Efficacy of ofev® (nintedanib) reinforced in range of patients with ipf in new analyses presented

RIDGEFIELD, Conn., Oct. Definition for free trade zone 24, 2016 /PRNewswire/ — At CHEST 2016, two post-hoc pooled analyses of the Phase III INPULSIS® trials were presented that further demonstrate the efficacy of Ofev® (nintedanib) in a range of people with idiopathic pulmonary fibrosis (IPF), regardless of disease severity at the start of the trials. Definition of international trade pdf IPF is a rare and serious lung disease causing permanent scarring of the lungs, typically affecting men over the age of 65.

“Understanding how treatment will affect disease progression for patients who begin drug therapy at different severity levels is critical to helping pulmonologists make treatment decisions,” said Luca Richeldi, Professor of Respiratory Medicine at the University of Southampton, United Kingdom. Definition of domestic slave trade “Both of these analyses demonstrated a consistent clinical effect with Ofev in patients irrespective of the severity of IPF at treatment initiation.”

Pooled analysis of the two Phase III INPULSIS® trials investigated the efficacy of Ofev on disease progression in subgroups of patients defined by their GAP ( gender, age, physiology) stage. Aids to trade definition GAP stage is a composite index developed to predict prognosis in patients with IPF. Modern trade theory definition Based on the index, patients were categorized as either GAP stage I or II/III. At baseline, 500 patients (nintedanib 304; placebo 196) were at GAP stage I, and 560 patients (nintedanib 334; placebo 226) were at GAP stage II/III.

The analysis showed a similar reduction in disease progression with Ofev versus placebo regardless of GAP stage (no significant difference between GAP stage I versus GAP stage II/III). Structured trade finance definition Disease progression was defined as an absolute decline in forced vital capacity (FVC) ≥5% predicted or death over 52 weeks.

What is slave trade definition In addition, treatment effect remained consistent between the two GAP subgroups when progression was measured as an absolute FVC decline ≥10% predicted or death over 52 weeks.

A second post-hoc pooled analysis of the two Phase III INPULSIS® trials investigated the effect of treatment on disease progression based on patients’ baseline composite physiologic index (CPI), a newer measure that also reflects disease severity through the use of spirometric volumes and measures of gas transfer without radiologic scoring. Off trade marketing definition Subgroup analyses were conducted of patients by baseline CPI of ≤45 versus >45, and ≤55 versus >55. Definition of a trader A higher CPI score is associated with a worse prognosis. At baseline, 500 patients (nintedanib 304; placebo 196) were at GAP stage I, and 560 patients (nintedanib 334; placebo 226) were at GAP stage II/III.

When using the baseline CPI threshold of 45, treatment effects were comparable based on the time to absolute decline in FVC ≥5% predicted or death over 52 weeks (≤45 vs. Trade journals or publications definition >45) or the time to absolute decline in FVC ≥10% predicted or death over 52 weeks. Inter industry trade definition Also, there were no significant differences in treatment effect when a baseline CPI threshold of 55 was used to define subgroups for time to absolute decline in FVC ≥5% or death and for time to absolute decline in FVC ≥10% or death.

IPF is a rare and serious lung disease that causes permanent scarring of the lungs. Trade accounts receivable definition It affects as many as 132,000 Americans, typically men over the age of 65. Trade deal definition Early diagnosis and proper care are critical to helping people treat their condition.

INPULSIS ®-1 and -2 are two global Phase III trials which evaluated the efficacy and safety of nintedanib in the treatment of idiopathic pulmonary fibrosis (IPF). Definition of international trade by different authors The INPULSIS® trials were identical in design, e.g., with matching dosing, inclusion criteria and endpoints. Informal trade barriers definition INPULSIS® recruited a range of patient types – similar to those seen in clinical practice including patients with early disease (FVC > 90% pred), no honeycombing on HRCT and/or concomitant emphysema. Trade deficit definition Patients who completed the 52-week treatment period and a 4-week follow-up period in the INPULSIS® trials were offered open-label treatment with OFEV® as part of an extension trial to assess the long-term safety and tolerability of OFEV. Wholesale trade definition The INPULSIS®-ON (Clinicaltrial.gov trial identifier: NCT01619085) trial included 734 patients and is currently ongoing.

