RESUMO
BACKGROUND: A recombinant humanized anti-IgE mAb, omalizumab, forms complexes with free IgE, blocking its interaction with mast cells and basophils; as a consequence, it might be effective in the treatment of asthma. OBJECTIVE: The purpose of this study was to evaluate the efficacy and safety of omalizumab in the treatment of inhaled corticosteroid-dependent asthma. METHODS: In this phase III, double-blinded, placebo-controlled trial, 525 subjects with severe allergic asthma requiring daily inhaled corticosteroids were randomized to receive placebo or omalizumab subcutaneously every 2 or 4 weeks, depending on baseline IgE level and body weight. Inhaled corticosteroid doses were kept stable over the initial 16 weeks of treatment and tapered during a further 12-week treatment period. RESULTS: Omalizumab treatment resulted in significantly fewer asthma exacerbations per subject and in lower percentages of subjects experiencing an exacerbation than placebo treatment during the stable steroid phase (0.28 vs 0.54 [P =.006] and 14.6% vs 23.3% [P =.009], respectively) and during the steroid reduction phase (0.39 vs 0.66 [P =.003] and 21.3% vs 32.3% [P =.004], respectively). Beclomethasone dipropionate reduction was significantly greater with omalizumab treatment than with placebo (median 75% vs 50% [P <.001]), and beclomethasone dipropionate discontinuation was more likely with omalizumab (39.6% vs 19.1% [P <.001]). Improvements in asthma symptoms and pulmonary function occurred along with a reduction in rescue beta-agonist use. Omalizumab was well tolerated, with an adverse-events profile similar to that of placebo. CONCLUSION: The addition of omalizumab to standard asthma therapy reduces asthma exacerbations and decreases inhaled corticosteroid and rescue medication use.
Assuntos
Antialérgicos/uso terapêutico , Antiasmáticos/uso terapêutico , Anticorpos Monoclonais/uso terapêutico , Asma/tratamento farmacológico , Imunoglobulina E/imunologia , Adolescente , Adulto , Idoso , Antialérgicos/efeitos adversos , Antiasmáticos/efeitos adversos , Anticorpos Anti-Idiotípicos , Anticorpos Monoclonais/efeitos adversos , Anticorpos Monoclonais Humanizados , Criança , Feminino , Humanos , Imunoglobulina E/sangue , Masculino , Pessoa de Meia-Idade , Omalizumab , Testes de Função RespiratóriaRESUMO
BACKGROUND: Olopatadine ophthalmic solution 0.1% (Patanol, Alcon Laboratories, Fort Woth, TX) is approved for the treatment of the signs and symptoms of allergic conjunctivitis. Loratadine 10 mg (Claritin, Schering-Plough, Madison, NJ) is a nonsedating oral antihistamine approved for the treatment of the signs and symptoms of allergic rhinitis. OBJECTIVE: To compare the efficacy of olopatadine used adjunctively with loratadine versus loratadine alone in patients with seasonal allergic conjunctivitis. METHODS: This three-center, observer-masked, treatment-controlled, randomized, parallel-group study involved patients aged 7 to 74 years with seasonal allergic conjunctivitis. Patients were treated for 7 days with either olopatadine twice daily adjunctive to loratadine once daily or only loratadine once daily. Efficacy variables (ocular itching and redness, physician's impression, patient's impression, patient diary ratings of ocular redness and itching), and safety parameters were evaluated during the screening visit and on days 0, 3, and 7. Patients completed the rhinoconjunctivitis quality of life questionnaire on days 0 and 7. RESULTS: Ninety-four patients received study drug. Patients receiving olopatadine twice daily in addition to loratadine once daily exhibited less ocular itching (P = 0.0436) and rated their ocular condition as more improved compared with those receiving loratadine alone (P < 0.0022). Twenty minutes after initial dosing, olopatadine plus loratadine relieved ocular itching and redness significantly better than loratadine alone (P = 0.001). Both treatment groups showed clinically meaningful improvements in overall quality of life in all but one of the rhinoconjunctivitis quality of life questionnaire domains. Overall, and in most domains, olopatadine plus loratadine also provided significantly better (P < 0.05) quality of life than loratadine alone at day 7. CONCLUSIONS: Compared with loratadine alone, olopatadine adjunctive to loratadine provides greater relief of ocular itching and redness, a better quality of life, and is well tolerated in patients with seasonal allergic conjunctivitis.
