scholarly journals The global Edoxaban Treatment in routine cliNical prActice (ETNA) noninterventional study program: rationale and design

2019 ◽  
Vol 42 (12) ◽  
pp. 1147-1154 ◽  
Author(s):  
Raffaele De Caterina ◽  
Giancarlo Agnelli ◽  
Petra Laeis ◽  
Martin Unverdorben ◽  
Heiko Rauer ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Routine Clinical Practice ◽  
Study Program ◽  
Noninterventional Study

scholarly journals A Multicenter, Prospective, Noninterventional Study in a Norwegian Cohort of Patients with Moderate-to-Severe Allergic Rhinitis Treated with MP-AzeFlu

2017 ◽  
Vol 8 (3) ◽  
pp. ar.2017.8.0216 ◽  
Author(s):  
Ralph Dollner ◽  
Petter Lorentz Larsen ◽  
Sinan Dheyauldeen ◽  
Sverre Steinsvåg
Keyword(s):  
Allergic Rhinitis ◽  
Clinical Practice ◽  
Disease Control ◽  
Symptom Severity ◽  
Symptom Control ◽  
Real Life ◽  
Routine Clinical Practice ◽  
Vas Score ◽  
Receive Treatment ◽  
Noninterventional Study

Background Allergic Rhinitis and its Impact on Asthma guidelines recently recommended a treatment strategy for allergic rhinitis (AR) based on disease control rather than symptom severity by using a visual analog scale (VAS) to categorize control Objectives To evaluate the effectiveness of MP-AzeFlu (Dymista®) by using this VAS in routine clinical practice in Norway. MP-AzeFlu comprises a novel formulation that contains azelastine hydrochloride, fluticasone propionate and excipients delivered in a single spray. Methods This multicenter, prospective, noninterventional study enrolled patients (n = 160) with moderate-to-severe AR and acute symptoms who were eligible to receive treatment with MP-AzeFlu according to its summary of product characteristics. Patients assessed symptom severity by using a VAS from 0 (not at all bothersome) to 100 mm (very bothersome) in the morning before MP-AzeFlu use on days 0, 1, 3, 7, and after ~14 days. On day 3, the patients assessed their level of disease control as well controlled, partly controlled, or uncontrolled. The proportion of Norwegian patients who achieved defined VAS score cutoffs for “well-controlled” and “partly controlled” AR were also calculated. Results MP-AzeFlu reduced the mean ± standard deviation VAS score from 68.1 ± 16.4 mm at baseline to 37.4 ± 25.9 mm on the last day, a reduction of 30.8 ± 27.2 mm. The results were consistent, irrespective of disease severity, phenotype (i.e., seasonal AR [SAR], perennial AR [PAR], SAR plus PAR, unknown) or age (i.e., 12–17, 18–65, and >65 years). Of the patients (with recorded data), 88.1% considered their symptoms to be partly or well controlled at day 3; and 19.5, 32.0, 50.0, and 61.0% of the patients achieved a ≤38 mm well-controlled VAS score cutoff on days 1, 3, 7, and the last day, respectively. Conclusions MP-AzeFlu provided rapid sustained symptom control in a routine clinical practice in Norway, which provided support for its effectiveness for the treatment of AR in real life.

scholarly journals Effectiveness, durability, and safety of darunavir/ritonavir in HIV-1-infected patients in routine clinical practice in Italy: a postauthorization noninterventional study

2016 ◽  
pp. 1589
Author(s):  
Roberta Termini ◽  
Andrea Antinori ◽  
Paola Meraviglia ◽  
Antonella d'Arminio Monforte ◽  
Antonella Castagna ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Routine Clinical Practice ◽  
Noninterventional Study ◽  
Hiv 1

Efficacy and tolerability of linaclotide in the treatment of irritable bowel syndrome with constipation in a real‑world setting – results from a German noninterventional study

