Dataset Information

Effectiveness and safety of dexamphetamine sulfate (Attentin^®) in the routine treatment of children and adolescents with ADHD: results from a 12-month non-interventional study.

ABSTRACT:

Background

Randomized controlled trials have shown that dexamphetamine sulfate (DEX) is efficacious in the treatment of attention-deficit/hyperactivity disorder (ADHD) in children and adolescents; however, data on the effectiveness and safety of DEX in routine practice are scarce.

Objective

This study investigated the long-term effectiveness and safety of Attentin^® (immediate-release DEX) in children and adolescents with ADHD in routine practice.

Methods

ATTENTION was a multicenter, prospective, observational, non-interventional study that enrolled pediatric patients with ADHD (aged 6-17 years) with a clinically inadequate response to previous methylphenidate (MPH) treatment. Patients were assessed at baseline and two follow-up visits after approx. 6 and 12 months of DEX treatment. The primary endpoint was the investigator-rated ADHD rating scale IV (ADHD-RS-IV) total score change from baseline to the first follow-up visit.

Results

The study enrolled 140 patients (mean age: 11.2 years). Significant reductions in ADHD-RS-IV total scores were observed in the titration phase and were maintained up to the second follow-up visit. The mean ADHD-RS-IV total score change from baseline to the first follow-up visit was -11.9 (27.1 vs. 13.4, p < .001). Beneficial effects of DEX were observed on both ADHD-RS-IV subscales ('hyperactivity/impulsivity' and 'inattention') and in both children and adolescents. Clinical response, defined as a reduction in the ADHD-RS-IV total score of at least 30% at the first follow-up visit, was observed in 78.1% of patients. Patients reported an average onset of action of 36.2 minutes and an average duration of action of 6.5 hours after intake of the first dose of DEX in the morning. DEX was well tolerated. Small significant increases in mean systolic and diastolic blood pressure compared to baseline were observed.

Conclusions

Attentin^® is an effective and well-tolerated long-term treatment for pediatric ADHD patients with a clinically inadequate response to previous MPH treatment.

SUBMITTER: Uebel-von Sandersleben H

PROVIDER: S-EPMC8077785 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:BackgroundSelection of the most appropriate device for a switch from one inhaler to an equivalent product is known to have a major impact on clinical outcomes in patients with asthma or chronic obstructive pulmonary disease (COPD). Salmeterol/fluticasone propionate (S/F) Easyhaler® has been demonstrated to be therapeutically equivalent with a reference product. However, no data on real-life effectiveness are currently available for patients switching to S/F Easyhaler from another S/F inhaler.MethodsThe aim of this prospective, open, multicenter, non-interventional study was to assess clinical effectiveness of propionate S/F Easyhaler in adult asthma and COPD patients switched from another inhaler. The primary endpoints were Asthma Control Test (ACT) and COPD Assessment Test (CAT). Secondary endpoints included assessments of patient satisfaction and preference and physician/nurse perception on S/F Easyhaler use. The study included three visits during a 12-week follow-up.ResultsA total of 211 patients (160 with asthma; 51 with COPD) were included in the analyses. In patients with asthma, there was a statistically significant increase in the mean ACT score at week 12 (20.2 ± 3.9) compared with the baseline (18.6 ± 4.1), with a mean increase of 1.6 (±3.5) points (p < 0.0001). In patients with COPD, CAT score persisted from baseline (19.9 ± 8.6) to week 12 (19.6 ± 7.0). Patients were significantly more satisfied with Easyhaler and most patients preferred Easyhaler over their previous inhaler. The physicians/nurses reported that it was 'very easy' to teach the use of Easyhaler and the training took less than 5 minutes in most cases.ConclusionThe results from this prospective real-life clinical study indicate better or at least similar treatment control of asthma and COPD after switching to S/F Easyhaler from another S/F inhaler. This study also shows that S/F Easyhaler was favored by the patients and that it is easy to teach, learn and use in a real-life setting.The reviews of this paper are available via the supplemental material section.

