Nighttime Heartburn Research Articles

Review article: impact of night‐time reflux on lifestyle − unrecognized issues in reflux disease

Gastro-oesophageal reflux disease (GERD), manifesting with symptoms including heartburn and regurgitation, affects people during both daytime and nocturnal hours. Night-time GERD has been reported to have a greater impact on a patient's life than daytime GERD due to prolonged oesophageal acid exposure time per reflux episode. To further understand this issue, it is important to implement quality of life (QOL) measures. QOL studies are becoming increasingly important to physicians in making clinical decisions, and generic and disease-specific health-related QOL (HRQL) tools have been developed to measure a wide variety of topics. There are currently no universally accepted guidelines on how to best measure HRQL in GERD patients. It is important to note that these surveys may not yield accurate results because many GERD sufferers may feel that their symptoms are not serious enough to seek treatment. Some surveys include the GERD-HRQL assessment, the Short Form Health Survey (SF-36), and the Gallup survey. When compared with daytime GERD patients, night-time GERD patients may suffer from sleep deprivation, which in turn leads to physical and emotional problems and a poor overall QOL. Studies indicate that the prevalence and impact of night-time heartburn have been underestimated and that adequate treatment of symptoms is often not achieved. In addition, GERD greatly affects work productivity and leads to a significant economic burden on society. Although limited studies are available on the impact of pharmacological treatment on GERD QOL, recent findings indicate that proton pump inhibitors are more effective than H(2)-receptor antagonists for the improvement of overall QOL.

Pantoprazole provides rapid and sustained symptomatic relief in patients treated for erosive oesophagitis

Effective symptom control is a primary concern of most heartburn suffers. To compare the safety and efficacy of pantoprazole, placebo and the H2 antagonist nizatidine in relieving symptoms in patients with erosive oesophagitis. Data from two randomized, double-blind studies were pooled. Patients received pantoprazole 10, 20 or 40 mg, or placebo daily (study 1, n = 603), or pantoprazole 20 or 40 mg daily or 150-mg nizatidine b.d. (study 2, n = 243) for either 4 or 8 weeks. Endoscopy was performed at baseline, week 4 and week 8. Persistent absence of symptoms was defined as the first day that no symptoms were reported by the patient on that day or any subsequent study day. A significantly higher percentage (P < 0.05) of pantoprazole patients reported elimination of all symptoms by week 8. Daytime heartburn, night-time heartburn and regurgitation were significantly better controlled with pantoprazole (with a dose-response at most time-points). Absence of symptoms was a powerful predictor of healing; presence of symptoms correlated poorly. Pantoprazole is more effective than placebo or nizatidine for controlling heartburn and acid regurgitation in patients with erosive oesophagitis. Relief of GERD symptoms is highly predictive of healing of erosive oesophagitis at 4 and 8 weeks.

OMEPRAZOLE IMMEDIATE-RELEASE ORAL SUSPENSION IS MORE EFFECTIVE THAN PANTOPRAZOLE DELAYED-RELEASE CAPSULES IN REDUCING NIGHTTIME GASTRIC ACIDITY IN GERD PATIENTS

Purpose: The present trial was conducted to evaluate nighttime dosing of omeprazole imediate-release oral suspension (OME-IR[SUSP]) in once- and twice-daily regimens, comparing the effect of OME-IR on nocturnal gastric acidity to that of pantoprazole (P), the only PPI with FDA-approved labeling for reduction in rate of nighttime heartburn symptoms. Methods: Thirty-two patients with nocturnal GERD symptoms were enrolled in a crossover trial with 40-mg doses of P (Protonix®, Wyeth-Ayerst, Philadelphia) given at 2200 hrs (bedtime) on Day 1 and prior to dinner on Days 2–6 and 40-mg OME-IR(SUSP) (Santarus, San Diego) given at 2200 hrs on Days 1-6. On Day 7, both PPIs were given 1 hr prior to breakfast and at 2200 hrs: P 40 mg (n = 32); OME-IR 40 mg (n = 17) and 20 mg (n = 15). Continuous 24-hr gastric pH monitoring (Medtronic) was performed on Days 1, 6, and 7. Median gastric pH,% time pH was >4, and the proportion of patients with “nocturnal acid breakthrough” (NAB) (> 1 hr of continuous pH <4) were determined for the nighttime period (2200-0600 hrs). Results: Nighttime median gastric pH on Day 6 is shown below. For this 8-hr period, median % time pH was >4 was greater for OME-IR (5 5%) than for P (27%) (p <0.001); median pH was 4.7 for OME-IR and 2.0 for P (p <0.001); and NAB occurred in fewer OME-IR-treated patients (17/32) than P-treated patients. (25/32) (p = 0.005). For the 8-hr nighttime period after twice-daily dosing, median % time pH was >4 was greater for OME-IR (40 mg and 20 mg) than for P (92% vs. 37% and 79% vs. 31%, p <0.001 each); median pH was also higher (6.5 vs. 1.5 and 5.8 vs. 1.9, p <0.001 each). NAB occurred in fewer OME-IR-treated patients than P-treated patients (2/17 vs. 12/17 and 7/15 vs. 12/15, p<0.025 each). Conclusions: OME-IR(SUSP) is more effective in reducing nighttime gastric acidity than P. These results suggest that OME-IR may also be more effective than delayed-release PPIs in controlling nighttime symptoms of GERD when dosed at bedtime.[figure 1]Figure

