US Renal Data System 2012 Annual Data Report Collins, Allan J., MD; Foley, Robert N., MB; Herzog, Charles, MD ...
American journal of kidney diseases,
01/2013, Letnik:
61, Številka:
1
Journal Article
US Renal Data System 2013 Annual Data Report Collins, Allan J., MD; Foley, Robert N., MB; Chavers, Blanche, MD ...
American journal of kidney diseases,
01/2014, Letnik:
63, Številka:
1
Journal Article
US Renal Data System 2011 Annual Data Report Collins, Allan J., MD; Foley, Robert N., MB; Chavers, Blanche, MD ...
American journal of kidney diseases,
01/2012, Letnik:
59, Številka:
1
Journal Article
Background In North America and Europe, millions of patients experience symptoms of allergic rhinitis with or without conjunctivitis (AR/C) on exposure to ragweed pollen. The disease burden can be ...significant, with most patients relying on symptomatic medications without disease-modifying potential. However, novel sublingual immunomodulatory treatment options may potentially play an important role if efficacy and side effect profiles allow the convenience of self-administration. Objectives This study evaluated an allergy immunotherapy tablet (AIT; SCH 39641/MK-3641) for treatment of ragweed-induced AR/C in the first large randomized, double-blind multinational trial of this therapeutic modality for ragweed allergy. Methods Adults (n = 784) with short ragweed-induced AR/C were randomly assigned to approximately 52 weeks of daily self-administered ragweed AIT of 1.5, 6, or 12 units of Ambrosia artemisiifolia major allergen 1 (Amb a 1-U) or placebo. Subjects could use as-needed allergy rescue medication. Symptoms and medications were recorded daily. The primary efficacy end point was total combined daily symptom/medication score (TCS) during peak ragweed season. Safety was monitored through adverse event diaries maintained through study duration. Results During peak ragweed season, ragweed AIT of 1.5, 6, and 12 Amb a 1-U reduced TCS by 9% (−0.76; P = .22), 19% (−1.58; P = .01), and 24% (−2.04; P = .002) compared with placebo. During the entire season, ragweed AIT of 1.5, 6, and 12 Amb a 1-U reduced TCS by 12% (−0.88; P = .09), 18% (−1.28; P = .01), and 27% (−1.92; P < .001) compared with placebo. Treatment was well tolerated; no systemic allergic reactions occurred. Conclusions In this trial, ragweed AIT of 12 Amb a 1-U was effective and tolerable with a safety profile that permitted daily self-administration of ragweed allergen immunotherapy.
To summarize adverse events reported in randomized controlled trials that applied progressive resistance strength training in older adults and to examine factors that might be associated with these ...events.
After systematic searches of databases, 2 reviewers independently screened and extracted adverse event-related information from identified trials.
Not applicable.
Older adults 60 years of age and above (N = 6700).
Muscle strength training exercise that increases load gradually.
Adverse events and reasons for dropout. Adverse events include any undesirable outcomes that may be directly related or unrelated to the intervention.
Among 121 trials identified, 53 trials provided no comments about adverse events, 25 trials reported no adverse events occurred, and 43 trials reported some types of adverse events. Most adverse events reported were musculoskeletal problems such as muscle strain or joint pain. Adverse events were reported more often in trials that recruited participants with certain health conditions, functional limitations, or sedentary lifestyle; in trials that applied high intensity; and in trials that were published after the 2001 Consolidated Standards of Reporting Trials statement had been published. Reasons reported for dropout in 58 trials might be related to adverse events. The most frequent reasons for dropout were illness or medical problems.
Adverse events may be underreported because there is no consensus on the definition. Reporting adverse events associated with progressive resistance strength training in older adults is informative for practitioners to translate clinical research to clinical practice by knowing both the benefits and risks. Future trials should clearly define adverse events and report them in the published article.
Ragweed is an important cause of allergic rhinitis with or without conjunctivitis (AR/C) in North America and elsewhere. Allergen immunotherapy enabling safe patient self-administration is considered ...an unmet clinical need. Allergy immunotherapy tablet (AIT) treatment has shown promising efficacy and safety for grass allergy but has not been assessed for ragweed allergy.
To evaluate efficacy and safety of 2 short ragweed AIT doses in patients with AR/C.
Adults with ragweed pollen-induced AR/C were randomized 1:1:1 to daily ragweed AIT (6 or 12 Amb a 1 units) or placebo before, throughout, and after ragweed season (approximately 52 weeks). Patients could use predefined allergy rescue medications in season. Efficacy end points included peak and entire season total combined score (TCS) and its components daily symptom score (DSS), and daily medication score (DMS). Safety assessments included adverse events.
A total of 565 patients were randomized. During peak season, the 6- and 12-Amb a 1 unit ragweed AIT doses showed 21% (-1.76 score) and 27% (-2.24 score) improvement in TCS vs placebo (P < .05). The 6- and 12-Amb a 1 unit AIT doses significantly improved DSS and DMS vs placebo (P < .05). Peak and entire season efficacy were comparable. The 12-Amb a 1 unit AIT dose reduced peak-season TCS vs placebo by 21% and 25% in subgroups with and without local application-site reactions, respectively. Most treatment-related adverse events were mild, oral reactions; no systemic allergic reactions were reported. One patient in the 6-Amb a 1 unit group received epinephrine at an emergency facility for sensation of localized pharyngeal edema.
