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Martin K Church - One of the best experts on this subject based on the ideXlab platform.

  • the effectiveness of levocetirizine and desloratadine in up to 4 times conventional doses in difficult to treat urticaria
    The Journal of Allergy and Clinical Immunology, 2010
    Co-Authors: Maria Staevska, Todor A Popov, Tanya Kralimarkova, Cvetelina Lazarova, Steliana Kraeva, Dora Popova, Diana S Church, Vasil Dimitrov, Martin K Church
    Abstract:

    Background H 1 -Antihistamines are first line treatment of chronic urticaria, but many patients do not get satisfactory relief with recommended doses. European guidelines recommend increased Antihistamine doses of up to 4-fold. Objective To provide supportive evidence for the European guidelines. Methods Eighty tertiary referral patients with chronic urticaria (age range, 19-67 years) were randomized for double-blind treatment with levocetirizine or desloratadine (40/40). Treatment started at the conventional daily dose of 5 mg and then increased weekly to 10 mg, 20 mg, or 20 mg of the opposite drug if relief of symptoms was incomplete. Wheal and pruritus scores, quality of life, patient discomfort, somnolence, and safety were assessed. Results Thirteen patients became symptom-free at 5 mg (9 levocetirizine vs 4 desloratadine), compared with 28 subjects on the higher doses of 10 mg (8/7) and 20 mg (5/1). Of the 28 patients nonresponsive to 20 mg desloratadine, 7 became symptom-free with 20 mg levocetirizine. None of the 18 levocetirizine nonresponders benefited with 20 mg desloratadine. Increasing Antihistamine doses improved quality of life but did not increase somnolence. Analysis of the effect of treatment on discomfort caused by urticaria showed great individual heterogeneity of Antihistamine responsiveness: ∼15% of patients were good responders, ∼10% were nonresponders, and ∼75% were responders to higher than conventional Antihistamine doses. No serious or severe adverse effects warranting discontinuation of treatment occurred with either drug. Conclusion Increasing the dosage of levocetirizine and desloratadine up to 4-fold improves chronic urticaria symptoms without compromising safety in approximately three quarters of patients with difficult-to-treat chronic urticaria.

  • the effectiveness of levocetirizine and desloratadine in up to 4 times conventional doses in difficult to treat urticaria
    The Journal of Allergy and Clinical Immunology, 2010
    Co-Authors: Maria Staevska, Todor A Popov, Tanya Kralimarkova, Cvetelina Lazarova, Steliana Kraeva, Diana S Church, Vasil Dimitrov, Martin K Church, D N Popova
    Abstract:

    Background H 1 -Antihistamines are first line treatment of chronic urticaria, but many patients do not get satisfactory relief with recommended doses. European guidelines recommend increased Antihistamine doses of up to 4-fold. Objective To provide supportive evidence for the European guidelines. Methods Eighty tertiary referral patients with chronic urticaria (age range, 19-67 years) were randomized for double-blind treatment with levocetirizine or desloratadine (40/40). Treatment started at the conventional daily dose of 5 mg and then increased weekly to 10 mg, 20 mg, or 20 mg of the opposite drug if relief of symptoms was incomplete. Wheal and pruritus scores, quality of life, patient discomfort, somnolence, and safety were assessed. Results Thirteen patients became symptom-free at 5 mg (9 levocetirizine vs 4 desloratadine), compared with 28 subjects on the higher doses of 10 mg (8/7) and 20 mg (5/1). Of the 28 patients nonresponsive to 20 mg desloratadine, 7 became symptom-free with 20 mg levocetirizine. None of the 18 levocetirizine nonresponders benefited with 20 mg desloratadine. Increasing Antihistamine doses improved quality of life but did not increase somnolence. Analysis of the effect of treatment on discomfort caused by urticaria showed great individual heterogeneity of Antihistamine responsiveness: ∼15% of patients were good responders, ∼10% were nonresponders, and ∼75% were responders to higher than conventional Antihistamine doses. No serious or severe adverse effects warranting discontinuation of treatment occurred with either drug. Conclusion Increasing the dosage of levocetirizine and desloratadine up to 4-fold improves chronic urticaria symptoms without compromising safety in approximately three quarters of patients with difficult-to-treat chronic urticaria.

