Drug Comparisons

Most ulcers arise because of Helicobacter pylori (H.pylori), a spiral-shaped bacterium present in more than 90% of patients who have intestinal (duodenal) ulcers and in more than 80% of those with stomach (gastric) ulcers. H. pylori infection is very common in the US; however, most people who have the bacteria in their stomach do not develop ulcers. Scientists now believe that it is a combination of H. pylori infection and other factors that predispose someone to developing an ulcer.

How does bacteria cause an ulcer? H. pylori is capable of surviving in the harsh acidic environment of the stomach. The bacteria can directly damage the stomach's protective mucous lining, decrease the body's ability to defend itself and cause an increase in acid production leading to the development of an ulcer, or sore.

Two-drug, three-drug, and four-drug regimens, or combination products (which consist of multiple drugs combined into one package) can be used to treat ulcers caused by H. pylori. However, the American College of Gastroenterology (specialists in treating ulcers) no longer recommends two-drug regimens since they are not as effective as other treatment regimens. The different classes of medication that may be combined are listed below.

Drugs in this Class
Bismuth Subsalicylate, Metronidazole, and Tetracycline Combination ( Helidac )
Lansoprazole, Clarithromycin and Amoxicillin ( Prevpac )

Summarizing the Evidence

Classes of Drugs used to Treat H. pylori

• The primary goal of therapy for ulcers caused by H. pylori is to eradicate or destroy the bacteria.

• To date, the most effective therapy for H. pylori are the three-drug regimens and four-drug regimens--specifically those regimens that contain a proton pump inhibitor (PPI) plus two antibiotics--since cure rates are typically higher with these therapies. Two-drug regimens tend to have a lower cure rate and should not be used, and four-drug regimens, while very effective,can be more complicated to take. Therefore, a three-drug regimen or possibly a pre-packaged, combination product is recommended as the most effective means of treating ulcers caused by H. pylori.

• Combination products such as Helidac, Prevpac, and Pylera are effective in treating H. pylori-induced ulcers. Use of these products may help improve compliance with the treatment regimens but they are also more expensive treatment options. Additionally, no head-to-head trials have been performed between these comparative products to determine if one is superior to the other in terms of improving compliance or in curing the H. pylori infection.

• Generally, you want to take a treatment regimen that provides at least an 80% cure rate (or eradication rate). The most effective treatment regimen contains a proton pump inhibitor (PPI), plus clarithromycin and either amoxicillin or metronidazole.

• The duration of therapy needed is still controversial. Some doctors favor a 7-day treatment regimen while others favor a 10- to 14-day treatment regimen. The shorter treatment duration may enhance compliance (which is important when treating a bacterial infection), but the longer treatment duration may have greater success in curing the infection (especially in persons who are compliant with taking their medications). If the first treatment attempt was not successful, a 14-day treatment duration is needed. The American College of Gastroenterology recommends a 14-day treatment duration.

• The four-drug regimen consisting of a PPI, bismuth, metronidazole, and tetracycline (all taken for 2 weeks) is also highly effective. For more information on the cure rates of specific regimens, please refer to the table below.

H. pylori Treatment Regimens

PPI = Proton Pump Inhibitor

* = Since H. pylori treatment regimens are often difficult and complex to take and be compliant with, combination products such as Helidac and Prevpac were developed. These come as individual daily dosing packages with three drug ingredients. These dose packs are meant to help with patient compliance. Pylera capsules contain 3 drug ingredients in one capsule. This product is also meant to aid in compliance. Helidac needs to be taken along with an H2 blocker or PPI. Pylera needs to be taken along with a PPI.

Dosing and Administration

• Exact dosing and administration will vary among treatment regimens. Drugs contained in each treatment regimen will be dosed multiple times each day (some drugs need to be taken up to four times each day). Generally, treatment for H. pylori infection will need to last at least 10 to 14 days.

Generic Availability

• Some drugs used in the H. pylori treatment regimens are available in generic formulations (e.g. all antibiotics--amoxicillin, clarithromycin, metronidazole, tetracycline; all H2 Blockers--cimetidine, famotidine, ranitidine, nizatidine; bismuth subsalicyate, sucralfate, and the PPI's--omeprazole and pantoprazole), which are significantly less expensive than brand name products. All of the other PPIs (Aciphex, Prevacid, Nexium) are only available as brand name products at this time.

• Neither pre-packaged, combination products--Helidac or Prevpac--are available generically. Helidac is a product that packages the drug ingredients of bismuth, metronidazole, and tetracycline together (however, all drugs are available generically when prescribed separately). Prevpac packages lansoprazole (Prevacid), amoxicillin (available generically), and clarithromycin (available generically) together. Pylera contains bismuth subcitrate potassium, metronidazole, and tetracycline. Each of the drug ingredients contained in Pylera are available generically but Pylera itself is not available generically. Since some drugs contained within these packaged products are available generically, it may be less expensive for you to ask your doctor to prescribe the generic drugs separately instead of prescribing Helidac, Prevpac, or Pylera.

Drug Interactions

Some interactions between medications can be more severe than others. The best way for you to avoid harmful interactions is to tell your doctor and/or pharmacist what medications you are currently taking, including any over-the-counter products, vitamins, and herbals. For specific information on how the drugs interact and the severity of the interaction, please use our Drug Interactions Checker.

Side Effects

To view specific side effect information, please use our Side Effect Checker.

Additional Information

References:

1. Centers for Disease Control and Prevention. Helicobacter pylori infections (H. Pylori). Accessed on 5/17/2007. http://www.cdc.gov/ncidod/dbmd/diseaseinfo/hpylori_g.htm
2. Centers for Disease Control and Prevention. Helicobacter pylori. Fact Sheet for Health Care Providers. Updated July 1998. Accessed on 05/09/2007. Available at: http://www.cdc.gov/ulcer/files/hpfacts.pdf
3. O?Morain C, Borody t, Farley A, et al. Efficacy and safety of single-triple capsules of bismuth subcitrate, metronidazole and tetracycline, given with omeprazole, for the eradication of Helicobacter pylori: an international multicentre study. Aliment Pharmacol Ther. 2003; 17: 415?420.
4. Howden CW, Hunt RH. Guidelines for the management of Helicobacter pylori infection. Am J Gastroenterol. 1998;93: 2330-2338. Accessed 05/09/2007. Available at: www.acg.gi.org/physicians/guidelines/managementofhpylori.pdf
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8. Pylera capsules (package insert). Birmingham, AL: Axcan Pharma; February 2007.
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Last Updated: March 2008
This content was created by members of the DrugDigest team of experts and is solely under DrugDigest's editorial control.

Note: The above information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist, or other healthcare professional. It should not be construed to indicate that the use of the product is safe, appropriate, or effective for you. Consult your healthcare professional before taking any medication.