Hybrid Tx for H. pylori Achieved Superior Results

NEW ORLEANS — For Helicobacter pylori infection, a 14-day hybrid therapy that combines sequential and concomitant drug treatments improved the eradication rate, compared with 14-day standard sequential therapy, according to Dr. Ping-I. Hsu.

“Worldwide, the eradication rate with standard triple therapy is less than 80% in intention-to-treat analyses,” Dr. Hsu of Kaohsiung (Taiwan) Veterans General Hospital said at the meeting. Standard triple therapy includes a proton pump inhibitor (PPI), clarithromycin, and either amoxicillin or metronidazole.

“The ideal antimicrobial therapy would have an eradication rate of at least 95% by per-protocol analysis,” which would earn it a grade A score, he said.

In a recent assessment of 15 trials, mean eradication rates were 93% with sequential therapy and less than 95% with concomitant therapy (Gut e-pub June 4, 2010), both of which are grade B results, he noted.

The specific aim of the current study was to investigate whether either extending the duration of sequential therapy to 14 days or a 14-day hybrid regimen that combined sequential and concomitant approaches might increase the eradication rate to at least 95% (grade A) in per-protocol analysis. Subjects had H. pylori infection proven by at least two positive results for the urease test, histology, and urea breath test.

The study was done as two separate pilot studies where 240 patients were randomized to the sequential therapy group, which included esomeprazole 40 mg b.i.d. plus amoxicillin 1 g b.i.d. (EA) for 7 days followed by esomeprazole, clarithromycin 500 mg b.i.d., and metronidazole 500 mg b.i.d. for 7 days, or to hybrid therapy, which included EA for 7 days followed by EA plus clarithromycin and metronidazole for 7 days. Patients were followed to week 8, when they underwent endoscopy with urease testing and histology, or urea breath test.

After excluding patients who had lack of compliance or incomplete follow-up, the final analyses included 115 in the sequential (control) group and 109 in the hybrid therapy group. The groups were similar demographically except for a higher proportion of metronidazole-susceptible patients in the sequential group.

In both the intention-to-treat and per-protocol analysis, the outcomes were superior after hybrid therapy, Dr. Hsu said (see box above).

“The study also showed that simply prolonging the treatment duration of sequential therapy does not achieve a grade A result,” Dr. Hsu pointed out, since a rate of 93% can be achieved with just 10 days of sequential therapy (Clin. Gastroenterol. Hepatol. 2010;8:36–41).

In a univariate analysis of clinical and bacterial factors associated with efficacy, no factors analyzed affected efficacy in the hybrid arm, but the presence of resistant strains reduced the eradication rate in the control arm to 88%.

When patients are resistant to both clarithromycin and metronidazole, 10-day sequential therapy carries only a 33% cure rate, and 14-day sequential therapy has a 75% cure rare; however, with hybrid therapy, amoxicillin administration is prolonged out to 14 days, which can result in a 100% cure rate, he reported.

AstraZeneca provided the study medications, but was not otherwise involved in the study.

The eradication rate was better after hybrid therapy than after standard sequential therapy.

Source DR. HSU

Source Elsevier Global Medical News

NEW ORLEANS — For Helicobacter pylori infection, a 14-day hybrid therapy that combines sequential and concomitant drug treatments improved the eradication rate, compared with 14-day standard sequential therapy, according to Dr. Ping-I. Hsu.

“Worldwide, the eradication rate with standard triple therapy is less than 80% in intention-to-treat analyses,” Dr. Hsu of Kaohsiung (Taiwan) Veterans General Hospital said at the meeting. Standard triple therapy includes a proton pump inhibitor (PPI), clarithromycin, and either amoxicillin or metronidazole.

“The ideal antimicrobial therapy would have an eradication rate of at least 95% by per-protocol analysis,” which would earn it a grade A score, he said.

In a recent assessment of 15 trials, mean eradication rates were 93% with sequential therapy and less than 95% with concomitant therapy (Gut e-pub June 4, 2010), both of which are grade B results, he noted.

The specific aim of the current study was to investigate whether either extending the duration of sequential therapy to 14 days or a 14-day hybrid regimen that combined sequential and concomitant approaches might increase the eradication rate to at least 95% (grade A) in per-protocol analysis. Subjects had H. pylori infection proven by at least two positive results for the urease test, histology, and urea breath test.

The study was done as two separate pilot studies where 240 patients were randomized to the sequential therapy group, which included esomeprazole 40 mg b.i.d. plus amoxicillin 1 g b.i.d. (EA) for 7 days followed by esomeprazole, clarithromycin 500 mg b.i.d., and metronidazole 500 mg b.i.d. for 7 days, or to hybrid therapy, which included EA for 7 days followed by EA plus clarithromycin and metronidazole for 7 days. Patients were followed to week 8, when they underwent endoscopy with urease testing and histology, or urea breath test.

