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 ◽  
...  
2017 ◽  
Vol 8 (3) ◽  
pp. ar.2017.8.0216 ◽  
Author(s):  
Ralph Dollner ◽  
Petter Lorentz Larsen ◽  
Sinan Dheyauldeen ◽  
Sverre Steinsvåg

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.


PLoS ONE ◽  
2015 ◽  
Vol 10 (12) ◽  
pp. e0144746 ◽  
Author(s):  
Valérie Potard ◽  
Jacques Reynes ◽  
Tristan Ferry ◽  
Céline Aubin ◽  
Laurent Finkielsztejn ◽  
...  

2014 ◽  
Vol 17 ◽  
pp. 19786 ◽  
Author(s):  
Andrea Antinori ◽  
Massimo Galli ◽  
Nicola Gianotti ◽  
Cristina Mussini ◽  
Tiziana Quirino ◽  
...  

2018 ◽  
Vol 56 (07) ◽  
pp. 738-744 ◽  
Author(s):  
Viola Andresen ◽  
Stephan Miehlke ◽  
Elmar Beck ◽  
Gwen Wiseman ◽  
Peter Layer

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.


2019 ◽  
Vol 42 (12) ◽  
pp. 1147-1154 ◽  
Author(s):  
Raffaele De Caterina ◽  
Giancarlo Agnelli ◽  
Petra Laeis ◽  
Martin Unverdorben ◽  
Heiko Rauer ◽  
...  

2014 ◽  
Vol 32 (15_suppl) ◽  
pp. e15505-e15505
Author(s):  
Margitta Retz ◽  
Patrick De Geeter ◽  
Peter J. Goebell ◽  
Ullrich Matz ◽  
Wito de Schultz ◽  
...  

2010 ◽  
Vol 15 (6) ◽  
pp. 231 ◽  
Author(s):  
S Reuter ◽  
P Braken ◽  
B Jensen ◽  
S Sierra-Aragon ◽  
M Oette ◽  
...  

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