PMID- 38420062
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20240301
IS  - 2168-8184 (Print)
IS  - 2168-8184 (Electronic)
IS  - 2168-8184 (Linking)
VI  - 16
IP  - 1
DP  - 2024 Jan
TI  - The Efficacy and Safety of High Dose (10 mg) of Desloratadine (Dazit(R) 10) in the 
      Treatment of Chronic Spontaneous Urticaria in India: A Phase III, Multicentric, 
      Open-Label, Single-Arm Study.
PG  - e53125
LID - 10.7759/cureus.53125 [doi]
LID - e53125
AB  - BACKGROUND: Chronic spontaneous urticaria (CSU) is a debilitating affliction that 
      affects diverse quality of life (QoL) parameters such as sleep, self-esteem, and 
      daily activities. Second-generation antihistamines, such as desloratadine, are 
      more effective and safer in managing CSU. Desloratadine is a nonsedating, potent, 
      and highly selective H1 receptor antagonist. At its daily dose of 5 mg, almost 
      half of CSU patients do not show symptomatic improvement. European Academy of 
      Allergy and Clinical Immunology (EAACI)/Global Allergy and Asthma European 
      Network (GA2LEN)/European Dermatology Forum (EDF) (EuroGuiDerm)/Asia Pacific 
      Association of Allergy, Asthma and Clinical Immunology (APAAACI) guidelines 
      recommend increasing the dosage to up to four times in such nonresponsive 
      patients. However, there is insufficient clinical evidence in Indian settings. 
      METHOD: We evaluated the efficacy and safety of 10 mg desloratadine (OD) in 256 
      nonresponsive patients with moderate to severe CSU. The primary outcome was the 
      change in Urticaria Activity Score (UAS7) from baseline to four weeks. 
      Additionally, change in Chronic Urticaria Quality of Life (CU-Q2oL) scores during 
      the course of treatment was also evaluated. RESULT: The mean UAS7 scores showed a 
      significant reduction from 31.9 +/- 4.8 at baseline to 18.2 +/- 8.1 at the end of the 
      study (p < 0.0001). The use of a higher dose of desloratadine also decreased the 
      CU-Q2oL scores significantly from 59.8 +/- 14.7 at baseline to 35.4 +/- 10 at four 
      weeks (p < 0.0001). The incidence of adverse events (AEs) possibly linked to the 
      drug was low (1.6%), and no serious adverse events were reported. CONCLUSION: 
      Results indicated improvements in the disease severity as well as its positive 
      impact on participants' QoL. This study confirms the efficacy and safety of daily 
      use of a twofold dose of desloratadine in nonresponsive moderate to severe CSU 
      patients.
CI  - Copyright (c) 2024, Kapadia et al.
FAU - Kapadia, Saurabh
AU  - Kapadia S
AD  - Department of Dermatology, Kanoria Hospital & Research Centre, Gandhinagar, IND.
FAU - Nageswaramma, Siddabathuni
AU  - Nageswaramma S
AD  - Department of Dermatology, Guntur Government General Hospital, Guntur, IND.
FAU - Shah, Keyur
AU  - Shah K
AD  - Department of Dermatology, Medilink Hospital & Research Center, Ahmedabad, IND.
FAU - Singh, Ajit
AU  - Singh A
AD  - Department of Allergy and Pulmonary Medicine, Sawai Man Singh (SMS) Hospital, 
      Jaipur, IND.
FAU - Mahajan, Satyaprakash C
AU  - Mahajan SC
AD  - Department of Dermatology, Supe Heart and Diabetes Hospital and Research Centre, 
      Nashik, IND.
FAU - Deshpande, Ajay
AU  - Deshpande A
AD  - Department of Dermatology, Oyster & Pearl Hospital, Pune, IND.
FAU - Chakraborty, Sayantani
AU  - Chakraborty S
AD  - Department of Dermatology, R. G. Kar Medical College and Hospital, Kolkata, IND.
FAU - Kar, Bikash R
AU  - Kar BR
AD  - Department of Dermatology, Institute of Medical Sciences (IMS) and SUM Hospital, 
      Bhubaneswar, IND.
FAU - Padmaja, Pinjala
AU  - Padmaja P
AD  - Department of Dermatology, Osmania General Hospital, Hyderabad, IND.
FAU - Bharija, Subhash C
AU  - Bharija SC
AD  - Department of Dermatology, Sir Ganga Ram Hospital, Delhi, IND.
FAU - Doshi, Maulik
AU  - Doshi M
AD  - Department of India Clinical Research, Sun Pharma Laboratories Limited, Mumbai, 
      IND.
FAU - Ghadge, Pravin
AU  - Ghadge P
AD  - Department of Medical Affairs and Clinical Research, Sun Pharma Laboratories 
      Limited, Mumbai, IND.
FAU - Gabhane, Mukesh
AU  - Gabhane M
AD  - Department of Medical Affairs and Clinical Research, Sun Pharma Laboratories 
      Limited, Mumbai, IND.
FAU - Dharmadhikari, Shruti
AU  - Dharmadhikari S
AD  - Department of Medical Affairs and Clinical Research, Sun Pharma Laboratories 
      Limited, Mumbai, IND.
FAU - Mane, Amey
AU  - Mane A
AD  - Department of Medical Affairs and Clinical Research, Sun Pharma Laboratories 
      Limited, Mumbai, IND.
FAU - Mehta, Suyog
AU  - Mehta S
AD  - Department of Medical Affairs and Clinical Research, Sun Pharma Laboratories 
      Limited, Mumbai, IND.
LA  - eng
PT  - Journal Article
DEP - 20240128
PL  - United States
TA  - Cureus
JT  - Cureus
JID - 101596737
PMC - PMC10899119
OTO - NOTNLM
OT  - antihistamine
OT  - chronic spontaneous urticaria (csu)
OT  - csu
OT  - desloratadine
OT  - dosing
OT  - oral antihistamine
OT  - quality of life (qol)
OT  - uas7
OT  - up-dosing
OT  - urticaria activity score
COIS- The authors have declared that no competing interests exist.
EDAT- 2024/02/29 06:42
MHDA- 2024/02/29 06:43
PMCR- 2024/01/28
CRDT- 2024/02/29 04:06
PHST- 2024/01/26 00:00 [accepted]
PHST- 2024/02/29 06:43 [medline]
PHST- 2024/02/29 06:42 [pubmed]
PHST- 2024/02/29 04:06 [entrez]
PHST- 2024/01/28 00:00 [pmc-release]
AID - 10.7759/cureus.53125 [doi]
PST - epublish
SO  - Cureus. 2024 Jan 28;16(1):e53125. doi: 10.7759/cureus.53125. eCollection 2024 
      Jan.