Comparison of Prilosec OTCTM (omeprazole magnesium 20.6 mg) to placebo for 14 days in the treatment of frequent heartburn

Allgood, Lisa D; Grender, Julie; Shaw, Michael; Peura, David A.

doi:10.1111/j.1365-2710.2004.00620.x

Cited by 18 publications

(27 citation statements)

References 12 publications

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“…In one study of 1,024 patients with frequent heartburn, 14-day treatment with omeprazole resulted in complete resolution of symptoms in approximately 50% of patients [26]. Sufficient relief or complete freedom from complaints is seen after an average of 1-3 days' treatment with PPIs in the majority of cases [26,31,44].…”

Section: Is 14-day Treatment Duration Sufficient? What Is the Recommementioning

confidence: 96%

“…Sufficient relief or complete freedom from complaints is seen after an average of 1-3 days' treatment with PPIs in the majority of cases [26,31,44]. Unlike the H 2 -RA famotidine, OTC omeprazole is associated with a therapeutic effect that lasts for more than 14 days of treatment [24,26], with some patients free of symptoms for 10 weeks [24].…”

Section: Is 14-day Treatment Duration Sufficient? What Is the Recommementioning

confidence: 97%

“…Clinical evidence supports the efficacy of PPIs when administered for 14 days [25,26,31,43,44,47]. In one study of 1,024 patients with frequent heartburn, 14-day treatment with omeprazole resulted in complete resolution of symptoms in approximately 50% of patients [26].…”

Section: Is 14-day Treatment Duration Sufficient? What Is the Recommementioning

confidence: 97%

“…Relief of GERD symptoms with OTC omeprazole occurs rapidly. In 1,024 patients with frequent heartburn, about 50% had complete relief from symptoms with OTC omeprazole 20 mg [26].…”

Section: Guidelines For Pharmacistsmentioning

confidence: 99%

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Guidance on the use of over-the-counter proton pump inhibitors for the treatment of GERD

et al. 2011

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As defined by the treatment algorithm, the pharmacist should first confirm the diagnosis based on the presence of typical symptoms and secondly, as a result, rule out general practitioner referral. The third step focuses on the nature, severity and frequency of the symptoms--the patients who might have the highest benefit from a short course (14 days) of OTC PPIs are those with less than three episodes of heartburn and/or acid regurgitation per week. Patients who have three or more episodes per week can use the OTC PPIs but should also be encouraged to visit a physician, and those who already have a diagnostic work-up can use proton pump inhibitors as rescue treatment if they are known responders. Guidance for pharmacists, in the form of questions and answers, summarises the current published clinical experience with PPIs in terms of their efficacy and safety, and optimal treatment schedule. Conclusions Gastroesophageal reflux disease imposes a considerable burden on sufferers. Owing to their accepted efficacy and safety, PPIs are becoming popular as OTC options for the treatment of gastroesophageal reflux disease symptoms such as heartburn and acid regurgitation. Effective self-management of gastroesophageal reflux disease with OTC PPIs, e.g. omeprazole, could lead to lasting freedom from symptoms and improved quality of life for sufferers.

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Section: Is 14-day Treatment Duration Sufficient? What Is the Recommementioning

confidence: 96%

Section: Is 14-day Treatment Duration Sufficient? What Is the Recommementioning

confidence: 97%

Section: Is 14-day Treatment Duration Sufficient? What Is the Recommementioning

confidence: 97%

“…Relief of GERD symptoms with OTC omeprazole occurs rapidly. In 1,024 patients with frequent heartburn, about 50% had complete relief from symptoms with OTC omeprazole 20 mg [26].…”

Section: Guidelines For Pharmacistsmentioning

confidence: 99%

See 2 more Smart Citations

Guidance on the use of over-the-counter proton pump inhibitors for the treatment of GERD

et al. 2011

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“…If it occurs on more than 2 days each week, it is described as frequent. [7][8][9] Management of acid secretion has been used frequently for the relief of symptoms of GERD. In clinical practice, histamine-2 receptor antagonists and proton pump inhibitors (PPIs) have been employed for the treatment of episodic and frequent heartburn, respectively.…”

mentioning

confidence: 99%

Review of proton pump inhibitors for the initial treatment of heartburn: Is there a dose ceiling effect?

