Pharmacy Pearl 11 APRIL 2001

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A 35 y/o patient with a history of one duodenal ulcer in the past is seen in clinic with symptoms of another possible ulcer. A diagnostic test confirms a recurrence of the patient's ulcer. Upon further testing, you find out he is H. pylori positive. He has no other risk factors for ulcers except the H pylori and a history of ulcers. The patient has no other medical problems and is not allergic to any medications.

You decide the patient needs treatment for the H pylori infection to prevent any further recurrences of his ulcer. What regimen do you use? Why?

Do you need to test the patient for H pylori infection after treatment to ensure eradication of the bacteria? Why or why not?

SELECT  here for discussion

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

DISCUSSION 11 APRIL 2001

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Once the diagnosis of H pylori infection is confirmed, treatment is indicated especially in a patient with n ulcer recurrence. There are LOTS of treatment regimens available to eradicate H pylori. A PEC review of H pylori treatment in 1998 concluded that (BMT + H2RA) consisting of bismuth subsalicylate (524 QID) plus metronidazole (500mg po TID) plus Tetracycline (500mg po QID) for 14 days PLUS an H2 receptor antagonist (H2RA). Cimetidine and ranitidine are BCF agents). Using a proton pump inhibitor instead of an H2RA costs more but may be slightly more effective. The incremental benefit (3.7 - 5.4% increase in cures) is offset by the PPI's increased incremental cost (63 - 82% more expensive compared to H2RA). BMTPPI is $574 per additional cure compared to BMT. CMPPI (clarithromycin 500mg BID plus metronidazole 500mg BID plus PPI) is $1,081 per additional cure compared to BMT.

Compliance is always an issue with antibiotics. Treatment of H pylori is no different. TID or QID regimens are probably best avoided, if possible. However, according to the Update, the effectiveness rates adjusted for compliance did not differ significantly. Because the BID regimens are much more expensive especially because of their inclusion of PPIs and new generation macrolides, one has to consider if the incremental benefit is worth the incremental cost.

Should the patient be re-tested after treatment to confirm eradication of the H pylori infection? The absolute answer has yet to be defined. Recently, a small study (n=34) in J Am Board of Fam Pract (2000;13:449-50) showed an overall failure rate for H pylori eradication of 15%. Other studies state a 10-20% failure rate. With the availability of availability and falling cost of office-based tests, follow-up confirmatory testing MAY (stress MAY!) be indicated. Others may argue we just re-treat the ulcer IF it recurs and use the recurrence as an indicator to re-test for H pylori or as an indicator to re-treat and try again to eradicate the organism. The literature states a recurrence rate of < 1% with confirmed eradication of the H pylori bacteria.

References:

- Zipser RD, Parikh MV. J Am Board of Fam Pract. 2000;13:449-50.

- PEC Update, Volume 98, Issue 6. www.pec.ha.osd.mil

- Abu-Manhof MZ, Prasad VM, Santogade P, Cutler AF. Am J Gastroenterol. 1997;92:2025-8.

- Laine L, Schower L, Frantz J, et al. Am J Gastroenterol 1998;93:2106-12.

 

Method                     Specimen              Sensitivity          Specificity              Comment

Quick Serology                 Serum                           95% 85%                     Qualitative                    10 minutes, cost?

Serology                            Serum                           95% 95%                                                             Lab (qualitative)

Urea Breath Test (UBT)    Breath Sample            95-98% 95-98%                                                  Best test for confirmation of eradication, cost?

Stool Antigen test (HpSA) Stool sample             96% 96% Recent                                              FDA approval, high false positive rate?

Biopsy Urease Test         Mucosal biopsy           90-95% 98%                                                      Simple test @ endoscopy, require invasive procedure

Giemsa Stain x 2               2 mucosal biopsies    98% 98%                                                           Simple, accurate, permanent record, requires invasive procedure

Culture of biopsy            Mucosal biopsy            90-95%                                                               100% require invasive procedure, may help guide treatment of refractory cases

From PEC Update, 98-06

Additional ulcer and H pylori info available at http://www.cdc.gov/ulcer/. National Ulcer Week is October 1-7, 2001.

This Pearl is meant for academic and educational purposes only. This Pearl is meant to raise important points regarding the safe and cost-effective pharmacotherapy of patients. It is not meant to be the definitive reference for the treatment or prophylaxis of various diseases. Although every effort is taken to ensure this Pearl is correct and factual, errors may occur. The Pharmacoeconomic Center assumes no liability for incorrect information or harm that may occur from the use of the information included in this Pearl.

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