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Randomised clinical trial: simvastatin as adjuvant therapy improves significantly the Helicobacter pylori eradication rate - a placebo-controlled study
Alimentary Pharmacology and Therapeutics, 06/01/2012
Clinical Article
Nseir W et al. – In the randomised clinical trial simvastatin as adjuvant to standard therapy improves significantly the H. pylori eradication rate.
Methods- The authors conducted a double–blind, placebo–controlled, randomised clinical trial comparing a 7–day, triple eradication regimen consisting of two antibiotics (clarithromycin 500 mg and amoxicillin 1 g, all twice per day) plus a proton pump inhibitor (omeprazole 20 mg twice daily) supplemented with simvastatin 20 mg (CAO + S) or a comparable placebo (CAO + P).
- Both the simvastatin and the placebo were taken orally twice daily for 1 week in 113 patients with H. pylori infection.
- The presence of H. pylori was determined by positive rapid urease test and histology.
- Eradication was confirmed by 13C–urea breath test at least 1 month after treatment.
- Adverse effects were assessed by questionnaire.
- A total of 113 patients underwent randomisation. Intention–to–treat analysis (ITT; n = 113) eradication rates were: CAO + S (86%; 95% CI: 78–92%), CAO + P (69%; 95% CI: 64–74%).
- Per protocol analysis (PP; n = 108) eradication rates were: CAO + S (91%; 95% CI: 84–94%), CAO + P (72%; 95% CI: 65–78%).
- Eradication rates were higher with CAO + S than CAO + P in PP and ITT (P = 0.03, P = 0.04 respectively).
- No differences were demonstrated between the two groups concerning compliance or adverse effects.