Efficacy of Aceclofenac and Ilaprazole Combination Therapy versus Celecoxib Monotherapy for Treating NSAID-Induced Dyspepsia in Lumbar Spinal Stenosis Patients
Abstract
:1. Introduction
2. Materials and Methods
2.1. Study Design
2.2. Particpants
2.3. Efficacy and Safety Evaluation
2.4. Sample Size Calculation
2.5. Statistical Analysis
3. Results
3.1. Demographic Characteristics
3.2. Primary Efficacy Results
3.3. Secondary Efficacy Results
3.4. Safety Results
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Aceclofenac + Ilaprazole n = 64 | Celecoxib n = 64 | p-Value | |
---|---|---|---|
Age (years) | 67.6 ± 8.4 | 67.2 ± 8.3 | 0.792 |
Sex (No.) | 0.465 | ||
Female | 42 (65.6%) | 38 (59.4%) | |
Male | 22 (34.4%) | 26 (40.6%) | |
Height, cm | 156.35 ± 8.35 | 158.01 ± 8.54 | 0.237 |
Weight, kg | 61.97 ± 9.53 | 63.52 ± 9.75 | 0.410 |
SF-LDQ a (initial) | 3.03 ± 4.57 | 2.91 ± 4.19 | 0.872 |
SF-12 b (initial) | |||
PCS c | 39.01 ± 7.34 | 38.54 ± 8.83 | 0.694 |
MCS d | 46.89 ± 9.81 | 48.36 ± 10.70 | 0.421 |
Aceclofenac + Ilaprazole | Celecoxib | p-Value | |
---|---|---|---|
Full analysis set | |||
Baseline | 2.76 ± 4.06 | 2.89 ± 4.21 | 0.866 |
Week 4 | 2.84 ± 5.71 | 4.61 ± 8.06 | 0.162 |
Week 8 | 2.88 ± 4.93 | 4.27 ± 7.07 | 0.234 |
Difference (Week 8—Baseline) | 0.13 ± 5.30 | 1.85 ± 6.70 | 0.140 |
Per protocol set | |||
Baseline | 2.86 ± 4.29 | 2.42 ± 3.99 | 0.580 |
Week 4 | 2.76 ± 5.93 | 3.15 ± 6.10 | 0.493 |
Week 8 | 1.94 ± 3.51 | 4.27 ± 7.07 | 0.286 |
Difference (Week 8—Baseline) | −0.51 ± 4.78 | 1.85 ± 6.70 | 0.054 |
Aceclofenac + Ilaprazole | Celecoxib | p-Value | |
---|---|---|---|
Full analysis set | |||
PCS a | |||
Baseline | 39.01 ± 7.36 | 38.71 ± 8.91 | |
Week 4 | 41.05 ± 7.78 | 41.13 ± 9.22 | |
Week 8 | 41.13 ± 9.34 | 40.19 ± 9.39 | |
Difference (Week 8—Baseline) | 2.54 ± 8.34 | 1.16 ± 10.78 | 0.457 |
MCS b | |||
Baseline | 47.04 ± 9.82 | 48.34 ± 10.84 | |
Week 4 | 47.47 ± 10.08 | 48.57 ± 10.42 | |
Week 8 | 48.81 ± 11.06 | 50.20 ± 10.32 | |
Difference (Week 8—Baseline) | 1.51 ± 12.10 | 0.37 ± 9.55 | 0.589 |
Per protocol set | |||
PCS a | |||
Baseline | 38.99 ± 7.08 | 39.03 ± 9.43 | |
Week 4 | 41.36 ± 7.62 | 41.01 ± 9.65 | |
Week 8 | 42.09 ± 9.21 | 40.19 ± 9.39 | |
Difference (Week 8—Baseline) | 3.10 ± 8.38 | 1.16 ± 10.78 | 0.310 |
MCS b | |||
Baseline | 47.48 ± 9.73 | 49.83 ± 10.43 | |
Week 4 | 48.35 ± 9.45 | 50.38 ± 9.50 | |
Week 8 | 48.98 ± 11.08 | 50.20 ± 10.32 | |
Difference (Week 8—Baseline) | 1.49 ± 11.92 | 0.37 ± 9.55 | 0.597 |
Aceclofenac + Ilaprazole n = 64 | Celecoxib n = 64 | p-Value | |
---|---|---|---|
Incidence of adverse events | 7 (10.9%) | 6 (9.4%) | 0.770 |
GI trouble | 3 | 4 | |
Swelling | 3 | 0 | |
Redness | 0 | 1 | |
Dehydration | 1 | 1 |
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Lee, S.; Kim, J.G.; Kim, H.-J. Efficacy of Aceclofenac and Ilaprazole Combination Therapy versus Celecoxib Monotherapy for Treating NSAID-Induced Dyspepsia in Lumbar Spinal Stenosis Patients. Medicina 2023, 59, 1307. https://doi.org/10.3390/medicina59071307
Lee S, Kim JG, Kim H-J. Efficacy of Aceclofenac and Ilaprazole Combination Therapy versus Celecoxib Monotherapy for Treating NSAID-Induced Dyspepsia in Lumbar Spinal Stenosis Patients. Medicina. 2023; 59(7):1307. https://doi.org/10.3390/medicina59071307
Chicago/Turabian StyleLee, Sanghoon, Jung Guel Kim, and Ho-Joong Kim. 2023. "Efficacy of Aceclofenac and Ilaprazole Combination Therapy versus Celecoxib Monotherapy for Treating NSAID-Induced Dyspepsia in Lumbar Spinal Stenosis Patients" Medicina 59, no. 7: 1307. https://doi.org/10.3390/medicina59071307