A“simplified”figure was proposed in 2011 to summarize the results of controlled trials that evaluate different treatments aimed at the same disease condition.The original criteria for classifying individual binary c...A“simplified”figure was proposed in 2011 to summarize the results of controlled trials that evaluate different treatments aimed at the same disease condition.The original criteria for classifying individual binary comparisons included superiority,inferiority and no significance difference;hence,they did not differentiate between no proof of difference vs proof of no difference.We updated the criteria employed in the original“simplified”figure in order to include this differentiation.A revised version of the simplified figure is proposed and described herein.An example of application is also presented.The example is focused on first-line treatments for paroxysmal atrial fibrillation.Three treatments(medical therapy,cryoballoon ablation,radiofrequency ablation)are compared with one another through direct and indirect comparisons.展开更多
BACKGROUND Gastritis is one of the most frequently diagnosed diseases requiring medical treatment in South Korea.Fexuprazan,a novel potassium-competitive acid blocker,has been approved for treating gastritis and erosi...BACKGROUND Gastritis is one of the most frequently diagnosed diseases requiring medical treatment in South Korea.Fexuprazan,a novel potassium-competitive acid blocker,has been approved for treating gastritis and erosive esophagitis.Meanwhile,rebamipide is the most commonly used mucoprotective agent for acute and chronic gastritis in real-world settings in South Korea.However,there have been no studies comparing the efficacy of these two drugs yet.AIM To compare the efficacy of fexuprazan with that of rebamipide for acute and chronic gastritis.METHODS This was a matching-adjusted indirect comparison.Individual patient data from a phase III study of fexuprazan(10 mg BID)were compared with cumulative data from two matching studies of rebamipide(100 mg TID).Erosion improvement and healing rates were compared between two weeks of fexurapan,two weeks of rebamipide,and four weeks of rebamipide.The two main outcome variables were presented as percentages,and the risk differences(RD)and 95%confidence intervals(CI)were calculated for the relative treatment effects.RESULTS In the primary analysis,the erosion improvement and healing rates after a twoweek treatment with fexuprazan were 64.5%and 53.2%,respectively,while a twoweek treatment with rebamipide resulted in erosion improvement and healing rates of 43.6%(RD:21.0%;95%CI:9.6-32.3;P<0.01)and 35.6%(RD:17.6%;95%CI:6.1-29.2;P=0.003),respectively.In the additional analysis,the erosion improvement and healing rates for the two-week fexuprazan treatment(64.2%and 51.2%,respectively)were similar to those obtained during a four-week treatment with rebamipide(60.6%;RD:3.6%;95%CI:-9.8,17.0;P=0.600 and 53.5%;RD:-2.3%;95%CI:-16.1,11.5;P=0.744,respectively).CONCLUSION The two-week fexuprazan treatment was superior to the two-week rebamipide treatment and similar to the fourweek rebamipide treatment for patients with gastritis.展开更多
This study was designed to evaluate the efficacy, tolerability, and sequential administration of abiraterone acetate (AA) and enzalutamide (Enz) for metastatic castration-resistant prostate cancer (mCRPC). A lit...This study was designed to evaluate the efficacy, tolerability, and sequential administration of abiraterone acetate (AA) and enzalutamide (Enz) for metastatic castration-resistant prostate cancer (mCRPC). A literature search was performed with PubMed, Embase, and Web of Science databases to identify relevant studies. Reviewed literature included published phase III trials of AA or Enz in mCRPC and studies regarding their sequential administration. Given the difference in control arms in AA (active comparator) and Enz (true placebo) randomized phase III studies, indirect comparisons between AA and Enz in mCRPC showed no statistically significant difference in overall survival in prechemotherapy and postchemotherapy settings (HR. 0.90, 95% CI, 0.73-1.11; HR: 0.85, 95% CI, 0.68-1.07). Compared with AA, Enz may better outperform control arms in treating mCRPC both before and after chemotherapy regarding secondary endpoints based on indirect comparisons: time to prostate-specific antigen (PSA) progression (HR. 0.34, 95% CI, 0.28-0.42; HR: 0.40, 95% CI, 0.30-0.53), radiographic progression-free survival (HR: 0.37, 95% CI, 0.28-0.48; HR: 0.61, 95% CI, 0.50-0.74), and PSA response rate (OR: 18.29, 95% CI, 11.20-29.88; OR: 10.69, 95% CI, 3.92-29.20). With regard to the effectiveness of Enz following AA or AA following Enz, recent retrospective case series reported overall survival and secondary endpoints for patients with mCRPC progression after chemotherapy. However, confirmatory head-to-head trials are necessary to determine the optimal sequencing of these agents.展开更多
