Journal of Gerontological Nursing

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Abstract

Two Phase III studies have shown that tapentadol extended release (ER) tablets, when compared with placebo, provide clinically significant improvements in pain intensity in patients with either moderate to severe osteoarthritis knee pain or chronic low back pain.

The knee osteoarthritis study, published in Clinical Drug Investigation, demonstrated that a significantly higher percentage of patients receiving tapentadol ER tablets achieved at least a 50% improvement in average pain intensity compared with placebo (32% versus 24.3%, respectively; nominal p = 0.027). In the back pain investigation, published in Expert Opinion on Pharmacotherapy, it was found that a significantly higher percentage of patients receiving tapentadol ER tablets achieved at least a 30% improvement in pain intensity compared with placebo (39.7% versus 27.1%, respectively; nominal p < 0.001), and a significantly higher percentage of patients receiving tapentadol ER achieved at least a 50% improvement in pain intensity compared with placebo (27% versus 18.9%; nominal p = 0.016). Primary endpoints for both studies were the changes in average daily pain intensity from baseline (11-point numerical rating scale) to the last week of the maintenance period and over the study’s entire 12-week maintenance period.

In both studies, patients were randomized in a 1:1:1 ratio to receive twice-daily, controlled, adjustable, oral doses of the investigational tapentadol ER (100 mg to 250 mg), oxycodone HCl (Roxicodone®) controlled release (CR) (20 mg to 50 mg), or placebo during a 15-week double-blind treatment period. In the knee osteoarthritis group, 1,023 patients received at least one dose of the study medication (placebo, n = 337; tapentadol ER, n = 344; oxycodone CR, n = 342); in the back pain group, 981 patients were initially randomized in the study, although 965 patients (placebo, n = 319; tapentadol ER, n = 318; oxycodone CR, n = 328) received at least one dose of the study medication.

Both studies also included an oxycodone CR versus placebo arm as an active control. In the knee osteoarthritis group, oxycodone CR was found to have significantly reduced average pain intensity from baseline throughout the maintenance period versus placebo (least squares mean difference, 95% confidence interval: −0.3, −0.67, −0.00), but not at Week 12 (−0.3, −0.68, 0.02). A significantly lower percentage of patients achieved at least a 50% improvement in average pain intensity in the oxycodone CR group compared with placebo (17.3% versus 24.3%, respectively; nominal p = 0.023). In the back pain group, results showed significant reductions in average pain intensity for the oxycodone CR group compared with the placebo group at Week 12 (oxycodone CR, mean change = −2.9, SD = 2.52; placebo, mean change = −2.1, SD = 2.33; nominal p < 0.001) and over the entire maintenance period (oxycodone CR, mean change = −2.9, SD = 2.36; placebo, mean change = −2.1, SD = 2.20; nominal p < 0.001). In the oxycodone CR group, the percentage of patients with at least a 30% and at least a 50% improvement did not differ significantly from placebo (30.4%, p = 0.365, and 23.3%, nominal p = 0.174, respectively for oxycodone CR).

Nucynta®, an immediate-release formulation of tapentadol, is currently approved for the relief of moderate to severe acute pain in adults. Tapentadol ER is currently under review by the U.S. Food and Drug Administration.

Sources.“Phase 3 Study Compares Tapentadol Extended Release Tablets to Placebo in Patients with Chronic Low Back Pain.” (2010, September 27). Retrieved September 28, 2010, from http://www.investor.jnj.com/releasedetail.cfm?ReleaseID=511187.“Pivotal Phase 3 Study Compares Tapentadol Extended Release Tablets to Placebo in Patients with Chronic Osteoarthritis Knee Pain.” (2010, August 30). Retrieved September 28, 2010, from http://www.investor.jnj.com/releasedetail.cfm?ReleaseID=503430.

Elmore Oil, a popular pain relief product in Australia,…

Analgesic Shows Promise for Knee, Back Pain

Two Phase III studies have shown that tapentadol extended release (ER) tablets, when compared with placebo, provide clinically significant improvements in pain intensity in patients with either moderate to severe osteoarthritis knee pain or chronic low back pain.

