The effect of time‐of‐day dosing on the pharmacokinetics and pharmacodynamics of dexlansoprazole MR: evidence for dosing flexibility with a Dual Delayed Release proton pump inhibitor

Lee, R. D.; Mulford, Darcy J.; Wu, Jingtao; Atkinson, Stuart

doi:10.1111/j.1365-2036.2010.04272.x

Cited by 43 publications

(44 citation statements)

References 31 publications

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“…In this study, patients were to take the study drug in the morning, without regard to food. Comparable acid suppression with dexlansoprazole MR dosing has been demonstrated regardless of the timing of food intake (fasting, before or aft er breakfast) ( 34 ) or the time of day (before breakfast, lunch, dinner, or evening snack) ( 35 ). Although additional studies are needed to assess the impact of various dosing timings of dexlansoprazole MR on GERD symptoms, it is not unreasonable to suggest that increased fl exibility in administration, and therefore increased compliance, would lead to reduced symptoms, particularly at night.…”

Section: Esophagusmentioning

confidence: 99%

The Effect of Dexlansoprazole MR on Nocturnal Heartburn and GERD-Related Sleep Disturbances in Patients With Symptomatic GERD

Fass

Johnson

Orr

et al. 2011

American Journal of Gastroenterology

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Approximately 14 -20 % of US adults experience gastroesophageal refl ux disease (GERD) weekly ( 1,2 ), which translates to more than 60 million adults ( 3 ). Among those reporting GERD symptoms, up to 89 % report nocturnal symptoms ( 1,4 -6 ), resulting in impairment in health-related quality of life (HRQoL) and signifi cantly worse sleep quality ( 7,8 ). Because continued sleep disruption leads to increased daytime sleepiness ( 9 ), nocturnal heartburn can reduce productivity while patients are present at work, as well as reduce function when performing normal daily activities ( 7,8,10,11 ). Th e continued presence of nocturnal heartburn despite routine medical treatment is strongly associated with decreases in HRQoL ( 12 ). In addition, the majority of GERD patients participating in a Gallup survey were not completely satisfi ed with their over-the-counter or prescription medication due to persistent nocturnal symptoms ( 6 ).Th e aims of this study were to assess, in patients with symptomatic GERD, the effi cacy and safety of dexlansoprazole MR 30 mg Nocturnal heartburn and related sleep disturbances are common among patients with gastroesophageal refl ux disease (GERD). This study evaluated the effi cacy of dexlansoprazole MR 30 mg in relieving nocturnal heartburn and GERD-related sleep disturbances, improving work productivity, and decreasing nocturnal symptom severity in patients with symptomatic GERD. METHODS:Patients ( N = 305) with frequent, moderate-to-very severe nocturnal heartburn and associated sleep disturbances were randomized 1:1 in a double-blind fashion to receive dexlansoprazole MR or placebo once daily for 4 weeks. The primary end point was the percentage of nights without heartburn. Secondary end points were the percentage of patients with relief of nocturnal heartburn and of GERD-related sleep disturbances over the last 7 days of treatment. At baseline and week 4 / fi nal visit, patients completed questionnaires that assessed sleep quality, work productivity, and the severity and impact of nocturnal GERD symptoms. RESULTS:Dexlansoprazole MR 30 mg ( n = 152) was superior to placebo ( n = 153) in median percentage of nights without heartburn (73.1 vs. 35.7 % , respectively; P < 0.001). Dexlansoprazole MR was signifi cantly better than placebo in percentage of patients with relief of nocturnal heartburn and GERD-related sleep disturbances (47.5 vs. 19.6 % , 69.7 vs. 47.9 % , respectively; P < 0.001), and led to signifi cantly greater improvements in sleep quality and work productivity and decreased nocturnal symptom severity. Adverse events were similar across treatment groups.CONCLUSIONS: In patients with symptomatic GERD, dexlansoprazole MR 30 mg is signifi cantly more effi cacious than placebo in providing relief from nocturnal heartburn, in reducing GERD-related sleep disturbances and the consequent impairments in work productivity, and in improving sleep quality / quality of life.SUPPLEMENTARY MATERIAL is linked to the online version of the paper at

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Section: Esophagusmentioning

confidence: 99%

The Effect of Dexlansoprazole MR on Nocturnal Heartburn and GERD-Related Sleep Disturbances in Patients With Symptomatic GERD

Fass

Johnson

Orr

et al. 2011

American Journal of Gastroenterology

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“…42 There were no clinically meaningful delays to the absorption of dexlansoprazole when dexlansoprazole was administered before lunch, dinner, or an evening snack compared with administration before breakfast, and there were no apparent differences in systemic exposure, with all regimens being pharmacokinetically bioequivalent (Fig. 4).…”