Toshitaka Nabeshima - One of the best experts on this subject based on the ideXlab platform.

  • Effects of single therapeutic doses of promethazine, fexofenadine and olopatadine on psychomotor function and histamine-induced wheal- and flare-responses: a randomized double-blind, placebo-controlled study in healthy volunteers
    Archives of Dermatological Research, 2012
    Co-Authors: Hiroyuki Kamei, Koji Senzaki, Kazuhiro Ishikawa, Yukihiro Noda, Ami Isaji, Kiyofumi Yamada, Kazumitsu Sugiura, Yasushi Tomita, Toshitaka Nabeshima
    Abstract:

    Since most first-generation Antihistamines have undesirable sedative effects on the central nervous systems (CNS), newer (second-generation) Antihistamines have been developed to improve patients’ quality of life. However, there are few reports that directly compare the antihistaminic efficacy and impairment of psychomotor functions. We designed a double-blind, placebo controlled, crossover study to concurrently compare the clinical effectiveness of promethazine, a first-generation Antihistamine, and fexofenadine and olopatadine, second-generation Antihistamines, by measuring their potency as peripheral inhibitors of histamine-induced wheal and flare. Further, we investigated their sedative effects on the CNS using a battery of psychomotor tests. When single therapeutic doses of fexofenadine (60 mg), olopatadine (5 mg) and promethazine (25 mg) were given in a double-blind manner to 24 healthy volunteers, all Antihistamines produced a significant reduction in the wheal and flare responses induced by histamine. In the comparison among Antihistamines, olopatadine showed a rapid inhibitory effect compared with fexofenadine and promethazine, and had a potent effect compared with promethazine. In a battery of psychomotor assessments using critical flicker fusion, choice reaction time, compensatory tracking, rapid visual information processing and a line analogue rating scale as a subjective assessment of sedation, promethazine significantly impaired psychomotor function. Fexofenadine and olopatadine had no significant effect in any of the psychomotor tests. Promethazine, fexofenadine and olopatadine did not affect behavioral activity, as measured by wrist actigraphy. These results suggest that olopatadine at a therapeutic dose has greater Antihistaminergic activity than promethazine, and olopatadine and fexofenadine did not cause cognitive or psychomotor impairment.

  • comparative study of acute effects of single doses of fexofenadine olopatadine d chlorpheniramine and placebo on psychomotor function in healthy volunteers
    Human Psychopharmacology-clinical and Experimental, 2003
    Co-Authors: Hiroyuki Kamei, Koji Senzaki, Isao Muraoka, Kazuhiro Ishikawa, Ian Hindmarch, Yoshinori Hasegawa, Yukihiro Noda, Toshitaka Nabeshima
    Abstract:

    Since most classical (first-generation) Antihistamines have undesirable sedative effects on the central nervous system (CNS), newer (second-generation) Antihistamines have been developed to relieve the sedative effects and to improve the patient's quality of life. However, the psychomotor profiles of second-generation Antihistamines are not fully elucidated. In this randomized, double-blind, crossover study, the acute effects of single doses of second-generation Antihistamines, fexofenadine (120 mg) and olopatadine (10 mg), on cognitive and psychomotor performance were investigated in comparison with those of placebo and d-chlorpheniramine (4 mg), a first-generation Antihistamine, using objective and subjective assessments, in 11 healthy Japanese volunteers. In a battery of psychomotor tests, d-chlorpheniramine impaired tracking ability in the compensatory tracking task and caused a reduction in behavioural activity as continuously measured by wrist actigraphy. Olopatadine, like d-chlorpheniramine, reduced the behavioural activity, while fexofenadine had no effect in any of the tests. No significant changes in the subjects' self-ratings of drowsiness were found with the three Antihistamines. These results suggest that d-chlorpheniramine and olopatadine, but not fexofenadine, produce sedative effects on psychomotor performance, and that the CNS profile of fexofenadine is different from that of olopatadine. Copyright © 2003 John Wiley & Sons, Ltd.

