scholarly journals Long-term use of solifenacin in pediatric patients with overactive bladder: Extension of a prospective open-label study

2014 ◽  
Vol 8 (3-4) ◽  
pp. 118 ◽  
Author(s):  
Geneviève Nadeau ◽  
Annette Schröeder ◽  
Katherine Moore ◽  
Lucie Genois ◽  
Pascale Lamontagne ◽  
...  

Introduction: We evaluate the efficacy and safety of solifenacin to treat incontinence in children with non-neurogenic (DO) or neurogenic detrusor overactivity (NDO) refractory to oxybutininor tolterodine.Methods: We updated and extended our previously published non-randomized uncontrolled study on open-label use of adjusted-dose regimens of solifenacin (1.25-10 mg) in children with refractory incontinence. The follow-up included voiding diaries, post-void residuals, urine cultures, ultrasounds and urodynamic studies. Clinical data were updated as of September 2012. Subjective improvement was assessed with the Patient Perception of Bladder Condition (PPBC) scale. The primary end point was efficacy toward continence and secondary end points were tolerability and safety.Results: Overall, 244 patients (112 girls, 132 boys) were enrolled; 53 with NDO and 191 with DO. Minimal follow-up was 5 months, the mean duration of treatment was 21.0 months and the mean age at initiation was 9.2 years. Urodynamic capacity improved from 145 ± 76 mL to 339 ± 152 mL and the amplitude of uninhibited contractions decreased from 66 ± 26 to 20 ± 20 cmH2O (p < 0.0001). The overall success rate is 91%, and more specifically 94% for non-neurogenic and 79% for neurogenic, which is significantly different (p = 0.013). Twenty-three patients discontinued treatment for unsatisfactory clinical response or bothersome side effects. No side effects were reported by 175 patients, mild by 46, moderate by 9, and 14 withdrew due to their side effects. Ten patients developed post-void residuals of ≥20 mL.Conclusion: Although higher in the non-neurogenic group, high subjective and objective success rates were maintained over a longer follow-up with an adjusted-dose regimen of solifenacin to treat pediatric NDO or DO refractory to oxybutynin or tolterodine. Moreover, we found acceptable tolerability and safety profiles. 

2014 ◽  
Vol 8 (5-6) ◽  
pp. 175 ◽  
Author(s):  
Geneviève Nadeau ◽  
Annette Schröeder ◽  
Katherine Moore ◽  
Lucie Genois ◽  
Pascale Lamontagne ◽  
...  

Introduction: In this study, we optimize pharmacotherapy in children who failed anticholinergic monotherapy by simultaneous administration of 2 anticholinergics (oxybutynin and/or tolterodine and/or solifenacin).Methods: This report is an update of our previously published study on double anticholinergic regimen in children with refractory incontinence due to neurogenic (NDO) and non-neurogenic (DO) detrusor overactivity. Patients with an insufficient response (clinically/urodynamically) to an optimized dose of a single anticholinergic (oxybutynin or tolterodine) received a second anticholinergic (tolterodine or solifenacin), in addition to the pre-existing medication. The primary end-point was efficacy (continence) and the secondary end-points were tolerability and safety. The Patient Perception of Bladder Condition (PPBC) scale was used to rate subjective improvement of patients.Results: In total, 56 patients with DO (n = 31) or NDO (n = 25) were enrolled at a mean age of 11.4 ± 3.5 years and were followed for a minimum of 3 months. The duration of double treatment was 36 ± 23 months. Our results found that 23 patients became dry, 18 improved significantly and 15 improved moderately. Urodynamic capacity improved from 158 ± 87 mL to 359 ± 148 mL and maximal pressure of contractions decreased from 76 ± 24 to 22 ± 22 cmH2O (p < 0.0001). The overall success rate was 82%, since 10 patients discontinued treatment for unsatisfactory clinical response or bothersome side effects. No side effects were reported by 28 patients, mild side effects by 20, moderate side effects by 8; 2 patients withdrew from the study due to their side effects. Of the 35 patients who voided spontaneously, 8 developed post-void residuals (>20%).Conclusions: With a larger cohort and prospective follow-up, we reiterated that double anticholinergic regimen in children with DO or NDO refractory to anticholinergic monotherapy is a feasible and efficient approach. 


