The American journal of gastroenterology
-
Am. J. Gastroenterol. · May 2014
ReviewHow drugs are developed and approved by the FDA: current process and future directions.
This article provides an overview of FDA's regulatory processes for drug development and approval, and the estimated costs associated with the development of a drug, and also examines the issues and challenges facing the FDA in the near future. ⋯ The FDA's improved processes for drug approval and post-market surveillance have achieved the goal of providing patients with timely access to effective drugs while minimizing the risk of drug-related harm. The FDA drug approval process is not without controversy, as a number of well-known gastroenterology drugs have been withdrawn from the US market over the past few years. With the approval of the new FDASIA law, the FDA will continue to improve their processes and, working together with the ACG through the FDA-Related Matters Committee, continue to develop safe and effective drugs for our patients.
-
Am. J. Gastroenterol. · Oct 2013
Review Meta AnalysisEfficacy of pharmacological therapies for the treatment of opioid-induced constipation: systematic review and meta-analysis.
There has been no definitive synthesis of the evidence for any benefit of available pharmacological therapies in opioid-induced constipation (OIC). We conducted a systematic review and meta-analysis to address this deficit. ⋯ μ-Opioid receptor antagonists are safe and effective for the treatment of OIC. More data are required before the role of prucalopride or lubiprostone in the treatment of OIC are clear.
-
Am. J. Gastroenterol. · Apr 2013
Review Meta AnalysisFecal microbiota transplantation for Clostridium difficile infection: systematic review and meta-analysis.
The clinical and economic burden of Clostridium difficile infection (CDI) is significant. Recurrent CDI management has emerged as a major challenge with suboptimal response to standard therapy. Fecal microbiota transplantation (FMT) has been used as a treatment to reconstitute the normal microbial homeostasis and break the cycle of antibiotic agents that may further disrupt the microbiome. Given the lack of randomized-controlled trials (RCTs) and limitations in previous systematic reviews, we aimed to conduct a systematic review with robust methods to determine the efficacy and safety profile of FMT in CDI. ⋯ FMT holds considerable promise as a therapy for recurrent CDI but well-designed, RCTs and long-term follow-up registries are still required. These are needed to identify the right patient, efficacy and safety profile of FMT before this approach can be widely advocated.
-
Am. J. Gastroenterol. · Apr 2013
Review Comparative StudyHCV RNA viral load assessments in the era of direct-acting antivirals.
Recent regulatory approvals of the NS3/4A protease inhibitors boceprevir and telaprevir launched a new therapeutic era for hepatitis C virus (HCV) genotype 1 infection. Decisions to shorten, extend, or stop treatment with these direct-acting antiviral (DAA) regimens require accurate quantification of serum HCV RNA levels. To effectively use DAA therapies, clinicians must understand performance characteristics of HCV RNA real-time PCR assays and the clinical significance of HCV RNA that is detectable below the lower limit of quantification. This review summarizes terms used to report HCV RNA viral load results, explains the analytical performance of the PCR assay used in the clinical trials of boceprevir and telaprevir, and compares currently available commercial assays.
-
Am. J. Gastroenterol. · Mar 2013
Review Meta AnalysisEffect of comorbidity on mortality in patients with peptic ulcer bleeding: systematic review and meta-analysis.
By systematic review and meta-analysis, we sought to assess the impact of comorbidity on short-term mortality in patients with peptic ulcer bleeding (PUB). ⋯ Underlying comorbidity is consistently associated with increased mortality in patients with PUB. The number and type of comorbidities in patients with PUB should be carefully evaluated and factored into initial management strategies.