Linking To And Excerpting From “Systemically Acting Diclofenac Sodium Patch for Control of Low Back Pain: A Randomized, Double-Blind, Placebo-Controlled Study in Japan” With A Link To An Additional Resource

In addition to today’s resource, here is a link on how to use the Diclofenac Transdermal Patch for musculoskeletal pain from Medline Plus of The National Library Of Medicine.*

IMPORTANT WARNING:

People who use nonsteroidal anti-inflammatory drugs (NSAIDs) (other than aspirin) such as transdermal diclofenac may have a higher risk of having a heart attack or a stroke than people who do not use these medications. These events may happen without warning and may cause death. The risk may be higher for people who use NSAIDs for a long time. Do not use an NSAID such as transdermal diclofenac if you have recently had a heart attack, unless directed to do so by your doctor. Tell your doctor if you or anyone in your family has or has ever had heart disease, a heart attack, or a stroke; if you smoke; and if you have or have ever had high cholesterol, high blood pressure, or diabetes. Get emergency medical help right away if you experience any of the following symptoms: chest pain, shortness of breath, weakness in one part or side of your body, or slurred speech.

*However, I recommend that patients consult with their physician before starting this medicine.

Today I review, link to, and excerpt from Systemically Acting Diclofenac Sodium Patch for Control of Low Back Pain: A Randomized, Double-Blind, Placebo-Controlled Study in Japan [PubMed Abstract] [Full-Text HTML] [Full-Text PDF]. Pain Ther. 2023 Apr;12(2):529-542. doi: 10.1007/s40122-023-00478-1. Epub 2023 Feb 1.

There are 103 similar results in PubMed.

All that follows is from the above resource.

Abstract

Introduction: Nonsteroidal antiinflammatory drugs (NSAIDs) are commonly used for pain disorders such as low back pain and exist in multiple formulations; however, no systemically acting transdermal formulations are available for low back pain. Transdermal formulations can be safely administered even to patients with trouble swallowing or at risk of aspiration, and without regard to the effect of food on drug absorption. Unlike locally acting formulations, systemically acting transdermal formulations need not be applied at the target site, so dosing is simple and the burden is not on one area of the skin. A patch with the systemically acting NSAID diclofenac sodium is approved in Japan for treatment of cancer-related pain, and we hypothesized that it would be useful for controlling low back pain.

Methods: This randomized, double-blind, placebo-controlled study aimed to evaluate the efficacy and safety of diclofenac sodium patch in Japanese patients with low back pain. Eligible patients were randomized to receive diclofenac sodium patch 75 mg or 150 mg or placebo once daily for 2 weeks. The primary endpoint was pain intensity assessed on a visual analog scale (VAS).

Results: Primary analysis of the primary endpoint showed that both doses of the diclofenac sodium patch (150 mg and 75 mg) were superior to placebo in terms of absolute change from baseline in mean 3-day VAS score after 2 weeks’ treatment; the mean difference between the active and placebo treatments in this variable was -5.67 [95% confidence interval (CI) -9.34 to -2.00] mm in the 150 mg group and -5.68 (95% CI -9.34 to -2.01) mm in the 75 mg group. Most adverse events were mild. No serious adverse events occurred.

Conclusion: In Japanese patients, diclofenac sodium patch is effective for the relief of low back pain and is well tolerated.

Trial registration: JPRN number, JPRN-JapicCTI-205134.

Keywords: Diclofenac sodium; Low back pain; NSAID; Randomized controlled trial; Systemic action; Transdermal formulation; Visual analog scale (VAS).

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