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A multi-center, Phase III, double-dummy, double-blind, active-controlled, noninferiority, parallel-group trial was conducted to explore the safety and efficacy of a fixed-dose combo of naproxen/esomeprazole magnesium and nimesulide/pantoprazole.
With no significant difference in treated dyspeptic symptoms the
nimesulide/pantoprazole FDC found to be equally efficient as
naproxen/esomeprazole FDC during the treatment of osteoarticular pain.
A multi-center, Phase III, double-dummy, double-blind,
active-controlled, noninferiority, parallel-group trial was conducted to
explore the safety and efficacy of a fixed-dose combo of naproxen/esomeprazole
magnesium and nimesulide/pantoprazole. The study assessed if both therapeutics
are equally effective to mitigate pain in patients suffering from dyspeptic
symptoms and osteoarticular diseases.
Participants were randomly allocated to either naproxen/esomeprazole magnesium (500 mg/20 mg) twice daily arm or nimesulide/pantoprazole (100 mg/20 mg) twice daily arm. The subjects were monitored for about 14 days with an intermediate follow-up on the 7th day. The mean alteration in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale was the primary outcome ascertained.
Following were the secondary outcomes ascertained : (a) The mean visual analog scale (VAS) score of individual dyspepsia symptoms, (b) mean VAS score of dyspeptic symptoms (nausea, epigastric burning, abdominal discomfort/pain, postprandial fullness), and (c) individual score of dyspeptic symptoms based on participants diary. Overall, 490 participants were recruited, out of which, 399 participants completed the treatment.
In the per-protocol population, the mean alteration in the WOMAC pain score is shown in the following table and figure:
The difference in mean alteration in the WOMAC pain score between the cohorts following seven and 14 days of treatment is shown in the following table:
In the per-protocol population, the mean decline in VAS scores for individual dyspeptic symptoms is shown in the following table and figure:
The adverse effects incidence demonstrated similarity between the groups. Abdominal discomfort, dyspepsia, abdominal distention, and nausea were the most frequent adverse events in the pooled group. However, none of these noxious events was deemed to be clinically meaningful.
It was also found that the gastrointestinal adverse effects associated with NSAID use may be diminished by using a fixed-dose combination of nimesulide/pantoprazole, which depicted good tolerability and sustained efficacy.
Thus, nimesulide/pantoprazole is non-inferior to
naproxen/esomeprazole in relieving osteoarticular pain.
Drug design, development and therapy
Efficacy and safety of a fixed-dose combination of nimesulide/pantoprazole compared to naproxen/ esomeprazole for pain relief in patients with osteoarticular diseases and dyspeptic symptoms
Morton Scheinberg et al.
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