New agent competes with triple therapy in H. pylori eradication
1
RESEARCH & DEVELOPMENT New agent competes with triple therapy in H. pylori eradication -Robert Short- With recent results showing that Helicobacter pylori eradication really does prevent stomach ulcers, Glaxo could be onto a winner with their new agent, ranitidine bismuth citrate. This single chemical molecule has been developed for use as monotherapy or in combination with antibacterials, and is likely to provide fierce competition for the currently-used triple therapy. Glaxo plans to fIle for regulatory approval for this drug later this year. Ranitidine bismuth citrate is under development for the treatment of gastric and duodenal ulcers and for the prevention of ulcers associated with the use of nonsteroidal anti-inflammatory drugs. Dr David Jackson, Glaxo's medical director, described the agent's 3 antiulcer actions at a recent press conference: 'It is antisecretory, so you cut down acid production; it is antibacterial, so it acts against Helicobacter pylori, and it also protects the mucosa '. Dr David Jackson, Claxo, UK This new compound may be just what is needed to preserve ranitidine's relevance as clinicians are increasingly convinced about the value of eradicating H. pylori. It also comes at a time of debate over the necessity for costly long-term maintenance therapy with pure H2 antagonists. H. pylori eradication works There is good reason for the recent focus on H. pylori as the organism responsible for the majority of cases of duodenal ulcer relapse [see Views & Reviews, this issue, p4]. On 29 January an article appeared in the Lancet showing the long-term follow-up of H. pylori eradication therapy in 63 patients with duodenal ulcers. I Of the 92% who remained H. pylori-negative after a mean of 7.1 years only 3% had recurrent ulcers. This compared with a 20% recurrence in the 8% of patients who were H. pylori-positive. This study has the longest follow-up of any published trial of eradication therapy. When patients have frequent relapses of duodenal ulcers, the traditional practice is to choose between repeated courses or long-term maintenance therapy with H2 receptor antagonists. The authors of the above study felt that the evidence they provided could change this practice. 'Our findings suggest that Helicobacter pylori eradication treatment is an alternative which may result in reduced costs and be used increasingly as less complex Helicobacter pylori 0156.2703194/0925.00011/$01.00° Adis International Limited 1994. All rights reserved eradication treatment regimens with fewer side effects are developed', they commented. Certainly, ranitidine bismuth citrate is likely to be a step in the right direction in simplifying eradication regimens for H. pylori. lliple therapy is conventional choice H. pylori can be suppressed temporarily by bismuth chelate, or suppressed in the long term by triple therapy. Triple therapy is a term used to describe the administration of antibacterials (amoxicillin or tetracycline with metronidazole) at the same time as bismuth chelate. It is the most effective way known of eradicating H. pylori, but it is notoriously difficult to use. Also, antibacterial-associated colitis is a potential risk and metronidazole resistance to H. pylori is easily acquired. If the antibacterials are widely used, resistance to them is likely to increase, particularly if therapy is carried out in general practice. According to Dr Anthony Morris of the Royal Liverpool University Hospital in the UK, tr.iple therapy is ' ... known to cause side effects in 20-40% of patients '. He added that 'eradication therapy is thus only appropriate for the young, fit patient with frequent relapses of chronic duodenal ulcer who does not want maintenance therapy with H2 antagonists or ulcer surgery'. Because of the difficulties of using triple therapy, Dr Jackson noted, some gastroenterologists favour dual therapy. When ranitidine bismuth citrate is given as dual therapy with antibacterials, such as amoxicillin, approximately 80% eradication of H. pylori can be achieved over a long period of time. 'These are the best results that we have had with any type of dual therapy,' commented Dr Jackson. However, he added that no trial had tested triple therapy against dual therapy using ranitidine bismuth citrate and amoxicillin. l. Forbes GM, et al. Duodenal ulcer treated with Helicobacter pylori eradication: seven-year follow-up. Lancet 343: 258-260, 29 Jan 1994 8002.""" INPHARMA" 19 Feb 1994 II
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Transcript of New agent competes with triple therapy in H. pylori eradication
RESEARCH & DEVELOPMENT
New agent competes with triple therapy in H. pylori eradication
-Robert Short-
With recent results showing that Helicobacter pylori eradication really does prevent stomach ulcers, Glaxo could be onto a winner with their new agent, ranitidine bismuth citrate. This single chemical molecule has been developed for use as monotherapy or in combination with antibacterials, and is likely to provide fierce competition for the currently-used triple therapy. Glaxo plans to fIle for regulatory approval for this drug later this year.
