Efficacy and safety of Pidotimod in childhood wheezing: a pilot study

Background: There is a growing need for effective therapies for the management of wheezing in the pediatric population. Aim: We conducted a pilot, mono-centre, prospective, follow-up study to assess the efficacy and the safety of Pidotimod (PDT) in the treatment of wheezing in children. Methods: Globally, 90 children (M:F=58:62, mean age 4.7±1.64 years) with recurrent viral wheezing were enrolled in the study between October-November 2018. At baseline, children received treatment with PDT as 1 vial of 400mg daily for 3 consecutive months. We evaluated the therapeutic efficacy of PDT treatment at the end of 3 (T3) months of therapy as well as the long efficacy and preventive efficacy of PDT treatment during a 3-months follow-up (T6) by using the following outcomes: (i) How many patients showed one or more episodes of viral wheezing? (ii) How many patients were taking concomitant medications (ICS, SABA, antibiotics)? (iii) How many patients required ED visits? (iv) How many patients required hospitalization? Results: A significant decrease in the number of patients with at least one or more episodes of wheezing and taking antibiotics was recorded after 3 months of treatment, and a further significant decrease for both outcomes was reported at 3-months follow-up period (p<0.05). Differently, after 3 months of treatment, we found a significant decrease in the number of patients taking ICS and SABA and in the number of patients requiring ED visits and/or hospitalization (p<0.05); however, for all these outcomes, no further significant decrease was reported at follow-up period. Conclusion: We first showed that the administration of PDT is useful in the management of patients with recurrent viral wheezing because we found a reduction in the number of patients requiring ED visits and/or hospitalization as well as the number of patients taking drugs during the treatment period. Moreover, to date, we found a long-term clinical effect over three months after treatment suspension counteracting the recurrence of the disease.

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Efficacy and Safety of Pidotimod in Childhood Wheezing: A Pilot Study

10.21203/rs.3.rs-89996/v1 ◽

2020 ◽

Author(s):

Sara Manti ◽

Giuseppe Fabio Parisi ◽

Maria Papale ◽

Federico Mollica ◽

Andrea Giugno ◽

...

Keyword(s):

Clinical Effect ◽

Pediatric Population ◽

Efficacy And Safety ◽

Follow Up Study ◽

Number Of Patients ◽

Preventive Efficacy ◽

Ed Visits ◽

Concomitant Medications

Abstract Background. Effective therapies for the management of wheezing in pediatric population are needed. We conducted a pilot, mono-centre, prospective, follow-up study to assess the efficacy and the safety of Pidotimod (PDT) in the treatment of wheezing in children. Methods. Globally, 90 children (M:F=58:62, mean age 4.7±1.64 years) with recurrent viral wheezing were enrolled in the study between October-November 2018. At baseline, children were receiving treatment with PDT as 1 vial of 400mg daily for 3 consecutive months. We evaluated the therapeutic efficacy of PDT treatment at the end of 3 (T3) months of therapy as well as the long efficacy and preventive efficacy of PDT treatment during a 3-months follow-up (T6) by using the following outcomes: (i) how many patients showed one or more episodes of viral wheezing, (ii) how many patients were taking concomitant medications (ICS, SABA, antibiotics), (iii) how many patients were requiring ED visits, and (iv) how many patients were requiring hospitalization.Results. A significant decrease in number of patients with at least one or more episodes of wheezing and taking antibiotics was recorded after 3 months of treatment, and a further significant decrease for both outcomes was reported at 3-months follow-up period (p<0.05). Differently, after 3 months of treatment, we found a significant decrease in number of patients taking ICS and SABA, in number of patients requiring ED visits and/or hospitalization (p<0.05); however, for all these outcomes no further significant decrease was reported at follow-up period. Conclusions. We firstly showed that administration of PDT is useful in the management of patients with recurrent viral wheezing because we found a reducing a number of patients requiring ED visits and/or hospitalization as well as number of patients taking drugs during the treatment period. Moreover, firstly to date, we found a long-term clinical effect over three months after treatment suspension counteracting the recurrence of disease.

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Levetiracetam: a long-term follow-up study of efficacy and safety

Acta Neurologica Scandinavica ◽

10.1111/j.1600-0404.2006.00657.x ◽

2006 ◽

Vol 114 (3) ◽

pp. 169-176 ◽

Cited By ~ 36

Author(s):

J. Bauer ◽

E. Ben-Menachem ◽

G. Kramer ◽

W. Fryze ◽

S. Da Silva ◽

...

