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flipper44

12/09/19 2:17 PM

#254888 RE: manibiotech #254887

No, that's wrong. No company is going to buy it until, at minimum, TLD comes back (if statistically significant.), and they review all the other data (certainly they've viewed more blinded data then us, as the opportunity to review additional data was offered in the JTM). Any earlier and LP would be asking too much in BP's view, and BP would be risking too much. IMO.
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X Master

12/09/19 3:46 PM

#254916 RE: manibiotech #254887

If this were true, why has strovax not been approved by the FDA? My wife suffered recurrent UTI’s for several years. While we were in Germany, she was able to receive the strovax vaccine. Since her treatment, she has only had a couple of breakthrough infections. Nothing like her Pre-vaccines years. We talk about, reducing the use of antibiotics, but are we really interested in doing so? Who’s pockets are we lining in the process?

Vaccines for the prevention of recurrent urinary tract infections: a systematic review.
Review article
Aziminia N, et al. BJU Int. 2019.
Show full citation
Abstract
OBJECTIVES: To systematically review the evidence regarding the efficacy of vaccines or immunostimulants in reducing the recurrence rate of urinary tract infections (UTIs).

MATERIALS AND METHODS: The Medical Literature Analysis and Retrieval System Online (MEDLINE), Excerpta Medica dataBASE (EMBASE), PubMed, Cochrane Library, World Health Organization (WHO) International Clinical Trials Registry Platform Search Portal, and conference abstracts were searched up to January 2018 for English-titled citations. Randomised placebo-controlled trials evaluating UTI recurrence rates in adult patients with recurrent UTIs treated with a vaccine were selected by two independent reviewers according to the Population, Interventions, Comparators, and Outcomes (PICO) criteria. Differences in recurrence rates in study populations for individual trials were calculated and pooled, and risk ratios (RRs) using random effects models were calculated. Risk of bias was assessed using the Cochrane Collaboration's tool and heterogeneity was assessed using chi-squared and I2 testing. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was used to evaluate the quality of evidence (QOE) and summarise findings.

RESULTS: In all, 599 records were identified, of which 10 studies were included. A total of 1537 patients were recruited and analysed, on whom data were presented. Three candidate vaccines were studied: Uro-Vaxom® (OM Pharma, Myerlin, Switzerland), Urovac® (Solco Basel Ltd, Basel, Switzerland), and ExPEC4V (GlycoVaxyn AG, Schlieren, Switzerland). At trial endpoint, the use of vaccines appeared to reduce UTI recurrence compared to placebo (RR 0.74, 95% confidence interval [CI] 0.67-0.81; low QOE). Uro-Vaxom showed the greatest reduction in UTI recurrence rate; the maximal effect was seen at 3 months compared with 6 months after initial treatment (RR 0.67, 95% CI 0.57-0.78; and RR 0.78, 95% CI 0.69-0.88, respectively; low QOE). Urovac may also reduce risk of UTI recurrence (RR 0.75, 95% CI 0.63-0.89; low QOE). ExPEC4V does not appear to reduce UTI recurrence compared to placebo at study endpoint (RR 0.82, 95% CI 0.62-1.10; low QOE). Substantial heterogeneity was observed across the included studies (chi-squared = 54.58; P < 0.001, I2 = 84%).

CONCLUSIONS: While there is evidence for the efficacy of vaccines in patients with recurrent UTIs, significant heterogeneity amongst these studies renders interpretation and recommendation for routine clinical use difficult at present. Further randomised trials using consistent definitions and endpoints are needed to study the long-term efficacy and safety of vaccines for infection prevention in patients with recurrent UTIs.

© 2018 The Authors BJU International © 2018 BJU International.