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Studies have shown that oral antifungals such as fluconazole (Diflucan) have been associated with abnormal elevations of liver enzymes. Because the body metabolizes fluconazole in the liver, interactions can occur if you take fluconazole along with other medications that are also metabolized in the liver. Even if you take just one tablet, fluconazole remains in your body for days. Before you take fluconazole to treat a yeast infection, check with your healthcare professional or pharmacist about potential interactions with medicines you may already be taking, or check for medication interactions online. This is especially important if you experience recurrent vaginal yeast infections, since your healthcare professional may be likely to prescribe multiple doses of fluconazole.
Eligible participants were 18 years or older at the time of enrolment and either were proven carriers or obligate carriers of a pathogenic or likely pathogenic mutation in one of the MMR genes (MLH1, MSH2/EPCAM, MSH6, PMS2, ie, patients with LS) or had been diagnosed with an MMR-deficient tumour with absence of somatic BRAF-V600E mutation and/or hypermethylation of the MLH1 promoter without evidence of a germline mutation in the MMR genes (ie, patients LLS). Randomised participants were required to have a portion of the distal colon or rectosigmoid intact in order to enable collection of normal mucosa biopsies. Therefore, this trial explored the effects of naproxen in primary and secondary prevention by recruiting unaffected carriers and cancer survivors. Participants were required to be off scheduled aspirin, NSAIDs or COX inhibitors at least 14 days prior to trial inclusion (wash-out period). Therefore, trial candidates on cardioprotective aspirin were not eligible to participate. In addition, the use of these agents was also prohibited as concomitant medications during the course of the trial. Full eligibility criteria and the protocol including the statistical analysis plan are available in the online supplementary materials and methods. All authors had full access to the data, control of the content of the manuscript and final responsibility for the decision to submit for publication.
A total of seven secondary efficacy end points evaluated changes after exposure to 6 months of treatment that included (1) naproxen concentrations in plasma and (2) colorectal mucosa, (3) levels of PGE2 metabolites in urine (PGE-M), (4) a broad panel of PGs with levels of PGF2, PGD2, thromboxane B2, 9a11b-PGF2a and 6-KetoPGF1, (4) number of polyps observed in the rectosigmoid at baseline and after 6 months of intervention, (6) mRNA and (7) histomorphometric analysis of lymphoid components within the colorectal mucosa. Details on the methodological approaches and measurements for each endpoint can be found in the online supplementary methods section.
Details on the methodology for the assessment and comparisons of pretreatment and post-treatment levels of PGE2 in tissue and plasma, PGE-M in urine, naproxen in plasma and tissue, whole genome transcriptomics (mRNA-seq) in colorectal mucosa, bioinformatic analyses, and quantification of intraepithelial lymphocytes (IELs) and mucosa-associated lymphoid tissue (MALT) for the histomorphometry analysis can be found in online supplementary methods section.
Information on the co-clinical trial assessing the activity of aspirin, naproxen and placebo in intestinal cancer prevention using a Msh2LoxP/LoxP;Villin-Cre mouse model of LS13 as well as the methods related to the validation of human expression profiles using an additional cohort of the mice with LS and six PDOs (online supplementary table S2) using both whole genome transcriptomics and qPCR (online supplementary table S3) can be found in online supplementary methods and tables.
In regards to the effect of naproxen on polyp growth, we restricted the evaluation to the rectosigmoid area in order to compare the findings from the baseline colonoscopy and the end-of-study flexible sigmoidoscopy. Among the group of evaluable patients (n=54), 14 (26%) participants had a polyp at baseline and only 2 (3.7%) had a polyp at the end-of-study. These two participants received placebo, both presenting adenomas (2 out of 23, online supplementary figure S1F), and none of the participants in the LD and HD naproxen arms displayed any polyps at the end-of-the-study scope (0 out of 15, and 16 participants, respectively).
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