Keyword(s):

Efficacy And Safety ◽

Follow Up Study ◽

Long Term Follow Up

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Long-term follow-up study to evaluate the efficacy and safety of the doxazosin gastrointestinal therapeutic system in patients with benign prostatic hyperplasia with or without concomitant hypertension

BJU International ◽

10.1111/j.1464-410x.2006.05858.x ◽

2006 ◽

Vol 97 (1) ◽

pp. 90-95 ◽

Cited By ~ 9

Author(s):

Byung Ha Chung ◽

Sung Joon Hong

Keyword(s):

Benign Prostatic Hyperplasia ◽

Prostatic Hyperplasia ◽

Efficacy And Safety ◽

Therapeutic System ◽

Follow Up Study ◽

Gastrointestinal Therapeutic System ◽

Long Term Follow Up ◽

Concomitant Hypertension

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Efficacy and safety of preoperative 5-fluorouracil, cisplatin, and mitomycin C in combination with radiotherapy in patients with resectable and borderline resectable pancreatic cancer: a long-term follow-up study

World Journal of Surgical Oncology ◽

10.1186/s12957-019-1687-4 ◽

2019 ◽

Vol 17 (1) ◽

Cited By ~ 5

Author(s):

Yutaka Endo ◽

Minoru Kitago ◽

Koichi Aiura ◽

Masahiro Shinoda ◽

Hiroshi Yagi ◽

...

Keyword(s):

Pancreatic Cancer ◽

Mitomycin C ◽

Efficacy And Safety ◽

Resectable Pancreatic Cancer ◽

Borderline Resectable ◽

Borderline Resectable Pancreatic Cancer ◽

Follow Up Study ◽

Long Term Follow Up

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152 A Long-Term Follow-Up Study of the Efficacy and Safety of Fecal Microbiota Transplant (FMT) for Recurrent/Severe/Complicated C. difficile Infection (CDI) in the Elderly

Gastroenterology ◽

10.1016/s0016-5085(14)60147-5 ◽

2014 ◽

Vol 146 (5) ◽

pp. S-42-S-43 ◽

Cited By ~ 4

Author(s):

Manasi Agrawal ◽

Olga C. Aroniadis ◽

Lawrence J. Brandt ◽

Colleen Kelly ◽

Sarah Freeman ◽

...

Keyword(s):

The Elderly ◽

Fecal Microbiota ◽

Efficacy And Safety ◽

Fecal Microbiota Transplant ◽

Follow Up Study ◽

Long Term Follow Up

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Efficacy and safety of fractionated conformal radiation therapy in acromegaly: a long-term follow-up study

Endocrine ◽

10.1007/s12020-019-01955-4 ◽

2019 ◽

Vol 65 (2) ◽

pp. 386-392 ◽

Cited By ~ 1

Author(s):

Baldomero Gonzales-Virla ◽

Guadalupe Vargas-Ortega ◽

Karen-Belen Martínez-Vázquez ◽

Ana Laura Espinosa de lo Monteros ◽

Ernesto Sosa-Erosa ◽

...

Keyword(s):

Radiation Therapy ◽

Efficacy And Safety ◽

Conformal Radiation Therapy ◽

Follow Up Study ◽

Long Term Follow Up

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Efficacy and Safety of Daflon® in the Treatment of Idiopathic Epistaxis

American Journal of Rhinology and Allergy ◽

10.1177/1945892418809237 ◽

2018 ◽

Vol 33 (1) ◽

pp. 62-68 ◽

Cited By ~ 3

Author(s):

Tamer M. Attia

Keyword(s):

Emergency Room ◽

Study Groups ◽

Control Group ◽

Efficacy And Safety ◽

Open Label ◽

Vascular Effects ◽

Number Of Patients ◽

Idiopathic Epistaxis

Background Epistaxis is a very common ENT emergency with the idiopathic variety being the commonest type. Daflon® is a mixture of flavonoids with beneficial vascular effects that may help in the treatment of epistaxis. Objective To assess the efficacy and safety of Daflon® in the treatment of idiopathic epistaxis. Methods This is an open-label randomized clinical trial conducted on patients with idiopathic epistaxis comparing 1 group receiving Daflon® for 1 month and a second group receiving Daflon® for 3 months with a control group receiving nothing. The groups were evaluated regarding the number of visits to an emergency room and the number of patients needing cautery as indicators for the control of epistaxis. Also, the severity of epistaxis was assessed using epistaxis severity score (ESS) before and after treatment. We followed the patients for 1 year to determine the long-term effect of both drug protocols. Results The study included 450 patients distributed equally among the 3 study groups. The administration of Daflon® whether for 1 month or 3 months resulted in a significant improvement in our indicators for control of epistaxis including the number of patients visiting an emergency room and those needing cauterization after the failure of light nasal packing when compared with control group. Also, the severity of epistaxis as defined by the ESS was significantly less at the end of each treatment period and at 1-year follow-up when compared with the pretreatment severity. However, the use of Daflon® for 3 months was associated with a significantly more epistaxis control at 1-year follow-up when compared with the 1-month administration. Conclusion Daflon® is a very effective and safe method for controlling idiopathic epistaxis. However, the daily use of Daflon® for 3 months has a more significant long-term beneficial effect than 1 month of use.

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