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PloS One 2014A large number of studies have tried to combine sorafenib with TACE for patients with unresectable hepatocellular carcinoma (HCC) and the results were controversial. We... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND AND AIM
A large number of studies have tried to combine sorafenib with TACE for patients with unresectable hepatocellular carcinoma (HCC) and the results were controversial. We conducted this systematic review and meta-analysis to evaluate the safety and efficacy of combination therapy of sorafenib and TACE in the management of unresectable HCC.
METHODS
MEDLINE, PsycINFO, Scopus, EMBASE, and the Cochrane Library were searched from January 1990 to October 2013 and these databases were searched for appropriate studies combining TACE and sorafenib in treatment of HCC. Two authors independently reviewed the databases and extracted the data and disagreements were resolved by discussion. Effective value and safety were analyzed. Effective value included disease control rate (DCR), time to progression (TTP) and overall survival (OS).
RESULTS
17 studies were included in the study. In the 10 noncomparative studies, DCR ranged from 18.4 to 91.2%. Median TTP ranged from 7.1 to 9.0 months, and median OS ranged from 12 to 27 months. In the 7 comparative studies, the hazard ratio (HR) for TTP was found to be 0.76 (95% CI 0.66-0.89; P<0.001) with low heterogeneity among studies (P = 0.243; I(2) = 25.5%). However, the HR for OS was found to be 0.81 (95% CI 0.65-1.01; P = 0.061) with low heterogeneity among studies (P = 0.259; I(2) = 25.4%). The common toxicities included fatigue, diarrhea, nausea, hand foot skin reaction (HFSR), hematological events, hepatotoxicity, alopecia, hepatotoxicity, hypertension and rash/desquamation. AEs are generally manageable with dose reductions.
CONCLUSIONS
Combination therapy may bring benefits for unresectable HCC patients in terms of TTP but not OS. Further well-designed randomized controlled studies are needed to confirm the efficacy of combination therapy.
Topics: Antineoplastic Agents; Carcinoma, Hepatocellular; Chemoembolization, Therapeutic; Combined Modality Therapy; Disease Progression; Humans; Liver Neoplasms; Niacinamide; Phenylurea Compounds; Sorafenib; Survival Analysis; Time Factors
PubMed: 24651044
DOI: 10.1371/journal.pone.0091124 -
Anticancer Research Nov 2017Metastatic colorectal cancer is a common disease encountered in oncology practice and treatment options beyond fluoropyrimidines, irinotecan, oxaliplatin and monoclonal... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Metastatic colorectal cancer is a common disease encountered in oncology practice and treatment options beyond fluoropyrimidines, irinotecan, oxaliplatin and monoclonal antibodies against epidermal growth factor receptor and vascular endothelium growth factor (VEGF) are limited. Regorafenib, a new drug that targets tyrosine kinases such as VEGF receptor as well as others, has been added recently to the armamentarium for metastatic colorectal cancer. This report analyzes the published experience with this drug in clinical practice outside of clinical trials.
MATERIALS AND METHODS
A literature search of major databases was performed for the identification of studies of regorafenib in metastatic colorectal cancer. Studies retained for further analysis were in English or French, describing 20 or more patients treated with regorafenib monotherapy and not part of a phase I, II or III trial. Results of the pooled analysis of retrospective studies were compared with results of the published phase III trials and a phase IIIb prospective study.
RESULTS
Twelve publications including a total of 702 patients were included in the meta-analysis. Summary response rate was 2% [95% confidence interval (CI) =0.8-3.2%] and the disease control rate 38.14% (95% CI=32.35-43.93%). Summary survival rates were 3.34 months (95% CI=2.71-3.97 months) for progression-free and 7.27 months (95% CI=6.23-8.3 months) for overall survival. These were similar to the phase III and IIIb studies. Most common adverse effects were also consistent with those of the published phase III experience.
CONCLUSION
This systematic review and meta-analysis confirmed a moderate efficacy of regorafenib in later-stage metastatic colorectal cancer in the everyday clinical practice setting outside of clinical trials. Future identification of biomarkers may aid in further tailoring of this treatment in order to obtain maximum clinical benefit.
Topics: Colorectal Neoplasms; Humans; Neoplasm Metastasis; Phenylurea Compounds; Prognosis; Pyridines; Retrospective Studies
PubMed: 29061771
DOI: 10.21873/anticanres.12039 -
Medicine Nov 2022Proton-pump inhibitors (PPIs) and vonoprazan are recommended as first-line therapies for erosive esophagitis (EE). However, it is uncertain how the magnitude of efficacy... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Proton-pump inhibitors (PPIs) and vonoprazan are recommended as first-line therapies for erosive esophagitis (EE). However, it is uncertain how the magnitude of efficacy and safety of first-line therapy, the choice of individual PPIs or vonoprazan in the treatment of EE remains controversial. This study aimed to evaluate the efficacy and safety of vonoprazan and PPIs in healing esophageal mucosal injury in patients with EE.
