Results of IMPULSIS on extension trial released.

By Dr Deepu



The interim findings from the INPULSIS-ON extension trial were presented at the European Respiratory Society (ERS) International Congress 2016 in London.



The findings were consistent with those previously reported from the INPULSIS Phase 3 trials (INPULSIS-1 and -2). The interim analysis from the extension trial demonstrated that nintedanib slows disease progression in IPF patients. In addition, long-term treatment with nintedanib  (up to 51 months) was associated with manageable side effects in most patients, with diarrhea being the most frequently reported side effect.

Results from the interim analysis of INPULSIS-ON demonstrated that in terms of forced vital capacity (FVC, a measure of lung function) in IPF patients who continued nintedanib treatment in the extension trial, the change between baseline and week 48 and between weeks 48 and 96 was similar to what was seen in IPF patients who were on active treatment with Ofev in the 52-week INPULSIS clinical trials.

Findings from the trials on the effect of nintedanib on FVC demonstrated that:

In INPULSIS, the mean FVC change from baseline to week 52 was −89mL compared to –203mL for placebo-treated patients;
In INPULSIS-ON, the mean FVC change for patients who continued treatment was −96 mL from baseline to week 48;
In INPULSIS-ON, the mean FVC change for patients who continued treatment was −124mL from week 48 to week 96;
In INPULSIS and INPULSIS-ON, the average exposure to Ofev was around three years (35.7 months).
Two additional sub-group analyses from the trials revealed that treatment with Ofev has a beneficial effect on the annual rate of FVC decline regardless of the patients’ baseline lung impairment, providing additional evidence of the benefits of the drug in slowing disease progression in a range of IPF patients.

nintedanib is a small molecule tyrosine kinase inhibitor, which has been approved and marketed globally for treating IPF in adults. nintedanib blocks multiple signaling pathways that may be involved in the scarring of lung tissue and fibrotic processes, reducing disease progression in IPF and slowing lung function decline.

Trial indicates Ofev slows progression in IPF patients

By Dr Deepu



The interim findings from the INPULSIS-ON extension trial were presented at the European Respiratory Society (ERS) International Congress 2016 in London.


The findings were consistent with those previously reported from the INPULSIS Phase 3 trials (INPULSIS-1 and -2). The interim analysis from the extension trial demonstrated that nintedanib slows disease progression in IPF patients. In addition, long-term treatment with nintedanib  (up to 51 months) was associated with manageable side effects in most patients, with diarrhea being the most frequently reported side effect.

Results from the interim analysis of INPULSIS-ON demonstrated that in terms of forced vital capacity (FVC, a measure of lung function) in IPF patients who continued nintedanib treatment in the extension trial, the change between baseline and week 48 and between weeks 48 and 96 was similar to what was seen in IPF patients who were on active treatment with Ofev in the 52-week INPULSIS clinical trials.

Findings from the trials on the effect of nintedanib on FVC demonstrated that:

In INPULSIS, the mean FVC change from baseline to week 52 was −89mL compared to –203mL for placebo-treated patients;
In INPULSIS-ON, the mean FVC change for patients who continued treatment was −96 mL from baseline to week 48;
In INPULSIS-ON, the mean FVC change for patients who continued treatment was −124mL from week 48 to week 96;
In INPULSIS and INPULSIS-ON, the average exposure to Ofev was around three years (35.7 months).
Two additional sub-group analyses from the trials revealed that treatment with Ofev has a beneficial effect on the annual rate of FVC decline regardless of the patients’ baseline lung impairment, providing additional evidence of the benefits of the drug in slowing disease progression in a range of IPF patients.

nintedanib is a small molecule tyrosine kinase inhibitor, which has been approved and marketed globally for treating IPF in adults. nintedanib blocks multiple signaling pathways that may be involved in the scarring of lung tissue and fibrotic processes, reducing disease progression in IPF and slowing lung function decline.

