Non-steroidal anti-inflammatory drug use and risk of venous thromboembolism

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its identifier (NCT number): NCT02278120
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Sponsors and Collaborators Novartis Pharmaceuticals Investigators Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals   More Information
Responsible Party: Novartis Pharmaceuticals Identifier: NCT02278120     History of Changes Other Study ID Numbers: CLEE011E2301
First Submitted: October 22, 2014 First Posted: October 29, 2014 Last Update Posted: July 11, 2017 Last Verified: July 2017 Individual Participant Data (IPD) Sharing Statement: Plan to Share IPD: Undecided Plan Description: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

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The investigators conducted a clinical examination comprising general examination and specific examination of the musculoskeletal system at inclusion, on day 0 and at the end of treatment (day 5). These examinations included feed intake, general behaviour, posture, lameness and pain on manipulation assessments and rectal temperature measurement. In addition, at the end of the treatment, the investigator evaluated the overall efficacy and palatability of the treatment. Diseases of the limbs, especially soft tissue injuries (contusions) and joint disorders (sprains and luxations) of less than 2 weeks duration were the most frequently diagnosed.

Formulations of topical diclofenac, ibuprofen, ketoprofen, piroxicam, and indomethacin demonstrated significantly higher rates of clinical success (more participants with at least 50% pain relief) than matching topical placebo (moderate or high quality data ). Benzydamine did not. Three drug and formulation combinations had NNTs for clinical success below 4. For diclofenac, the Emulgel® formulation had the lowest NNT of (95% CI to ) in two studies using at least 50% pain intensity reduction as the outcome . Diclofenac plasters other than Flector® also had a low NNT of ( to ) based on good or excellent responses in some studies. Ketoprofen gel had an NNT of ( to ), from five studies in the 1980s, some with less well defined outcomes. Ibuprofen gel had an NNT of ( to ) from two studies with outcomes of marked improvement or complete remission. All other drug and formulation combinations had NNT values above 4, indicating lesser efficacy .

SOURCES: Byron Cryer, MD, spokesman, American Gastroenterological Association; associate professor of medicine, University of Texas Southwestern Medical Center, Dallas. Nieca Goldberg, MD, spokeswoman for the American Heart Association; chief of women's cardiac care, Lennox Hill Hospital, New York; author, Women Are Not Small Men: Lifesaving Strategies For Preventing And Healing Heart Disease In Women . John Klippel, MD, president and CEO, Arthritis Foundation, Atlanta. Scott Zashin, clinical assistant professor, University of Texas Southwestern Medical Center; author of Arthritis Without Pain . American College of Rheumatology web site. Arthritis Foundation web site. American Heart Association web site. American College of Gastroenterology web site. American Gastroenterological Association web site. American Academy of Family Physicians web site. American Academy of Allergy, Asthma, and Immunology web site.

Non-steroidal anti-inflammatory drug use and risk of venous thromboembolism

non-steroidal anti-inflammatory drug use and risk of venous thromboembolism

Formulations of topical diclofenac, ibuprofen, ketoprofen, piroxicam, and indomethacin demonstrated significantly higher rates of clinical success (more participants with at least 50% pain relief) than matching topical placebo (moderate or high quality data ). Benzydamine did not. Three drug and formulation combinations had NNTs for clinical success below 4. For diclofenac, the Emulgel® formulation had the lowest NNT of (95% CI to ) in two studies using at least 50% pain intensity reduction as the outcome . Diclofenac plasters other than Flector® also had a low NNT of ( to ) based on good or excellent responses in some studies. Ketoprofen gel had an NNT of ( to ), from five studies in the 1980s, some with less well defined outcomes. Ibuprofen gel had an NNT of ( to ) from two studies with outcomes of marked improvement or complete remission. All other drug and formulation combinations had NNT values above 4, indicating lesser efficacy .

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non-steroidal anti-inflammatory drug use and risk of venous thromboembolismnon-steroidal anti-inflammatory drug use and risk of venous thromboembolismnon-steroidal anti-inflammatory drug use and risk of venous thromboembolismnon-steroidal anti-inflammatory drug use and risk of venous thromboembolismnon-steroidal anti-inflammatory drug use and risk of venous thromboembolism

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