METHODS
Relevant databases were searched to collect randomized controlled trials of proton pump inhibitors and vonoprazan in the treatment of reflux esophagitis up to December 2021. Studies on standard-dose PPIs or vonoprazan that were published in Chinese or English and assessed healing effects in EE were included in the analysis. Stata16.0 was used to conduct a network Meta-analysis to evaluate the efficacy and safety of the treatment.
RESULTS
A total of 41 literatures were included with 11,592 enrolled patients. For the endoscopic cure rate, all the PPIs and vonoprazan significantly improve compared to Placebo; Based on the surface under the cumulative ranking curve, Ilaprazole ranked first, followed by esomeprazole, vonoprazan, pantoprazole, lansoprazole, omeprazole, rabeprazole and placebo therapy ranked the last. For the rate of adverse events, there was no significant difference among all the PPIs, vonoprazan, and placebo.
CONCLUSIONS
Ilaprazole, esomeprazole and vonoprazan have more advantages in mucosal erosion healing, there was no significant difference in the comparative safety among all interventions.
Topics: Humans; Proton Pump Inhibitors; Esomeprazole; Network Meta-Analysis; Peptic Ulcer; Rabeprazole; Esophagitis, Peptic; Abdominal Injuries
PubMed: 36451489
DOI: 10.1097/MD.0000000000031807 -
Clinical Therapeutics Dec 2010Findings from clinical studies of the efficacy and tolerability of nicotine preparations in maintaining remission of ulcerative colitis (UC) have been inconsistent. (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Findings from clinical studies of the efficacy and tolerability of nicotine preparations in maintaining remission of ulcerative colitis (UC) have been inconsistent.
OBJECTIVES
This systematic review and meta-analysis aimed to assess the efficacy and tolerability of nicotine preparations in inducing remission in UC.
METHODS
A literature search (1966 August 2010) of Scopus (EMBASE), PubMed, Web of Science, and the Cochrane Central Register of Controlled Trials was conducted for clinical trials that investigated the efficacy and/or tolerability (any adverse events [AEs] and withdrawals due to AEs) of any nicotine preparation for the induction of remission in UC.
RESULTS
The electronic searches yielded 788 items. Of these, 3 placebo-controlled trials representing 233 patients with UC and 2 randomized controlled trials that compared nicotine to corticosteroids in 81 patients with UC were included in meta-analysis. The summary relative risks (RRs) (95% CI) in comparing nicotine to placebo were 1.40 (0.63-3.12) (P = NS) for clinical remission, 1.95 (1.38-2.78) (P < 0.001) for AEs, and 3.44 (0.71-16.71) (P = NS) for withdrawal due to AEs. The summary RRs in comparing nicotine to corticosteroids (prednisolone/prednisone) were 0.74 (0.5-1.09) (P = NS) for clinical remission in 2 trials and 2.28 (0.76-6.83) (P = NS) for withdrawal due to AEs.
CONCLUSION
The findings from this meta-analysis do not support the efficacy or tolerability of nicotine preparations in inducing remission in UC.
Topics: Adrenal Cortex Hormones; Anti-Inflammatory Agents; Clinical Trials as Topic; Colitis, Ulcerative; Humans; Nicotine; Remission Induction; Treatment Outcome
PubMed: 21353102
DOI: 10.1016/j.clinthera.2011.01.004 -
PloS One 2015Idiopathic pulmonary fibrosis (IPF) is a progressive disease with poor prognosis. In the last decades pirfenidone an anti-inflammatory and anti-fibrotic agent has shown... (Meta-Analysis)
Meta-Analysis Review
UNLABELLED
Idiopathic pulmonary fibrosis (IPF) is a progressive disease with poor prognosis. In the last decades pirfenidone an anti-inflammatory and anti-fibrotic agent has shown benefit in inhibit collagen production and has also demonstrated benefit in decline progression in IPF in physiological outcomes as Forced vital capacity (FVC), in clinical outcomes such as progression free survival (PFS) and a benefit in mortality but no in clinically relevant outcomes as exacerbations or worsening of IPF.
METHODS
We conducted a systematic review to evaluate the effectiveness of physiological and clinical outcomes of pirfenidone compared to placebo in IPF. We performed a search with no language restriction. Two researchers performed literature search, quality assessment, data extraction and analysis. And was performed a summary of findings table following the GRADE approach.