  • comparative study of acute effects of single doses of fexofenadine olopatadine d chlorpheniramine and placebo on psychomotor function in healthy volunteers
    Human Psychopharmacology-clinical and Experimental, 2003
    Co-Authors: Hiroyuki Kamei, Koji Senzaki, Isao Muraoka, Kazuhiro Ishikawa, Yoshinori Hasegawa, Yukihiro Noda, I Hindmarch, Toshitaka Nabeshima
    Abstract:

    Since most classical (first-generation) Antihistamines have undesirable sedative effects on the central nervous system (CNS), newer (second-generation) Antihistamines have been developed to relieve the sedative effects and to improve the patient's quality of life. However, the psychomotor profiles of second-generation Antihistamines are not fully elucidated. In this randomized, double-blind, crossover study, the acute effects of single doses of second-generation Antihistamines, fexofenadine (120 mg) and olopatadine (10 mg), on cognitive and psychomotor performance were investigated in comparison with those of placebo and d-chlorpheniramine (4 mg), a first-generation Antihistamine, using objective and subjective assessments, in 11 healthy Japanese volunteers. In a battery of psychomotor tests, d-chlorpheniramine impaired tracking ability in the compensatory tracking task and caused a reduction in behavioural activity as continuously measured by wrist actigraphy. Olopatadine, like d-chlorpheniramine, reduced the behavioural activity, while fexofenadine had no effect in any of the tests. No significant changes in the subjects' self-ratings of drowsiness were found with the three Antihistamines. These results suggest that d-chlorpheniramine and olopatadine, but not fexofenadine, produce sedative effects on psychomotor performance, and that the CNS profile of fexofenadine is different from that of olopatadine.

Fabrizio Ponti - One of the best experts on this subject based on the ideXlab platform.

  • Pro-Arrhythmic Potential of Oral Antihistamines (H1): Combining Adverse Event Reports with Drug Utilization Data across Europe
    PLOS ONE, 2015
    Co-Authors: Elisabetta Poluzzi, Emanuel Raschi, Ariola Koci, Marija Kalaba, Björn Wettermark, Brian Godman, Miriam C. J. M. Sturkenboom, Ugo Moretti, Fabrizio Ponti
    Abstract:

    Background. There is appreciable utilisation of Antihistamines (H1) in European countries, either prescribed by physician and purchased by patients for self-medication. Terfenadine and astemizole underwent regulatory restrictions in ’90 because of their cardiac toxicity, but only scarce clinical data are available on other Antihistamines. Aim. To investigate the pro-arrhythmic potential of Antihistamines by combining safety reports of the FDA Adverse Event Reporting System (FAERS) with drug utilization data from 13 European Countries. Methods. We identified signals of Antihistamine arrhythmogenic potential by analyzing FAERS database for all cases of Torsades de Pointes (TdP), QT abnormalities (QTabn), ventricular arrhythmia (VA) and sudden cardiac death/cardiac arrest (SCD/CA). Number of cases ≥3 and disproportionality were used to define alert signals: TdP and QTabn identified stronger signals, whereas SCD/CA identified weaker signals. Drug utilization data from 2005 to 2010 were collected from administrative databases through health authorities and insurance.Results. Antihistamines were reported in 109 cases of TdP/QT prolongation, 278 VA and 610 SCD/CA. Five agents resulted in stronger signals (cetirizine, desloratadine, diphenhydramine, fexofenadine, loratadine) and 6 in weaker signals (alimemazine, carbinoxamine, cyclizine, cyproeptadine, dexchlorpheniramine and doxylamine). Exposure to Antihistamines with stronger signal was markedly different across European countries and was at least 40% in each Country. Cetirizine was >29 Defined Daily Doses per 1000 inhabitants per day (DID) in Norway, desloratadine >11 DID in France and loratadine >9 DID in Sweden and Croatia. Drugs with weaker signals accounted for no more than 10% (in Sweden) and in most European countries their use was negligible.Conclusions. Some second-generation Antihistamines are associated with signal of torsadogenicity and largely used in most European countries. Although confirmation by analytical studies is required, regulators and clinicians should consider risk-minimisation activities. Also Antihistamines without signal but with peculiar use in a few Countries (e.g., levocetirizine) or with increasing consumption (e.g., rupatadine) deserve careful surveillance.