2016 ◽  
Vol 65 (06) ◽  
pp. 484-490 ◽  
Author(s):  
Timo Telaranta ◽  
Tuomo Rantanen

Background Endoscopic thoracic sympathectomy (ETS) is an effective treatment for primary hyperhidrosis. However, compensatory sweating (CS) may occur in many patients. Sympathetic nerve reconstruction (SNR) can be used to counteract severe CS, but the studies on the effects of SNR are few. Patients and Methods Nineteen out of 150 SNR patients were contacted by employing a long-term questionnaire. In this questionnaire, different kinds of sweating were evaluated using a four-graded symptom analysis and the visual analog scale before ETS, after ETS, and after SNR. Results The mean age of the 16 male and 3 female patients at the SNR was 32 years. The mean follow-up was 87 months. According to the long-term questionnaire, the benefit was either excellent (4 patients, 21%), good (3 patients, 15.8%), or reasonable (7 patients, 36.8%) in 14 patients (73.8%), while the benefit was questionable in 1 patient (5.3%). For three patients (15.8%), no benefit was found, and in one patient (5.3%), the situation had deteriorated. Conclusions Improvement in the side effects of ETS after SNR was found in nearly 75% of the patients. This indicates that SNR can be considered as an alternative treatment for patients with severe CS after ETS that is unresponsive to conservative treatment.


2019 ◽  
Author(s):  
Chayma Ladhari ◽  
Pierre Le Blay ◽  
Thierry Vincent ◽  
Ahmed Larbi ◽  
Emma Rubenstein ◽  
...  

Abstract Background Strategic drug therapy for rheumatoid arthritis (RA) patients with prolonged remission is not well defined. According to recent guidelines, tapering biological Disease Modifying Anti-Rheumatic Drugs (bDMARDs) may be considered. We aimed to evaluate the long-term maintenance of tocilizumab (TCZ) treatment after the progressive tapering of infusions. Methods We conducted an exploratory, prospective, single-center, open label study, on RA patients with sustained remission for at least 3 months and treated with TCZ infusions every 4 weeks. The initial re-treatment interval was 6 weeks for the first 3 months. Thereafter, the spacing between infusions was determined by the clinician. Successful long-term maintenance following the tapering of TCZ infusions was defined by patients still treated after two years by TCZ with a minimum dosing interval of 5 weeks. Results Thirteen patients were enrolled in the study. Eight out of thirteen were still treated by TCZ after two years. Successful long-term maintenance was possible in six patients, with four patients maintaining a re-treatment interval of 8-weeks or more. We observed 5 patients with TCZ withdrawal: one for adverse drug reaction (neutropenia) and four with secondary failure. Patients achieving successful long-term maintenance with TCZ were significantly younger than those with secondary failure (p<0.05). In addition, RA patients with positive rheumatoid factor and anti-citrullinated peptide antibodies, experienced a significantly greater number of flares during our 2-year follow-up (p<0.01). Conclusions A progressive tapering of TCZ infusions seems possible in most of the patients. However, larger studies, including more patients, are needed to confirm this therapeutic option.