RESULTS
We included 5 RCTs (Randomized controlled trials) in analysis. The meta-analysis resulted in a decrease in all cause-mortality (RR 0.52 IC 0.32-0.88) and IPF related mortality (RR 0.32 IC 0.14-0.75); other outcomes evaluated were worsening of IPF (RR 0.64 IC 0.50-0.83) and acute exacerbation (RR: 0.72 IC 0.30-1.66 respectively). Also there was a decrease in the risk of progression (RR of PFS: 0.82 IC 0.73–0.92) compared to placebo. Conclusions: We observed significant differences in physiologic and clinically relevant outcomes such as reduction in all-cause mortality, IPF related mortality, worsening of IPF and improvement of PFS. So pirfenidone treatment should be considered not only for its benefits in pulmonary function tests but also by its clinically relevant outcomes [corrected].
Topics: Anti-Inflammatory Agents, Non-Steroidal; Humans; Idiopathic Pulmonary Fibrosis; Pyridones
PubMed: 26308723
DOI: 10.1371/journal.pone.0136160 -
Neurogastroenterology and Motility Jan 2023The comparative efficacy and safety of medical therapies for gastro-esophageal reflux symptoms in endoscopy-negative reflux disease is unclear. We conducted a network... (Meta-Analysis)
Meta-Analysis
BACKGROUND
The comparative efficacy and safety of medical therapies for gastro-esophageal reflux symptoms in endoscopy-negative reflux disease is unclear. We conducted a network meta-analysis to evaluate efficacy and safety of proton pump inhibitors (PPIs), histamine-2-receptor antagonists, potassium-competitive acid blockers (PCABs), and alginates in patients with endoscopy-negative reflux disease.
METHODS
We searched MEDLINE, EMBASE, EMBASE Classic, and the Cochrane central register of controlled trials from inception to February 1, 2022. We included randomized controlled trials (RCTs) comparing efficacy of all drugs versus each other, or versus a placebo, in adults with endoscopy-negative reflux disease. Results were reported as pooled relative risks with 95% confidence intervals to summarize effect of each comparison tested, with treatments ranked according to P-score.
KEY RESULTS
We identified 23 RCTs containing 10,735 subjects with endoscopy-negative reflux disease. Based on failure to achieve complete relief of symptoms between ≥2 and <4 weeks, omeprazole 20 mg o.d. (P-score 0.94) ranked first, with esomeprazole 20 mg o.d. or 40 mg o.d. ranked second and third. In achieving adequate relief, only rabeprazole 10 mg o.d. was significantly more efficacious than placebo. For failure to achieve complete relief at ≥4 weeks, dexlansoprazole 30 mg o.d. (P-score 0.95) ranked first, with 30 ml alginate q.i.d. combined with omeprazole 20 mg o.d., and 30 ml alginate t.i.d. second and third. In terms of failure to achieve adequate relief at ≥4 weeks, dexlansoprazole 60 mg o.d. ranked first (P-score 0.90), with dexlansoprazole 30 mg o.d. and rabeprazole 20 mg o.d. second and third. All drugs were safe and well-tolerated.
CONCLUSIONS & INFERENCES
Our results confirm superiority of PPIs compared with most other drugs in treating endoscopy-negative reflux disease. Future RCTs should aim to better classify patients with endoscopy-negative reflux disease, and to establish the role of alginates and PCABs in achieving symptom relief in both the short- and long-term.
Topics: Adult; Humans; Gastrointestinal Agents; Rabeprazole; Dexlansoprazole; Heartburn; Network Meta-Analysis; Gastroesophageal Reflux; Proton Pump Inhibitors; Omeprazole; Endoscopy, Gastrointestinal; Alginates; Treatment Outcome
PubMed: 36153790
DOI: 10.1111/nmo.14469 -
Dermatologic Surgery : Official... Jan 2017Basosquamous carcinoma is a rare cutaneous neoplasm that has caused considerable controversy as to its classification, pathogenesis, and management. (Review)
Review
BACKGROUND
Basosquamous carcinoma is a rare cutaneous neoplasm that has caused considerable controversy as to its classification, pathogenesis, and management.
OBJECTIVE
To review and summarize current literature on the definition, pathogenesis, incidence, and management of basosquamous carcinoma.
MATERIALS AND METHODS
Through December 2015, an electronic search of the Pubmed database was performed using combinations of basosquamous carcinoma and metatypical basal cell carcinoma as search terms.
RESULTS
A selection of 39 publications including case reports and series, retrospective studies, and systematic reviews of the literature were included. Descriptions of the definition of basosquamous carcinoma, clinical behavior, histopathological characteristics, current treatment therapies, and future advances are summarized.
CONCLUSION
This systematic review provides a comprehensive overview of the current understanding of basosquamous carcinoma. Further study is required to elucidate the mechanisms driving the formation of this aggressive tumor.
Topics: Anilides; Antineoplastic Agents; Carcinoma, Basosquamous; Combined Modality Therapy; Humans; Immunohistochemistry; Mohs Surgery; Pyridines; Skin Neoplasms
PubMed: 27340741
DOI: 10.1097/DSS.0000000000000815 -
Clinical Drug Investigation Apr 2022Atogepant is the latest calcitonin gene-related peptide (CGRP) antagonist approved exclusively for prophylaxis of episodic migraine and is administered orally in doses...
