Gene/Protein Disease Symptom Drug Enzyme Compound
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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.
Allergy Asthma Proc
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

The intranasal corticosteroid triamcinolone acetonide (TAA) is an effective treatment for allergic rhinitis (AR). A new hydrofluoroalkane-134a (HFA)-propelled formulation (TAA-HFA) has been approved recently. This study assessed the safety and efficacy of TAA-HFA in patients with perennial AR over 1 year. A total of 396 patients aged 12-69 years with perennial AR (PAR) enrolled in this 1-year, open-label study. Patients received TAA-HFA, 220 microg, once daily for 2 weeks before adjusting their dose to 440 or 110 microg once daily as needed to control symptoms. Doses were standardized to 440 microg across all patients at approximately 4 months. Physical examinations, vital signs, and laboratory measurements were conducted at baseline, 6 months, and study end. Patient and physician global symptom evaluations were performed at visits 3-10. Patients recorded any adverse events (AEs) on daily diary cards. Of the 396 patients enrolled, 349 (88.1%) reported AEs. The most frequently reported AEs were pharyngitis, rhinitis, local reactions, headache, epistaxis, and sinusitis. Most AEs were mild to moderate in intensity; 34 patients discontinued because of AEs. There were no clinically relevant changes in physical examinations, vital signs, or laboratory measurements. A total of four serious AEs were reported; all were recorded as not related to study drug. Mean patient and physician scores of symptom relief showed significant relief from week 2 (visit 3) through the final visit. Long-term administration of TAA-HFA, 440 microg, exhibited a good safety and tolerability profile, while providing moderate-to-complete symptom relief as rated by patients and physicians.
Allergy Asthma Proc
PMID:Safety and clinical relief over 1 year with triamcinolone acetonide hydrofluoroalkane-134a nasal aerosol in patients with perennial allergic rhinitis. 1691 68

Allergic and nonallergic reactions to nitroglycerin occur. The aims of this study were to review the different manifestations of nitroglycerin allergy, to explain how to evaluate for it, and to discuss its treatment. We reviewed relevant literature in peer-reviewed journals, computerized databases, and references identified from relevant bibliographics. Nitroglycerin's most common side effects are headache, facial flushing, head throbbing, fainting, hypotension, tachycardia, and syncope. The majority of reported skin reactions to topical and transdermal nitroglycerin products are irritant contact dermatitis, allergic contact dermatitis, and urticaria. Five cases of presumed allergic reactions to oral, sublingual, intravenous, or perianal nitroglycerin products have been described. Patch testing may be helpful in subjects with skin reactions to topical or transdermal nitroglycerin. In subjects with positive patch tests to nitroglycerin (allergic contact dermatitis), transdermal nitroglycerin patches and other topical nitroglycerin products should be avoided. Most patients with contact dermatitis to nitroglycerin have tolerated oral nitroglycerin, sublingual nitroglycerin, or oral isosorbide challenges.
Allergy Asthma Proc
PMID:Allergic and nonallergic reactions to nitroglycerin. 1691 73

The i.v. immunoglobulin (IVIG) therapy is one of the mainstays of treatment for humoral immunodeficiencies, but there is limited knowledge of the adverse reactions associated with this therapy, especially reactions occurring in the postinfusion period. The purpose of this prospective, observational, multicenter study was to identify and quantify the adverse reactions that can occur both during and after IVIG infusions (Gamimune N) in patients with humoral immunodeficiency. Patients with primary immunodeficiencies requiring IVIG therapy were followed over a 6-month period, and data regarding adverse events, particularly the time of onset, duration, and type of reaction associated with IVIG infusions wzas collected via direct observation and patient interviews. Data were obtained during and up to 72 hours after the completion of infusions. Sixty-five patients were recruited and received a total of 447 infusions over a 6-month period. Four hundred fifty-one adverse reactions were noted, with 17% of infusions associated with an intrainfusion reaction and 41% associated with a postinfusion reaction. Most postinfusion reactions occurred within 24 hours of the infusion and consisted mainly of headaches, fatigue, and nausea. Adverse reactions to Gamimune N infusions are common and occur primarily in the postinfusion period. Estimates of the rate of adverse reactions to Gamimune N infusions currently are underestimated because they do not account for postinfusion reactions. In addition, once recognized, effective treatment of postinfusion reactions may improve patient compliance and quality of life.
Allergy Asthma Proc
PMID:Intrainfusion and postinfusion adverse events related to intravenous immunoglobulin therapy in immunodeficiency states. 1717 91

