Comparative efficacy and safety of a once-daily loratadine-pseudoephedrine combination versus its components alone and placebo in the management of seasonal allergic rhinitis

Bronsky, Edwin A.; Boggs, Peter B.; Findlay, Steven R.; Gawchik, Sandra M.; Georgitis, John W.; Mansmann, Herbert C.; Sholler, Lawrence J.; Wolfe, James; Meltzer, Eli O.; Morris, RW

doi:10.1016/s0091-6749(95)70001-3

Cited by 60 publications

(42 citation statements)

References 13 publications

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“…This is the mean of the daily symptom scores recorded for each of the assessed symptoms. 56 2) The percentage of days with a severity symptom score <1 (PDmax) for each patient -the main variable in the PAR studies. 57 3) Mean daily symptom score (DSSm); a secondary variablethe mean of all the scores recorded for a given symptom per patient and for all the study days.…”

Section: Clinical Studies On Rupatadine In Allergic Rhinitismentioning

confidence: 99%

Pharmacological profile, efficacy and safety of rupatadine in allergic rhinitis

Katiyar

Prakash

2008

Primary Care Respiratory Journal

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Allergic rhinitis (AR) is a disease with high prevalence. In AR, exposure to airborne allergens elicits an allergic response which involves epithelial accumulation of effector cells -e.g. mast cells and basophils -and subsequent inflammation. During the early response in AR, histamine has been found to be the most abundant mediator and it is associated with many symptoms of this disease mediated through the histamine H1 receptor. Therefore, anti-histamines have a role to play in the management of AR. However, the available antihistamines have certain well-known side effects like sedation and potential pro-arrythmic effects owing to their interactions with other drugs, as well as having poor or no effect on platelet activating factor (PAF) which also plays an important role in AR. This article is a qualitative systematic literature review on the pharmacological profile of rupatadine in order to evaluate its safety and efficacy in AR as compared to other anti-histamines. Rupatadine is a once-daily non-sedative, selective, long-acting H1 anti-histamine with antagonistic PAF effects through its interaction with specific receptors. Rupatadine significantly improves nasal symptoms in patients with AR. It has a good safety profile and is devoid of arrythmogenic effects. These properties make rupatadine a suitable first line anti-histamine for the treatment of AR.

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Section: Clinical Studies On Rupatadine In Allergic Rhinitismentioning

confidence: 99%

Pharmacological profile, efficacy and safety of rupatadine in allergic rhinitis

Katiyar

Prakash

2008

Primary Care Respiratory Journal

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“…These differences were significant for the combination group (3.3-4.5 beats per minute) compared to loratadine and placebo groups, but numerically higher but not statistically significant for the pseudoephedrine group (2.5-3.0 beats per minute). The conclusion drawn from the study was that the combination treatment was safe and more effective than the other treatments and placebo (Bronsky et al, 1995).…”

Section: Pseudoephedrinementioning

confidence: 95%

“…The relief of symptoms of seasonal allergic rhinitis was studied in 874 subjects in a double-blind, placebo-controlled multicenter study (Bronsky et al, 1995). The patients were treated orally for 2 weeks with either a combination of 10 mg loratadine (a non-sedating antihistamine) and 240 mg pseudoephedrine sulphate once daily, 10 mg loratadine once daily, 120 mg pseudoephedrine sulphate every 12 hours or placebo.…”

Section: Pseudoephedrinementioning

confidence: 99%

Untitled

2013

EFSA Journal

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The ANS Panel provides a scientific opinion evaluating the safety in use of Ephedra herb and its preparations originating from Ephedra species when used in food, e.g. in food supplements. Ephedra species contain alkaloids of biological relevance: ephedrine, pseudoephedrine, norephedrine, norpseudoephedrine (cathine), methylephedrine and methylpseudoephedrine. They have sympathomimetic activity and some of them are also used as active ingredients in medicinal products for which adverse effects are described. The use of Ephedra herb in food supplements is prohibited in several European countries, however food supplements containing Ephedra herb, also in combination with caffeine, are offered for sale via the internet. The Panel reviewed the available scientific data on a possible association between the intake of Ephedra herb, its preparations or its alkaloids and potential harmful effects on health. There is wide variation in the concentration of the individual ephedra alkaloids in different Ephedra species and in their preparations for use in food. No adequately specified individual preparations of Ephedra herb are known for which sufficient toxicological data for hazard characterisation exist. Due to the absence of adequate data on genotoxicity, short-term, long-term and reproductive and developmental toxicity the Panel could not provide advice on a daily intake of Ephedra herb and its preparations that do not give rise to concerns about harmful effects to health. Ephedra herb and its preparations in food supplements may result in exposure to total ephedra alkaloids or ephedrine which falls within or may exceed the therapeutic dose ranges for the individual ephedra alkaloids or ephedrine, respectively, in medicinal products. Such an exposure could lead to severe adverse effects, which may be enhanced by the combination with caffeine. The Panel concluded that Ephedra herb and its preparations containing ephedra alkaloids used as food supplements were of significant safety concern at the estimated use levels. In particular, EFSA was requested to review the existing scientific data on the possible link between the intake of Ephedra species and harmful effects on health, and to provide advice on a tolerable upper intake level (UL) for Ephedra species for the general population, and as appropriate, for vulnerable subgroups of the population. In the absence of a tolerable upper intake level, EFSA was asked to provide advice on a daily intake of Ephedra species that does not give rise to concerns about harmful effects to health.The risk assessment was performed by the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS Panel) in accordance with the 2009 EFSA Guidance on safety assessment of botanicals and botanical preparations intended for use as ingredients in food supplements.In addressing the Terms of Reference of this request, the ANS Panel noted that the term -tolerable upper intake level‖, was used by EFSA so far only for nutrients, such as vitamins or minerals, to describe the maximum ...

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“…Histamine receptor antagonists, such as cetirizine and loratadine, reduce symptoms of rhinorrhea, sneezing, and itching and are often combined with oral decongestants to help decrease nasal congestion. Studies combining the oral decongestant pseudoephedrine with loratadine, cetirizine, and desloratadine demonstrated that the combination therapy of oral decongestants with oral antihistamines was more effective in reducing symptoms of allergic rhinitis than if the individual components were administered alone (Bertrand et al 1996;Bronsky et al 1995;Grubbe et al 2009). …”

Section: Clinical Safety and Efficacymentioning

confidence: 99%

Occupational Contact Dermatitis Due to Acrylates and Methacrylates

Torrijos

2014

Encyclopedia of Medical Immunology

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Comparative efficacy and safety of a once-daily loratadine-pseudoephedrine combination versus its components alone and placebo in the management of seasonal allergic rhinitis

Cited by 60 publications

References 13 publications

Pharmacological profile, efficacy and safety of rupatadine in allergic rhinitis

Pharmacological profile, efficacy and safety of rupatadine in allergic rhinitis

Untitled

Occupational Contact Dermatitis Due to Acrylates and Methacrylates

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