CUMULATIVE PROPORTION OF RESPONDERS ANALYSIS (CPRA) OF A RANDOMIZED, CONTROLLED TRIAL INVESTIGATING THE EFFECTS OF THE FIXED DOSE COMBINATION (FDC) NICOBOXIL/NONIVAMIDE (FINALGON®), NICOBOXIL, NONIVAMIDE AND PLACEBO OINTMENT FOR THE TREATMENT OF ACUTE LOW BACK PAIN

T. Weiser, R. Lange, C. Holm
Sanofi Aventis Deutschland GmbH

Background
A multicenter, active and placebo-controlled, double-blind, randomized trial in 805 patients has demonstrated pronounced analgesic efficacy of nicoboxil/nonivamide ointment (Finalgon®) for treating acute low back pain. Pain intensity was assessed by the use of a numerical rating (range 0–10) scale. Efficacy of the FDC versus placebo, expressed as pain intensity difference (PID) versus baseline, was shown as early as 4h after onset of treatment and for the entire treatment period (up to 4 days; Eur J Pain 20 (2016) 263). Here we present a detailed CPRA. 

Methods
At 8h after treatment, and at the last individual treatment day (LID) the percentages of patients with ‘minimum-/moderate-/substantial-/clinical benefit; almost complete pain relief’ (i.e. 15/30/50/90% PID), and corresponding numbers needed to treat (NNT) for the FDC compared to placebo (PLA) were calculated.

Results
At 8h, the FDC[PLA] provided 15% PID for 77.5% [43.5%], 30% PID for 56.9% [25.1%], 50% PID for 29.9% [9.9%], and 90% PID for 4.9% [1.1%] of patients, resulting in NNT of 2.9, 3.1, 5.0, and 26.1 compared to PLA (p<0.0234). 
On LID, the FDC[PLA] provided 15% PID for 86.8% [56.9%], 30% PID for 73.7% [42.3%], 50% PID for 55.8% [29.0%], and 90% PID for 16.1% [5.9%] of patients, with NNT of 3.3, 3.2, 3.7, and 9.8 compared to PLA (p<0.001).

Conclusion
The FDC provided statistically significantly higher percentages for different levels of response in patients suffering from acute low back pain, when compared to placebo, at 8 hours after start of treatment and at the last treatment day. 

Sponsor: Boehringer Ingelheim; EudraCT No.: 2011-003890-27

EFFICACY AND SAFETY OF TOPICAL NONIVAMIDE/NICOBOXIL FIXED DOSE COMBINATION (NONI) IN ACUTE LOW BACK PAIN (A-LBP): A RANDOMISED, PLACEBO CONTROLLED TRIAL