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Prospective evaluation of serum vitamin B12 levels in patients receiving long-term lansoprazole for gastroesophageal reflux disease

Posted on:2001-10-25Degree:Pharm.DType:Thesis
University:Long Island University, The Brooklyn CenterCandidate:Sotiriou, Christopher GusFull Text:PDF
GTID:2464390014454993Subject:Pharmaceutical sciences
Abstract/Summary:
Objective. To determine whether long-term lansoprazole therapy (≥9 months) in veteran patients diagnosed with GERD is associated with decreased serum vitamin B12 levels, compared with an age-matched veteran cohort of patients without GERD. If a significant difference in serum vitamin B12 levels between groups is detected, this study would also determine whether serum vitamin B12 levels should be monitored periodically and/or if cobalamin supplementation is warranted in either group.;Methods. Forty male patients, over 50 years of age, from the New York Veterans Administration Medical Center (NYVAMC) ambulatory care clinic were prospectively enrolled and evaluated. Twenty patients were receiving lansoprazole 30 mg/d for maintenance of chronic GERD. The age-matched cohort (n = 20) did not have GERD, nor were they receiving any chronic acid suppressive therapy. Patients were excluded if they had any of the following: anemia, gastric surgery, liver disease, pancreatic insufficiency, intestinal disease, documented alcoholism, excessive alcohol consumption (e.g., ≥3 alcoholic beverages/d), malnutrition, cancer, or HIV. Patients were also excluded if they were receiving vitamins containing B12, drugs known to decrease B12 levels, or who were vegan-vegetarians. Patients who were scheduled to be in the outpatient clinic were identified via computer records, and assessed for study eligibility. Serum vitamin B12, folate, and complete blood counts were obtained for analysis. The reference interval for vitamin B12 used was >187--1059 pg/mL and B 12 deficiency was classified as <157 pg/mL. Upon enrollment into the study, patients were assessed for clinical manifestations of B12 deficiency by their physician.;Results. The mean (+/-SD) age of patients was 62.7 +/- 6.57 years and 64.7 +/- 8.13 years in the lansoprazole and control groups, respectively. The mean (+/-SD) duration of lansoprazole therapy was 19.2 +/- 4.13 months. There was an apparently small, but statistically insignificant, difference in serum vitamin B12 levels between each group. The mean (+/-SD) serum B12 levels were 305.7 +/- 50.63 and 337.5 +/- 76.11 in the lansoprazole and control groups, respectively; p = 0.065, Student's-t test. Serum B12 levels were within the normal range in all patients under investigation. There were no significant differences in serum folate, hemoglobin, and hematocrit between the two groups. No participant had signs, symptoms, or laboratory abnormalities consistent with anemia of any etiology.;Conclusion. Long-term lansoprazole therapy is associated with a small, but statistically insignificant, decline in cobalamin levels. Whether this is a trend remains to be demonstrated through further study with a larger sample size and a longer duration of follow-up. Periodic B12 monitoring and supplementation may still be warranted in select patients who may be at risk for cobalamin deficiency such as the elderly or malnourished.
Keywords/Search Tags:Serum vitamin B12 levels, Lansoprazole, GERD, Receiving
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