The analysis examined the time to a first clinically important deterioration which was determined by the occurrence of any of the following events: A decrease in lung function of ≥100 ml from baseline as measured by trough FEV1; a deterioration in health-related quality of life defined as ≥4 unit increase from baseline in St George’s Respiratory Questionnaire (SGRQ) total score; or the occurrence of an on-treatment moderate-to-severe COPD exacerbation.
The results of the analysis showed that the risk of experiencing a clinically important deterioration was significantly lower for patients on UMEC/VI 62.5/25mcg once daily compared to tiotropium 18mcg once daily (hazard ratio: 0.62; 95% confidence interval [CI]: 0.54, 0.71; p
nothing to prohibit prescribing
On a positive
, safety results were reassuring with no major imbalances in common
or serious adverse events. We vie
w this as encouraging given the chronic nature of
asthma therapy and historical safety worries over both ICS (pneumonia) and LABA
(asthma related death and CV) containing therapies.
No impact on forecasts
SALFORD Lung more important.
g, we had not assumed that
would cause any inflection in
Breo prescriptions given we believe any positive result would have been viewed as a
class effect in
a subset of patients hence there is no change to our forecasts.
NEW YORK (AP) -- Shares of The Medicines Co. surged in premarket trading Monday after the company and its partner Alnylam Pharmaceuticals Inc. reported study results suggesting effectiveness for a potential cholesterol drug.
The companies said that results from an ongoing Phase 1 clinical trial showed that their experimental treatment ALN-PCSsc lowered bad cholesterol by up to 83 percent compared to published results from studies with anti-PCSK9 MAbs, another class of drugs aimed at treating cholesterol. Both classes of drugs work by blocking a gene related to high cholesterol.