2018 ◽  
Vol 56 (07) ◽  
pp. 738-744 ◽  
Author(s):  
Viola Andresen ◽  
Stephan Miehlke ◽  
Elmar Beck ◽  
Gwen Wiseman ◽  
Peter Layer
Keyword(s):  
Irritable Bowel Syndrome ◽  
Abdominal Pain ◽  
Clinical Practice ◽  
Real World ◽  
Common Adverse Event ◽  
Routine Clinical Practice ◽  
Guanylate Cyclase C ◽  
Bowel Movements ◽  
Irritable Bowel ◽  
Noninterventional Study

Abstract Background Linaclotide is a minimally absorbed peptide guanylate cyclase-C agonist approved for the treatment of irritable bowel syndrome with constipation (IBS-C). This study assessed the efficacy and tolerability of linaclotide in IBS-C in routine clinical practice in Germany. Methods This was a 52-week, noninterventional study of linaclotide in patients aged ≥ 18 years with moderate to severe IBS-C. Severity of abdominal pain and bloating and frequency of bowel movements were assessed over 5 study visits. Treatment-related adverse events were recorded. Results The study enrolled 375 patients; the mean observation duration was 4.4 months. Linaclotide marketing was halted during the study period for economic reasons, accounting for low patient numbers and short observation duration. Linaclotide significantly reduced mean (standard deviation [SD]) scores between treatment start (visit 1) and study end (visit 5) for abdominal pain intensity (visit 1: 4.87 [2.63] vs. visit 5: 2.40 [2.20], p < 0.0001), mean [SD] bloating intensity (visit 1: 5.30 [2.70] vs. visit 5: 2.86 [2.34], p < 0.0001), and increased mean [SD] bowel movement frequency (visit 1: 2.71 [1.80] vs. 4.38 [1.86], p < 0.0001). Diarrhea, occurring in 5.1 % of patients, was the most common adverse event. Conclusion Linaclotide is effective in improving the major symptoms of IBS-C and demonstrates a favorable safety profile in the real-world environment of routine clinical practice. DRKS (www.drks.de/): DRKS00005088.

Prospective, noninterventional study of vinflunine treatment in advanced urothelial cell carcinoma (UCC) in routine clinical practice.

2014 ◽  
Vol 32 (15_suppl) ◽  
pp. e15505-e15505
Author(s):  
Margitta Retz ◽  
Patrick De Geeter ◽  
Peter J. Goebell ◽  
Ullrich Matz ◽  
Wito de Schultz ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Cell Carcinoma ◽  
Routine Clinical Practice ◽  
Urothelial Cell ◽  
Urothelial Cell Carcinoma ◽  
Noninterventional Study

Diagnosis and Management of Cardiomyopathies – A Focus on Genetics, Cardiac Magnetic Resonance and Clinical Features

2011 ◽  
Vol 7 (3) ◽  
pp. 225
Author(s):  
Gianfranco Sinagra ◽  
Michele Moretti ◽  
Giancarlo Vitrella ◽  
Marco Merlo ◽  
Rossana Bussani ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Cardiac Magnetic Resonance ◽  
Magnetic Resonance ◽  
Imaging Techniques ◽  
Molecular Genetic ◽  
Molecular Genetic Analysis ◽  
Routine Clinical Practice ◽  
Clinical Approach ◽  
Diagnosis And Management ◽  
Made In

In recent years, outstanding progress has been made in the diagnosis and treatment of cardiomyopathies. Genetics is emerging as a primary point in the diagnosis and management of these diseases. However, molecular genetic analyses are not yet included in routine clinical practice, mainly because of their elevated costs and execution time. A patient-based and patient-oriented clinical approach, coupled with new imaging techniques such as cardiac magnetic resonance, can be of great help in selecting patients for molecular genetic analysis and is crucial for a better characterisation of these diseases. This article will specifically address clinical, magnetic resonance and genetic aspects of the diagnosis and management of cardiomyopathies.

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