BACKGROUND AND OBJECTIVE
Atogepant is the latest calcitonin gene-related peptide (CGRP) antagonist approved exclusively for prophylaxis of episodic migraine and is administered orally in doses of 10-60 mg/day. This article aims to provide a systematic review of the efficacy and safety of atogepant in migraine prevention.
METHODS
The literature was searched in different databases, i.e., the National Institute of Health clinical trials registry, PubMed, and the Cochrane library between 2018 to October 2021 using the keywords atogepant, MK-8031, and migraine. Conference abstracts listed in the Cochrane database (includes Embase) and drug information provided by the US Food and Drug Administration (FDA) label were also reviewed. Only English-language clinical trials were included. The authors retrieved 58 articles. Eventually, two randomized, double-blind, multicenter clinical trials involving 1,727 participants and one open-label trial were analyzed.
RESULTS
The FDA approved atogepant for migraine prevention in September 2021 based on two randomized, double-blind, placebo-controlled trials. Atogepant approved for migraine prevention acts as a CGRP receptor antagonist and is administered orally. Based on the 12-week clinical trials, atogepant was efficacious in prevention of migraine and it was well tolerated. The most common treatment-emergent adverse events were nausea, constipation, and upper respiratory infection.
RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE
Atogepant had a statistically significant change from baseline in monthly migraine days, monthly headache days, and acute medication use days.
CONCLUSIONS
Atogepant seems to be beneficial for migraine prevention, and it may be of more benefit in individuals who do not wish to take the drug as an injection or do not require a prolonged duration of drug effect. However, head-to-head trials with other CGRP antagonists are required to ascertain its place in migraine prevention.
Topics: Analgesics; Calcitonin Gene-Related Peptide; Double-Blind Method; Headache; Humans; Migraine Disorders; Multicenter Studies as Topic; Piperidines; Pyridines; Pyrroles; Randomized Controlled Trials as Topic; Spiro Compounds; Treatment Outcome
PubMed: 35230651
DOI: 10.1007/s40261-022-01130-0 -
International Urology and Nephrology Feb 2014Clinical trials have shown that niacin and its analog, niacinamide, significantly reduce serum phosphate in patients undergoing dialysis. This review aimed to assess the... (Meta-Analysis)
Meta-Analysis Review
PURPOSE
Clinical trials have shown that niacin and its analog, niacinamide, significantly reduce serum phosphate in patients undergoing dialysis. This review aimed to assess the benefits and harm of niacin and niacinamide in renal dialysis patients.
METHODS
PubMed, EMBASE, and Cochrane Library were searched, without language limitation, randomized controlled trials (RCTs). Standard methods, consistent with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, were used. Reviewer Manager software, version 5.2, was used for meta-analysis.
RESULTS
Five RCTs with a sample size of 230 patients were included. The meta-analysis showed that niacin and niacinamide significantly decreased serum phosphorus levels [weight mean difference (WMD) -0.88; 95 % confidence interval (CI) -1.19 to -0.57] as well as the calcium × phosphorus product (Ca × P) (WMD -9.15; 95 % CI -13.23 to -5.08), and increased high-density lipoprotein (HDL) levels (WMD 9.30; 95 % CI 5.86-12.74) in renal dialysis patients. Niacin significantly increased the risk of flushing [relative risk (RR) 33; 95 % CI 4.71-232.12] in these patients, while the risk of thrombocytopenia was significantly increased in the niacinamide group (RR 2.82; 95 % CI 1.14-6.94). However, sensitivity analysis showed that our finding regarding thrombocytopenia should be regarded with a low degree of certainty.
CONCLUSION
Niacin and its analog effectively improved phosphorus metabolism in renal dialysis patients. However, niacin can cause flushing and niacinamide probably cause thrombocytopenia. Further larger sample size and well-designed RCTs are needed.
Topics: Flushing; Humans; Lipoproteins, HDL; Niacin; Niacinamide; Phosphorus; Randomized Controlled Trials as Topic; Renal Insufficiency, Chronic; Thrombocytopenia; Vitamin B Complex
PubMed: 24114284
DOI: 10.1007/s11255-013-0559-z -
Thrombosis and Haemostasis Jul 2012
Meta-Analysis Review
Topics: Alleles; Aryl Hydrocarbon Hydroxylases; Clopidogrel; Cytochrome P-450 CYP2C19; Genetic Association Studies; Genetic Predisposition to Disease; Genotype; Hemorrhage; Humans; Polymorphism, Genetic; Risk; Thrombosis; Ticlopidine
PubMed: 22552318
DOI: 10.1160/TH12-02-0095