Background: Psoriasis is a common, chronic, immune-mediated inflammatory skin disease with increased epidermal proliferation. The objective of this review was to systematically identify the evidence and perform a netw...Background: Psoriasis is a common, chronic, immune-mediated inflammatory skin disease with increased epidermal proliferation. The objective of this review was to systematically identify the evidence and perform a network meta-analysis (NMA) to estimate the relative efficacy of secukinumab (SEC) against adalimumab (ADA) and infliximab (INF) for the treatment of moderate-to-severe plaque psoriasis.Methods: A systematic literature review (SLR) was conducted according to a pre-specified protocol to identify relevant studies. Initially, the databases were searched from database inception till June 2013, and the SLR was updated in April 2020. The eligibility criteria included adult patients (≥18 years old) with moderate-to-severe plaque psoriasis, and the SLR included randomized controlled trials (RCTs). The comparators of interest were SEC, ADA, INF, and placebo (PLA), while outcomes of interest were Psoriasis Area and Severity Index (PASI) (50, 75, and 90) at weeks 12, 16, and 24. A Bayesian NMA for PASI was utilized with a framework that evaluated the probability of PASI responses in different categories of PASI thresholds within a single model.Results: A total of 23 RCTs that assessed the efficacy of SEC, ADA, and INF in patients with moderate-to-severe plaque psoriasis were identified. At 12 weeks, SEC was associated with a significantly better response compared with PLA and ADA for PASI 75 and 90, while response results were comparable against INF. At 12 weeks, risk ratio (95% confidence interval) derived from NMA for SECvs. ADA and INF for PASI 75 was 1.35 (1.19, 1.57) and 1.01 (0.90, 1.18), respectively. At the 16-week and 24-week time interval, SEC was significantly better than PLA, ADA, and INF for PASI 75 and 90.Conclusion: Efficacy of SEC in the treatment of patient populations with moderate-to-severe plaque psoriasis is well demonstrated through NMA.展开更多
文摘A“simplified”figure was proposed in 2011 to summarize the results of controlled trials that evaluate different treatments aimed at the same disease condition.The original criteria for classifying individual binary comparisons included superiority,inferiority and no significance difference;hence,they did not differentiate between no proof of difference vs proof of no difference.We updated the criteria employed in the original“simplified”figure in order to include this differentiation.A revised version of the simplified figure is proposed and described herein.An example of application is also presented.The example is focused on first-line treatments for paroxysmal atrial fibrillation.Three treatments(medical therapy,cryoballoon ablation,radiofrequency ablation)are compared with one another through direct and indirect comparisons.
文摘BACKGROUND Gastritis is one of the most frequently diagnosed diseases requiring medical treatment in South Korea.Fexuprazan,a novel potassium-competitive acid blocker,has been approved for treating gastritis and erosive esophagitis.Meanwhile,rebamipide is the most commonly used mucoprotective agent for acute and chronic gastritis in real-world settings in South Korea.However,there have been no studies comparing the efficacy of these two drugs yet.AIM To compare the efficacy of fexuprazan with that of rebamipide for acute and chronic gastritis.METHODS This was a matching-adjusted indirect comparison.Individual patient data from a phase III study of fexuprazan(10 mg BID)were compared with cumulative data from two matching studies of rebamipide(100 mg TID).Erosion improvement and healing rates were compared between two weeks of fexurapan,two weeks of rebamipide,and four weeks of rebamipide.The two main outcome variables were presented as percentages,and the risk differences(RD)and 95%confidence intervals(CI)were calculated for the relative treatment effects.RESULTS In the primary analysis,the erosion improvement and healing rates after a twoweek treatment with fexuprazan were 64.5%and 53.2%,respectively,while a twoweek treatment with rebamipide resulted in erosion improvement and healing rates of 43.6%(RD:21.0%;95%CI:9.6-32.3;P<0.01)and 35.6%(RD:17.6%;95%CI:6.1-29.2;P=0.003),respectively.In the additional analysis,the erosion improvement and healing rates for the two-week fexuprazan treatment(64.2%and 51.2%,respectively)were similar to those obtained during a four-week treatment with rebamipide(60.6%;RD:3.6%;95%CI:-9.8,17.0;P=0.600 and 53.5%;RD:-2.3%;95%CI:-16.1,11.5;P=0.744,respectively).CONCLUSION The two-week fexuprazan treatment was superior to the two-week rebamipide treatment and similar to the fourweek rebamipide treatment for patients with gastritis.
