The efficacy and safety of clarithromycin, roxithromycin and erythromycin stearate in mild pneumonia were compared in an open randomized trial. Eighty-six male patients, doing their obligatory military service, ranging between 19 and 24 years of age (mean 20), were randomly treated: 29 with clarithromycin 500 mg 12-hourly, 30 with roxithromycin 150 mg 12-hourly, and 27 with erythromycin stearate 500 mg 6-hourly, each course being administered for 10 days. Seventy-eight patients were able to be evaluated for efficacy, 28 receiving clarithromycin, 28 roxithromycin, and 22 erythromycin stearate. There were no significant differences among the groups in terms of clinical success rates (clinical cure or improvement: 89% for clarithromycin, 82% for roxithromycin, and 73% for erythromycin stearate, p = 0.32). However, we found that there were significant differences among the groups in terms of clinical cure rates (75% for clarithromycin, 64% for roxithromycin, and 41% for erythromycin stearate, p = 0.04). Adverse events, mostly gastrointestinal, caused discontinuation of treatment in 3.4% of the patients in the clarithromycin group, in 6.6% of the patients in the roxithromycin group, and in 18.5% of the patients in the erythromycin stearate group. The results indicate that there were no statistically significant differences among the three treatment groups in terms of clinical success rates, but that clarithromycin and roxithromycin were better tolerated.
Adult ; Antibiotics, Macrolide/therapeutic use* ; Antibiotics, Macrolide/adverse effects ; Clarithromycin/therapeutic use* ; Clarithromycin/adverse effects ; Comparative Study ; Erythromycin/therapeutic use* ; Erythromycin/analogs & derivatives* ; Erythromycin/adverse effects ; Female ; Human ; Male ; Pneumonia/radiography ; Pneumonia/physiopathology* ; Pneumonia/microbiology ; Pneumonia/drug therapy* ; Radiography, Thoracic ; Roxithromycin/therapeutic use* ; Roxithromycin/adverse effects

BACKGROUNDThe emergence of bacterial resistance to commonly used antibiotics, such as macrolides, is complicating the management of respiratory tract infections (RTIs). Telithromycin, a ketolide antimicrobial structurally related to macrolides, is approved for the treatment of community-acquired RTIs, and shows lower pathogen resistance rates. The purpose of this study was to compare the efficacy and safety of telithromycin with clarithromycin, a macrolide routinely used as therapy for RTIs.

METHODSWe performed a meta-analysis of relevant randomized-controlled trials (RCTs) identified in PubMed, the Cochrane Library, Embase, CNKI and VIP databases. The primary efficacy outcome was clinical treatment success assessed at the test-of-cure time in the per-protocol population, and the primary safety outcome was drug related adverse effects.

RESULTSSeven RCTs, involving 2845 patients with RTIs, were included in the meta-analysis. Oral telithromycin and clarithromycin showed a similar clinical treatment success in modified intention to treat and per-protocol population (cure and improvement) (odds ratios (ORs): 0.84, 95% confidence intervals (CI): 0.64 - 1.11 and OR: 1.14, 95%CI: 0.71 - 1.85, respectively). Similar findings were obtained for secondary efficacy outcomes: clinical treatment success at a late post-therapy visit (OR: 0.92, 95%CI: 0.57 - 1.48) and microbiological treatment success at the test-of-cure time (OR: 1.14; 95%CI: 0.71 - 1.85). The safety outcome analysis indicated telithromycin had a similar risk of drug-related adverse effect and serious adverse effect with clarithromycin.

CONCLUSIONSOur findings indicate that oral telithromycin and clarithromycin have similar treatment efficacy and adverse effect. The advantages of lower antimicrobial resistance rates, once-daily short-duration dosing and reported lower health-care costs make oral telithromycin a useful option for the empiric management of mild-to-moderate RTIs.

