Analysis of Drug Loratadine - Research Paper Example

Loratadine In the paper by Ratner, et.al. (1998), the set out to compare the efficacy, safety, and impact on the quality of life of fluticasone propionate aqueous nasal spray (FP ANS), loratadine, FP ANS plus loratadine, and placebo in treating seasonal allergic rhinitis during the mountain cedar allergy season in south central Texas. This paper covered about 600 patients who were afflicted with seasonal allergic rhinitis and for 2 weeks were given either FP ANS 200mcg once a day, or loratadine 10mg, once a day, or FP ANS and loratadine regimens combined, or placebo (Ratner, et.al., 1998). The assignment of patients to the different types of treatment was randomized and the randomization was also double-blinded, with neither the researchers nor the respondents knowing what treatment was assigned to them. At the start of each trial, the respondents assigned to each group were similar and baseline characteristics for each respondent were also similar. The baseline characteristic established for the patients included their age, gender, and ethnic origin (Ratner, et.al., 1998). Aside from the allocated treatment, the patients were all treated equally and no other additional procedures or treatments were included for any of the other treatment groups. There were 28 losses in respondents in the course of the study; this represented an acceptable number – less than 20% of the total number of respondents. The respondents were also analysed in the groups where they were randomised. They were analysed and compared to the other groups based on statistical variances and evaluations. This study is very much ideal because the clinicians and the researchers were blinded during the course of their research. Neither of them knew who was receiving what form of treatment. Previous knowledge and perceptions of the possible impact of treatments did not affect the results of the study and the outcome of the treatments (Ratner, et.al., 1998). The paper of Cauwenberge and Juniper (2000) sought to compare the efficacy, safety and impact of quality of life in seasonal allergic rhinitis patients after treatment with either fexofenadine and loratadine (with placebo) given once a day. The respondents were randomised through the application of appropriate computer techniques. Such randomisation was concealed from the respondents and researchers. The groups were similar at the start of the trial and the baseline characteristics of age, gender, and conditions including nasal congestion were all similar to each other (Cauwenberge & Juniper, 2000). Aside from the allocated treatment, all the respondents were treated equally and manifestations of symptoms also measured equally. Losses during follow up were minimal and well below the minimum 20% loss allowed to maintain significance of respondents. The patients were also analysed based on the groups which they were included in. They were analysed based on the treatments applied and then compared with each other based on similar measures of efficacy. This study was conducted as a randomised and double-blind research with both the clinicians and respondents not knowing which treatments were given to each patient. The reliability of the research and its results were maintained as a result. In the paper by Nayak, et.al., (2002), the authors set out to evaluate the effectiveness and tolerability of montelukast, loratadine, and combination therapy with montelukast and loratadine in the treatment of patients with fall seasonal allergic rhinitis. In this study, the randomisation of the respondent-subjects was computerised and, therefore, free of bias and intended groupings. This increased the reliability of the study. The randomisation process revealed similar groupings for the respondents, based on the baseline characteristics as described in the study from their age, their gender, and their daytime nasal symptoms. Aside from the treatment administered, each group of respondents also underwent similar applications in the treatment – the respondents were grouped, randomised, and administered different treatments once daily at bedtime for 2 weeks. They were all assessed based on symptoms score on mean congestion, rhinorrhea, pruritus, and sneezing. Losses to follow-up were very much minimal – less than 20% of the respondent population. Each group was also analysed as such and subsequent comparisons were made based on the symptoms as specified by the study. This is a single-blind study with the researchers being aware of the treatment being administered to each patient. The patients did not know what type of treatment was being administered to them. Ratner, Lim, and Georges (1999) sought to compare the efficacy and safety of Ebastine 20mg and 10mg, loratadine 10mg, placebo given once a day for 4 weeks for patients with seasonal allergic rhinitis. The randomisation of the respondents in this research was done through the computer, thereby freeing the process from any bias. The randomisation process also created groups which were more or less similar to