Section: Clinical Benefitsmentioning

confidence: 99%

“…Additionally, no clinically meaningful differences have been found when taking dexlansoprazole at different times of the day relative to food (fasted or fed conditions), indicating that it can be taken without regard to food or timing of meals. 41,42 A comparison of single-dose dexlansoprazole 60 mg with esomeprazole 40 mg found that at 0-24 hours post-dose, the mean percentage of time with pH > 4 was 58% and 48%, respectively (P = 0.003), and the average mean pH values were 4.3 and 3.7, respectively (P < 0.001). 40 At > 12-24 hours post-dose, dexlansoprazole resulted in greater mean percentage of time with pH > 4 and average mean pH than esomeprazole (60% versus 42% and 4.5 versus 3.5, respectively; P < 0.001).…”

Section: Pharmacodynamicsmentioning

confidence: 99%

Pharmacological and Safety Profile of Dexlansoprazole: A New Proton Pump Inhibitor – Implications for Treatment of Gastroesophageal Reflux Disease in the Asia Pacific Region

Goh

Choi

Hsu

et al. 2016

J Neurogastroenterol Motil

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Although gastroesophageal reflux disease is not as common in Asia as in western countries, the prevalence has increased substantially during the past decade. Gastroesophageal reflux disease is associated with considerable reductions in subjective well-being and work productivity, as well as increased healthcare use. Proton pump inhibitors (PPIs) are currently the most effective treatment for gastroesophageal reflux disease. However, there are limitations associated with these drugs in terms of partial and non-response. Dexlansoprazole is the first PPI with a dual delayed release formulation designed to provide 2 separate releases of medication to extend the duration of effective plasma drug concentration. Dexlansoprazole has been shown to be effective for healing of erosive esophagitis, and to improve subjective well-being by controlling 24-hour symptoms. Dexlansoprazole has also been shown to achieve good plasma concentration regardless of administration with food, providing flexible dosing. Studies in healthy volunteers showed no clinically important effects on exposure to the active metabolite of clopidogrel or clopidogrel-induced platelet inhibition, with no dose adjustment of clopidogrel necessary when coprescribed. This review discusses the role of the new generation PPI, dexlansoprazole, in the treatment of gastroesophageal reflux disease in Asia.

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“…Studies in healthy volunteers about the effect of PPIs on GERD symptom control and mucosal healing show differences in efficacy, onset of action, potency, and duration of acid suppression (% of time during which intragastric pH > 4/24 h) (42)(43)(44). At standard doses, PPIs maintain intragastric pH > 4 for 10-14 hours (46); doubling the dose increases control, although 50% subjects will have a drop in nocturnal pH with its related symptoms (45).…”

Section: Clinical Evidencementioning

confidence: 99%

Proton pump inhibitors in gastroesophageal reflux disease: a custom-tailored therapeutic regimen

Sobrino-Cossío

López-Alvarenga

Remes-Troche

et al. 2012

Rev. esp. enferm. dig.

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The Montreal Definition and Classification divides Gastroesophageal Reflux Disease (GERD) into esophageal symptomatic syndromes (and with mucosal damage) and extraesophageal syndromes (with acid established association and proposed association). In typical GERD symptoms, an 8-week treatment with PPIs is satisfactory in most cases (> 90%). Response rates to PPIs in GERD are highly variable, as they also rely on an appropriate clinical diagnosis of the disease; endoscopy differentiates the macroscopic GERD phenotype. The non-erosive variety (50-70% prevalence) has a different symptomatic response rate, as gastric acid is not the sole etiology of symptoms. The possible explanations of treatment failure include treatment adherence, PPI metabolism alterations and characteristics, and inadequate diagnosis. Refractory symptoms are related to gastric content neutralization by the chronic use of PPIs.Extraesophageal manifestations are associated with other pathophysiological mechanisms where an autonomic nervous system disturbance gives rise to symptoms. In these clinical entities, the relationship between symptoms and acid needs to be established in order to determine the use of PPIs, or consider other drugs. In other words, so as to "custom-tailor the best-fitting therapy" we need to answer the questions for whom, for what, how and for how long. Finally, PPI safety and tolerability are factors to be considered in elderly patients requiring chronic PPI use, who usually have chronic concomitant illnesses.

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The effect of time‐of‐day dosing on the pharmacokinetics and pharmacodynamics of dexlansoprazole MR: evidence for dosing flexibility with a Dual Delayed Release proton pump inhibitor

Abstract: SUMMARY BackgroundDexlansoprazole MR is a Dual Delayed Release proton pump inhibitor formulated to extend the duration of acid suppression.

Cited by 43 publications

References 31 publications

The Effect of Dexlansoprazole MR on Nocturnal Heartburn and GERD-Related Sleep Disturbances in Patients With Symptomatic GERD

The Effect of Dexlansoprazole MR on Nocturnal Heartburn and GERD-Related Sleep Disturbances in Patients With Symptomatic GERD

Pharmacological and Safety Profile of Dexlansoprazole: A New Proton Pump Inhibitor – Implications for Treatment of Gastroesophageal Reflux Disease in the Asia Pacific Region

Proton pump inhibitors in gastroesophageal reflux disease: a custom-tailored therapeutic regimen

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