Gene/Protein Disease Symptom Drug Enzyme Compound
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Query: UMLS:C0917801 (insomnia)
10,606 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

In a double-blind, multicenter study, we compared the effects of SCH 434 (Claritin-D; Schering Corp., Kenilworth, N.J.), a new sustained-release, combination antihistamine/decongestant medication, with the effects of its individual components and placebo in 435 patients with seasonal allergic rhinitis. SCH 434 contains 5 mg of loratadine, a nonsedating antihistamine, and 120 mg of pseudoephedrine as the decongestant component. Administered twice daily in this study, SCH 434 effected a 50% decrease in total symptom scores at day 4 and was significantly (p less than or equal to 0.03) more effective than the components alone or the placebo. Loratadine or pseudoephedrine alone, with 43% and 33% decline in symptom scores, respectively, also was more effective than placebo (p less than 0.05). As expected, pseudoephedrine alone was more effective than loratadine (p less than 0.01) in relieving nasal stuffiness; SCH 434 was more effective (p less than or equal to 0.01) than placebo and loratadine in relieving nasal stuffiness. All treatments were safe and well tolerated, although insomnia and dry mouth were noted in a significant number of patients who received either SCH 434 or pseudoephedrine. No serious side effects were noted. The incidence of sedation did not differ significantly among the four treatment groups. We conclude that SCH 434 is a safe and effective treatment for symptoms of seasonal allergic rhinitis. The combination drug (SCH 434) was better than its components for some, but not all, symptoms.
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PMID:SCH 434: a new antihistamine/decongestant for seasonal allergic rhinitis. 247 18

Two hundred sixty-four patients with moderate to severe seasonal allergic rhinitis were treated with loratadine 5 mg plus pseudoephedrine 120 mg twice a day or placebo in a 28-day multicenter study. Four nasal and four non-nasal symptoms were evaluated for efficacy. At the last evaluable visit, the active treatment group had significantly lower (P = .05) mean combined nasal and non-nasal symptom scores than the placebo group. Also, the physician's rating of overall therapeutic response was significantly better in the active-treatment group (P = .03). Dry mouth, insomnia, and nervousness were reported by a significantly greater proportion (P less than or equal to .04) in the active-treatment group. Sedation occurred in 7% of patients in each treatment group and 6% of patients in each group discontinued the study because of adverse experiences. Loratadine plus pseudoephedrine was safe and significantly more effective than placebo in relieving the symptoms of allergic rhinitis.
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PMID:Loratadine-pseudoephedrine combination versus placebo in patients with seasonal allergic rhinitis. 252 98

The aim of the study was to assess efficacy and safety of 5 mg loratadine/120 mg pseudoephedrine combination drug in patients with seasonal allergic rhinitis. 30 patients allergic to grass pollen were treated with the new drug (Clarinase) twice a day in 15-day study during grass pollen seasonal. Nasal an non-nasal symptoms were evaluated for efficacy. Loratadine/pseudoephedrine combination effected a significant decrease in total symptoms score as well as individual evaluated symptoms score: nasal stuffiness, itching and discharge, sneezing, eye itching, tearing and redness of the eyes. The treatments was well tolerated. No serious side effects were noticed. The incidence of mild sedation, dry mouth, insomnia and nervousness was only 3 to 7 percent. 5 mg loratadine plus 120 mg pseudoephedrine was safe and effective in relieving the symptoms of allergic rhinitis.
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PMID:[Evaluation of the efficiency and safety of the loratadine with pseudoephedrine combination drug in treatment of seasonal allergic rhinitis]. 963 91

The objective of the study was to evaluate the adverse reactions of Loratadine plus Pseudoephedrine Sulfate Repetabs Tables (LTD+PSE Repetabs) (Loratadine 5 mg + Pseudoephedrine 120 mg) twice daily with that of loratadine (5 mg) twice daily and pseudoephedrine (60 mg) quarter daily in the treatment of patients with allergic rhinitis. The study was designed as an investigator-blind, parallel group study. In this study, 56 patients were equally separated into 2 groups and treated for 14 days with either LTD+PSE Repetabs or loratadine + pseudoephedrine tablet. Both groups were comparable in age, gender, weight; baseline systolic blood pressure, diastolic blood pressure and pulse rate. The change of systolic blood pressure, diastolic blood pressure, and pulse rate did not reach clinical significance throughout the study period. There was no significant difference in occurrences of insomnia, palpitation, mouth dryness and anxiety. However, the incidence of patients with tremor at day 14 in the loratadine + pseudoephedrine tablet group was significantly higher than the LTD+PSE Repetabs group (39% vs 10.7%, p-value = 0.03). Furthermore, one patient in the loratadine + pseudoephedrine tablet group had to discontinue medication at day 7 due to insomnia. In conclusion, LTD+PSE Repetabs is well tolerated and has fewer adverse effects when compared to the loratadine + pseudoephedrine tablet.
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PMID:A comparative study of the side effects between pseudoephedrine in Loratadine plus Pseudoephedrine Sulfate Repetabs Tables and loratadine + pseudoephedrine tablet in treatment of allergic rhinitis in Thai patients. 1232 47

Although antihistamines are highly effective in alleviating many symptoms associated with seasonal allergic rhinitis (SAR), relief from nasal congestion is variable. The efficacy of desloratadine, an effective antihistamine, in combination with pseudoephedrine, a potent nasal decongestant, was evaluated to determine whether combination therapy was more effective than individual component therapy in reducing nasal congestion, as well as other SAR symptoms. This multicenter, randomized, double-blind, three-arm study included 650 patients with SAR. For 2 weeks, patients were administered a combination tablet of desloratadine plus pseudoephedrine (desloratadine/pseudoephedrine, 2.5/120 mg) twice per day (b.i.d.), desloratadine (5 mg) once per day, or pseudoephedrine (120 mg) b.i.d. Patients assessed the severity of their SAR symptoms twice daily on symptom diary cards. The primary variable-change from baseline in the reflective A.M./P.M. total symptom score, excluding nasal congestion-was significantly superior (-6.7) compared with desloratadine (-5.4) or pseudoephedrine (-5.3) alone (p < or = 0.001 versus either group). Secondary efficacy variables including total symptom scores (plus congestion), total nasal symptom scores, and total nonnasal symptom scores were significantly reduced after desloratadine/pseudoephedrine therapy compared with the individual components. The most frequently reported adverse events were insomnia, headache, and dry mouth. Desloratadine/pseudoephedrine, 2.5/120 mg b.i.d., therapy was more effective in reducing total symptom scores of SAR, including nasal congestion, than were the individual components. These results support the use of this combination therapy over desloratadine or pseudoephedrine alone.
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PMID:Efficacy and safety of desloratadine/pseudoephedrine tablet, 2.5/120 mg two times a day, versus individual components in the treatment of patients with seasonal allergic rhinitis. 1645 May 74