The U.S. External trade definition Food and Drug Administration (FDA) approved OFEV for the treatment of idiopathic pulmonary fibrosis (IPF) on October 15, 2014. Trade definition economics OFEV is one of the first FDA-approved drug treatments for IPF and the only kinase inhibitor approved to treat this disease.

The approval was based on findings from a robust clinical trial program involving more than 1,200 patients with IPF worldwide, and included the Phase II TOMORROW® trial and the Phase III INPULSIS® trials (INPULSIS®-1 and INPULSIS®-2. Direct trade definition All these studies were randomized, double-blind, placebo-controlled trials comparing OFEV 150 mg twice daily to placebo for 52 weeks. What is trade agreement definition Both INPULSIS® trials were identically designed while the TOMORROW™ study design was similar.

OFEV is a prescription medicine used to treat people with a lung disease called idiopathic pulmonary fibrosis (IPF). Definition for trademark It is not known if OFEV is safe and effective in children.

OFEV can cause harm, birth defects or death to an unborn baby. Definition international trade Women should not become pregnant while taking OFEV. Trade price definition Women who are able to become pregnant should have a pregnancy test before starting treatment and should use birth control during and for at least 3 months after your last dose. Definition of trade show If you become pregnant while taking OFEV, tell your doctor right away.

• are breastfeeding or plan to breastfeed. What is local trade definition It is not known if OFEV passes into your breast milk. International trade definition You should not breastfeed while taking OFEV.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, herbal supplements such as St. Balance trade definition John’s wort.

• Liver problems. Trade work definition Unexplained symptoms may include yellowing of your skin or the white part of your eyes (jaundice), dark or brown (tea colored) urine, pain on the upper right side of your stomach area (abdomen), bleeding or bruising more easily than normal or feeling tired. Trade publishing definition Your doctor will do blood tests regularly to check how well your liver is working during your treatment with OFEV.

• Diarrhea, nausea, and vomiting. Trade imbalances definition Your doctor may recommend that you drink fluids or take medicine to treat these side effects. Trade finance definition Tell your doctor if you have these symptoms, if they do not go away, or get worse and if you are taking over-the-counter laxatives, stool softeners, and other medicines or dietary supplements.

• Heart attack. Trade in goods definition Symptoms of a heart problem may include chest pain or pressure, pain in your arms, back, neck or jaw, or shortness of breath.

• Bleeding problems. Trade publications definition OFEV may increase your chances of having bleeding problems. Concept of international trade definition Tell your doctor if you have unusual bleeding, bruising, or wounds that do not heal and/or if you are taking a blood thinner, including prescription blood thinners and over-the-counter aspirin.

• Tear in your stomach or intestinal wall (perforation). Trade job definition OFEV may increase your chances of having a tear in your stomach or intestinal wall. Definition of free trade in economics Tell your doctor if you have pain or swelling in your stomach area.

The most common side effects of OFEV are diarrhea, nausea, stomach pain, vomiting, liver problems, decreased appetite, headache, weight loss, and high blood pressure.

These are not all the possible side effects of OFEV. Simple explanation of fair trade For more information, ask your doctor or pharmacist. Trade payable definition You are encouraged to report negative side effects of prescription drugs to the FDA. The definition of trade winds Visit www.fda.gov/medwatch or call 1-800-FDA-1088 .

Boehringer Ingelheim is one of the world’s 20 leading pharmaceutical companies. Trade marketing definition Headquartered in Ingelheim, Germany, the company operates globally with 145 affiliates and more than 47,000 employees. Trade out definition Since its founding in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel treatments for human and veterinary medicine.

Boehringer Ingelheim is committed to improving lives and providing valuable services and support to patients and their families. Trade off economics definition Our employees create and engage in programs that strengthen our communities. Free trade economics definition To learn more about how we make more health for more people, visit our Corporate Social Responsibility Report.

In 2015, Boehringer Ingelheim achieved net sales of about $15.8 billion (14.8 billion euros). Trade and industry definition R&D expenditure corresponds to 20.3 percent of its net sales.

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