each other, based on age, gender, and nasal symptoms, including, nasal discharge, congestion, sneezing, and total eye symptoms. Aside from the treatment administered, these groups were all treated equally. The treatments were administered to each group accordingly at the same time and recorded every morning. Monitoring was also based on morning and evening reflective scores, and also snapshot scores for symptoms in relation to nasal discharge, congestions, sneezing, itching, and eye symptoms. All the patients included in the trial were accounted for, some dropped out of the treatment, but no more than 20% of respondents were lost during follow-up. Each group was also analysed based on the group to which it was included. A comparison with the other treatment groups was later carried out based on the different assessment measures laid out by the researchers. This is a double-blind randomised study with the clinicians and the patients not knowing which treatment was being administered in the course of the research. This process has ensured the reliability and the validity of the results in this study. Hampel, et.al., (2004) set out to compare the H1-receptor antagonists loratadine and ebastine in seasonal allergic rhinitis patients. This study covered 749 patients (12-70 years old) based on their symptoms, like: nasal discharge, congestion, itching, sneezing, and total eye symptoms). The authors did not mention if the randomisation process was computerised. They also did not mention how the randomisation process was accomplished. The randomisation process carried out by the authors was able to ensure that the groups being studied for this paper presented with similar characteristics. Baseline characteristics for this study included age, gender, race, weight, and years with allergy. Aside from the treatment assigned to each group, all groups were treated equally. All groups were treated to the same screening period and a double-blind treatment period. At the first and final visits, all patients underwent a full medical history, physical examination, standard laboratory panel, and ECG. Patients were given the corresponding medicines: one capsule immediately after breakfast, with 8 ounces of water. They were also given a daily diary card where they were asked to score their rhinitis symptoms in the morning and in the evening. They were also all assessed based on nasal discharge, nasal congestion, itching, sneezing, and total eye symptoms. The severity of symptoms was graded from 0-3, with a score of 0 for absent symptoms, and 3 for severe symptoms. There were some patients who were lost during the follow-up, but their total did not exceed 20% of the total population. The members of the group were also analysed as a group based on the different symptoms as scored during the research process. They were also compared with each other, based on the scores placed by each respondent and based on the symptoms being assessed for this research. This is also a randomised and double-blind research, with neither the clinicians, nor the respondents knowing which treatment is being administered to them. This method has assisted in ensuring the reliability and the validity of this research. Irander, Odkvist, and Ohlander (2007) set out to evaluate the efficacy and safety of loratadine, which is a new orally specific H-receptor blocking antihistamine with poor penetration into the central nervous system. It covered 107 hay fever patients who were sensitive to birch pollen and grouped into three parallel groups receiving loratadine 40mg once a day; clemastine 1mg twice a day; or placebo during the birch season. The randomisation process in this research was computerised and therefore was achieved without bias; reliability of the randomisation was therefore ensured. The groups were similar to each other during the beginning of the trial. Baseline characteristics for all groups included age, gender, race, and symptoms in relation to allergic conditions. Aside from the allocated treatments, the groups were all treated equally with the process of administering the medications registering at similar times and similar projected impact on respondents. The monitoring process of the patient-respondents was also similar to each other and the allergic conditions evaluated for each group was also based on similar standards. Some patients were lost during the follow-up, but their number did not exceed 20% of the total population of respondents. In effect, the reliability of the respondent population was still maintained. Each group was also treated and evaluated separately. Each treatment group was collated separately and the results from their allocated treatment were compared with the other groups. Standard measures in relation to nasal stuffiness and other allergic conditions were used to compare results between the different groups of respondents. This paper was conducted as a double-blind study. The respondents and the clinicians were not aware of the treatment administered. Thereby, the validity and the reliability of this study were