News | October 07, 2008

FDA Says No Risk of Stroke Seen With Tiotropium

October 8, 2008 – FDA informed healthcare professionals this week it reviewed preliminary data from UPLIFT (Understanding the Potential Long-Term Impacts on Function with Tiotropium) reported by Boehringer Ingelheim, which showed no increased risk of stroke with tiotropium bromide compared to placebo.

Tiotropium is marketed as Spiriva HandiHaler. UPLIFT is a large, four-year, placebo controlled clinical trial with Spiriva HandiHaler in about 6,000 patients with chronic obstructive pulmonary disease. Two recent publications reported increased risk for mortality and/or cardiovascular events in patients who received tiotropium or inhaled anticholinergics. Both studies examined cardiovascular outcomes.

FDA expects to receive the complete report for UPLIFT in November 2008. Results from this trial will also help to address some issues raised about tiotropium in the two recent publications. Due to the amount of data collected in UPLIFT, a complete review of the results could take several months, at which time FDA will make an update with the final results of the UPLIFT analysis, as well as all the available data regarding tiotropium and stroke risk.

For more information: www.fda.gov/medwatch/safety/2008/safety08.htm#Tiotropium

Related Content

Medtronic Announces Global Resolute Onyx DES One-Month DAPT Study
News | Antiplatelet and Anticoagulation Therapies| August 18, 2017
Medtronic plc announced a global randomized clinical trial that will evaluate one-month dual antiplatelet therapy (DAPT...
Abbott Initiates XIENCE Short DAPT Clinical Trial
News | Antiplatelet and Anticoagulation Therapies| August 03, 2017
Abbott recently announced the first patient has been enrolled in a clinical study evaluating the short-term use of...
Study Discovers Anticoagulant Drugs Are Being Prescribed Against Safety Advice
News | Antiplatelet and Anticoagulation Therapies| July 25, 2017
July 25, 2017 — A study by researchers at the University of Birmingham has shown that general practitioners (GPs) are
long-duration dual anti-platelet therapy (L-DAPT) compared to short-duration dual antiplatelet (S-DAPT) after DES stent implantation
News | Antiplatelet and Anticoagulation Therapies| July 12, 2017
June 12, 2017 — Researchers have evaluated the long-term efficacy and safety of long-duration dual anti-platelet ther
Sex-Specific Cardiovascular Drug Dosages Needed to Reduce Adverse Reactions in Women
News | Womens Healthcare| July 07, 2017
Sex-specific cardiovascular drug dosages are needed to reduce adverse reactions in women, according to a position paper...
Bayer Now Enrolling Patients for Global Pulmonary Arterial Hypertension Study
News | Hypertension| July 05, 2017
Bayer has enrolled the first patient in a global Phase IV study assessing the clinical effects of riociguat in patients...
FDA Grants Priority Review of Xarelto sNDA for 10 mg Dose
News | Antiplatelet and Anticoagulation Therapies| June 29, 2017
Janssen Research & Development LLC announced the U.S. Food and Drug Administration (FDA) accepted for Priority...
radial access, transradial access trial using anticoagulants
News | Radial Access| June 15, 2017
June 15, 2017 — In patients undergoing t...
Cost comparison between NOACs, novel oral anticoagulants
News | Antiplatelet and Anticoagulation Therapies| May 31, 2017
May 31, 2017 – The results from the first real-world, matched head-to-head study comparing all-cause healthcare costs
Data was positive from the Watchman Left Atrial Appendage Closure (LAAC) Device from the EWOLUTION registry
News | Atrial Fibrillation| May 30, 2017
May 30, 2017 — Data was positive for safety and efficacy rates of the Watchman Left Atrial Appendage Closure (LAAC) D
Overlay Init