  • Pro-arrhythmic potential of oral Antihistamines (H1)
    'Public Library of Science (PLoS)', 2015
    Co-Authors: Poluzzi E., Raschi E., Godman B., Koci A., Moretti U., Kalaba M., Wettermark B., Sturkenboom M.c.j.m., Fabrizio Ponti
    Abstract:

    Background: There is appreciable utilisation of Antihistamines (H1) in European countries, either prescribed by physician and purchased by patients for self-medication. Terfenadine and astemizole underwent regulatory restrictions in '90 because of their cardiac toxicity, but only scarce clinical data are available on other Antihistamines. Aim: To investigate the pro-arrhythmic potential of Antihistamines by combining safety reports of the FDA Adverse Event Reporting System (FAERS) with drug utilization data from 13 European Countries. Methods: We identified signals of Antihistamine arrhythmogenic potential by analyzing FAERS database for all cases of Torsades de Pointes (TdP), QT abnormalities (QTabn), ventricular arrhythmia (VA) and sudden cardiac death/cardiac arrest (SCD/CA). Number of cases ≥3 and disproportionality were used to define alert signals: TdP and QTabn identified stronger signals, whereas SCD/CA identified weaker signals. Drug utilization data from 2005 to 2010 were collected from administrative databases through health authorities and insurance. Results: Antihistamines were reported in 109 cases of TdP/QT prolongation, 278 VA and 610 SCD/CA. Five agents resulted in stronger signals (cetirizine, desloratadine, diphenhydramine, fexofenadine, loratadine) and 6 in weaker signals (alimemazine, carbinoxamine, cyclizine, cyproeptadine, dexchlorpheniramine and doxylamine). Exposure to Antihistamines with stronger signal was markedly different across European countries and was at least 40% in each Country. Cetirizine was >29 Defined Daily Doses per 1000 inhabitants per day (DID) in Norway, desloratadine >11 DID in France and loratadine > 9 DID in Sweden and Croatia. Drugs with weaker signals accounted for no more than 10% (in Sweden) and in most European countries their use was negligible. Conclusions: Some second-generation Antihistamines are associated with signal of torsadogenicity and largely used in most European countries. Although confirmation by analytical studies is required, regulators and clinicians should consider risk-minimisation activities. Also Antihistamines without signal but with peculiar use in a few Countries (e.g., levocetirizine) or with increasing consumption (e.g., rupatadine) deserve careful surveillance

Hiroyuki Kamei - One of the best experts on this subject based on the ideXlab platform.

  • Effects of single therapeutic doses of promethazine, fexofenadine and olopatadine on psychomotor function and histamine-induced wheal- and flare-responses: a randomized double-blind, placebo-controlled study in healthy volunteers
    Archives of Dermatological Research, 2012
    Co-Authors: Hiroyuki Kamei, Koji Senzaki, Kazuhiro Ishikawa, Yukihiro Noda, Ami Isaji, Kiyofumi Yamada, Kazumitsu Sugiura, Yasushi Tomita, Toshitaka Nabeshima
    Abstract:

    Since most first-generation Antihistamines have undesirable sedative effects on the central nervous systems (CNS), newer (second-generation) Antihistamines have been developed to improve patients’ quality of life. However, there are few reports that directly compare the antihistaminic efficacy and impairment of psychomotor functions. We designed a double-blind, placebo controlled, crossover study to concurrently compare the clinical effectiveness of promethazine, a first-generation Antihistamine, and fexofenadine and olopatadine, second-generation Antihistamines, by measuring their potency as peripheral inhibitors of histamine-induced wheal and flare. Further, we investigated their sedative effects on the CNS using a battery of psychomotor tests. When single therapeutic doses of fexofenadine (60 mg), olopatadine (5 mg) and promethazine (25 mg) were given in a double-blind manner to 24 healthy volunteers, all Antihistamines produced a significant reduction in the wheal and flare responses induced by histamine. In the comparison among Antihistamines, olopatadine showed a rapid inhibitory effect compared with fexofenadine and promethazine, and had a potent effect compared with promethazine. In a battery of psychomotor assessments using critical flicker fusion, choice reaction time, compensatory tracking, rapid visual information processing and a line analogue rating scale as a subjective assessment of sedation, promethazine significantly impaired psychomotor function. Fexofenadine and olopatadine had no significant effect in any of the psychomotor tests. Promethazine, fexofenadine and olopatadine did not affect behavioral activity, as measured by wrist actigraphy. These results suggest that olopatadine at a therapeutic dose has greater Antihistaminergic activity than promethazine, and olopatadine and fexofenadine did not cause cognitive or psychomotor impairment.

