The incidence of asthma has been positively associated with obesity. Asthma comprises diverse ''phenotypes'' reflecting heterogeneity in a number of characteristics, including response to therapy. The present authors examined whether body mass index (BMI) influenced the response to placebo, as well as to two asthma controller medications.A post hoc analysis was performed, pooling data from four double-blind, placebo-controlled studies randomising 3,073 moderate asthmatic adults to montelukast (n51,439), beclomethasone (n5894) or placebo (n5740). The primary end point was asthma control days; other end points were forced expiratory volume in one second, b-agonist use and nocturnal awakening. Analyses were conducted using BMI classification into normal (,25.0 kg?m ; 16%) categories, as well as BMI as a continuous variable.The treatment groups were balanced for BMI, demographic characteristics and parameters of asthma control. The placebo response for all end points was generally lower with increasing BMI. Similarly, the response to the inhaled corticosteroid decreased, whereas the response to the leukotriene antagonist remained stable.In conclusion, post hoc data from the present study suggested that body mass index may influence the natural history of asthma control (as reflected by response to placebo) and may differentially influence response to the two active agents, warranting explicit testing in future prospective studies.
Background: Sitagliptin, a highly selective dipeptidyl peptidase-4 inhibitor, is the first in a new class of oral antihyperglycemic agents (AHAs) for the treatment of patients with type 2 diabetes. Type 2 diabetes is a life-long disease requiring chronic treatment and management. Therefore, robust assessment of the long-term safety and tolerability of newer therapeutic agents is of importance. The purpose of this analysis was to assess the safety and tolerability of sitagliptin by pooling 12 large, double-blind, Phase IIb and III studies up to 2 years in duration. Methods: This analysis included 6139 patients with type 2 diabetes receiving either sitagliptin 100 mg/day (N = 3415) or a comparator agent (placebo or an active comparator) (N = 2724; non-exposed group). The 12 studies from which this pooled population was drawn represent the double-blind, randomized, Phase IIB and III studies that included patients treated with the clinical dose of sitagliptin (100 mg/day) for at least 18 weeks up to 2 years and that were available in a single safety database as of November 2007. These 12 studies assessed sitagliptin as monotherapy, initial combination therapy with metformin, or add-on combination therapy with other oral AHAs (metformin, pioglitazone, sulfonylurea, sulfonylurea + metformin, or metformin + rosiglitazone). Patients in the non-exposed group were taking placebo, pioglitazone, metformin, sulfonylurea, sulfonylurea + metformin, or metformin + rosiglitazone. This safety analysis used patient-level data from each study to evaluate clinical and laboratory adverse experiences.
The phase III AZA-001 study established that azacitidine significantly improves overall survival compared with conventional care regimens (hazard ratio 0.58 [95% confidence interval 0.43-0.77], P<0.001). This analysis was conducted to investigate the relationship between treatment response and overall survival. AZA-001 data were analyzed in a multivariate Cox regression analysis with response as a time-varying covariate. Response categories were "Overall Response" (defined as complete remission, partial remission, or any hematologic improvement) and "Stable Disease" (no complete or partial remission, hematologic improvement, or progression) or "Other" (e.g. disease progression). Achieving an Overall Response with azacitidine reduced risk of death by 95% compared with achieving an Overall These results demonstrate azacitidine benefit on overall survival compared with conventional care regimens in patients with higher-risk myelodysplastic syndromes who achieve hematologic response but never attain complete or partial remission, in addition to the survival advantage conferred by achievement of complete or partial remission. This study was registered with clinicaltrials.gov (NCT00071799).A multivariate analysis of the relationship between response and survival among patients with higher-risk myelodysplastic syndromes treated within azacitidine or conventional care regimens in the randomized AZA-001 trial
In the subgroup of asthmatic patients with AR, a combined treatment approach that included montelukast and budesonide provided significantly greater efficacy in reducing airflow obstruction compared with doubling the dose of budesonide. These results support recommendations by the Allergic Rhinitis and its Impact on Asthma initiative that suggest a unified approach aimed at treating the airway inflammation common to both diseases is beneficial for the large proportion of asthmatics who also suffer from AR.
Purpose. Myelodysplastic syndromes (MDSs) are a heterogenous group of clonal hematopoietic disorders affecting approximately 60,000 people in the U.S. Little information is available regarding how aware MDS patients are of their disease severity, prognosis, and treatment outcomes.Methods. This Internet-based survey assessed patient perceptions regarding these factors, determined differences between patients with higher-and lower-risk disease and between those receiving active treatment and supportive care, and assessed patient-reported outcomes.Results. Among 358 patients (median age, 65 years), the median time since MDS diagnosis was 3 years and time from initial hematologic abnormality detection was 6 years. Many patients (55%) did not know their International Prognostic Scoring System score, 42% were unaware of their blast percentage, and 28% were unaware of their cytogenetics. Patients were unlikely to recall having their MDS described as cancer (7%), 37% felt their treatment would improve survival, and 16% felt treatment would be curative. Patients receiving active treatment were more likely to believe their therapy would prolong survival than those receiving supportive care (52% versus 31%; p < .001) or be curative (23% versus 14%; p ؍ .03). Patients with higher-risk disease were more likely to think their therapy would be curative than those with lower-risk disease (26% versus 11%; p ؍ .01). Patients with MDS reported poor phys-
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