By Dr Arun M, KMC Mangalore
Pulmonary Hypertension PowerPoint presentation.
The presentation gives a overview of etiology, pathogenesis , diagnosis and management of pulmonary hypertension. Please download the PowerPoint presentation from the link below
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FDA regulations for e cigarettes released.
By Dr Deepu
After years of debate about the health risks of electronic cigarettes, the federal government on Thursday made it final: They need to be regulated and kept out of the hands of children.
The Food and Drug Administration issued sweeping new rules that for the first time extend federal regulatory authority to e-cigarettes, banning their sale to anyone under 18 and requiring that adults under the age of 26 show a photo identification to buy them.
Statistics about the Use
More than 3 million middle and high school students were current users of e-cigarettes in 2015, up from an estimated 2.46 million in 2014.
Sixteen percent of high school and 5.3 percent of middle school students were current users of e-cigarettes in 2015, making e-cigarettes the most commonly used tobacco product among youth for the second consecutive year.
During 2011-2015, e-cigarette use rose from 1.5 percent to 16.0 percent among high school students and from 0.6 percent to 5.3 percent among middle school students.
In 2013-2014, 81% of current youth e-cigarette users cited the availability of appealing flavors as the primary reason for use.
In 2014, 12.6% of U.S. adults had ever tried an e-cigarette, and about 3.7% of adults used e-cigarettes daily or some days.
In 2016, FDA finalized a rule extending our regulatory authority to cover all tobacco products, including vaporizers, vape pens, hookah pens, electronic cigarettes (e-cigs), e-pipes, and all other ENDS. FDA now regulates the manufacture, import, packaging, labeling, advertising, promotion, sale, and distribution of ENDS. This includes components and parts of ENDS* but excludes accessories.
However, products marketed for therapeutic purposes (for example, marketed as a product to help people quit smoking) are regulated by the FDA through the Center for Drug Evaluation and Research (CDER). FDA recently proposed a rule clarifying the jurisdiction over tobacco products, drugs, and devices.
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After years of debate about the health risks of electronic cigarettes, the federal government on Thursday made it final: They need to be regulated and kept out of the hands of children.
The Food and Drug Administration issued sweeping new rules that for the first time extend federal regulatory authority to e-cigarettes, banning their sale to anyone under 18 and requiring that adults under the age of 26 show a photo identification to buy them.
Statistics about the Use
More than 3 million middle and high school students were current users of e-cigarettes in 2015, up from an estimated 2.46 million in 2014.
Sixteen percent of high school and 5.3 percent of middle school students were current users of e-cigarettes in 2015, making e-cigarettes the most commonly used tobacco product among youth for the second consecutive year.
During 2011-2015, e-cigarette use rose from 1.5 percent to 16.0 percent among high school students and from 0.6 percent to 5.3 percent among middle school students.
In 2013-2014, 81% of current youth e-cigarette users cited the availability of appealing flavors as the primary reason for use.
In 2014, 12.6% of U.S. adults had ever tried an e-cigarette, and about 3.7% of adults used e-cigarettes daily or some days.
In 2016, FDA finalized a rule extending our regulatory authority to cover all tobacco products, including vaporizers, vape pens, hookah pens, electronic cigarettes (e-cigs), e-pipes, and all other ENDS. FDA now regulates the manufacture, import, packaging, labeling, advertising, promotion, sale, and distribution of ENDS. This includes components and parts of ENDS* but excludes accessories.
However, products marketed for therapeutic purposes (for example, marketed as a product to help people quit smoking) are regulated by the FDA through the Center for Drug Evaluation and Research (CDER). FDA recently proposed a rule clarifying the jurisdiction over tobacco products, drugs, and devices.
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Research suggests umeclidinium and glycopyrronium have similar effects in treating COPD
By Dr Deepu
Research indicates “umeclidinium and glycopyrronium have similar effects in treating chronic obstructive pulmonary disease (COPD).”
This study demonstrated non-inferiority between once-daily UMEC 62.5 µg delivered by the Ellipta DPI and GLYCO 50 µg delivered by the Breezhaler DPI for trough FEV1 at day 85 in the per-protocol population. Clinically important lung-function improvements (trough FEV1 ≥100 mL ) achieved with both UMEC and GLYCO were accompanied by clinically important improvements in other endpoints TDI (≥1 unit), SGRQ (improvement of ≥4 units ) and at the population level for CAT with UMEC only (≥1.6 units [30]). While the MCID for CAT is a change of 2 units in an individual , the threshold is smaller for a population at 1.6 units [30]. Treatment with UMEC improved the population mean CAT score in this study beyond this threshold. Overall, both treatments, therefore, not only improved lung function but also improved symptoms and HRQoL within the study.
There was a difference in time to onset favouring GLYCO versus UMEC (15 versus 30 min, respectively) on day 1; however, the magnitude of the difference is small and the study was not designed to show statistical differences between arms in terms of time to onset. However, the difference in time to onset was small and the magnitude of lung-function improvements on day 1 after the first 30 min was similar between the two treatments. Serial lung-function improvements were similar at all timepoints at other days of testing. A similar transient treatment difference has been reported between GLYCO and TIO in a previous study; however, it was evident only at day 1 of that study. The difference was not maintained with repeat dosing, as there was no difference at week 12 .
The findings were published in ERJ Open Research.
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Research indicates “umeclidinium and glycopyrronium have similar effects in treating chronic obstructive pulmonary disease (COPD).”
