Impact of proton pump inhibitor utilization patterns on gastroesophageal reflux disease-related costs. Effect of sex and menstrual cycle phase on cytochrome P450 2C19 activity with omeprazole used as a biomarker. Rx drugs

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nottingham.ac.uk

BACKGROUND AND AIMS: Factors predisposing to endoscopic ulcer formation or healing with non-steroidal anti-inflammatory drugs (NSAIDs) have not been well defined. METHODS: We used multivariate analysis of data from three large similar trials to identify factors associated with endoscopic lesions and healing. We compared the effectiveness of omeprazole 20 mg and 40 mg daily, misoprostol 200 micro g four times daily, and ranitidine 150 mg twice daily in healing ulcers and erosions at different sites and in patients who were Helicobacter pylori positive and negative. RESULTS: Older age, past ulcer history, rheumatoid arthritis, and H pylori infection were significantly associated with ulcers. Duodenal ulcer was significantly more likely than gastric ulcer with a past ulcer history (odds ratio 1.59, 1.16-2.17), H pylori infection (1.4, 1.04-1.92), and male sex (2.35, 1.75-3.16) while female sex, older age (> or = 60 years: 1.39, 1.03-1.88), and higher NSAID dose (>1 defined daily dose: 1.57, 1.16-2.14) were associated with gastric ulceration. Sex differences were seen in both H pylori positive and negative patients. Gastric and duodenal ulcer healing was significantly faster with omeprazole 20 mg than with misoprostol 200 micro g four times daily or ranitidine 150 mg twice daily although misoprostol was more effective at healing erosions. Gastric ulcer healing was slower with large ulcers (0.37, 0.25-0.54 for >10 mm v 5-10 mm) or a past ulcer history (0.51, 0.34-0.76), and faster with H pylori infection (1.55, 1.06-2.29), especially with acid suppression (72% v 37% at four weeks with ranitidine). CONCLUSIONS: Among NSAID users, H pylori and male sex independently increase the likelihood of duodenal ulceration. H pylori infection does not affect duodenal ulcer healing and enhances gastric ulcer healing by ranitidine and possibly other acid suppressing treatments.

online pharmacy ref source: www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12171954&dopt=Abstract

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Manag Care. 2002 Jul;11(7 Suppl):14-8.
Impact of proton pump inhibitor utilization patterns on gastroesophageal reflux disease-related costs.

Hall J, Dodd S, Durkin M, Sloan S.

OBJECTIVE: To determine proton pump inhibitor (PPI) treatment patterns and their effect on costs related to gastroesophageal reflux disease. METHODS: This study used claims data to identify continuously enrolled subjects diagnosed with gastroesophageal reflux disease (GERD) and newly treated with a PPI between Oct. 1, 1999 and March 31, 2000. Data were analyzed for 6 months following PPI initiation. Results were stratified by first PPI filled during the study period. Compliance (as measured by a medication-possession ratio), dosage escalation (> 25 percent of initial dose), and daily average consumption (DACON) were measured. Regression analysis was performed on GERD-related costs using treatment patterns, type of PPI drug, and compliance as independent variables of interest. RESULTS: Of 75,452 subjects, there were 51,232 (67.9 percent) lansoprazole, 22,829 (30.3 percent) omeprazole, and 1,391 (1.8 percent) rabeprazole subjects. The possession ratio was not significantly different by drug. Only 3.5 percent of rabeprazole subjects escalated versus 5.5 percent of omeprazole subjects and 9.3 percent of lansoprazole subjects (p = .0001). Among subjects with esophageal ulcer or hiatal hernia, rabeprazole users had a significantly lower final DACON (1.03) versus both lansoprazole (1.20) and omeprazole subjects (1.22, p = .0299). Subjects who were compliant with therapy (ratio > 0.80) had 43 percent higher GERD-related pharmacy costs and 33 percent higher GERD-related total costs (both p < .001). GERD-related medical costs were not significantly affected by compliance. Subjects who filled lansoprazole prescriptions had 9.4 percent higher GERD-related pharmacy costs versus rabeprazole subjects (p < .01). Omeprazole subjects had 12.5 percent higher GERD-related total costs versus rabeprazole subjects (p < .01), while lansoprazole subjects had 18 percent higher GERD-related total costs versus rabeprazole subjects (p < .001). CONCLUSIONS: Rabeprazole subjects had lower GERD-related costs, less escalation, and lower DACON (measured as number of tablets consumed per day), compared to lansoprazole and omeprazole subjects. Compliance was not significantly different between the drugs, nor did increased compliance decrease GERD-related costs.

online pharmacy ref source: www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12181872&dopt=Abstract

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Clin Pharmacol Ther. 2002 Aug;72(2):192-9.
Effect of sex and menstrual cycle phase on cytochrome P450 2C19 activity with omeprazole used as a biomarker.

Kim MJ, Bertino JS Jr, Gaedigk A, Zhang Y, Sellers EM, Nafziger AN.

Clinical Pharmacology Research Center, Department of Medicine, Bassett Healthcare, One Atwell Road, Cooperstown, NY 13326-1394, USA.

BACKGROUND: Literature addressing the effect of sex on cytochrome P450 (CYP) 2C19 activity is conflicting. The exogenous female sex steroid hormones used in oral contraceptives are believed to significantly inhibit CYP2C19 activity. However, the effect of variations in endogenous sex steroid concentrations throughout the menstrual cycle has not been investigated. OBJECTIVE: The objective of this study was to determine the effects of sex and menstrual cycle phase on CYP2C19 activity by using omeprazole. METHODS: White subjects with body weights between 45 and 66 kg received a single oral dose of 30 mg omeprazole. Those with weights of 67 to 90 kg received a dose of 40 mg. Twelve female subjects were phenotyped during the midfollicular and midluteal phases of the menstrual cycle for 3 complete cycles. Twelve male subjects were phenotyped every 14 days for 12 weeks. The 2-hour postdose plasma concentration ratio of omeprazole to 5'-hydroxyomeprazole was used as a measure of CYP2C19 activity. All subjects were genotyped for CYP2C19*2 and *3 alleles. RESULTS: Twelve women and 8 men were extensive metabolizers (EMs) with a CYP2C19*1/*1 genotype, whereas 4 male subjects were heterozygous (CYP2C19*1/*2). Median metabolic ratios during the midfollicular and midluteal visits were 0.845 and 0.930, respectively (P =.7). Sex had no effect on CYP2C19 activity in CYP2C19*1/*1 EMs (0.875 for men versus 1.070 for women, P =.140). The median metabolic ratios of all individuals with 2C19*1/*1 and *1/*2 genotypes were 0.94 and 3.75, respectively. CONCLUSION: There is no sex difference in CYP2C19 activity in healthy white CYP2C19*1/*1 EMs with the omeprazole ratios. A gene-dose effect was observed. In addition, variations in endogenous sex steroid concentrations throughout the menstrual cycle did not influence CYP2C19 activity.

online pharmacy ref source: www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12189366&dopt=Abstract

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