Assuntos
Conjuntivite Alérgica/tratamento farmacológico , Dibenzoxepinas/uso terapêutico , Loratadina/uso terapêutico , Adolescente , Adulto , Idoso , Astenia/induzido quimicamente , Criança , Dibenzoxepinas/efeitos adversos , Quimioterapia Combinada , Dispepsia/induzido quimicamente , Feminino , Humanos , Loratadina/efeitos adversos , Masculino , Pessoa de Meia-Idade , Cloridrato de Olopatadina , Xerostomia/induzido quimicamenteAssuntos
Corticosteroides/uso terapêutico , Agonistas Adrenérgicos beta/uso terapêutico , Albuterol/análogos & derivados , Albuterol/uso terapêutico , Asma/tratamento farmacológico , Administração por Inalação , Corticosteroides/administração & dosagem , Agonistas Adrenérgicos beta/administração & dosagem , Albuterol/administração & dosagem , Quimioterapia Combinada , Humanos , Xinafoato de SalmeterolRESUMO
This randomized, double-blind, double-dummy, parallel group clinical trial compared the efficacy and safety of adding salmeterol xinafoate to concurrent inhaled beclomethasone dipropionate therapy with doubling the dose of beclomethasone dipropionate in patients experiencing symptoms on low-dose beclomethasone. Salmeterol added to low-dose beclomethasone was superior (p < or = 0.05) to doubling the dose of beclomethasone in improving peak expiratory flow (PEF) and forced expiratory volume in 1 sec (FEV1), and in reducing symptoms of asthma, sleep loss, nighttime awakenings, and use of albuterol. Both treatment regimens had comparable safety profiles. In asthma patients inadequately controlled despite the use of low-dose inhaled corticosteroids (i.e., less than 400 microg per day), the addition of salmeterol may be a more effective treatment option than doubling the dose of inhaled corticosteroids.
Assuntos
Albuterol/análogos & derivados , Antiasmáticos/uso terapêutico , Asma/tratamento farmacológico , Beclometasona/uso terapêutico , Broncodilatadores/uso terapêutico , Administração por Inalação , Adolescente , Adulto , Idoso , Albuterol/efeitos adversos , Albuterol/uso terapêutico , Antiasmáticos/administração & dosagem , Antiasmáticos/efeitos adversos , Asma/fisiopatologia , Beclometasona/administração & dosagem , Beclometasona/efeitos adversos , Broncodilatadores/efeitos adversos , Relação Dose-Resposta a Droga , Método Duplo-Cego , Combinação de Medicamentos , Feminino , Volume Expiratório Forçado/efeitos dos fármacos , Humanos , Masculino , Prontuários Médicos , Pessoa de Meia-Idade , Pico do Fluxo Expiratório/efeitos dos fármacos , Xinafoato de SalmeterolRESUMO
BACKGROUND: Suppression of adrenocortical function, a risk associated with oral corticosteroids, is minimized with intranasal corticosteroids. Triamcinolone acetonide (TAA) aqueous nasal spray, at therapeutic doses, has no measurable effect on adrenocortical function in adults with allergic rhinitis. OBJECTIVE: This double-blind, placebo-controlled study compared the effect of once-daily TAA aqueous nasal spray (220 or 440 microg) with placebo on adrenocortical function after 6 weeks of treatment in pediatric (children 6 to 12 years of age) patients with allergic rhinitis. The pharmacokinetic profile of TAA was examined after once-daily intranasal administration of TAA aqueous nasal spray 440 microg for 6 weeks. METHODS: Eighty children received TAA aqueous nasal spray 220 microg or 440 microg or placebo for 6 weeks. Adrenocortical function was assessed by analyzing plasma cortisol levels before stimulation (0 hour) and at 30 and 60 minutes after a rapid 1-hour intravenous cosyntropin stimulation test performed before treatment and after 6 weeks of treatment. Samples for pharmacokinetic evaluation were collected from 19 patients at baseline (0 hour) and at 0.5, 1, 1.5, and 6 hours after the final dose of study medication. RESULTS: After 6 weeks, no significant effects on adrenocortical function were observed at 30 or 60 minutes after cosyntropin stimulation with either dose of TAA aqueous nasal spray. TAA concentrations in plasma showed rapid elimination of the drug, with little or no accumulation. CONCLUSIONS: TAA aqueous nasal spray (220 or 440 microg/day) has no measurable effect on adrenocortical function in pediatric patients with allergic rhinitis. Pharmacokinetic parameters after 440 microg/day of TAA aqueous nasal spray indicate a rapid decline of plasma drug levels, with little or no systemic accumulation of study drug.