Although migraine affects about 15 % of the population, and many studies have been performed to find the mechanism and successful management, the physiopathology of migraine is still largely unknown. The possibility of an IgE-mediated allergic mechanism and the role of histamine remains controversial. The aim of the present study was the evaluation of serum total IgE and histamine levels in migraine patients and the intluence of allergy on them. 70 patients (18-58 years) with migraine without aura were divided in to 2 groups according to their history of allergy (60% with and 40% without allergy). Serum samples were collected during fasting without allowing any premedication in 2 conditions of attack and remission periods. There was a control group containing 45 healthy volunteers. Serum total IgE and histamine levels were measured by ELISA and fluorimetric methods respectively. Mean and standard error of serum histamine (ng/ml) and total IgE (lU/mI) levels were found in control group as 48.16+/-2.70, 38.31+/-3.20 and in migraine with an allergy group as 159.11+/-4.60, 303.30+/-42.50 and in migraine without an allergy group as 105.01 +/-8.50, 79.07+/-2.70 respectively. Total IgE levels in migraine group with allergy were found significantly (P<0.0001) above the control and another group suggesting an influence of an IgE-mediated mechanism on migraine. Plasma histamine levels were significantly elevated (P<0.0001) in patients with migraine both during headache and symptom-free periods compared with control group although it shows that there is an increased susceptibility to histamine in allergic conditions, nonetheless this molecule has also an unrelated role in migraine. The relationship between allergy and migraine can be based in part on IgE-mediated mechanism, with histamine release playing an important role. Thus avoidance of allergic conditions in migraine patients may be a simple helpful way to prophylaxis or their treatment.
Iran J Allergy Asthma Immunol 2003 Mar
PMID:A Correlation between Migraine, Histamine and Immunoglobulin E. 1730 52

Long-term intravenous immunoglobulin (IVIG) infusion is an effective treatment for children with humoral immunodeficiencies, already be complicated by systemic adverse effects. In order to determine the adverse effects of intravenous immunoglobulin in patients with antibody deficiency, 45 immunodeficient patients receiving intravenous immunoglobulin were studied during a 36 month period at Children's Medical Center. The investigated group included 25 patients with common variable immunodeficiency, 14 patients with X-linked agammaglobulinemia and 6 patients with IgG subclass deficiency. A total of fifty adverse effects occurred through 955 infusions (5.2%). The most frequent immediate adverse effects were mild (40 infusions out of 955) in 22 cases, including: chills, flushing, fever, nausea and headache. Three patients experienced moderate effects (10 infusions out of 955) such as rash, severe headache, joint pain and chest tightness. None of the effects was anaphylactic type. It can be concluded that intravenous immunoglobulin is generally a well-tolerated medical agent for patients with antibody deficiency, but all patients should be monitored by a physician who is familiar with its indications, risks, adverse effects and their appropriate management.
Iran J Allergy Asthma Immunol 2003 Sep
PMID:Adverse effects of intravenous immunoglobulin therapy in patients with antibody deficiency. 1730 67

Sodium fluorescein (SF) is widely used to assess chorioretinal disorders. Adverse reactions are well documented but the underlying mechanism is still uncertain. The aim of this study was the evaluation of skin testing to predict SF reaction, the identification of possible predisposing factors, and the objective record of the reported reactions. All patients with adequate indication for SF angiography (SFA) during an 18-month period were evaluated as follows: (a) detailed personal history of atopy, diabetes, previous SFA, and/or diagnostic procedures with radiocontrast media (RCM) and possible side effect; (b) skin testing with SF 10% diluted preparations; (c) SFA with 5 mL of SF, objective record of any reaction. Two hundred twenty-four patients (108 men and 116 women) with a mean age of 65.2 years (SD, 12.86; range, 16-92 years) underwent SFA. The overall rate of adverse reactions was 3.6% (8/224), which consists of 5 (2.2%) individuals with transient mild nausea; 2 (0.9%) subjects with face and upper trunk flushing that appeared in one case after 60 minutes and in the other case 24 hours later and both resolved without treatment, and I subject with transient bilateral frontal headache and dizziness. None of the 224 patients had positive skin or intradermal testings. One hundred thirty-six of 224 (60.7%) patients stated no previous SFA and 74.1% had not performed RCM injection. None of the recorded variables correlated with increased risk of reaction. SFA is a safe procedure with minor adverse effects. Although in vivo testing can not identify reactors it may help to exclude an underlying IgE-mediated mechanism in susceptible individuals.
Allergy Asthma Proc
PMID:Skin testing and adverse reactions in fluorescein: a prospective study. 1788 17