文摘This study was designed to evaluate the efficacy, tolerability, and sequential administration of abiraterone acetate (AA) and enzalutamide (Enz) for metastatic castration-resistant prostate cancer (mCRPC). A literature search was performed with PubMed, Embase, and Web of Science databases to identify relevant studies. Reviewed literature included published phase III trials of AA or Enz in mCRPC and studies regarding their sequential administration. Given the difference in control arms in AA (active comparator) and Enz (true placebo) randomized phase III studies, indirect comparisons between AA and Enz in mCRPC showed no statistically significant difference in overall survival in prechemotherapy and postchemotherapy settings (HR. 0.90, 95% CI, 0.73-1.11; HR: 0.85, 95% CI, 0.68-1.07). Compared with AA, Enz may better outperform control arms in treating mCRPC both before and after chemotherapy regarding secondary endpoints based on indirect comparisons: time to prostate-specific antigen (PSA) progression (HR. 0.34, 95% CI, 0.28-0.42; HR: 0.40, 95% CI, 0.30-0.53), radiographic progression-free survival (HR: 0.37, 95% CI, 0.28-0.48; HR: 0.61, 95% CI, 0.50-0.74), and PSA response rate (OR: 18.29, 95% CI, 11.20-29.88; OR: 10.69, 95% CI, 3.92-29.20). With regard to the effectiveness of Enz following AA or AA following Enz, recent retrospective case series reported overall survival and secondary endpoints for patients with mCRPC progression after chemotherapy. However, confirmatory head-to-head trials are necessary to determine the optimal sequencing of these agents.
文摘Background: Psoriasis is a common, chronic, immune-mediated inflammatory skin disease with increased epidermal proliferation. The objective of this review was to systematically identify the evidence and perform a network meta-analysis (NMA) to estimate the relative efficacy of secukinumab (SEC) against adalimumab (ADA) and infliximab (INF) for the treatment of moderate-to-severe plaque psoriasis.Methods: A systematic literature review (SLR) was conducted according to a pre-specified protocol to identify relevant studies. Initially, the databases were searched from database inception till June 2013, and the SLR was updated in April 2020. The eligibility criteria included adult patients (≥18 years old) with moderate-to-severe plaque psoriasis, and the SLR included randomized controlled trials (RCTs). The comparators of interest were SEC, ADA, INF, and placebo (PLA), while outcomes of interest were Psoriasis Area and Severity Index (PASI) (50, 75, and 90) at weeks 12, 16, and 24. A Bayesian NMA for PASI was utilized with a framework that evaluated the probability of PASI responses in different categories of PASI thresholds within a single model.Results: A total of 23 RCTs that assessed the efficacy of SEC, ADA, and INF in patients with moderate-to-severe plaque psoriasis were identified. At 12 weeks, SEC was associated with a significantly better response compared with PLA and ADA for PASI 75 and 90, while response results were comparable against INF. At 12 weeks, risk ratio (95% confidence interval) derived from NMA for SECvs. ADA and INF for PASI 75 was 1.35 (1.19, 1.57) and 1.01 (0.90, 1.18), respectively. At the 16-week and 24-week time interval, SEC was significantly better than PLA, ADA, and INF for PASI 75 and 90.Conclusion: Efficacy of SEC in the treatment of patient populations with moderate-to-severe plaque psoriasis is well demonstrated through NMA.