On-demand proton pump inhibitory treatment in overweight/obese patients with gastroesophageal reflux disease: are there pharmacodynamic arguments for using higher doses?

BACKGROUND: Increased body mass index (BMI) is associated with a higher risk of gastroesophageal reflux disease (GORD). AIM: To investigate whether overweight/obesity affects proton pump inhibitor pharmacodynamics when used in a single dose in patients with GORD. METHODS: Post hoc analyses by patient BMI were performed on data from two single-center, double-blind, single-dose, crossover studies comparing the pharmacodynamics of rabeprazole 20 mg and pantoprazole 40 mg in GORD patients with a history of nocturnal heartburn. The primary endpoint was the mean percentage of time with intragastric pH >4 between lean and overweight/obese patients (BMI <25 and ≥25). RESULTS: 24 h baseline intragastric pH values were not different between BMI groups. The pharmacodynamic effects of both proton pump inhibitors were not significantly different between BMI groups, and no evidence was found for an interaction between BMI and treatment. As compared with pantoprazole, rabeprazole showed a significantly greater effect on the antisecretory response for both BMI groups. CONCLUSIONS: Overweight/obesity in GORD patients does not appear to affect the antisecretory efficacy of a single dose of rabeprazole and pantoprazole. These data do not support adapting the dosage of rabeprazole and pantoprazole according to BMI in GORD patients when administered as an on-demand therapy schedule.

ORTHO birth control satisfaction assessment tool: assessing sensitivity to change and predictors of satisfaction.

OBJECTIVE: To test the sensitivity to change of the ORTHO Birth Control Satisfaction Assessment Tool (ORTHO BC-SAT) among dissatisfied women switching to a new hormonal birth control method and to better understand which factors contribute to a woman's satisfaction with the method. MATERIALS AND METHODS: Women switching to a new hormonal birth control method [oral contraceptives (OCs), injections, vaginal ring or transdermal patch] completed the ORTHO BC-SAT, a questionnaire measuring satisfaction, two times over a 3-month period. Sensitivity to change was measured by examining change scores, as well as the Guyatt's statistic. Predictors of satisfaction were examined using forward-stepping linear regression. RESULTS: Fifty-six women completed the ORTHO BC-SAT twice. With the exception of Future Fertility Concerns, women reported statistically significant improvements on all scales of the questionnaire. The scales most sensitive to change were Overall Satisfaction, Assurance/Confidence, Lifestyle Impact, and Ease of Use/Convenience. Being older, switching from a nonhormonal method of birth control at baseline and more bodily pain at baseline predicted the increase in satisfaction scales. CONCLUSION: The ORTHO BC-SAT has demonstrated sensitivity to change in this population. In addition, we identified several factors at baseline that predicted an increase in satisfaction scale scores.

Does BMI affect the clinical efficacy of proton pump inhibitor therapy in GERD? The case for rabeprazole.

BACKGROUND: Increased BMI is associated with a higher risk of gastroesophageal reflux disease. AIMS: To investigate whether overweight/obesity (BMI≥25 kg/m(2)) affects rabeprazole clinical efficacy versus omeprazole in patients with erosive esophagitis (EE). PATIENTS AND METHODS: Post-hoc analysis of EE healing rate and symptom response stratified by patient BMI was performed on data from a multicenter, double-blind, randomized, 4-to-8-week trial comparing EE healing with rabeprazole (20 mg daily) and omeprazole (20 mg daily). Analysis of variance, two-sample t-test, Blackwelder's test for equivalence, log-rank, and Cochran-Mantel-Haenszel tests were used to analyze comparisons. RESULTS: In the two BMI groups (<25 kg/m(2) and ≥25 kg/m(2) respectively), rabeprazole and omeprazole were equally effective for mucosal healing regardless of patient's BMI (N=542, P>0.05). However, in overweight/obese patients, rabeprazole was significantly faster than omeprazole in inducing heartburn relief during the first treatment week (P<0.0001). CONCLUSIONS: Results of this study show that the clinical efficacy of rabeprazole is maintained in overweight/obese patients with gastroesophageal reflux disease and suggest that this subgroup of patients may derive, from rabeprazole, even greater benefit than lean patients.

Suppression of estrogen-withdrawal headache with extended transdermal contraception.

A randomized clinical trial was conducted with 239 women at nine clinical research sites to compare bleeding profile, headache frequency, and subject satisfaction with the transdermal contraceptive, ORTHO EVRA (norelgestromin/ethinyl estradiol transdermal system) used in an extended regimen (84 days) with a traditional, 28-day cyclic regimen. In a majority of women studied, compared with cyclic use, extended use of transdermal norelgestromin/ethinyl estradiol delayed menses and reduced the total incidence of mean headache days during the hormone-free interval.