Nighttime GERD: Clinical implications and therapeutic challenges

Limited available data specifically addressing nocturnal gastroesophageal reflux indicate its association with more severe injuries such as esophagitis and stricture, adenocarcinoma of the esophagus, respiratory and ENT disorders as well as sleep disturbances, diminished quality of life and undesired changes in activities of daily living. In a recent survey, altogether 79% of respondents reported experiencing heartburn at night. Among those, 75% reported that symptoms affected their sleep, 63% believed that heartburn negatively affected their ability to sleep well, and 40% believed that nocturnal heartburn impaired their ability to function the following day. Of the 791 respondents with nighttime heartburn, 71% reported taking over-the-counter medicine for it, only 29% of these rated this approach extremely effective. Forty-one percent reported trying prescription medicines and 49% of these rated this approach extremely satisfactory. This recent understanding of the prevalence and impact of nighttime heartburn is an indicator of nocturnal acid reflux events and suggests that nighttime heartburn occurs in a large majority of adults with gastroesophageal reflux disease. The fact that expected result from implemented therapy for heartburn is not achieved by a sizable percentage of patients can have significant management implications.

Single-dose non-prescription ranitidine 75mg is superior to single-dose omeprazole 20mg for prevention of postprandial and nighttime heartburn following a provocative meal

Single-dose non-prescription ranitidine 75mg is superior to single-dose omeprazole 20mg for prevention of postprandial and nighttime heartburn following a provocative meal

Pantoprazole positively impacts nighttime heartburn symptoms and quality of sleep in patients with gastroesophageal reflux disease

Pantoprazole positively impacts nighttime heartburn symptoms and quality of sleep in patients with gastroesophageal reflux disease

H. pylori status influences the efficacy of omeprazole 20mg but not ranitidine 75mg for prevention of nighttime heartburn following a provocative meal

Purpose: Acid inhibition appears less effective in H. pylori negative individuals (Hp neg) than in H. pylori positive ones (Hp pos) with proton pump inhibitors but not with H2-antagonists and may result in insufficient control of heartburn (HB) in many subjects. We evaluated a bedtime provocative meal and response to treatment in healthy subjects (18–75 yrs) who tested Hp neg (429) or pos (61) with a history of nighttime HB (2 episodes/wk) rated as moderate to very severe.

Nighttime heartburn is an under-appreciated clinical problem that impacts sleep and daytime function: the results of a Gallup survey conducted on behalf of the American Gastroenterological Association

Objective Although a large body of information exists about the prevalence of gastroesophageal reflux disease (GERD) in general, available data specifically addressing nocturnal reflux are limited. Because nocturnal acid reflux is reported to be associated with more severe injuries such as esophagitis and stricture, as well as adenocarcinoma of the esophagus, a better understanding of the prevalence and impact of nighttime heartburn as a sign of nocturnal acid reflux events can have significant potential management implications. The aims of this study were to determine the prevalence of nighttime heartburn and reflux-attributed supraesophageal symptoms among patients with GERD; and the impact of nighttime heartburn on sleep and several activities of daily living that could affect quality of life. Methods A nationwide telephone survey of 1000 adults experiencing heartburn at least once a week was conducted by the Gallup Organization on behalf of the American Gastroenterological Association. Results Altogether, 79% of respondents reported experiencing heartburn at night. Among those, 75% reported that symptoms affected their sleep, 63% believed that heartburn negatively affected their ability to sleep well, and 40% believed that nocturnal heartburn impaired their ability to function the following day. Of the 791 respondents with nighttime heartburn, 71% reported taking over-the-counter medicine for it, but only 29% of these rated this approach extremely effective. Forty-one percent reported trying prescription medicines, and 49% of these rated this approach extremely effective. Conclusions Nighttime heartburn occurs in a large majority of adults with GERD, resulting in sleeping difficulties and impaired next-day function. The expected result from implemented therapy for heartburn is not achieved by a sizable percentage of patients.