secured. Skassa-Brociek, et.al., (1988) sought to compare the efficacy and safety of loratadine and mequitazine. Their study covered 69 patients who were allergic to grass pollens and treatments for these patients were grouped into the loratadine group, the mequitazine group, and the placebo group. The groups were not randomised through the computer, but through the table of random numbers. Considering that the population of respondents was only 69, this method of randomisation served to be appropriate. Since the randomisation process worked out well, the groups were similar at the start of the trial. Baseline characteristics evaluated for each patient included age, gender, race, and nasal symptoms. There were no significant differences in these groups based on baseline characteristics at the start of each trial. Aside from the allocated treatment, the groups were treated equally. The groups underwent 2 weeks of treatment during the peak of the pollen season and the monitoring of their symptoms was done at baseline and after 3, 7, and 14 days of treatment; monitoring was done by the physician and with the patients rating their response on daily diary cards. The groups were all assessed based on degree of relief they experienced after allocated treatments were administered. Some of the patients were lost during follow-up; however, their loss did not exceed 20% of the respondent patients. Each group was also analysed as a group separate and distinct from the others. The data gathered for each group was collated and later compared with the results from the different groups. The results gathered from such comparison and individual analysis revealed logical and well-founded results. Statistical difference was seen after treatment and based on the different manifesting nasal affectations. The conduct of this study was randomised and double-blinded. The patient-respondent and the clinicians were not aware of the treatment administered to each patient. Consequently, the results of this research are considered reliable and valid. Bias and personal influence during treatment was reduced or eliminated. In a paper by Horak, et.al., (1988), the authors sought to compare a 14-day treatment with loratadine 10mg once a day, with terfenadine 60mg twice a day and with placebo. This study covered about 275 outpatients having seasonal allergic rhinitis with 87 enrolled in the loratadine group; 89 in the terfenadine group; and 80 in the placebo group. The randomisation for this study was computerised and this process ensured that there was no bias in the grouping process. The groups were similar at the start of the trial. Baseline characteristics included age, gender, race, blood, and chemistry tests. There were no significant differences in these groups at the start of the trial. Aside from the allocated treatment, groups were treated equally. The treatments were all given at the same time and the respondent-patients were all graded based on severity of nasal symptoms and the rating of the disease process was all based on evaluation on the 3rd, 7th, and 14th day of treatment. The signs and symptoms of rhinitis were also recorded on all the treatment groups. All the patients were asked uniform questions in relation to the possible adverse experiences from their treatment. Any differences in the treatment of these groups were assessed and deemed not significant for the study. Some patients included as respondents were lost during follow up, but their number did not exceed 20% of the total respondents. The groups were also analysed on an individual basis. Each variable and symptom was assessed based on each group. Comparisons were later carried out based on similar standards and variables on the 3rd, 7th, and 14th day of treatment. The measures undertaken were objective. The patients and the clinicians were kept blind to the treatment being administered to each patient group. This ensured the objectivity, validity, and reliability of the research process and its results. The paper by Del Carpio, et.al., (1989) was conducted in order to study the efficacy and safety of loratadine (10mg once a day), terfenadine (60mg twice daily), and placebo in treating seasonal allergic rhinitis. This study covered 317 patients grouped into three groups under the abovementioned treatment groups. At the start of the trial, the three groups started off equally with baseline characteristics including age, gender, race, vital signs, and four nasal symptoms. Any differences in these groups were deemed not significant. Aside from the allocated treatment, all three groups were treated equally. They were all monitored at the same time and the responses to treatment for each patient and group were assessed using same standards or measures. No group received any preferential treatment or any other comfort measures to relieve their symptoms. Almost all patients who entered the treatment were accounted for; some were lost during follow-up, but their numbers did not exceed 20% of the respondent-population. In effect, the lost numbers did not significantly impact on the