In this trial, ragweed AIT was effective and well tolerated in ragweed-allergic North American adults.
clinicaltrials.gov Identifier: NCT00783198.
Background Prostaglandin D2 is a proinflammatory mediator believed to be important in asthma and allergic rhinitis (AR). Allelic variants in the prostaglandin D2 receptor type 1 (DP1) gene (PTGDR) ...have been suggested to be associated with asthma susceptibility. Objectives We sought to investigate the efficacy of the DP1 antagonist laropiprant (alone or with montelukast) in asthma and seasonal AR and explore whether sequence variations in PTGDR are associated with asthma severity. Methods For asthma, in a double-blind crossover study, 100 patients with persistent asthma were randomized to placebo or laropiprant, 300 mg/d for 3 weeks, followed by addition of montelukast, 10 mg/d for 2 weeks. PTGDR promoter haplotypes were categorized as high, medium, or low transcriptional efficiency. The primary efficacy end point was FEV1 . For AR, in a double-blind parallel-group study, 767 patients sensitized to a regionally prevalent fall allergen with symptomatic fall rhinitis were allocated to laropiprant, 25 mg/d or 100 mg/d; cetirizine, 10mg/d; or placebo for 2 weeks. The primary end point was the Daytime Nasal Symptoms Score. Results For asthma, no significant differences in FEV1 or asthma symptoms were noted for laropiprant versus placebo or laropiprant plus montelukast vs montelukast (differences between montelukast and placebo: P ≤ .001). No clear association was seen between haplotype pair (ie, diplotype) and asthma severity. For AR, although cetirizine (vs placebo) demonstrated an improvement in the Daytime Nasal Symptoms Score ( P < .001), laropiprant did not. Conclusion Laropiprant did not demonstrate efficacy in asthmatic patients or patients with AR. Variations in PTGDR did not appear related to baseline asthma severity or treatment response (NCT00533208; NCT00783601).
This review summarizes the findings of randomized controlled trials of progressive resistance training (PRT) by older people with osteoarthritis (OA). A significant benefit was found in ...lower-extremity extensor strength, function, and pain reduction. Across all 3 outcomes, the estimated effect size was moderate, which contrasted with trials of PRT in non-OA-specific groups of older adults where a large effect was found in strength but a small effect on function. This suggests that strength training has strong functional benefits for older adults with OA. Older adults with OA benefit from a strength-training program that provides progressive overload to maintain intensity throughout an exercise program.
Background Classifying asthma severity or activity has evolved, but there are no published weighted composite measures of asthma disease activity that account for the relative importance of the many ...individual clinical variables that are widely used. Objectives We sought to develop a weighted and responsive measure of asthma disease activity. Methods Discriminant and multiple regression analyses based on 2 previously conducted clinical trials were used to develop the Asthma Disease Activity Score (ADAS-6). Results The ADAS-6 demonstrated content validity because its components assess different manifestations of asthma: FEV1 (percent predicted), Asthma Quality of Life Questionnaire–Symptom domain, rescue β-agonist use, nocturnal awakenings, peak expiratory flow diurnal variability, and rescue β-agonist use diurnal variability. The ADAS-6 demonstrated cross-sectional and longitudinal validity. It was discriminating: it distinguished levels of disease activity and response to different treatment intensities ( P < .0001). Similar results were obtained with an independent clinical trial. The ADAS-6 was highly responsive to treatment effects, with a standardized effect size exceeding that of other widely used outcome measures. Using ADAS-6 as the primary end point in the montelukast pivotal trials would have significantly reduced the sample size needed to detect a comparable change in outcome. Furthermore, increments in the ADAS-6 predicted the risk of future asthma attacks. A simplified Asthma Disease Activity Score 4-variable version (ADAS-4) demonstrated similar measurement properties. Conclusions The ADAS-6 and ADAS-4 are novel, weighted, and responsive measures of asthma disease activity. Use of these measures in clinical trials might better separate treatment effects, predict future asthma attacks, and substantially reduce sample size.
The cardioprotective effects of long-chain n-3 polyunsaturated fatty acids (PUFAs) and fish consumption have been observed. However, data on the specific associations of these dietary factors with ...inflammation and endothelial activation are sparse. A cross-sectional study was conducted of 5,677 men and women from the Multi-Ethnic Study of Atherosclerosis (MESA) cohort, including African Americans, Caucasians, Chinese, and Hispanics aged 45 to 84 years and free of clinical cardiovascular disease. Dietary information was collected using a self-administered food frequency questionnaire. Multivariate linear regression analyses were used to examine relations between the intake of long-chain n-3 PUFAs, nonfried fish, and fried fish and biomarkers of inflammation and endothelial activation. Long-chain n-3 PUFA intake was inversely associated with plasma concentrations of interleukin-6 (p = 0.01) and matrix metalloproteinase–3 (p = 0.03) independent of age, body mass index, physical activity, smoking, alcohol consumption, and dietary variables. Nonfried fish consumption was inversely related to C-reactive protein (p = 0.045) and interleukin-6 (p <0.01), and fried fish consumption was inversely related to soluble intercellular adhesion molecule–1 (p <0.01) but was not associated with other biomarkers after adjustment for potential confounders. In conclusion, the results of this study suggest that the dietary intake of long-chain n-3 PUFAs and fish is inversely associated with concentrations of some biomarkers, reflecting lower levels of inflammation and endothelial activation. These results may partially explain the cardioprotective effects of fish consumption.
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