After excluding patients who had lack of compliance or incomplete follow-up, the final analyses included 115 in the sequential (control) group and 109 in the hybrid therapy group. The groups were similar demographically except for a higher proportion of metronidazole-susceptible patients in the sequential group.

In both the intention-to-treat and per-protocol analysis, the outcomes were superior after hybrid therapy, Dr. Hsu said (see box above).

“The study also showed that simply prolonging the treatment duration of sequential therapy does not achieve a grade A result,” Dr. Hsu pointed out, since a rate of 93% can be achieved with just 10 days of sequential therapy (Clin. Gastroenterol. Hepatol. 2010;8:36–41).

In a univariate analysis of clinical and bacterial factors associated with efficacy, no factors analyzed affected efficacy in the hybrid arm, but the presence of resistant strains reduced the eradication rate in the control arm to 88%.

When patients are resistant to both clarithromycin and metronidazole, 10-day sequential therapy carries only a 33% cure rate, and 14-day sequential therapy has a 75% cure rare; however, with hybrid therapy, amoxicillin administration is prolonged out to 14 days, which can result in a 100% cure rate, he reported.

AstraZeneca provided the study medications, but was not otherwise involved in the study.

The eradication rate was better after hybrid therapy than after standard sequential therapy.

Source DR. HSU

Source Elsevier Global Medical News

NEW ORLEANS — For Helicobacter pylori infection, a 14-day hybrid therapy that combines sequential and concomitant drug treatments improved the eradication rate, compared with 14-day standard sequential therapy, according to Dr. Ping-I. Hsu.

“Worldwide, the eradication rate with standard triple therapy is less than 80% in intention-to-treat analyses,” Dr. Hsu of Kaohsiung (Taiwan) Veterans General Hospital said at the meeting. Standard triple therapy includes a proton pump inhibitor (PPI), clarithromycin, and either amoxicillin or metronidazole.

“The ideal antimicrobial therapy would have an eradication rate of at least 95% by per-protocol analysis,” which would earn it a grade A score, he said.

In a recent assessment of 15 trials, mean eradication rates were 93% with sequential therapy and less than 95% with concomitant therapy (Gut e-pub June 4, 2010), both of which are grade B results, he noted.

The specific aim of the current study was to investigate whether either extending the duration of sequential therapy to 14 days or a 14-day hybrid regimen that combined sequential and concomitant approaches might increase the eradication rate to at least 95% (grade A) in per-protocol analysis. Subjects had H. pylori infection proven by at least two positive results for the urease test, histology, and urea breath test.

The study was done as two separate pilot studies where 240 patients were randomized to the sequential therapy group, which included esomeprazole 40 mg b.i.d. plus amoxicillin 1 g b.i.d. (EA) for 7 days followed by esomeprazole, clarithromycin 500 mg b.i.d., and metronidazole 500 mg b.i.d. for 7 days, or to hybrid therapy, which included EA for 7 days followed by EA plus clarithromycin and metronidazole for 7 days. Patients were followed to week 8, when they underwent endoscopy with urease testing and histology, or urea breath test.

After excluding patients who had lack of compliance or incomplete follow-up, the final analyses included 115 in the sequential (control) group and 109 in the hybrid therapy group. The groups were similar demographically except for a higher proportion of metronidazole-susceptible patients in the sequential group.

In both the intention-to-treat and per-protocol analysis, the outcomes were superior after hybrid therapy, Dr. Hsu said (see box above).

“The study also showed that simply prolonging the treatment duration of sequential therapy does not achieve a grade A result,” Dr. Hsu pointed out, since a rate of 93% can be achieved with just 10 days of sequential therapy (Clin. Gastroenterol. Hepatol. 2010;8:36–41).

In a univariate analysis of clinical and bacterial factors associated with efficacy, no factors analyzed affected efficacy in the hybrid arm, but the presence of resistant strains reduced the eradication rate in the control arm to 88%.

When patients are resistant to both clarithromycin and metronidazole, 10-day sequential therapy carries only a 33% cure rate, and 14-day sequential therapy has a 75% cure rare; however, with hybrid therapy, amoxicillin administration is prolonged out to 14 days, which can result in a 100% cure rate, he reported.

AstraZeneca provided the study medications, but was not otherwise involved in the study.

The eradication rate was better after hybrid therapy than after standard sequential therapy.

Source DR. HSU

Source Elsevier Global Medical News