Efficacy and Safety of Postmenopausal Osteoporosis Treatments: A Systematic Review and Network Meta-Analysis of Randomized Controlled Trials.
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ABSTRACT:
SUBMITTER: Lin SY
PROVIDER: S-EPMC8305263 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:We conducted meta-analyses of findings from randomized, placebo-controlled, short-term trials for acute mania in manic or mixed states of DSM (III-IV) bipolar I disorder in 56 drug-placebo comparisons of 17 agents from 38 studies involving 10,800 patients. Of drugs tested, 13 (76%) were more effective than placebo: aripiprazole, asenapine, carbamazepine, cariprazine, haloperidol, lithium, olanzapine, paliperdone, quetiapine, risperidone, tamoxifen, valproate, and ziprasidone. Their pooled effect size for mania improvement (Hedges' g in 48 trials) was 0.42 (confidence interval (CI): 0.36-0.48); pooled responder risk ratio (46 trials) was 1.52 (CI: 1.42-1.62); responder rate difference (RD) was 17% (drug: 48%, placebo: 31%), yielding an estimated number-needed-to-treat of 6 (all p<0.0001). In several direct comparisons, responses to various antipsychotics were somewhat greater or more rapid than lithium, valproate, or carbamazepine; lithium did not differ from valproate, nor did second generation antipsychotics differ from haloperidol. Meta-regression associated higher study site counts, as well as subject number with greater placebo (not drug) response; and higher baseline mania score with greater drug (not placebo) response. Most effective agents had moderate effect-sizes (Hedges' g=0.26-0.46); limited data indicated large effect sizes (Hedges' g=0.51-2.32) for: carbamazepine, cariprazine, haloperidol, risperidone, and tamoxifen. The findings support the efficacy of most clinically used antimanic treatments, but encourage more head-to-head studies and development of agents with even greater efficacy.
| S-EPMC3055677 | biostudies-other
Project description:BackgroundSystemic treatments, namely, either monotherapy or combination therapy, are commonly administered to patients with advanced or metastatic colorectal cancer (CRC). This study aimed to provide the complete efficacy and safety profiles and ranking of systemic therapies for the treatment of unresectable advanced or metastatic CRC.MethodsWe searched PubMed, Embase, the Cochrane Library, and ClinicalTrials.gov from inception until June 30, 2021, and also the bibliographies of relevant studies. Randomized controlled trials comparing two or more treatments, namely, at least capecitabine, 5-fluorouracil, leucovorin, irinotecan, bevacizumab, cetuximab, oxaliplatin, or panitumumab were investigated. A network meta-analysis using the Bayesian approach was performed to compare the efficacy and safety of treatments. The surface under the cumulative ranking curve (SUCRA) was calculated for the probability of each treatment as the most effective. The overall response rate (ORR), disease control rate (DCR), overall survival (OS), progression-free survival (PFS), adverse events (AEs) grade ≥3, and serious adverse events (SAEs) were evaluated.ResultsOne hundred two publications with 36,147 participants were assigned to 39 different treatments. Among 11 treatments with full information on six outcomes, FOLFIRI/FOLFOX/FOLFOXIRI + bevacizumab significantly improved both the ORR and DCR, compared to FOLFIRI. Although FOLFOX and FOLFIRI/FOLFOX + cetuximab significantly prolonged both OS and PFS, treatments were comparable in terms of AEs grade ≥3 and SAEs. The top highest SUCRA values were observed in the FOLFOXIRI + panitumumab group for ORR (96%) and DCR (99%), FOLFIRI + bevacizumab + panitumumab group for OS (62%) and PFS (54%), and FOLFOXIRI + bevacizumab group for AEs grade ≥3 (59%) and SAEs (59%) outcomes.ConclusionsThese findings suggest an available range of systemic treatment therapies with different efficacy and safety profiles with patients. Further investigations of the side effects and mutation status are required to confirm our findings.Systematic review registrationhttps://www.crd.york.ac.uk/prospero/, identifier CRD42019127772.