The knee osteoarthritis study, published in Clinical Drug Investigation, demonstrated that a significantly higher percentage of patients receiving tapentadol ER tablets achieved at least a 50% improvement in average pain intensity compared with placebo (32% versus 24.3%, respectively; nominal p = 0.027). In the back pain investigation, published in Expert Opinion on Pharmacotherapy, it was found that a significantly higher percentage of patients receiving tapentadol ER tablets achieved at least a 30% improvement in pain intensity compared with placebo (39.7% versus 27.1%, respectively; nominal p < 0.001), and a significantly higher percentage of patients receiving tapentadol ER achieved at least a 50% improvement in pain intensity compared with placebo (27% versus 18.9%; nominal p = 0.016). Primary endpoints for both studies were the changes in average daily pain intensity from baseline (11-point numerical rating scale) to the last week of the maintenance period and over the study’s entire 12-week maintenance period.

In both studies, patients were randomized in a 1:1:1 ratio to receive twice-daily, controlled, adjustable, oral doses of the investigational tapentadol ER (100 mg to 250 mg), oxycodone HCl (Roxicodone®) controlled release (CR) (20 mg to 50 mg), or placebo during a 15-week double-blind treatment period. In the knee osteoarthritis group, 1,023 patients received at least one dose of the study medication (placebo, n = 337; tapentadol ER, n = 344; oxycodone CR, n = 342); in the back pain group, 981 patients were initially randomized in the study, although 965 patients (placebo, n = 319; tapentadol ER, n = 318; oxycodone CR, n = 328) received at least one dose of the study medication.

Both studies also included an oxycodone CR versus placebo arm as an active control. In the knee osteoarthritis group, oxycodone CR was found to have significantly reduced average pain intensity from baseline throughout the maintenance period versus placebo (least squares mean difference, 95% confidence interval: −0.3, −0.67, −0.00), but not at Week 12 (−0.3, −0.68, 0.02). A significantly lower percentage of patients achieved at least a 50% improvement in average pain intensity in the oxycodone CR group compared with placebo (17.3% versus 24.3%, respectively; nominal p = 0.023). In the back pain group, results showed significant reductions in average pain intensity for the oxycodone CR group compared with the placebo group at Week 12 (oxycodone CR, mean change = −2.9, SD = 2.52; placebo, mean change = −2.1, SD = 2.33; nominal p < 0.001) and over the entire maintenance period (oxycodone CR, mean change = −2.9, SD = 2.36; placebo, mean change = −2.1, SD = 2.20; nominal p < 0.001). In the oxycodone CR group, the percentage of patients with at least a 30% and at least a 50% improvement did not differ significantly from placebo (30.4%, p = 0.365, and 23.3%, nominal p = 0.174, respectively for oxycodone CR).

Nucynta®, an immediate-release formulation of tapentadol, is currently approved for the relief of moderate to severe acute pain in adults. Tapentadol ER is currently under review by the U.S. Food and Drug Administration.

Sources.“Phase 3 Study Compares Tapentadol Extended Release Tablets to Placebo in Patients with Chronic Low Back Pain.” (2010, September 27). Retrieved September 28, 2010, from http://www.investor.jnj.com/releasedetail.cfm?ReleaseID=511187.“Pivotal Phase 3 Study Compares Tapentadol Extended Release Tablets to Placebo in Patients with Chronic Osteoarthritis Knee Pain.” (2010, August 30). Retrieved September 28, 2010, from http://www.investor.jnj.com/releasedetail.cfm?ReleaseID=503430.

Australian Oil Eases Muscle, Joint Aches

Elmore Oil, a popular pain relief product in Australia, is now available in the United States. The preferred method of treatment for joint and muscle pain for many Australian Olympians, Elmore Oil is composed of four natural ingredients: olive oil, tea tree oil, eucalyptus oil, and vanilla. The ingredients are specially matured over time, which allows them to bind in the most effective and efficient way possible. Elmore Oil is blended using a “triple maturation” process, providing a natural product that can deliver pain relief for muscle aches, hip pain, and arthritis. For more information, visit http://www.elmoreoilusa.com.

Source.“Bye, Bye Muscle and Joint Pain—Hello New Healing Oil” (2010, July 6). Retrieved September 29, 2010, from http://bestproductsmediaguide.info/participant_pdf/1592/press_release.pdf.

10.3928/00989134-20101101-08

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