Project description:The aim of this study was to analyze the difference in neointima pattern assessed by intravascular ultrasound (IVUS) between two dedicated bifurcation stents, BiOSS® Expert and BiOSS® LIM at 12-month follow-up. This manuscript reports IVUS findings obtained from the analysis of patients enrolled into first-in-man registries initially assessing the BiOSS Expert® (paclitaxel) and BiOSS LIM® (sirolimus) stents. Quantitative angiographic analysis was performed pre, post-stenting, and at follow-up. IVUS examination was performed at 12 months. There were analyzed 34 cases (BiOSS Expert® 11 patients, BiOSS LIM® 23 patients). Procedural characteristics in the two groups were similar, except for rates of main vessel predilatation and FKB/POT, which were higher in BiOSS® LIM group, 54.5?% vs 73.9?% (P?<?0.05) and 0?% vs 39.1?% (P?<?0.05), respectively. When comparing late lumen loss (LLL) for both stents there were significantly bigger values for main vessel and main branch in the BiOSS® Expert group, but not in side branch. Intravascular ultrasound examination showed that in the BiOSS LIM® group comparing with the BiOSS Expert® group there was lower neointima burden in the whole stent (24.7?±?7.5?% vs 19.4?±?8.6?%, P?<?0.05) as well as in main vessel (22.8?±?5.6?% vs 16.9?±?6.1?%, P?<?0.05) and main branch (36.1?±?6.5?% vs 27.6?±?8.7?%, P?<?0.05), but not at the level of bifurcation (15.1?±?3.8?% vs 13.6?±?5.4?%, P?=?NS). In addition, we found that final kissing balloon/proximal optimization technique (FKB/POT) was associated with significantly smaller value of LLL in main vessel (0.24?±?0.09 mm vs 0.32?±?0.14 mm, P?<?0.05), which in IVUS analysis resulted in smaller neointima burden in main vessel (13.7?±?3.9?% vs 18.9?±?4.45?%, P?<?0.05) as well as at the bifurcation site (12.6?±?4.1?% vs 14.1?±?2.4?%, P?<?0.05). The obtained results suggest that neointima proliferation was the largest in main branches of both stents assessed in quantitative angiography (LLL) as well as in IVUS (neointima burden) and the neointima increase was smaller in BiOSS LIM® stents than in BiOSS Expert® stents. Moreover, the middle part of the stent seems to not to be associated with excessive neointima proliferation and more aggressive protocol of implantation with the use FKB/POT seems to decrease this process.

Project description:PurposeTo evaluate the effectiveness and safety of Selective Laser Trabeculoplasty (SLT) with the SLT mode of the VISULAS® green laser in patients with primary open-angle glaucoma (POAG).MethodsThis prospective, interventional multicenter clinical investigation included patients with POAG who either needed a treatment escalation because the individual intraocular pressure (IOP) target was not met or treatment initiation and had an IOP ≥ 17 mmHg at baseline in the study eye. The study was conducted in five research centers across Germany. Approximately 100 laser applications were delivered to 360° of the trabecular meshwork. Glaucoma medications were not modified during the 3-month follow-up to allow evaluation of the sole effect of VISULAS® green with SLT. Efficacy outcomes were postoperatively absolute and relative IOP changes at 1 and 3 months. Safety outcomes analyzed the rate of intra- and postoperative adverse events.ResultsThirty-four eyes of 34 POAG patients were included. The overall mean number of preoperative glaucoma medications was 2.2 ± 1.4 in 29 treated eyes, 5 eyes were treatment naïve. Mean baseline IOP (mmHg) was 21.0 ± 2.69 and was reduced by - 3.53 ± 3.34 [95% CI - 4.61; - 2.45] and - 3.59 ± 3.41 [95% CI - 4.64; - 2.53] at the 1- and 3-month follow-up, respectively (p < 0.0001), with 48.5% of cases achieving a ≥ 20% IOP reduction at 3 months [95% CI = 30.8%; 66.5%]. The mean relative IOP reduction was - 16.4% and - 16.3% at 1 and 3 months, respectively (p < 0.0001). Potentially device- or procedure-related adverse events were mild to moderate and included 3 postoperative IOP-spikes and 6 reports regarding eye pain and discomfort. All were resolved without sequelae.ConclusionsSLT performed with the VISULAS® green laser achieved clinically significant additional IOP reductions in medically treated as well as in treatment naïve eyes with POAG and there were no relevant safety issues. The results are comparable to other reported SLT studies.

Project description:Although guidelines for the assessment and treatment of mental disorders in childhood and adolescence have been available in Germany for several years, there are barely any data on adherence to guidelines in national routine care. Therefore, the study aimed at a nationwide evaluation of guideline adherence (GA) for the assessment and treatment of children and adolescents with attention-deficit/hyperactivity disorder (ADHD) in German routine care in various groups of health care providers (HCPs). Besides a detailed description of GA, the study focused on examining possible differences between professional groups. Furthermore, data based on global self-reports of clinicians were compared with ratings of documented care in individual patients. Protocols of 73 clinicians regarding their handling of ADHD in routine care for 167 patients were rated according to German guideline recommendations for ADHD care. GA was measured as the proportion of components fulfilled in each individual patient as documented by the HCP. The results were compared to a preceding interview with clinicians regarding their GA. Multilevel models were constructed to detect differences in GA between professional groups. Based on mandatory guideline components, adherence rates of 38.9-72.7% were found and classified as moderate (33.3% < GA ≤ 66.6%) to high (GA > 66.6%). The comparison of the GA between the professional groups generally yielded only small differences. Correlations between GA reported globally by the HCPs and GA documented and rated for individual cases were low. Overall, most rates of GA for ADHD in German routine care lay within a moderate range. Targets for enhancement of GA may be the involvement of teachers and schools in the treatment process, the implementation of psychoeducational methods in general, as well as a careful examination of patients, including monitoring of treatment effects during titration trials. The development of further strategies to monitor the quality of ADHD routine care is needed.

