms both during objective examination and according to patient questionnaires. So, according to the patients’ estimates, the use of Relief® Pro, regardless of the form, led to a decrease in the severity or disappearance of the main symptoms of hemorrhoids — bleeding, itching, edema, the presence of discharge, discomfort already by Visit 2 and in almost all patients by the end of observation. A similar change of the symptoms due the digital examination: by day 5–7, the severity of edema and bleeding in the perianal region, bleeding decreased. About 96% of patients and about 97% of doctors were satisfied with the treatment. Application of both forms of Relief® The ABM was characterized by good tolerability: there were no adverse events associated, according to the researcher, with the studied drug.CONCLUSIONS: combined topical product Relief® Pro is effective for hemorrhoids.

Urgent-SQ implant in treatment of overactive bladder syndrome: 9-year follow-up study

2012 ◽  
Vol 32 (5) ◽  
pp. 472-475 ◽  
Author(s):  
Dick A. Janssen ◽  
Fawzy Farag ◽  
John P. Heesakkers
Keyword(s):  
Overactive Bladder ◽  
Overactive Bladder Syndrome ◽  
Follow Up Study
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