Assuntos
Córtex Suprarrenal/efeitos dos fármacos , Córtex Suprarrenal/fisiopatologia , Glucocorticoides/efeitos adversos , Glucocorticoides/uso terapêutico , Rinite Alérgica Perene/tratamento farmacológico , Rinite Alérgica Perene/fisiopatologia , Rinite Alérgica Sazonal/tratamento farmacológico , Rinite Alérgica Sazonal/fisiopatologia , Triancinolona Acetonida/efeitos adversos , Triancinolona Acetonida/uso terapêutico , Administração por Inalação , Criança , Método Duplo-Cego , Feminino , Glucocorticoides/farmacocinética , Humanos , Masculino , Placebos , Triancinolona Acetonida/farmacocinética , Água/químicaAssuntos
Asma/tratamento farmacológico , Teofilina/uso terapêutico , Agonistas Adrenérgicos beta/uso terapêutico , Beclometasona/uso terapêutico , Broncodilatadores/uso terapêutico , Criança , Ensaios Clínicos como Assunto , Cromolina Sódica/uso terapêutico , Humanos , Metaproterenol/uso terapêutico , Ensaios Clínicos Controlados Aleatórios como Assunto , Teofilina/efeitos adversosRESUMO
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.
Assuntos
Ciproeptadina/análogos & derivados , Efedrina/uso terapêutico , Antagonistas dos Receptores Histamínicos/uso terapêutico , Rinite Alérgica Sazonal/tratamento farmacológico , Adolescente , Adulto , Idoso , Criança , Ciproeptadina/efeitos adversos , Ciproeptadina/uso terapêutico , Combinação de Medicamentos , Efedrina/efeitos adversos , Feminino , Humanos , Loratadina , Masculino , Pessoa de Meia-Idade , Estudos Multicêntricos como Assunto , Placebos , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
A prospective, randomized, double-masked study of three commercially available ocular decongestant products was conducted to compare their relative efficacies in the treatment of allergic conjunctivitis. All three products contained a vasoconstrictor (naphazoline hydrochloride) and an antihistamine (antazoline phosphate or pheniramine maleate) in varying concentrations. Eighty-nine (89) patients presenting the ocular signs and symptoms of allergic conjunctivitis were enrolled and randomly distributed among the three treatment groups. Patients were evaluated for three ocular signs (lid swelling, bulbar conjunctival inflammation and palpebral conjunctival inflammation) and three ocular symptoms (itching, tearing and discomfort). An overall follow-up impression of treatment results was also recorded. The treatment period lasted one week. The three preparations were found to vary greatly in patient comfort and acceptability but were not different in their ability to ameliorate the itching, tearing, redness, edema and discomfort when dosed topically for the relief of allergic conjunctivitis.
Assuntos
Conjuntivite/tratamento farmacológico , Hipersensibilidade/tratamento farmacológico , Antazolina/uso terapêutico , Ensaios Clínicos como Assunto , Método Duplo-Cego , Feminino , Humanos , Masculino , Nafazolina/uso terapêutico , Soluções Oftálmicas , Pacientes Desistentes do Tratamento , Feniramina/uso terapêutico , Distribuição AleatóriaAssuntos
Conjuntivite/tratamento farmacológico , Antagonistas dos Receptores Histamínicos H1/uso terapêutico , Hipersensibilidade/tratamento farmacológico , Vasoconstritores/uso terapêutico , Adulto , Antazolina/uso terapêutico , Ensaios Clínicos como Assunto , Conjuntivite/induzido quimicamente , Combinação de Medicamentos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Nafazolina/uso terapêutico , Feniramina/uso terapêutico , Estudos Prospectivos , Distribuição Aleatória , p-Metoxi-N-metilfenetilaminaRESUMO
A retrospective review of 740 charts of patients with a history of adverse reaction to tetanus toxoid immunization was undertaken. The most common reactions, by history, were local edema and tenderness (33%), fever (15%), and anaphylactoid response (33%). Three patients who had a vesicular eruption at the immunization site were found to have delayed hypersensitivity to mercury. Thirty percent of the patients had received tetanus toxoid within one year and 55% within five years of evaluation. Reactive responses to immediate skin tests were exceedingly rare (less than 1%). None of the challenge patients suffered an adverse reaction.