Project description:Persistence with and adherence to osteoporosis therapy are critical for fracture reduction. This non-interventional study is evaluating medication-taking behavior of women with postmenopausal osteoporosis (PMO) receiving denosumab in Germany, Austria, Greece, and Belgium. Patients were representative of the PMO population and highly persistent with and adherent to denosumab at 12 months.Persistence with and adherence to osteoporosis therapy are important for optimal treatment efficacy, namely fracture reduction. This ongoing, non-interventional study will evaluate medication-taking behavior of women with postmenopausal osteoporosis (PMO) receiving denosumab in routine practice in four European countries.The study enrolled women who had been prescribed subcutaneous denosumab (60 mg every 6 months) in accordance with prescribing information and local guidelines. Persistence was defined as receiving the subsequent injection within 6 months + 8 weeks of the previous injection. Adherence was defined as receiving two consecutive injections within 6 months ± 4 weeks of each other. Medication coverage ratio (MCR) was calculated using the time a patient was covered with denosumab, as assessed from prescription records. Treatment was assigned prior to and independently of enrollment; outcomes are recorded during routine practice.These planned 12-month interim analyses included data from 1500 patients from 141 sites. Mean age was 66.4-72.4 years, mean baseline total hip T-scores ranged from -2.0 to -2.1 and femoral neck T-scores from -2.2 to -2.6, and 30.7-62.1% of patients had prior osteoporotic fracture. Persistence was 87.0-95.3%, adherence 82.7-89.3%, and MCR 91.3-95.4%. In a univariate analysis, increased age, decreased mobility, and increased distance to the clinic were associated with significantly decreased persistence; parental history of hip fracture was associated with significantly increased persistence.These data extend the real-world evidence regarding persistence with and adherence to denosumab, both of which are critical for favorable clinical outcomes, including fracture risk reduction.

Project description:BackgroundThe incidence and mortality rate of men with prostate cancer have been increasing in Asia. ELIGARD® is a formulation of leuprorelin acetate whose safety and efficacy have been well-established in Western regions. However, limited safety data are available for Asian populations.MethodsELIGANT (ELIGard AsiaN sTudy) was a Phase 4, multicenter, prospective, single-arm, interventional study. Men with locally advanced or metastatic prostate cancer without concomitant chemotherapy, or another androgen receptor pathway inhibitor, were enrolled across Asia to receive ELIGARD® (22.5 mg subcutaneous depot injection) every 3 months for 15 months, with a follow-up visit at 18 months. The primary objective was to establish the safety of ELIGARD® in Asian men with hormone-dependent prostate cancer. The secondary objectives were to assess efficacy, via prostate-specific antigen (PSA) progression and testosterone levels, and health-related quality of life (HRQoL).ResultsIn total, 106 patients were included in the safety analysis set (SAF). The most common treatment-emergent adverse events (TEAEs) included PSA increase, cough, back pain, hot flush, anemia, and upper respiratory tract infection. TEAEs considered related to ELIGARD® were reported in 13.2% of patients (n=14), two of which were serious. In the full analysis set (FAS) (n=105), 81.2% (n=56) and 68.5% (n=61) of patients achieved a PSA reduction of ≥90% from baseline at 12 and 18 months, respectively. At 18 months, the numbers of patients with testosterone levels <20, 20-50, and >50 ng/dL were 65 (61.9%), 17 (16.2%), and two (1.9%), respectively; 20% had missing testosterone measurements. HRQoL remained stable throughout the study with minimal change from baseline at study completion.ConclusionsIn conclusion, the safety profile of ELIGARD® (22.5 mg) in Asian men with hormone-dependent prostate cancer is comparable to previous studies in Western regions.Trial registrationClinical trial registration number NCT03035032.

Dataset Information

Effectiveness and safety of dexamphetamine sulfate (Attentin^®) in the routine treatment of children and adolescents with ADHD: results from a 12-month non-interventional study.

Background

Objective

Methods

Results

Conclusions

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets

Dataset Information

Effectiveness and safety of dexamphetamine sulfate (Attentin®) in the routine treatment of children and adolescents with ADHD: results from a 12-month non-interventional study.

Background

Objective

Methods

Results

Conclusions

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets

Effectiveness and safety of dexamphetamine sulfate (Attentin^®) in the routine treatment of children and adolescents with ADHD: results from a 12-month non-interventional study.