| S-EPMC8864322 | biostudies-literature
Project description:ObjectEldecalcitol (ED-71) is a vitamin D analog for the treatment of osteoporosis. However, inconsistent results have been reported in this regard. Hence, this meta-analysis of randomized controlled trials (RCTs) aimed to assess the efficacy and safety of ED-71 for osteoporosis.MethodsThe PubMed, Embase, and the Cochrane Library databases were systematically searched to identify potential trials from inception until April 2021. The investigated outcomes included bone mineral density and fractures at various sites, and potential adverse events. The pooled effect estimates were calculated using weighted mean difference (WMD) and relative risk (RR) with 95% confidence interval (CI) using the random-effects model.ResultsEight RCTs involving 2368 patients were selected for the final meta-analysis. The pooled results showed that ED-71 were associated with a higher level of femoral neck (FN) bone mineral density (BMD) (WMD: 0.92; 95% CI: 0.24-1.60; P = 0.008), while it had no significant effect on lumbar spine BMD (WMD: 1.09; 95% CI: -0.11 to 2.30; P = 0.076) and hip BMD (WMD: 1.12; 95% CI: -0.16 to 2.40; P = 0.088). Moreover, the use of ED-71 could protect against the risk of all osteoporotic fracture (RR: 0.70; 95% CI: 0.55-0.88; P = 0.003) and vertebral fracture (RR: 0.74; 95% CI: 0.55-0.98; P = 0.038), while it did not affect the risk of nonvertebral fracture (RR: 0.53; 95%CI: 0.23-1.23; P = 0.140). The subgroup analyses found that the effects of ED-71 were superior to those of alfacalcidol on both BMD and fracture results. Moreover, the use of ED-71 plus bisphosphonate was associated with a greater improvement in BMD at various sites compared with bisphosphonate alone. Finally, ED-71 was associated with an increased risk of increased urine calcium level (RR: 1.69; 95% CI: 1.33-2.15; P < 0.001).ConclusionThis study found that the use of ED-71 could improve BMD and fractures at various sites, especially compared with alfacalcidol or a combination with bisphosphonate for patients with osteoporosis.Systematic review registration[http://www.crd.york.ac.uk/prospero], identifier [CRD42021270536].
| S-EPMC9063410 | biostudies-literature
Project description:Background: We provided a comprehensive evaluation of efficacy of available treatments for coronavirus disease 2019 (COVID-19). Methods: We searched for candidate COVID-19 studies in WHO COVID-19 Global Research Database up to August 19, 2021. Randomized controlled trials for suspected or confirmed COVID-19 patients published on peer-reviewed journals were included, regardless of demographic characteristics. Outcome measures included mortality, mechanical ventilation, hospital discharge and viral clearance. Bayesian network meta-analysis with fixed effects was conducted to estimate the effect sizes using posterior means and 95% equal-tailed credible intervals (CrIs). Odds ratio (OR) was used as the summary measure for treatment effect. Bayesian hierarchical models were used to estimate effect sizes of treatments grouped by the treatment classifications. Results: We identified 222 eligible studies with a total of 102,950 patients. Compared with the standard of care, imatinib, intravenous immunoglobulin and tocilizumab led to lower risk of death; baricitinib plus remdesivir, colchicine, dexamethasone, recombinant human granulocyte colony stimulating factor and tocilizumab indicated lower occurrence of mechanical ventilation; tofacitinib, sarilumab, remdesivir, tocilizumab and baricitinib plus remdesivir increased the hospital discharge rate; convalescent plasma, ivermectin, ivermectin plus doxycycline, hydroxychloroquine, nitazoxanide and proxalutamide resulted in better viral clearance. From the treatment class level, we found that the use of antineoplastic agents was associated with fewer mortality cases, immunostimulants could reduce the risk of mechanical ventilation and immunosuppressants led to higher discharge rates. Conclusions: This network meta-analysis identified superiority of several COVID-19 treatments over the standard of care in terms of mortality, mechanical ventilation, hospital discharge and viral clearance. Tocilizumab showed its superiority compared with SOC on preventing severe outcomes such as death and mechanical ventilation as well as increasing the discharge rate, which might be an appropriate treatment for patients with severe or mild/moderate illness. We also found the clinical efficacy of antineoplastic agents, immunostimulants and immunosuppressants with respect to the endpoints of mortality, mechanical ventilation and discharge, which provides valuable information for the discovery of potential COVID-19 treatments.