This study demonstrated non-inferiority between once-daily UMEC 62.5 µg delivered by the Ellipta DPI and GLYCO 50 µg delivered by the Breezhaler DPI for trough FEV1 at day 85 in the per-protocol population. Clinically important lung-function improvements (trough FEV1 ≥100 mL ) achieved with both UMEC and GLYCO were accompanied by clinically important improvements in other endpoints TDI (≥1 unit), SGRQ (improvement of ≥4 units ) and at the population level for CAT with UMEC only (≥1.6 units [30]). While the MCID for CAT is a change of 2 units in an individual , the threshold is smaller for a population at 1.6 units [30]. Treatment with UMEC improved the population mean CAT score in this study beyond this threshold. Overall, both treatments, therefore, not only improved lung function but also improved symptoms and HRQoL within the study.
There was a difference in time to onset favouring GLYCO versus UMEC (15 versus 30 min, respectively) on day 1; however, the magnitude of the difference is small and the study was not designed to show statistical differences between arms in terms of time to onset. However, the difference in time to onset was small and the magnitude of lung-function improvements on day 1 after the first 30 min was similar between the two treatments. Serial lung-function improvements were similar at all timepoints at other days of testing. A similar transient treatment difference has been reported between GLYCO and TIO in a previous study; however, it was evident only at day 1 of that study. The difference was not maintained with repeat dosing, as there was no difference at week 12 .
The findings were published in ERJ Open Research.
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Noninvasive ventilation therapy reduces reintubation risk after abdominal surgery
Patients who received noninvasive ventilation therapy after hypoxemic respiratory failure following abdominal surgery had a reduced risk of reintubation 7 days after initiation of ventilator therapy when compared with standard oxygen therapy.
The study was based on data from 293 patients (mean age 63.4 years).
These findings support the use of NIV in hypoxemic Respiratory failure after abdominal surgery.
The study was published in JAMA.
Read the article here
Liquid biopsy shows promise in study of lung cancer patients
Liquid biopsy accurately told whether a lung cancer patient had a mutation that makes the disease treatable with certain pills that can have remarkable effects.The test could also tell if less-fortunate patients had a different mutation, saving them weeks or months of treatment that would ultimately be useless. The findings published in JAMA Oncology revealed the following things.
Plasma ddPCR detected EGFR and KRAS mutations rapidly with the high specificity needed to select therapy and avoid repeat biopsies. It may also detect EGFR T790M missed by tissue genotyping due to tumor heterogeneity in resistant disease.
The study investigated the sensitivity, specificity, test turnaround time, and robustness of droplet digital polymerase chain reaction–based plasma genotyping for the rapid detection of targetable genomic alterations in patients with advanced non–small-cell lung cancer.
Read the complete article here
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The study investigated the sensitivity, specificity, test turnaround time, and robustness of droplet digital polymerase chain reaction–based plasma genotyping for the rapid detection of targetable genomic alterations in patients with advanced non–small-cell lung cancer.
Read the complete article here
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By Dr Deepu
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Antacid therapies may not improve outcomes in patients with IPF
By Dr Deepu
proton pump inhibitors or other antacid therapies” may not “improve outcomes in patients with idiopathic pulmonary fibrosis (IPF), and the treatment may increase infection risk in patients with advanced disease, according to findings from a post-hoc analysis of three large, randomized trials. Patients with IPF from the placebo groups of three trials of pirfenidone (CAPACITY 004, CAPACITY 006, and ASCEND) were included in the analysis. They analysed effects of antacid therapy use from baseline for pulmonary function, exercise tolerance, survival, hospital admission, and adverse events for 52 weeks.
Of 624 patients, 291 (47%) received antacid therapy and 333 (53%) did not. At 52 weeks, there was no significant difference between groups for disease progression. Rates also did not differ for all-cause mortality, IPF-related mortality, absolute FVC decrease, or mean observed change in FVC. The rate of hospital admission was non-significantly higher in the antacid therapy group . When stratified by baseline FVC (<70% or ≥70%), disease progression, mortality, FVC, 6MWD, and hospital admission did not differ between groups. Adverse events were similar between treatment and no treatment groups;
proton pump inhibitors or other antacid therapies” may not “improve outcomes in patients with idiopathic pulmonary fibrosis (IPF), and the treatment may increase infection risk in patients with advanced disease, according to findings from a post-hoc analysis of three large, randomized trials. Patients with IPF from the placebo groups of three trials of pirfenidone (CAPACITY 004, CAPACITY 006, and ASCEND) were included in the analysis. They analysed effects of antacid therapy use from baseline for pulmonary function, exercise tolerance, survival, hospital admission, and adverse events for 52 weeks.
Of 624 patients, 291 (47%) received antacid therapy and 333 (53%) did not. At 52 weeks, there was no significant difference between groups for disease progression. Rates also did not differ for all-cause mortality, IPF-related mortality, absolute FVC decrease, or mean observed change in FVC. The rate of hospital admission was non-significantly higher in the antacid therapy group . When stratified by baseline FVC (<70% or ≥70%), disease progression, mortality, FVC, 6MWD, and hospital admission did not differ between groups. Adverse events were similar between treatment and no treatment groups;
Researchers find genes linked to development of active TB.
By Dr Deepu
Researchers in Seattle and South Africa have identified markers in the blood of infected people that may predict those at high risk for developing an active and potentially fatal form of the disease.
A signature pattern of 16 genes, detected in analysis of samples from more than 6,000 South African adolescents, may one day help create a test to identify and treat people likely to develop active TB more than a year before they get sick.
A signature pattern of 16 genes, detected in analysis of samples from more than 6,000 South African adolescents, may one day help create a test to identify and treat people likely to develop active TB more than a year before they get sick.
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