  • comparative study of acute effects of single doses of fexofenadine olopatadine d chlorpheniramine and placebo on psychomotor function in healthy volunteers
    Human Psychopharmacology-clinical and Experimental, 2003
    Co-Authors: Hiroyuki Kamei, Koji Senzaki, Isao Muraoka, Kazuhiro Ishikawa, Ian Hindmarch, Yoshinori Hasegawa, Yukihiro Noda, Toshitaka Nabeshima
    Abstract:

    Since most classical (first-generation) Antihistamines have undesirable sedative effects on the central nervous system (CNS), newer (second-generation) Antihistamines have been developed to relieve the sedative effects and to improve the patient's quality of life. However, the psychomotor profiles of second-generation Antihistamines are not fully elucidated. In this randomized, double-blind, crossover study, the acute effects of single doses of second-generation Antihistamines, fexofenadine (120 mg) and olopatadine (10 mg), on cognitive and psychomotor performance were investigated in comparison with those of placebo and d-chlorpheniramine (4 mg), a first-generation Antihistamine, using objective and subjective assessments, in 11 healthy Japanese volunteers. In a battery of psychomotor tests, d-chlorpheniramine impaired tracking ability in the compensatory tracking task and caused a reduction in behavioural activity as continuously measured by wrist actigraphy. Olopatadine, like d-chlorpheniramine, reduced the behavioural activity, while fexofenadine had no effect in any of the tests. No significant changes in the subjects' self-ratings of drowsiness were found with the three Antihistamines. These results suggest that d-chlorpheniramine and olopatadine, but not fexofenadine, produce sedative effects on psychomotor performance, and that the CNS profile of fexofenadine is different from that of olopatadine. Copyright © 2003 John Wiley & Sons, Ltd.

  • comparative study of acute effects of single doses of fexofenadine olopatadine d chlorpheniramine and placebo on psychomotor function in healthy volunteers
    Human Psychopharmacology-clinical and Experimental, 2003
    Co-Authors: Hiroyuki Kamei, Koji Senzaki, Isao Muraoka, Kazuhiro Ishikawa, Yoshinori Hasegawa, Yukihiro Noda, I Hindmarch, Toshitaka Nabeshima
    Abstract:

    Since most classical (first-generation) Antihistamines have undesirable sedative effects on the central nervous system (CNS), newer (second-generation) Antihistamines have been developed to relieve the sedative effects and to improve the patient's quality of life. However, the psychomotor profiles of second-generation Antihistamines are not fully elucidated. In this randomized, double-blind, crossover study, the acute effects of single doses of second-generation Antihistamines, fexofenadine (120 mg) and olopatadine (10 mg), on cognitive and psychomotor performance were investigated in comparison with those of placebo and d-chlorpheniramine (4 mg), a first-generation Antihistamine, using objective and subjective assessments, in 11 healthy Japanese volunteers. In a battery of psychomotor tests, d-chlorpheniramine impaired tracking ability in the compensatory tracking task and caused a reduction in behavioural activity as continuously measured by wrist actigraphy. Olopatadine, like d-chlorpheniramine, reduced the behavioural activity, while fexofenadine had no effect in any of the tests. No significant changes in the subjects' self-ratings of drowsiness were found with the three Antihistamines. These results suggest that d-chlorpheniramine and olopatadine, but not fexofenadine, produce sedative effects on psychomotor performance, and that the CNS profile of fexofenadine is different from that of olopatadine.

Maria Staevska - One of the best experts on this subject based on the ideXlab platform.