| S-EPMC8506153 | biostudies-literature
Project description:Background: Melasma is an acquired pigmentation disorder with challenges in treatment because of its refractory nature and high risk of recurrence. Objectives: This study aimed to compare the efficacy and side effects of 14 common therapies for melasma using a systematic review and network meta-analysis (NMA). Methods: The PubMed, Embase, and Cochrane Library databases were searched till December 2020 using the melasma area and severity index as a therapeutic index. A total of 59 randomized controlled trials (RCTs) met the inclusion criteria and were selected. Results: The ranking of relative efficacy compared with placebo in descending order was Q-switched Nd:Yag 1,064-nm laser (QSND), intense pulsed light, ablative fractional laser (AFL), triple combined cream (TCC), topical vitamin C, oral tranexamic acid (oTA), peeling, azelaic acid, microneedles (MNs), topical tranexamic acid (tTA), tretinoin, picosecond laser, hydroquinone (HQ), and non-AFL. Moreover, QSND was more effective than HQ and tTA against melasma. The ranking of percentage (%) of side effects in ascending order for each of 14 therapies with more than 80 participants was tretinoin (10.1%), oTA (17.6%), HQ (18.2%), AFL (20.0%), QSND (21.5%), TCC (25.7%), tTA (36.75%), peeling (38.0%), and MN (52.3%). Taking both efficacy and safety into consideration, TCC was found to be the most favorable selection among the topical drugs for melasma. QSND and AFL were still the best ways to treat melasma among photoelectric devices. oTA as system administration was a promising way recommended for melasma. Among 31 studies, 87% (27/31) studies showed that the efficacy of combination therapies is superior to that of single therapy. The quality of evidence in this study was generally high because of nearly 50% of split-face RCTs. Conclusions: Based on the published studies, this NMA indicated that QSND, AFL, TCC, and oTA would be the preferred ways to treat melasma for dermatologists. However, more attention should be paid to the efficacy and safety simultaneously during the clinical application. Most of the results were in line with those of the previous studies, but a large number of RCTs should be included for validation or update. Systematic Review Registration: identifier: CRD42021239203.
| S-EPMC8511390 | biostudies-literature
Project description:BackgroundThis phase 3 study evaluated the efficacy and safety of 6-month treatment with romosozumab in Korean postmenopausal women with osteoporosis.MethodsSixty-seven postmenopausal women with osteoporosis (bone mineral density [BMD] T-scores ≤-2.5 at the lumbar spine, total hip, or femoral neck) were randomized (1:1) to receive monthly subcutaneous injections of romosozumab (210 mg; n=34) or placebo (n=33) for 6 months.ResultsAt month 6, the difference in the least square (LS) mean percent change from baseline in lumbar spine BMD (primary efficacy endpoint) between the romosozumab (9.5%) and placebo (-0.1%) groups was significant (9.6%; 95% confidence interval, 7.6 to 11.5; P<0.001). The difference in the LS mean percent change from baseline was also significant for total hip and femoral neck BMD (secondary efficacy endpoints). After treatment with romosozumab, the percent change from baseline in procollagen type 1 N-terminal propeptide transiently increased at months 1 and 3, while that in C-terminal telopeptide of type 1 collagen showed a sustained decrease. No events of cancer, hypocalcemia, injection site reaction, positively adjudicated atypical femoral fracture or osteonecrosis of the jaw, or positively adjudicated serious cardiovascular adverse events were observed. At month 9, 17.6% and 2.9% of patients in the romosozumab group developed binding and neutralizing antibodies, respectively.ConclusionTreatment with romosozumab for 6 months was well tolerated and significantly increased lumbar spine, total hip, and femoral neck BMD compared with placebo in Korean postmenopausal women with osteoporosis (ClinicalTrials.gov identifier NCT02791516).
| S-EPMC7937846 | biostudies-literature
Project description:BackgroundGlucocorticoids are widely used in a variety of diseases, especially autoimmune diseases and inflammatory diseases, so the incidence of glucocorticoid-induced osteoporosis is high all over the world.ObjectivesThe purpose of this paper is to use the method of network meta-analysis (NMA) to compare the efficacy of anti-osteoporosis drugs directly and indirectly, and to explore the advantages of various anti-osteoporosis drugs based on the current evidence.MethodsWe searched PubMed, Embase and Cochrane Library for randomized controlled trials (RCTs), of glucocorticoid-induced osteoporosis (GIOP) and compared the efficacy and safety of these drugs by NMA. The risk ratio (RR) and its 95% confidence interval (CI) are used as the influence index of discontinuous data, and the standardized mean difference (SMD) and its 95% CI are used as the influence index of continuous data. The statistical heterogeneity was evaluated by the calculated estimated variance (τ2), and the efficacy and safety of drugs were ranked by the surface under the cumulative ranking curve (SUCRA). The main outcome of this study was the incidence of vertebral fracture after taking several different types of drugs, and the secondary results were the incidence of non-vertebral fracture and adverse events, mean percentage change of lumbar spine (LS) and total hip (TH)bone mineral density (BMD) from baseline to at least 12 months.ResultsAmong the different types of anti-GIOP, teriparatide (SUCRA 95.9%) has the lowest incidence of vertebral fracture; ibandronate (SUCRA 75.2%) has the lowest incidence of non-vertebral fracture; raloxifene (SUCRA 98.5%) has the best effect in increasing LS BMD; denosumab (SUCRA 99.7%) is the best in increasing TH BMD; calcitonin (SUCRA 92.4%) has the lowest incidence of serious adverse events.ConclusionsTeriparatide and ibandronate are effective drugs to reduce the risk of vertebral and non-vertebral fractures in patients with GIOP. In addition, long-term use of raloxifene and denosumab can increase the BMD of LS and TH.