Author(s):  
Devendra Mishra ◽  
Girish H Patel ◽  
Rupali Gathani

<p>ABSTRACT<br />Objective: An open label study to assess the effect of colicarmin plus syrup on colic and griping pain, indigestion, nausea and vomiting in children,<br />and geriatric patients.<br />Methods: (a) A study was conducted on 75 number of patients to evaluate the effect of colicarmin plus syrup on colic and griping pain, indigestion,<br />nausea and vomiting in children, and adults, (b) mostly these children were selected from different classes of families, (c) all the patients were checked<br />on the 1<br />st<br />, 2<br />nd<br />, and 3<br />rd<br /> week after starting the therapeutic dose.<br />Dosage schedule: (a) Children: 1 Teaspoonful thrice a day after meals, (b) adults: 2 Teaspoonful twice to thrice a day after meals.<br />Results: (a) Colic and griping pain: In the total duration of treatment, no of patients recovering were 23-on 1<br />st<br /> week, 4-on 2<br /> week,<br />overall result is 93.54%, (b) indigestion: In the total duration of treatment, no of patients recovering were 26-on 1<br />st<br />nd<br /> week, and 3-on 3<br /> week, 3-on 2<br /> week, and 1-on<br />3<br />rd<br /> week, the overall result is 93.75%, (c) nausea and vomiting: In the total duration of treatment, no of patients recovering were 8-on 1<br /> week, 2-on<br />2<br />nd<br /> week, and 1-on 3<br />rd<br /> week, the overall result is 91.33%.<br />Conclusion: Based on the study, we can conclude that colicarmin plus syrup is an Ayurvedic formulation with benefits such as digestive, carminative,<br />anthelmintic, antiflatulent, antispasmodic, and devoid of side effects.<br />Keywords: Digestive, Carminative, Anthelmintic, Antiflatulent and Antispasmodic.<br />nd</p><p>st</p><p>rd</p>


Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 2561-2561
Author(s):  
Larisa Geskin ◽  
Francine Foss ◽  
Madeleine Duvic ◽  
David Straus ◽  
Steven Horwitz ◽  
...  

Abstract Background: Mycosis Fungoides (MF) and its leukemic variant Sezary syndrome (SS) are disorders of malignant, skin homing helper/memory T-cells. MF presents with patches, plaques, or tumors, while SS presents with generalized erythroderma and blood involvement. Either can involve lymph nodes, blood, and viscera. A multi-center, open label, single arm clinical trial previously demonstrated the safety and efficacy of ECP as a monotherapy in the treatment of patients with advanced/refractory MF/SS (Edelson, et al, 1987, N Engl J Med, 316:297–303). The primary endpoint of this study was a ≥25% improvement in skin score maintained for at least 4 weeks. We present a long-term, secondary analysis of these patients to further evaluate clinical outcomes and predictors of response for ECP as a monotherapy in MF/SS. Partial (≥50%) and complete (≥90%) skin score responses, extent of skin disease, number of ECP treatments administered, and the time required to achieve 50% and 90% improvement in skin involvement were evaluated. Patients and Methods: Thirty-nine patients (pts) who met eligibility criteria were included in the secondary efficacy analysis as the intent-to-treat (ITT) patient population. Thirty-one pts with generalized erythroderma (GE) and 8 pts with extensive patch plaque (EPP) were treated with ECP on 2 consecutive days every 4–5 weeks for 3 months. No concomitant systemic medications for MF/SS were allowed on study; however, topical steroids could be applied to the hands and feet. Patients had received an average of 3.7 (range 0–13) prior therapies (systemic and topical). Immediately prior to undergoing ECP, all pts received oral doses of methoxsalen in order to achieve blood level concentrations ≥50 ng/mL. Skin improvement was calculated by comparing baseline skin score to skin scores on all subsequent treatment dates. The mean baseline skin score of the 39 ITT patients was 262 (median = 291) based on a maximum possible skin score of 400 points. Results: The median follow-up of the 39 ITT pts was approximately 4 years (range 9 days–7.8 years). Twenty-nine pts (74%) achieved at least a ≥50% improvement in skin score, and 16 pts (41%) achieved ≥90% improvement on ECP monotherapy. The type and extent of skin disease (GE vs. EPP) prior to the start of treatment did not predict response. Patients received a median of 12 (range 4–65) or 30.0 (range 12–109) individual ECP treatments to achieve a ≥50% or ≥90% response, respectively. The mean times to reach a ≥50% or ≥90% response were 8.4 ± 6 months (median=6.5) or 25.2 ±14.9 mos (median=19.6), respectively. The mean duration of a ≥50% response was 32.5 ± 28.6 mos, which included a median of 20 (range 0–153) ECP treatments. Median survival from date of diagnosis and from date of first ECP treatment was 10.6 yrs and 5.4 yrs, respectively. Conclusions: In this long-term, follow-up analysis, ECP monotherapy was associated with a significant and durable improvement in skin score in the majority of patients with MF/SS.


