Two-hundred and twenty eligible patients were randomised (lornoxicam = 110; diclofenac potassium = 110) between September 2003 and July 2004. Figure 1 illustrates patient flow through the study. Three patients were withdrawn from the study: two for adverse events (upper abdominal pain, urticaria) and one for personal reasons. All patients were included in the efficacy and safety analyses (ITT population). The three patients withdrawn were excluded from the PP analysis. There were no deviations from the study protocol.
Flow of patients through the study. DP = diclofenac potassium; ITT = intent-to-treat; LNX = lornoxicam; PP = per-protocol.
The treatment groups were comparable with respect to demographics and baseline characteristics of the current episode of low back pain ( Table I ).
Figure 2. (click image to zoom)
Pain intensity difference (PID), day 1. Means and standard errors (SE) are raw summary measures. DP = diclofenac potassium; LNX = lornoxicam.
Figure 3. (click image to zoom)
Pain intensity difference (PID), days 1–6. Means and standard errors (SE) are raw summary measures. DP = diclofenac potassium; LNX = lornoxicam.
Pain Relief. TOTPAR over the 90-minute in-house period was significantly higher for lornoxicam compared with diclofenac potassium ( Table IV ).
Although the difference was slight, a trend in favour of lornoxicam was observed for mean PAR observed during the 8 hours following the first drug administration and from day 1 to day 6. Peak PAR over the 90-minute in-house period was significantly higher with lornoxicam (2.25 ± 0.10) compared with diclofenac potassium (1.99 ± 0.09) [p = 0.039].
Rescue Medication. The proportion of patients requiring rescue medication was similar between the two groups (lornoxicam: 43/110 patients; diclofenac potassium: 42/110 patients). The total number of paracetamol tablets taken as rescue medication was lower in the lornoxicam group (2.10 ± 0.39) compared with the diclofenac potassium group (3.15 ± 0.58). However, this difference was not statistically significant.
Global Evaluation of the Study Medication and Ability to Perform Daily Activities. The patients' global evaluation of the study medication on day 1 was significantly higher with lornoxicam (mean 2.03 ± 0.10) compared with diclofenac potassium (1.68 ± 0.07) [p = 0.015; figure 4a]. Similar results were observed on day 7 (lornoxicam: 2.45 ± 0.10; diclofenac potassium: 2.15 ± 0.09; p = 0.021) [figure 4b]. The proportion of patients prevented from continuing usual daily activities was slightly lower with lornoxicam (50/110 patients) compared with diclofenac potassium (60/110 patients). The number of days on which patients were prevented from continuing usual daily activities was lower with lornoxicam (1.72 ± 0.22) compared with diclofenac potassium (2.01 ± 0.23). However, this difference was not statistically significant.
Figure 4. (click image to zoom)
Global evaluation of the study medications on a five-point verbal rating scale (0 = poor, 1 = fair, 2 = good, 3 = very good, 4 = excellent) on (a) day 1 and (b) day 7.
Safety Outcomes. A total of 123 adverse events were reported during the study period: 56 by 27/110 (24.5%) patients in the lornoxicam group and 67 by 28/110 (25.5%) patients in the diclofenac potassium group. No serious adverse event was reported. Two patients withdrew from the study because of an adverse event (lornoxicam: upper abdominal pain; diclofenac potassium: urticaria). The intensity of the adverse events was mild in most cases (50/56 for lornoxicam, 64/67 for diclofenac potassium), none were severe. Ninety-nine adverse events were considered probably or possibly related to study medication: 46 of these occurred in 23 patients in the lornoxicam group and 53 occurred in 23 patients in the diclofenac potassium group. The most frequently reported adverse events were abdominal pain, dyspepsia, diarrhea, nausea, eructation, dizziness and headache. Adverse events occurring at a rate >1% are presented in Table V .
Clin Drug Invest. 2006;26(5):267-277. © 2006 Adis Data Information BV
Cite this: Analgesic Efficacy and Safety of Lornoxicam Quick-Release Formulation Compared With Diclofenac Potassium - Medscape - Jun 01, 2006.