Lansoprazole and Esomeprazole in Symptomatic GERD

William Chey, Bidan Huang, Robert L. Jackson

Disclosures

Clin Drug Invest. 2003;23(2) 

In This Article

Discussion

The results of this large-scale, randomised, multicentre, double-blind, prospective clinical trial indicate that treatment with lansoprazole 30mg or esomeprazole 40mg once daily effectively relieves daytime and night-time heartburn in patients with GERD. After 1 day and during the first 3 days, the first week and the overall 2 weeks of treatment, substantial percentages of patients in each treatment group reported relief compared with baseline in the percentages of days without heartburn and nights without heartburn. In addition, treatment was associated with decreases in the severities of these symptoms. Using the rigorous outcome of the cumulative percentage of patients who achieved sustained heartburn relief, the regimens remained comparable at each treatment day.

Both treatments were well tolerated and the once-daily regimen was associated with excellent medical compliance. Overall, the great majority of patients in each group were pleased with and reported benefit from their treatment regimen. More than half reported greater symptom relief with lansoprazole or esomeprazole compared with prior therapies. Perhaps most importantly, over 85% of patients would recommend the use of either lansoprazole 30mg or esomeprazole 40mg once daily to someone else with heartburn.

The findings of this study help to clarify the discrepancies that have been observed in the recent literature regarding these two widely utilised treatment regimens. For example, in a large study involving over 5200 patients published in early 2002, Castell and colleagues[13] found a slight advantage with esomeprazole 40mg once daily versus lansoprazole 30mg once daily in the onset of sustained resolution of heartburn relief. On the other hand, in a different study of 284 patients, the percentage of days or nights patients treated with lansoprazole 30mg who were daytime, night-time, and daytime and night-time heartburn-free after 1 day (41.5%, 47.9%, 34.5%, respectively), 3 days (52.2%, 55.9%, 43.8%, respectively), and 1 week (60.3%, 61.5%, 51.8%, respectively) were consistently higher, although not significantly so, than those treated with esomeprazole 40mg once daily (1 day: 34.5%, 41.7%, 27.3%; 3 days: 44.4%, 51.9%, 37.4%; 1 week: 53.6%, 59.2%, 45.9%; respectively).[14] Dohmen and colleagues[15] found, in an open-label prospective study, that patients treated with lansoprazole 30mg once daily were more likely to be pain-free after one dose com-pared with patients treated with esomeprazole 40mg once daily (100% [62/62] vs 80% [48/60], respectively). Vakil and colleagues[16] performed a meta-analysis of five randomised controlled trials to evaluate the effects of esomeprazole, omeprazole and lansoprazole on nocturnal heartburn relief in patients with erosive oesophagitis. They found a slight, but statistically significant, advantage in the percentage of heartburn-free nights among the 2015 patients on esomeprazole 40mg compared with the 1101 patients on lansoprazole 30mg (65.5% vs 63.3%, p < 0.05) after 1 week of treatment.

In this study, the effects of lansoprazole 30mg and esomeprazole 40 mg, once daily, on night-time heartburn relief are particularly encouraging as recently reported studies suggest that those with nocturnal GERD symptoms have significantly worse impairment in all eight health-related quality-of-life domains (as measured by the Medical Outcomes Study Short-Form 36 Health Survey [SF-36]), with the greatest impairments found in the areas of pain, psychological wellbeing and social functioning.[19] Those with nocturnal GERD had a significantly greater quality-of-life impairment than those with hypertension and diabetes and a similar quality-of-life impairment to those with angina and congestive heart failure. In addition, a growing body of evidence suggests that night-time reflux may be more important than daytime reflux in the development of severe GERD-related complications.[19,20]

In addition to its size and design, the strengths of this study include its use of limited exclusion criteria and its intent-to-treat analysis. Our findings should accurately reflect what would be expected to occur in clinical practice where relief of heartburn is the most important criteria by which clinicians judge the effectiveness of PPI therapy in GERD. The short duration of the study does not allow us to address whether or not differences between these agents may occur with long-term treatment. However, based upon longer term studies comparing lansoprazole with omeprazole[21] or esomeprazole,[14] the comparable heartburn relief noted in the present study is likely to persist with continued treatment.

In the treatment of GERD, and as in several other chronic disorders, patient expectations and satisfaction with treatment are highly dependent on how quickly relief is attained. With either lansoprazole 30mg or esomeprazole 40mg, substantial relief of heartburn was attained after the first day of treatment, with the percentages of days without heartburn and nights without heartburn rising during the first 3 days, the first week and the 2-week treatment period. In addition, these patients experienced substantial reductions in the severities of their daytime and night-time heartburn symptoms after the first day as well as during the first 3 days, the first week and the 2-week treatment period. Whether or not the onset of heartburn relief (i.e. after the first day or after the first 3 days) or the 'patient satisfaction' aspect of treatment are of clinical importance to physicians remains to be determined. However, more rapid resolution of symptoms is intuitively attractive. Clinicians should consider our findings in the context of the effect of symptoms on patients' overall wellbeing, productivity and quality-of-life.

Treatment with lansoprazole 30mg or esomeprazole 40mg once daily for 2 weeks effectively increases the percentage of days and nights that patients are without heartburn and reduces the average severity of daytime and night-time heartburn.

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