Kushner

Peura

2011

Adv Therapy

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Proton pump inhibitors (PPIs) are widely used in clinical practice. However, concerns have been expressed about their long-term use, particularly with regard to bone health, Clostridium difficile infections, and drug interactions with platelet aggregation inhibitors. There has been limited guidance for clinicians concerning appropriate dose selection of PPIs for the initial treatment of heartburn. This review explored whether published clinical trials provide evidence of a ceiling above which higher PPI doses do not provide additional clinical benefit over the lowest approved dose. All articles of randomized, controlled clinical trials in nonerosive gastroesophageal reflux disease (GERD) in which the effects of two or more doses of the same PPI on symptomatic relief of heartburn were quantified as a study endpoint were identified and analyzed through PubMed searches up to the end of September 2010. The majority of trials evaluated provided no evidence that higher PPI doses were superior to the lowest approved dose for the initial treatment of heartburn. There were no clinically relevant findings with respect to dose dependence and safety outcomes in these studies. Efficacy outcomes from the trials suggest there may be a dose ceiling effect and highlight the need for further research on the use of the lowest effective PPI doses as an appropriate strategy in the initial treatment of uncomplicated heartburn. Observational studies and some meta-analyses have suggested that long-term PPI pharmacotherapy might be associated with safety concerns, which necessitate the periodic evaluation of therapeutic benefit in terms of symptom resolution and regimen tolerability. However, evidence to date suggests that use of the lowest effective dose for the indication is not associated with significant adverse events, particularly in the short term. Clinical practice suggests that patients requiring long-term treatment should be maintained on the lowest dose necessary to control symptoms, and monitored for potentially confounding factors that may lead to safety concerns.

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Evidence-based treatment of frequent heartburn: The benefits and limitations of over-the-counter medications

McRorie

Gibb

Miner

2014

Journal of the American Association of Nurse Practitioners

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Purpose This review summarizes the pharmacological effects of over‐the‐counter (OTC) heartburn drugs, and the implications for treating frequent heartburn. Data sources PubMed and SCOPUS were searched across all years to identify well‐controlled, randomized clinical studies that assessed mechanism of action and efficacy. Conclusions Antacids can transiently neutralize acid in the esophagus, but do not significantly affect gastric pH or prevent subsequent heartburn episodes. Histamine‐2 receptor antagonists (H2RAs) rapidly develop tolerance with repeat dosing, and exhibit an analgesic effect that may provide heartburn relief while leaving the esophagus exposed to acid. Proton pump inhibitors (PPIs) provide a sustained inhibition of gastric acid production, and are superior to antacids and H2RAs for control of gastric acid and treatment of frequent heartburn. Implications for practice When recommending therapies for frequent heartburn, it is of particular importance to understand the strengths and weaknesses of available OTC medications. Antacids and H2RAs are not recommended for treatment of frequent heartburn, while OTC PPIs are both indicated for, and effective for, treatment of frequent heartburn. A PPI dose of 20 mg is optimal for empiric treatment of frequent heartburn, and consistent with the 2013 treatment guidelines established by the American College of Gastroenterology (ACG) for treatment with a minimum effective dose.

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Comparison of Prilosec OTCTM (omeprazole magnesium 20.6 mg) to placebo for 14 days in the treatment of frequent heartburn

Abstract: These trials demonstrated the safety and effectiveness of a novel 14-day regimen of Ome-Mg 20 in completely preventing heartburn for 24 h establishing it as an excellent self-care treatment for frequent heartburn and supporting the approval of Prilosec OTC.

Cited by 18 publications

References 12 publications

Guidance on the use of over-the-counter proton pump inhibitors for the treatment of GERD

Guidance on the use of over-the-counter proton pump inhibitors for the treatment of GERD

Review of proton pump inhibitors for the initial treatment of heartburn: Is there a dose ceiling effect?

Evidence-based treatment of frequent heartburn: The benefits and limitations of over-the-counter medications

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