Loratadine Versus Levocetirizine in Chronic Idiopathic Urticaria_ a Comparative Study of Efficacy and Safety

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Loratadinr versus levocetirizine
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  4/9/2018Loratadine versus levocetirizine in chronic idiopathic urticaria: A comparative study of efficacy and safetyhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC2885633/1/9 Go to: Indian J Pharmacol. 2010 Feb; 42(1): 12–16.doi: 10.4103/0253-7613.62399PMCID: PMC2885633PMID: 20606830 Loratadine versus levocetirizine in chronic idiopathic urticaria: Acomparative study of efficacy and safety P. Anuradha, Rituparna Maiti, J. Jyothirmai, Omer Mujeebuddin, and M. Anuradha Department of Pharmacology, Prathima Institute of Medical Sciences, Nagunur Road, Karimnagar, Andhra Pradesh, IndiaDepartment of Dermatology, Prathima Institute of Medical Sciences, Nagunur Road, Karimnagar, Andhra Pradesh, India Correspondence to:  Dr. Rituparna Maiti E-mail: rituparnamaiti@rediffmail.comReceived 2008 Aug 25; Revised 2009 May 8; Accepted 2010 Feb 3.Copyright © Indian Journal of PharmacologyThis is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use,distribution, and reproduction in any medium, provided the srcinal work is properly cited.This article has been cited by other articles in PMC.  Abstract Background: Treatment of chronic idiopathic urticaria (CIU) is challenging because of its unpredictable course andnegative influence on the quality of life. New treatments are being developed, but antihistaminicsremain the cornerstone of the therapeutic approach. Newer generation antihistaminics such asloratadine and levocetirizine have already proved to be safe and efficacious for CIU. Objective: To choose the better drug between loratadine and levocetirizine for CIU, by comparing their efficacyand safety. Methods: A randomized, open, outdoor-based clinical study was conducted on 60 patients of CIU, to compare thetwo drugs. After initial clinical assessment and baseline investigations, loratadine was prescribed to 30 patients and levocetirizine to another 30 patients for four weeks. At follow-up, the patients were re-evaluated and then compared using different statistical tools. Result: The comparative study showed that the changes in differential eosinophil count (  P   = 0.006) andabsolute eosinophil count (  P   = 0.003) in the levocetirizine group was statistically significant. Theresults of the Total Symptom Score showed better symptomatic improvement of CIU withlevocetirizine as compared to loratadine. The overall incidence of adverse drug reactions was alsofound to be less in the levocetirizine group. Conclusion: An analysis of the results of all the parameters of safety and efficacy proves the superiority of levocetirizine over loratadine for CIU. Keywords: Absolute eosinophil count, chronic idiopathic urticaria, levocetirizine, loratadine, totalsymptom score 11  4/9/2018Loratadine versus levocetirizine in chronic idiopathic urticaria: A comparative study of efficacy and safetyhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC2885633/2/9 Go to:Go to: Introduction Urticaria is a transient vascular reaction pattern characterized by circumscribed, edematous, itchylesions, usually lasting for a few hours to one or two days. In particular, chronic urticaria ischaracterized by the occurrence of wheals daily or almost daily for a period of at least six weeks, withan estimated lifetime prevalence of 0.5% across all populations studied.[1,2] Despite an exhaustive and expensive diagnostic approach, searches for the etiology of chronic urticaria are mostly frustrating, because in most cases the causative agent is unknown. In these cases a diagnosis of chronic idiopathicurticaria (CIU) is made.[3]CIU is a distressing condition that severely affects the patients' quality of life and performance.Effective treatment is thus required in all cases, where avoidance of eliciting factors is not feasible.General practitioners and specialists have to deal with the challenge of treating the symptoms andensuring a decent quality of life for their patients. In the last few decades an increasing understandingof the pathomechanisms involved in urticaria has highlighted the heterogeneity of different subtypes.Clarity of nomenclature is required not only to choose the correct measures in diagnosis andmanagement, but also to compare data from different studies.[4] New treatments are being developed, but antihistaminic drugs remain the cornerstone of the therapeuticapproach. During recent years, new antihistaminics such as loratadine and levocetirizine have beenmarketed and indicated for the treatment of urticaria, with the benefit of a better safety profile.[2,3,5 –  11]Although individually loratadine and levocetirizine are efficacious for CIU, unique findings in somestudies indicate a likelihood of differences between these two drugs.[9,12 – 16] Therefore, this study has  been conducted to compare the therapeutic efficacy and tolerability of levocetirizine and loratadine in patients suffering from CIU. The relative absence of data in this domain is an incentive to further explore this aspect of the disease. Materials and Methods The present study is a randomized, open, comparative clinical study between levocetirizine andloratadine for CIU. Procedures followed in this study are in accordance with the ethical standards laiddown by ICMR's Ethical Guidelines for Biomedical Research on Human Subjects (2006), with prior  permission from the Institutional Ethics Committee. Subjects Patients (n = 60) between the ages of 12 and 60 years, suffering from CIU, were recruited from theDermatology Outpatient Department of Prathima Institute of Medical Sciences, Karimnagar, AndhraPradesh, India. Patients suffering from other forms of urticaria, with significant concomitant illness(e.g., malignancies or hepatic, psychiatric, endocrine or other major systemic diseases), pregnantwomen, lactating mothers, females on oral contraceptive pills, patients on antihistaminic therapy for 72hours, or steroids for one month, were excluded from