Lack of significant interactions between clopidogrel and proton pump inhibitor therapy: meta-analysis of existing literature.

BACKGROUND: Published data regarding the effect of concomitant clopidogrel and proton pump inhibitor (PPI) therapy on cardiovascular outcomes have been conflicting. AIM: To perform an updated meta-analysis in order to determine changes in risk differences (RD) between primary and secondary outcome analyses. METHODS: Primary analysis was based on definite vascular outcomes, including all cause mortality, cardiac death, myocardial infarction, and/or stroke. Secondary analysis also incorporated probable cardiac events, which included re-hospitalization for cardiac symptoms or revascularization procedures. RD were combined using a random-effects model. RESULTS: We reviewed 1,204 publications of which 26 studies (16 published articles, 10 abstracts) met inclusion criteria. The meta-analysis of outcomes from the two randomized controlled trials did not show an increased risk (RD 0.0, 95% CI -0.01, 0.01) for adverse outcomes. The meta-analysis of primary outcomes showed a RD of 0.02 (95% CI 0.01, 0.03) for all studies. The meta-analysis for secondary outcomes yielded a RD of 0.02 (95% CI 0.01-0.04) based on 19 published papers and abstracts. When primary and secondary outcomes were combined, the meta-analysis for published papers yielded an overall RD of 0.05 (95% CI 0.03-0.06). CONCLUSIONS: In patients using concomitant clopidogrel and PPI therapy, the risk of adverse cardiac outcomes was 0% based on data from well-controlled randomized trials. Data from retrospective studies and the addition of probable vascular events significantly increased the RD estimates, likely due to lack of adjustment for potential confounders.

Systematic review: benefits and harms of in-hospital use of recombinant factor VIIa for off-label indications.

BACKGROUND: Recombinant factor VIIa (rFVIIa), a hemostatic agent approved for hemophilia, is increasingly used for off-label indications. PURPOSE: To evaluate the benefits and harms of rFVIIa use for 5 off-label, in-hospital indications: intracranial hemorrhage, cardiac surgery, trauma, liver transplantation, and prostatectomy. DATA SOURCES: Ten databases (including PubMed, EMBASE, and the Cochrane Library) queried from inception through December 2010. Articles published in English were analyzed. STUDY SELECTION: Two reviewers independently screened titles and abstracts to identify clinical use of rFVIIa for the selected indications and identified all randomized, controlled trials (RCTs) and observational studies for full-text review. DATA EXTRACTION: Two reviewers independently assessed study characteristics and rated study quality and indication-wide strength of evidence. DATA SYNTHESIS: 16 RCTs, 26 comparative observational studies, and 22 noncomparative observational studies met inclusion criteria. Identified comparators were limited to placebo (RCTs) or usual care (observational studies). For intracranial hemorrhage, mortality was not improved with rFVIIa use across a range of doses. Arterial thromboembolism was increased with medium-dose rFVIIa use (risk difference [RD], 0.03 [95% CI, 0.01 to 0.06]) and high-dose rFVIIa use (RD, 0.06 [CI, 0.01 to 0.11]). For adult cardiac surgery, there was no mortality difference, but there was an increased risk for thromboembolism (RD, 0.05 [CI, 0.01 to 0.10]) with rFVIIa. For body trauma, there were no differences in mortality or thromboembolism, but there was a reduced risk for the acute respiratory distress syndrome (RD, -0.05 [CI, -0.02 to -0.08]). Mortality was higher in observational studies than in RCTs. LIMITATIONS: The amount and strength of evidence were low for most outcomes and indications. Publication bias could not be excluded. CONCLUSION: Limited available evidence for 5 off-label indications suggests no mortality reduction with rFVIIa use. For some indications, it increases thromboembolism.

Three-port versus four-port laparoscopic cholecystectomy in acute and chronic cholecystitis.

BACKGROUND: Several modifications have been introduced to laparoscopic cholecystectomy (LC). The three-port technique has been practiced on a limited scale. Our aim was to compare the three-port and four-port LC in acute (AC) and chronic cholecystitis (CC). METHODS: The medical records of 495 patients who underwent LC between September 1999 and September 2003 were reviewed. Variables such as complications, operating time, conversion to open procedure, hospital stay, and analgesia requirements were compared. RESULTS: Two hundred and eighty-three patients underwent three-port LC and 212 patients underwent four-port LC. In total, 163 (32.9%) patients were diagnosed with AC and 332 (67.1%) with CC by histology. There was no statistical difference between the three and four-port groups in terms of complications, conversion to open procedure (p = 0.6), and operating time (p = 0.4). Patients who underwent three-port LC required less opiate analgesia (pethidine) than those who underwent four-port LC (p = 0.0001). The hospital stay was found to be related to the amount of opiates consumed (p = 0.0001) and was significantly shorter in the three-port LC group (p = 0.005). CONCLUSION: Three-port LC is a safe procedure for AC and CC in expert hands. The procedure offers considerable advantages over the traditional four-port technique in the reduction of analgesia requirements and length of hospital stay.