| S-EPMC7743932 | biostudies-literature
Project description:The present study aims to compare the relative efficacy and safety of different interventions for IgA nephropathy (IgAN) with proteinuria more than 1 g/d by using network meta-analysis. We searched PubMed, Embase, and the Cochrane Library for studies compared the rate of clinical remission and/or end-stage renal disease (ESRD) and/or serious adverse events in IgAN patients with proteinuria (>1 g/d). The surface under the cumulative ranking area (SUCRA) was calculated to rank the interventions. A total of 21 randomized controlled trials with 1822 participants were included for the comparisons of 7 interventions. The rank of the most effective treatments to induce clinical remission was renin-angiotensin system inhibitors (RASi) plus urokinase, steroid plus tonsillectomy, and RASi plus steroid with a SUCRA of 0.912, 0.710, and 0.583, respectively. As for the prevention of ESRD or doubling of serum creatinine, RASi plus steroid (SUCRA 0.012) was the most effective, followed by RASi (SUCRA 0.282) and steroid (SUCRA 0.494), leaving mycophenolate mofetil as the least effective (SUCRA 0.644). There was no statistical difference among all interventions in the occurrence of serious adverse events. The current network meta-analysis demonstrated for the first time that RASi plus steroid is probably the best therapeutic choice, not only for reducing proteinuria but also for maintaining long-term renal protection.
| S-EPMC6035132 | biostudies-literature
Project description:Background Primary osteoporosis (PO) is a systemic metabolic skeletal disease. Previous studies have shown that moxibustion can reduce pain intensity and enhance response rate, bone mineral density (BMD), and living function of the patients with PO. However, consensus on its efficacy does not exist, and evidence of moxibustion for PO is also insufficient. Methods We searched five English and four Chinese databases with various additional sources and published reviews through December 1, 2021, to evaluate potentially concerned randomized controlled trials (RCTs). Two independent researchers addressed selection screening, data extraction, and risk of bias assessment. The data of this meta-analysis were analyzed using the RevMan v.5.4 software. Additionally, the trial sequential analysis v.0.9.5.10 β was used to estimate the sample size. In contrast, the quality of evidence from the RCTs was assessed using the Grading of Recommendations, Assessment, Development, and Evaluation tool. Results The current meta-analysis included 14 RCTs containing 898 participants. The methodological quality of the RCTs was moderate. The review demonstrated that a combination of moxibustion and conventional medicine (CM) significantly reduced pain intensity and improved the BMD compared with CM. Furthermore, it was found that moxibustion plus CM/moxibustion could improve response rates compared with CM. However, it was found that the reduction of pain intensity and improvement of BMD by moxibustion showed no significant difference compared with CM. It was also evident that the sample size of most outcomes was inadequate. Moreover, all evidence obtained in this study was ranked as low to critically low. Conclusions In conclusion, it was demonstrated that moxibustion is a potentially effective agent for treating PO. However, high-quality studies should be implemented in the future because this study only obtained low-quality evidence. This study was registered in the PROSPERO platform (CRD42021291310).
| S-EPMC9532117 | biostudies-literature
Project description:Hypertension is a prevalent risk factor for cardiovascular disease. Angiotensin II receptor blockers are widely prescribed to patients with hypertension, while new drugs are continuously developed. However, data on comparative efficacy and safety of novel agents, such as fimasartan, are scarce. Here, we aimed to collect clinical evidence on different angiotensin II receptor blockers using a network meta-analysis. Randomized controlled trials whose follow-up time is within 12 weeks were identified from eight databases via a systematic literature review. Of the 7909 possibly relevant studies, 61 studies with 14,249 adult patients were included in the analysis. These studies were further subjected to quality appraisal using Cochran's Risk of Bias, and sitting systolic blood pressure was considered the primary endpoint. A Bayesian random effect generalized linear model was used for the network meta-analysis, and the treatment rank probability was determined. Olmesartan (standardized mean difference -0.987 [-1.29, -0.729]) and fimasartan (standardized mean difference -0.966 [-1.21, -0.745]) showed the highest rank probabilities (37% and 35%) in the 4-week group, considering the primary endpoint. Furthermore, the odds ratio of adverse events for all agents did not differ significantly from that of the placebo. The treatment rank of angiotensin II receptor blockers varied depending on the outcome type and follow-up period considerably. Fimasartan rapidly lowered blood pressure in 4 weeks, which was further maintained until 12 weeks, indicating its competent efficacy and tolerability. Our findings may help medical practitioners and patients to select the best angiotensin II receptor blocker against hypertension.
| S-EPMC9380168 | biostudies-literature