the study. Certain special tests, such as, test for dermographism, ice-cube test, and exercise test were carried out in selected patients, as suggested bythe history of their illness, to rule out other forms of chronic urticaria. A written informed consent wastaken from all the patients included in the trial after explaining the patient's diagnosis, the nature and purpose of the proposed treatment, the risks and benefits of the proposed treatment (loratadine /levocetirizine), alternative treatment (corticosteroids), and the risks and benefits of the alternativetreatment. After systematic randomization, 60 patients who participated in the study were divided intotwo groups; 30 patients were assigned to receive loratadine, 10 mg daily, and 30 patients receivedlevocetirizine 5 mg daily, for a period of four weeks. The patients received the drugs free of cost fromour institute pharmacy. At the first visit, selected cases of CIU were thoroughly interviewed,individually, to record the circumstances that precipitated the attacks and a detailed history was takenon baseline symptomatology. The vital signs were measured as, routine clinical check up. Physicalexaminations, especially dermatological tests, the size of the wheals were measured, and baselineclinical investigations were carried out. At the four-week follow-up, a physical examination and baseline investigations were repeated and all post drug symptoms were recorded.  4/9/2018Loratadine versus levocetirizine in chronic idiopathic urticaria: A comparative study of efficacy and safetyhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC2885633/3/9 Go to: Laboratory measurements Routine analysis of blood [Total Leucocyte Count (TLC), Differential Count (DC), and AbsoluteEosinophil Count (AEC)] was estimated in each patient at baseline (First Visit) and at follow-up(Second Visit). Efficacy measures All patients were evaluated for the degree of pruritus, size of wheals, number of wheals, and number of separate urticarial episodes. At both visits, evaluations were made for each patient by the sameinvestigator.Efficacy measures were scored according to the following scales: Pruritus: 0 (none), 1 (mild), 2(moderate), and 3 (severe); Number of wheals: 0 (none), 1 (1 – 10 wheals), 2 (11 – 20 wheals), 3 (> 20wheals); Size of wheals (mean diameter): 0 (no lesion), 1 (< 1.27 cm), 2 (1.27 – 2.54 cm), 3 (> 2.54cm); Number of separate urticarial episodes: 0 (no episodes), 1 (1 episode), 2 (2 – 3 episodes), 3 (> 3episodes). The maximum value of the total symptoms score (TSS) was 12.[3] Safety measures Safety and tolerability were assessed on the basis of the adverse events reported, or by comparing the baseline symptoms with post-drug symptoms, or changes in vital signs and physical examinationfindings recorded before and at the end of treatment. Statistical Analysis Statistical analysis was carried out by Paired t-test / Wilcoxon Signed Rank test, t-test / Mann WhitneyRank Sum test, and Fisher's Exact test, using statistical software Jandel SigmaStat version 2. Intervaldata have been expressed as Mean ± SD and categorical data in percentage. A  P   value of <0.05 wasconsidered as statistically significant. Results The two groups were homogenous with respect to baseline demographic data, including patients' ageand sex, duration of disease, and severity [Table 1]. At follow up, nine were lost and a total of 51 patients (26 in the loratadine group and 25 in the levocetirizine group) completed the trial. Among nine patients, six patients did not report for follow-up and three patients were non-compliant with thetreatment. The percentages of the female patients were 60 and 56.7 in the loratadine and levocetirizinegroups, respectively. The mean age of the patients was 33.4 and 34.8 years and the patients weresymptomatic for a mean duration of 10.7 and 9.6 weeks in the loratadine and levocetirizine groups,respectively. Table 1 Baseline demographic data and clinical characteristics of the patients of chronic idiopathicurticaria CharacteristicsLoratadine groupLevocetirizine groupP value  Number of patients recruited3030 Number of patients at follow-up2625Female sex (%)6056.7Age (years)33.43 ± 12.2334.80 ± 12.160.67Duration of CIU (weeks)10.7 ± 2.99.6 ± 2.10.13Total leucocyte count8420 ± 10958678 ± 10240.34 @  4/9/2018Loratadine versus levocetirizine in chronic idiopathic urticaria: A comparative study of efficacy and safetyhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC2885633/4/9 CharacteristicsLoratadine groupLevocetirizine groupP value DC neutrophil (%)63.1 ± 4.763.7 ± 4.30.65DC lymphocyte (%)32.6 ± 4.134.8 ± 4.90.07DC eosinophil (%)4.1 ± 1.54.2 ± 1.30.57Absolute eosinophil Count350.5 ± 164.7377.7±127.70.19Total Symptom Score7.8 ± 1.97.3 ± 2.20.23Data are in Mean ± SDAnalysis: by Student's ‘t’-test Change in Total Leucocyte Count There was a 2.1% decrease in TLC in the loratadine group in comparison to 2.9% in the levocetirizinegroup. The change in the loratadine group was not statistically significant (  P   = 0.07), but there was asignificant decrease (  P   = 0.004) in the levocetirizine group. When the changes in the two groups werecompared using the Mann Whitney Rank Sum test, the change in the levocetirizine group was found to be statistically non-significant (  P   = 0.41) [Table 2]. Table 2 Comparison of different variables studied before and after treatment in both groups, amongfollow-up cases, in the comparative study between loratadine and levocetirizine VariableLoratadine groupLevocetirizine groupDifference between the groups [Δ% Loratadine group vs. Δ% Levocetirizine group] Ψ 1Visit 2Visit %change P value Ω1Visit 2Visit %change P value Ω Totalleucocytecount8485±11088277±9352.10.0708690±10678408±8382.90.0040.41DCneutrophil(%)63.5± .862.5±± 4.561.8±± 4.334.3±± 5.337.2± 3.62.5<0.0010.96DCeosinophil(%)4.12±1.633.69±1.380.430.0214.24±1.393.12±1.331.12<0.0010.006Absoluteeosinophilcount357±176310±1347.740.004368±131262±11627.89<0.0010.003Totalsymptomscore7.85±1.997.46±1.924.850.0027.32±2.296.24±1.7413.32<0.001< 0.001 @ stndstnd  *************
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