Ranitidine bismuth citrate is under development for the treatment of gastric and duodenal ulcers and for the prevention of ulcers associated with the use of nonsteroidal anti-inflammatory drugs. Dr David Jackson, Glaxo's medical director, described the agent's 3 antiulcer actions at a recent press conference:
'It is antisecretory, so you cut down acid production; it is antibacterial, so it acts against Helicobacter pylori, and it also
protects the mucosa '. Dr David Jackson, Claxo, UK
This new compound may be just what is needed to preserve ranitidine's relevance as clinicians are increasingly convinced about the value of eradicating H. pylori. It also comes at a time of debate over the necessity for costly long-term maintenance therapy with pure H2 antagonists.
H. pylori eradication works There is good reason for the recent focus on H.
pylori as the organism responsible for the majority of cases of duodenal ulcer relapse [see Views & Reviews, this issue, p4]. On 29 January an article appeared in the Lancet showing the long-term follow-up of H. pylori eradication therapy in 63 patients with duodenal ulcers. I Of the 92% who remained H. pylori-negative after a mean of 7.1 years only 3% had recurrent ulcers. This compared with a 20% recurrence in the 8% of patients who were H. pylori-positive. This study has the longest follow-up of any published trial of eradication therapy.
When patients have frequent relapses of duodenal ulcers, the traditional practice is to choose between repeated courses or long-term maintenance therapy with H2 receptor antagonists. The authors of the above study felt that the evidence they provided could change this practice. 'Our findings suggest that Helicobacter pylori eradication treatment is an alternative which may result in reduced costs and be used increasingly as less complex Helicobacter pylori
0156.2703194/0925.00011/$01.00° Adis International Limited 1994. All rights reserved
eradication treatment regimens with fewer side effects are developed', they commented.
Certainly, ranitidine bismuth citrate is likely to be a step in the right direction in simplifying eradication regimens for H. pylori.
lliple therapy is conventional choice H. pylori can be suppressed temporarily by
bismuth chelate, or suppressed in the long term by triple therapy. Triple therapy is a term used to describe the administration of antibacterials (amoxicillin or tetracycline with metronidazole) at the same time as bismuth chelate. It is the most effective way known of eradicating H. pylori, but it is notoriously difficult to use.
Also, antibacterial-associated colitis is a potential risk and metronidazole resistance to H. pylori is easily acquired. If the antibacterials are widely used, resistance to them is likely to increase, particularly if therapy is carried out in general practice.
According to Dr Anthony Morris of the Royal Liverpool University Hospital in the UK, tr.iple therapy is ' ... known to cause side effects in 20-40% of patients '. He added that 'eradication therapy is thus only appropriate for the young, fit patient with frequent relapses of chronic duodenal ulcer who does not want maintenance therapy with H2 antagonists or ulcer surgery'. Because of the difficulties of using triple therapy, Dr Jackson noted, some gastroenterologists favour dual therapy. When ranitidine bismuth citrate is given as dual therapy with antibacterials, such as amoxicillin, approximately 80% eradication of H. pylori can be achieved over a long period of time. 'These are the best results that we have had with any type of dual therapy,' commented Dr Jackson. However, he added that no trial had tested triple therapy against dual therapy using ranitidine bismuth citrate and amoxicillin.
l. Forbes GM, et al. Duodenal ulcer treated with Helicobacter pylori eradication: seven-year follow-up. Lancet 343: 258-260, 29 Jan 1994 8002."""
INPHARMA" 19 Feb 1994
II
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