Add-on Tiotropium Therapy Improves Asthma

By Dr Deepu

At least 40% of asthma patients remain symptomatic despite treatment with inhaled corticosteroids with or without long-acting β2-agonists. The long-acting anticholinergic bronchodilator tiotropium (Spiriva Respimat/Boehringer Ingelheim) has been incorporated into the Global Initiative for Asthma 2015 treatment strategy as an add-on therapy option for patients with a history of asthma exacerbations, and the clinical efficacy and safety of add-on tiotropium therapy have been established in adults across differing asthma severity levels.

Now, two randomized, double-blind, parallel-group twin trials reported in Respiratory Medicine have shown that add-on tiotropium therapy helps to control asthma in symptomatic patients regardless of many patient characteristics. These findings indicate that add-on tiotropium therapy could be useful for a wide range of asthma patients who still have asthma symptoms despite treatment with other agents.

In these two international, multicenter trials, add-on therapy with tiotropium improved lung function and asthma symptom control and reduced the risk of asthma exacerbation episodes and worsening of asthma in symptomatic asthma patients taking an inhaled corticosteroid with a long-acting β2-agonist, regardless of patient age, allergic status, and degree of airway obstruction at baseline.

The trials enrolled 912 patients with severe, symptomatic asthma who had been taking at least 800 μg of budesonide or the equivalent as well as a long-acting β2-agonist for at least 4 weeks. Currently symptomatic patients between the ages of 18 and 75 years with a history of asthma of at least 5 years and an initial diagnosis before age 40 years were eligible to participate in the study. Moderate or persistent airflow limitation at the initial screening visit and at least one exacerbation in the last year requiring systemic glucocorticoid therapy were also requirements for study participation.

Patients were randomly assigned in a 1:1 ratio to receive either tiotropium, 5 μg once daily via the Respimat Soft Mist inhaler (Boehringer Ingelheim), or placebo for 48 weeks.

The study investigators measured the following asthma parameters:
Peak force expiratory volume in 1 second (FEV1)
Trough FEV1
Time to first severe exacerbation
Time to first episode of worsening asthma
Results from the seven-question Asthma Control Questionnaire
Subgroup analysis of the relation between these parameters and patients’ baseline characteristics indicated that, compared with placebo, once-daily  tiotropium improved lung function and control of asthma in these patients independently of a broad range of characteristics including gender, body mass index, disease duration, age at asthma onset, FEV1 percentage predicted at screening, and FEV1 reversibility.

The cervical rib

By Dr Deepu







A cervical rib in humans is a supernumerary (or extra) rib which arises from the seventh cervical vertebra. Sometimes known as "neck ribs", their presence is a congenital abnormality located above the normal first rib. A cervical rib is estimated to occur in 0.6% (1 in 150 people) to 0.8% of the population. People may have a cervical rib on the right, left or both sides.

Most cases of cervical ribs are not clinically relevant and do not have symptoms; cervical ribs are generally discovered incidentally. However, they vary widely in size and shape, and in rare cases, they may cause problems such as contributing to thoracic outlet syndrome, because of pressure on the nerves that may be caused by the presence of the rib.

A cervical rib represents a persistent ossification of the C7 lateral costal element. During early development, this ossified costal element typically becomes re-absorbed. Failure of this process results in a variably elongated transverse process or complete rib that can be anteriorly fused with the T1 first rib below.

On imaging, cervical ribs can be distinguished because their transverse processes are directed inferolaterally, whereas those of the adjacent thoracic spine are directed anterolaterally.

Associated conditions

The presence of a cervical rib can cause a form of thoracic outlet syndrome due to compression of the lower trunk of the brachial plexus or subclavian artery. These structures become encroached upon by the cervical rib and scalene muscles. Compression of the brachial plexus may be identified by weakness of the muscles around the muscles in the hand, near the base of the thumb. Compression of the subclavian artery is often diagnosed by finding a positive Adson's sign on examination, where the radial pulse in the arm is lost during abduction and external rotation of the shoulder. A positive Adson's sign is non-specific for the presence of a cervical rib however, as many individuals without a cervical rib will have a positive test.




Spotter: Is this X ray Normal???

By Dr Deepu



See the answer here

Important chest radiology signs.

By Dr Arun M, MD (Respiratory Medicine).
 Faculty in department of medicine, KMC Mangalore.
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