Seasonal allergic rhinitis (SAR) treatment should reduce symptoms and help patients resume normal function. This study was performed to determine the effect of olopatadine (Olo) nasal spray on symptoms, quality of life (QoL), work, and activities of SAR patients. A pooled analysis was conducted of two Institutional Review Board-approved, randomized, double-blind clinical trials that compared 2-week treatment with Olo 0.6% and Olo 0.4% to placebo. Symptoms were assessed with the Total Nasal Symptom Score (TNSS) from daily diaries. Health outcomes were measured by the Work Productivity and Activity Impairment Questionnaire-Allergy Specific (WPAI-AS) and Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ). The studies included 1240 SAR patients with a mean age of 37 years; 64% were women. TNSS and RQLQ improvements were significantly different from placebo: TNSS, Olo 0.6% (p < 0.0001) and Olo 0.4% (p < 0.0037); RQLQ, Olo 0.6% (p < 0.001) and Olo 0.4% (p < 0.05). WPAI-AS improvements also were significant for overall work impact and activity impairment in the Olo 0.6% (p < 0.001) and Olo 0.4% (p < 0.05). Correlations between Olo 0.6% TNSS scores and work impact were r = 0.45 (p < 0.0001); activities, r = 0.55 (p < 0.0001); and RQLQ score, r = 0.61 (p < 0.0001), indicating that symptom reduction with Olo therapy was associated with improvements in function and QoL. Adverse events were nonserious and infrequent in all treatment groups. The most frequent adverse events were unpleasant taste and headache. This analysis indicates that Olo is a safe and effective intranasal treatment and is associated with significant improvement in QoL and ability to perform work and conduct usual activities of SAR patients.
Allergy Asthma Proc
PMID:Comprehensive report of the efficacy, safety, quality of life, and work impact of Olopatadine 0.6% and Olopatadine 0.4% treatment in patients with seasonal allergic rhinitis. 1820 38

A woman with multiple illnesses including allergic rhinitis presented for a follow-up visit at our clinic with constant rhinorrhea for 2 weeks despite regular use of nasal corticosteroids. Two weeks earlier, after alcohol drinking and doubling some of her medications for missed doses, she fell on her face. The Emergency Department records documented headache, bradycardia, hypotension, dehydration, and right infraorbital swelling. She was admitted for hydration and observation, and was discharged after two days without radiologic evaluation of the head. At our clinic, physical examination revealed pale turbinates bilaterally and clear watery discharge from the right nostril. Cerebrospinal fluid (CSF) rhinorrhea was suspected, but glucose testing was not available at our clinic. The patient was immediately admitted into the hospital. A beta-2-transferrin test confirmed CSF from the right nostril. High resolution sinus CT revealed fluid in the right sphenoid sinus, a large cyst in the left maxillary sinus, a cribriform plate dehiscence on the right side, and fluid collection adjacent to the middle turbinate. A lumbar drain was placed to release the pressure and antibiotic prophylaxis was started. Nasal endoscopy revealed CSF leak from the cribriform plate with bone dehiscence and a dural tear. A graft from nasal septal cartilage and temporalis fascia was applied using Tisseal fibrin glue. The persistent rhinorrhea resolved and on follow-up visits, the patient remained asymptomatic. Thinking of CSF rhinorrhea in the differential diagnosis of rhinitis would lead to early diagnosis and prevention of serious medical complications and potential legal liabilities.
Allergy Asthma Proc
PMID:Rhinorrhea not responding to nasal corticosteroids. 1820 40

Allergic rhinitis (AR) often requires regular prophylactic use of allergy medications for the effective long-term management of nasal symptoms. However, patient adherence to AR treatment is frequently poor. The Allergies in America survey of nasal allergy sufferers assessed 2500 adults diagnosed with AR. Four hundred healthcare professionals also participated in this survey. Participants were interviewed about their perceptions of the effectiveness and tolerability of AR medications and the relationship of these parameters to patient satisfaction with therapy. Only 15% of nasal allergy sufferers reported that their intranasal corticosteroid (INCS) provided complete symptom relief, and 48% of patients indicated that their INCS did not provide 24-hour symptom relief. Healthcare professionals agreed that intranasal corticosteroids do not provide complete 24-hour symptom relief. The most commonly reported adverse effects of all nasal allergy medications were a drying feeling (47%), dripping down the throat (41%), drowsiness (37%), bad taste (32%), burning (17%), and headaches (16%). Many patients indicated that these adverse effects were moderately or extremely bothersome. Thirty-two percent and 25% of patients, respectively, discontinued treatment because their nasal allergy medications did not provide 24-hour symptom relief or were associated with bothersome adverse effects. Patients and healthcare professionals do not believe that INCSs provide complete 24-hour symptom relief. In general, allergy medications also are perceived as conferring unpleasant adverse effects. Lack of efficacy and bothersome adverse effects contribute to lack of satisfaction with treatment and treatment discontinuation in patients with AR.
Allergy Asthma Proc
PMID:Patient and physician perspectives on the attributes of nasal allergy medications. 1830 39


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