  • the effectiveness of levocetirizine and desloratadine in up to 4 times conventional doses in difficult to treat urticaria
    The Journal of Allergy and Clinical Immunology, 2010
    Co-Authors: Maria Staevska, Todor A Popov, Tanya Kralimarkova, Cvetelina Lazarova, Steliana Kraeva, Dora Popova, Diana S Church, Vasil Dimitrov, Martin K Church
    Abstract:

    Background H 1 -Antihistamines are first line treatment of chronic urticaria, but many patients do not get satisfactory relief with recommended doses. European guidelines recommend increased Antihistamine doses of up to 4-fold. Objective To provide supportive evidence for the European guidelines. Methods Eighty tertiary referral patients with chronic urticaria (age range, 19-67 years) were randomized for double-blind treatment with levocetirizine or desloratadine (40/40). Treatment started at the conventional daily dose of 5 mg and then increased weekly to 10 mg, 20 mg, or 20 mg of the opposite drug if relief of symptoms was incomplete. Wheal and pruritus scores, quality of life, patient discomfort, somnolence, and safety were assessed. Results Thirteen patients became symptom-free at 5 mg (9 levocetirizine vs 4 desloratadine), compared with 28 subjects on the higher doses of 10 mg (8/7) and 20 mg (5/1). Of the 28 patients nonresponsive to 20 mg desloratadine, 7 became symptom-free with 20 mg levocetirizine. None of the 18 levocetirizine nonresponders benefited with 20 mg desloratadine. Increasing Antihistamine doses improved quality of life but did not increase somnolence. Analysis of the effect of treatment on discomfort caused by urticaria showed great individual heterogeneity of Antihistamine responsiveness: ∼15% of patients were good responders, ∼10% were nonresponders, and ∼75% were responders to higher than conventional Antihistamine doses. No serious or severe adverse effects warranting discontinuation of treatment occurred with either drug. Conclusion Increasing the dosage of levocetirizine and desloratadine up to 4-fold improves chronic urticaria symptoms without compromising safety in approximately three quarters of patients with difficult-to-treat chronic urticaria.

  • the effectiveness of levocetirizine and desloratadine in up to 4 times conventional doses in difficult to treat urticaria
    The Journal of Allergy and Clinical Immunology, 2010
    Co-Authors: Maria Staevska, Todor A Popov, Tanya Kralimarkova, Cvetelina Lazarova, Steliana Kraeva, Diana S Church, Vasil Dimitrov, Martin K Church, D N Popova
    Abstract:

    Background H 1 -Antihistamines are first line treatment of chronic urticaria, but many patients do not get satisfactory relief with recommended doses. European guidelines recommend increased Antihistamine doses of up to 4-fold. Objective To provide supportive evidence for the European guidelines. Methods Eighty tertiary referral patients with chronic urticaria (age range, 19-67 years) were randomized for double-blind treatment with levocetirizine or desloratadine (40/40). Treatment started at the conventional daily dose of 5 mg and then increased weekly to 10 mg, 20 mg, or 20 mg of the opposite drug if relief of symptoms was incomplete. Wheal and pruritus scores, quality of life, patient discomfort, somnolence, and safety were assessed. Results Thirteen patients became symptom-free at 5 mg (9 levocetirizine vs 4 desloratadine), compared with 28 subjects on the higher doses of 10 mg (8/7) and 20 mg (5/1). Of the 28 patients nonresponsive to 20 mg desloratadine, 7 became symptom-free with 20 mg levocetirizine. None of the 18 levocetirizine nonresponders benefited with 20 mg desloratadine. Increasing Antihistamine doses improved quality of life but did not increase somnolence. Analysis of the effect of treatment on discomfort caused by urticaria showed great individual heterogeneity of Antihistamine responsiveness: ∼15% of patients were good responders, ∼10% were nonresponders, and ∼75% were responders to higher than conventional Antihistamine doses. No serious or severe adverse effects warranting discontinuation of treatment occurred with either drug. Conclusion Increasing the dosage of levocetirizine and desloratadine up to 4-fold improves chronic urticaria symptoms without compromising safety in approximately three quarters of patients with difficult-to-treat chronic urticaria.