validity of the results. Each respondent group was also analysed and evaluated as a group. The analysis covered the baseline characteristics and the comparative variables. Differences in these three groups were later established after mean total scores and statistical measures were carried out on the different groups. The assessment of the groups was mainly based on the relief of nasal discharge, sneezing, itching, and burning eyes. The measures used were objective. The respondent patients and the clinicians were ‘blinded’ to the treatments applied to each patient. In so doing, any bias or prejudice for each form of treatment was eliminated. The outcome was assessed through applicable statistical measures. These measures were able to create mathematical translations to the responses of each group of respondents. Finally, in a paper by Grubbe, Lumry, and Anolik (2009), the authors set out to evaluate whether a tablet combining the nonsedating antihistamine desloratadine and the decongestant pseudoephedrine was more effective than either drug administered in reducing the symptoms of seasonal allergic rhinitis, including nasal congestion. This study covered 598 patients who exemplified seasonal allergic rhinitis. The randomisation process was computerised and this process helped to ensure the reliability of the grouping process. The groups were all similar at the start of each trial. Baseline characteristics included age, gender, and race. Evaluation for hematopoietic, cardiovascular, hepatic, renal, neurologic, psychiatric, and autoimmune diseases also yielded negative results for all patient-respondents. Possible differences were not deemed significant. Aside from allocated treatment, groups were treated equally. Their symptoms were assessed for severity twice daily over a 2 week period. They were also monitored for vital signs applicability for the symptoms. There were patient-respondents who were lost during follow-up, but were not significant enough to affect the results of the study. The respondents lost were less than 20% of the respondent population. Each group was also treated as a separate group. The assessment measures were indicated per group based on variables measuring treatment effectiveness. Comparison was later based on each group; statistical treatments were used to ensure objectivity of results. Finally, the measures were objective because both the clinicians and the patients were not aware of the treatment being administered to them. They were “blinded” to the treatment. In effect, the reliability of the results was ensured. Works Cited Del Carpio J, Kabbash L, Turenne Y, et al. Efficacy and safety of loratadine (10 mg once daily), terfenadine (60 mg twice daily), and placebo in the treatment of seasonal allergic rhinitis. J Allergy Clin Immunol 1989; 84:741–746. [PubMed] Grubbe, R., Lumry, W., Anolik, R. Efficacy and safety of desloratadine/pseudoephedrine combination vs its components in seasonal allergic rhinitis. J Investig Allergol Clin Immunol. 2009; 19(2):117-24. [PubMed] Hampel F Jr, Howland W III, Van Bavel J, et al. A randomized, double-blind, placebo-controlled study comparing the efficacy and safety of ebastine (20 mg and 10 mg) to loratadine 10 mg once daily in the treatment of seasonal allergic rhinitis. J Invest Allergol Clin Immunol 2004;14: 56–63. [PubMed] Horak F, Bruttmann G, Pedrali P, et al. A multicentric study of loratadine, terfenadine and placebo in patients with seasonal allergic rhinitis. Arzneimittelforschung 1988; 38: 124–128. [PubMed] Irander K, Odkvist LM, Ohlander B. Treatment of hay fever with loratadine — a new non-sedating antihistamine. Allergy 1990;45:86–91. [PubMed] Nayak A, Philip G, Lu S, et al, and the Montelukast Fall Rhinitis Investigator Group. Efficacy and tolerability of montelukast alone or in combination with loratadine in seasonal allergic rhinitis: a multicenter, randomized, double-blind, placebo-controlled trial performed in the fall. Ann Allergy Asthma Immunol 2002;88:592–600. Ratner PH, Van Bavel JH, Martin BG, et al. A comparison of the efficacy of fluticasone propionate aqueous nasal spray and loratadine, alone and in combination, for the treatment of seasonal allergic rhinitis. J Fam Pract 1998;47:118–125. [PubMed] http://www.ncbi.nlm.nih.gov/pubmed/9722799 Ratner PH, Lim JC, Georges GC. Comparison of once-daily ebastine 20mg, ebastine 10mg, loratadine 10mg, and placebo in the treatment of seasonal allergic rhinitis. J Allergy Clin Immunol 2000;105:1101–1107. [PubMed] Skassa-Brociek W, Bousquet J, Montes F, et al. Double-blind placebo-controlled study of loratadine, mequitazine, and placebo in the symptomatic treatment of seasonal allergic rhinitis. J Allergy Clin Immunol 1988; 81:725–730. [PubMed] Van Cauwenberge P, Juniper EF, Albegger Almeida M, et al. Comparison of the efficacy, safety and quality of life provided by fexofenadine hydrochloride 120 mg, loratadine 10 mg and placebo administered once daily for the treatment of seasonal allergic rhinitis. Clin Exp Allergy 2000;30:891–899. 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