2010 ◽  
Vol 25 (3) ◽  
pp. 289-299 ◽  
Author(s):  
Laura Cif ◽  
Xavier Vasques ◽  
Victoria Gonzalez ◽  
Patrice Ravel ◽  
Brigitte Biolsi ◽  
...  

1997 ◽  
Vol 12 (S5) ◽  
pp. 353s-355s ◽  
Author(s):  
LH Lindström ◽  
T Lundberg

SummaryControlled clinical trials have shown that the atypical neuroleptic clozapine is highly effective in schizophrenic patients who are unresponsive to conventional neuroleptic agents. The long-term outcome of clozapine treatment was studied in 122 patients who were treated between 1974 and 1991. The mean duration of treatment was 5.2 years. At follow-up, 74 patients (61%) were still receiving clozapine. Only 11 patients discontinued treatment because of adverse events and eight because of poor compliance. Clinical improvement was seen in 87% of patients; 40% had resumed employment after 2 years' treatment. About one-third of patients who received clozapine for 5–10 years continued to improve during this time; this was probably because of a continuing process of socialisation. Thus, clozapine offers important advantages in schizophrenic patients resistant to conventional neuroleptics in terms of long-term efficacy and lack of extrapyramidal side-effects.


Author(s):  
Chukwuma Okoye ◽  
Valeria Calsolaro ◽  
Filippo Niccolai ◽  
Alessia Maria Calabrese ◽  
Riccardo Franchi ◽  
...  

The aim of this single-center, open-label, non-controlled randomized study was to evaluate which formulation of vitamin D between cholecalciferol and calcifediol is most effective in the treatment of hypovitaminosis D in older adults. Demographic characteristics, clinical history and comprehensive geriatric assessment were recorded at admission. Eligible patients randomly received an equivalent vitamin D supplement either with cholecalciferol or calcifediol from hospital admission to three months after discharge. Among the 140 older patients included (mean age 83&plusmn;6.6, 57.8% females), 69 received cholecalciferol and 71 calcifediol. The mean plasma values of 25OH-Vitamin D3 found at the enrollment were 16.8 &plusmn; 9.9 ng/mL in patients receiving cholecalciferol and 18.8 &plusmn; 13.3 ng/mL in those treated with calcifediol (p =0.31). At the 3-month follow up, the mean concentration of 25OH-Vitamin D3 was significantly higher in patients treated with calcifediol than in patients treated with cholecalciferol (respectively, 30.7 &plusmn; 8.4 vs 45.4 &plusmn; 9.8 ng/mL, p &amp;lt;0.001). Supplementation with cholecalciferol or calcifediol results in both cases effective in reaching optimal circulating values of 25OH-VitaminD3 in the older patients suffering from hypovitaminosis D. However, supplementation with calcifediol led to average circulating values of 25OH- VitaminD3 significantly higher (over 50%) than those obtained with cholecalciferol.


2020 ◽  
Vol 57 (1) ◽  
pp. 1-7
Author(s):  
Lucile Giraud ◽  
Maud Girod ◽  
Laurent Cauzinille

ABSTRACT Treatment with high corticosteroid dosages for steroid-responsive meningitis-arteritis (SRMA) is correlated with severe adverse effects and worse quality of life. In order to improve immunosuppression and decrease dosage and duration of glucocorticoid treatment, a second immunosuppressive drug is commonly used in most of the immune-mediated diseases. The objective of this retrospective study was to evaluate the efficacy, tolerability, and occurrence of relapse for the combination of prednisolone and azathioprine. All dogs received azathioprine 2 mg/kg q 24 hr for 1 mo and then 2 mg/kg every other day for 2 mo; prednisolone was started at an immunosuppressive dosage and tapered off gradually during a mean of 3 mo. Twenty-six dogs met inclusion criteria. Twenty-one dogs (81%) were in clinical remission with no relapse observed within the 2 yr follow-up period. Treatment was well tolerated in all dogs and side effects were most of the time mild and self-limiting. The relapse rate (19%) was lower than most published rates. A prednisolone and azathioprine combination appeared to be effective for primary treatment of dogs with SRMA and allows a quicker tapering in prednisolone dosage, a decrease in long-term side effects of steroids, a shorter duration of treatment, and a low relapse rate.


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