FLV used as monotherapy in vivo showed suppressive effects of HCV clinically that are modest, variable, and often short-lived. These findings support "proof-of-concept" for pilot trials combining fluvastatin with standard therapy. Statins and fluvastatin, in particular, appear to be safe for use in hepatitis C.
Fluvastatin or simvastatin has demonstrable antiviral activity against hepatitis C virus (HCV) as monotherapy. The safety and efficacy of adding fluvastatin or simvastatin to peginterferon/ribavirin for 48 weeks was tested in HCV genotype 1 naïve-to-treatment veterans. Thirty-seven naïve-to-treatment genotype 1 HCV patients were randomized to either a control group (n = 20) to receive peginterferon alfa plus ribavirin or an experimental group (n = 18) to similarly receive peginterferon alfa plus ribavirin as well as fluvastatin 20 mg/day. In addition, seven patients who presented for HCV treatment already were on simvastatin and could not be withdrawn. These simvastatin users were not randomized but were entered into a concurrent prospective pilot arm. There were no unique safety issues with fluvastatin or simvastatin when these drugs were given with peginterferon/ribavirin for 48 weeks. Thirteen of 25 statin patients achieved sustained viral response (SVR), while 5 of 20 control patients achieved SVR. Analysis of SVR by intention-to-treat showed P = 0.078. In this phase 2 study, there were no safety issues with the addition of fluvastatin or simvastatin to peginterferon and ribavirin for 48 weeks. There was a trend towards improvement in SVR when fluvastatin or simvastatin was administered with peginterferon/ribavirin. The size of the groups did not reach the prestudy size thought needed to show significant difference (type II error). These results support the significant results of two other larger randomized controlled trials reported using the same dose of fluvastatin in naïve-to-treatment genotype 1 HCV patients.
Background and Aims
Oral sodium sulfate (OSS) solution and low‐volume polyethylene glycol‐based solutions are two of the more common low‐volume purgatives used as colonoscopy preparations. Data on how these different low‐volume solutions compare are mixed. Our aim was to conduct a meta‐analysis of randomized controlled trials (RCTs) to compare OSS with low‐volume polyethylene glycol solutions (PEG) plus ascorbic acid (PEG + Asc) solution with respect to (i) satisfactory bowel preparation, (ii) excellent bowel preparation, and (iii) tolerability.
Methods
Studies were identified by searching 10 medical databases for reports published from 1974 until 2019. Only fully published RCTs comparing OSS and low‐volume PEG‐based products with regard to overall satisfactory bowel preparation were included. Pooling was conducted by both fixed‐effects and random effects models; results are presented from the random effects model when heterogeneity was significant.
Results
Seven studies (involving 2049 subjects) met the inclusion criteria. There was no difference between OSS and PEG + Asc with respect to adequate bowel preparation (risk ratio [RR] 1.02 [0.99–1.06]; P = 0.16). OSS did result in a higher chance of excellent bowel preparation (RR 1.18 [1.06–1.31]; P = 0.03). OSS was associated with a 30% increased risk of nausea (RR 1.35 [1.03–1.77]; P = 0.03) and more than double the risk of vomiting (RR 2.30 [1.63–2.23]; P < 0.05) compared with PEG + Asc. Begg's funnel plot indicated low probability of publication bias.
Conclusions
Individuals at low risk of inadequate bowel preparation who use OSS for bowel preparation are more likely to achieve excellent bowel preparation, but are more likely to experience nausea and vomiting than are individuals using low‐volume PEG‐based solutions.
A 68-year-old male presented with progressive abdominal pain, dyspnea, weight loss, and dysuria. Lab work revealed elevated creatine phosphokinase levels, prostate-specific antigen level (approximately 60 ng/mL), and elevated liver enzymes. He was admitted to the intensive care unit for worsening respiratory distress and confusion. He continued to deteriorate, and his bilirubin peaked at 8.5 mg/dL. The patient subsequently died, and an autopsy revealed extensive hepatic necrosis with diffuse intravascular and intraparenchymal permeation of metastatic prostatic carcinoma. Fulminant hepatic failure remains a rare presentation of metastatic prostatic carcinoma, with a rapidly progressive course toward hepatic coma and death. A high index of suspicion is needed to investigate the possibility of palliative chemotherapy.
In patients on chronic opioid therapy, administration of diphenhydramine does not allow for lower doses of procedural sedatives but improves quality of sedation without increasing the number of adverse events. (Clinical trial registration number: NCT T01967433.).
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