Anti-Bacterial Agents ; therapeutic use ; Clarithromycin ; adverse effects ; therapeutic use ; Community-Acquired Infections ; drug therapy ; Humans ; Ketolides ; adverse effects ; therapeutic use ; Randomized Controlled Trials as Topic ; Respiratory Tract Infections ; drug therapy

BACKGROUND/AIMS: Antibiotic resistance of Helicobacter pylori (H. pylori) is a significant clinical problem because it reduces the efficacy of eradication therapy. The aims of this study were to assess the changing patterns of antibiotic resistance of H. pylori in patients with peptic ulcer diseases and to evaluate the eradication rate in antibiotic resistant H. pylori strains. METHODS: One hundred forty four H. pylori isolates obtained from 466 patients with peptic ulcer disease between June 2001 and December 2005 were examined for antimicrobial resistance. The minimum inhibitory concentration (MIC) of metronidazole was determined by modified broth microdilution method (mBMD) and E test. MICs of clarithromycin and amoxicillin were determined by mBMD, E test, and disc diffusion test. The breakpoints for metronidazole, clarithromycin, and amoxicillin resistance were defined as >8microgram/mL, >1microgram/mL, and > or =1microgram/mL, respectively. RESULTS: Resistance to metronidazole and clarithromycin was detected in 34.7% and 16.7% of H. pylori isolates, respectively. During the recent 5-year study period, amoxicillin-resistant rate of H. pylori was 11.8%, and multi-drug resistance rate of H. pylori was 16.7%. The eradication rate of clarithromycin containing triple therapies was low (7.8%) in clarithromycin-resistant H. pylori strains. CONCLUSIONS: The proportions of clarithromycin-resistant H. pylori strains have increased significantly over the last 5-years. There is an increasing tendency for the emergence of strains with multi-drug resistance. The increase in clarithromycin-resistant strains results in a decrease in eradication rate for H. pylori. In areas with high clarithromycin resistance, new alternative first-line treatment combination should be considered.
Adult ; Aged ; Amoxicillin/therapeutic use ; Anti-Bacterial Agents/therapeutic use ; Clarithromycin/adverse effects/therapeutic use ; Disk Diffusion Antimicrobial Tests ; *Drug Resistance, Bacterial ; Drug Therapy, Combination ; Female ; Helicobacter Infections/*drug therapy/microbiology ; Helicobacter pylori/*drug effects/isolation & purification ; Humans ; Male ; Metronidazole/therapeutic use ; Microbial Sensitivity Tests ; Middle Aged ; Peptic Ulcer/*drug therapy ; Retrospective Studies

BACKGROUND/AIMS: Trends in successful eradication of Helicobacter pylori using first-line triple therapy, consisting of a proton pump inhibitor, amoxicillin, and clarithromycin, have been understudied. We evaluated H. pylori eradication rates at a single center over the last 10 years and identified risk factors related to eradication failure. METHODS: This study included 1,413 patients who were diagnosed with H. pylori infection and received 7 days of triple therapy between January 2003 and December 2012. We investigated H. pylori eradication rates retrospectively with respect to the year of therapy, as well as demographic and clinical factors. H. pylori eradication was confirmed by a 13C-urea breath test or a rapid urease test at least 4 weeks after the completion of triple therapy. RESULTS: The overall H. pylori eradication rate was 84.9%. Annual eradication rates from 2003 to 2012 were 93.5%, 80.0%, 87.2%, 88.5%, 92.0%, 88.3%, 85.7%, 84.1%, 83.7%, and 78.8%, respectively, by per-protocol analysis. The eradication rate with first-line triple therapy decreased during the last 10 years (p = 0.015). Multivariate analysis showed that female gender (odds ratio [OR], 1.69; 95% confidence interval [CI], 1.12 to 2.55) and smoking (OR, 1.61; 95% CI, 1.05 to 2.47) were associated with the failure of H. pylori eradication therapy. CONCLUSIONS: The efficacy of first-line triple therapy for H. pylori infection has decreased over the last 10 years, suggesting an increase in antibiotic-resistant H. pylori strains. Thus, other first-line therapies may be necessary for H. pylori eradication in the near future.
Adolescent ; Adult ; Aged ; Aged, 80 and over ; Amoxicillin/therapeutic use ; Anti-Bacterial Agents/adverse effects/*therapeutic use ; Breath Tests ; Chi-Square Distribution ; Clarithromycin/therapeutic use ; Drug Resistance, Bacterial ; Drug Therapy, Combination ; Female ; Helicobacter Infections/diagnosis/*drug therapy/microbiology ; Helicobacter pylori/*drug effects ; Humans ; Linear Models ; Logistic Models ; Male ; Middle Aged ; Multivariate Analysis ; Odds Ratio ; Proton Pump Inhibitors/adverse effects/*therapeutic use ; Republic of Korea ; Retrospective Studies ; Risk Factors ; Sex Factors ; Smoking/adverse effects ; Time Factors ; Treatment Failure ; Young Adult