Nighttime heartburn is an under-appreciated clinical problem that impacts sleep and daytime function: the results of a Gallup survey conducted on behalf of the American Gastroenterological Association.

Although a large body of information exists about the prevalence of gastroesophageal reflux disease (GERD) in general, available data specifically addressing nocturnal reflux are limited. Because nocturnal acid reflux is reported to be associated with more severe injuries such as esophagitis and stricture, as well as adenocarcinoma of the esophagus, a better understanding of the prevalence and impact of nighttime heartburn as a sign of nocturnal acid reflux events can have significant potential management implications. The aims of this study were to determine the prevalence of nighttime heartburn and reflux-attributed supraesophageal symptoms among patients with GERD; and the impact of nighttime heartburn on sleep and several activities of daily living that could affect quality of life. A nationwide telephone survey of 1000 adults experiencing heartburn at least once a week was conducted by the Gallup Organization on behalf of the American Gastroenterological Association. Altogether, 79% of respondents reported experiencing heartburn at night. Among those, 75% reported that symptoms affected their sleep, 63% believed that heartburn negatively affected their ability to sleep well, and 40% believed that nocturnal heartburn impaired their ability to function the following day. Of the 791 respondents with nighttime heartburn, 71% reported taking over-the-counter medicine for it, but only 29% of these rated this approach extremely effective. Forty-one percent reported trying prescription medicines, and 49% of these rated this approach extremely effective. Nighttime heartburn occurs in a large majority of adults with GERD, resulting in sleeping difficulties and impaired next-day function. The expected result from implemented therapy for heartburn is not achieved by a sizable percentage of patients.

Rabeprazole improves and maintains overall well being in gastroesophageal reflux disease (GERD) over 5 years

Purpose: To compare the impact on overall physical well being of rabepmzole 20 rag, rabeprazole 10 mg, and placebo over 5 years of mainter~ance therapy in GERD patients. Methods: 497 patients, previously diagnosed with erosive/ulcerative GERD healed in an acute efficacy trial, entered a multicenter, double-blind, placebo-controlled, parallel-arm, 1year maintenance study. All patients completing 1 year without GERD relapse were eligible to participate for 4 more years in an extension phase. Efficacy variables of the combined 5 years (260 weeks) of study included: overall physical well-being score (scale, 0 = very good; 4 = very poor), relapse of seventy/frequency of daytime and nighttime heartburn, and antacid use. Results: At endpoint (260 weeks), both rabeprazole groups had significantly higher ratings in overall well being versus placebo (p 2; p-<0.008). Rabeprazole 20 mg also produced a significantly lower relapse rate than rabeprazole 10 mg for weeks 4-65 (p~0.038). These results in overall well being corresponded with significantly lower relapse rates with rabeprazole versus placebo in heartburn frequency and severity seen over 5 years (p-<0.02). Mean daily antacid dose consumed by the rabeprazole 20 mg group (0.17) was less than in the rabeprazole 10 mg (0.24) or placebo groups (0.24) at endpoint. For weeks 4-104 and week 143, there were significant differences in change in daily antacid use from baseline favoring both rabeprazole groups versus the placebo group (p-<0.05). Conclusions: 5-year maintenance therapy with rabeprazole improves overall well being compared with placebo. Research supported by Eisai Inc., Teaneck, NJ and Janssen Pharmaceutica Inc., Titusville, NJ.

The effect of over the counter ranitidine (75 mg) on nighttime heartburn in patients with erosive esophagitis on daily proton pump inhibitor maintenance therapy

The effect of over the counter ranitidine (75 mg) on nighttime heartburn in patients with erosive esophagitis on daily proton pump inhibitor maintenance therapy

Lansoprazole and Esomeprazole in Symptomatic GERD

To evaluate the onset and degree of symptom relief in a population of patients with symptomatic gastro-oesophageal reflux disease (GERD) treated with lansoprazole 30mg or esomeprazole 40mg, each administered once daily. This was a phase IIIb, prospective, randomised, double-blind, active-controlled, multicentre study of patients with a history of symptomatic GERD. Patients with symptomatic GERD based on preset criteria were randomised in a 1: 1 ratio to lansoprazole or esomeprazole for 2 weeks. Efficacy endpoints were the percentage of patients without daytime heartburn after the first treatment day, the percentage of patients without night-time heartburn after the first treatment day, and symptom relief (measured as percentage of days and nights without heartburn) and average symptom severity after the first day, during the first 3 days (primary efficacy endpoint), during the first week and during the 2-week treatment period. 3034 patients were randomised to lansoprazole 30mg (n = 1520) or esomeprazole 40mg (n = 1514). Patients in both treatment groups reported increases from baseline in the percentages of days and nights without heartburn and decreases in the average daytime and night-time heartburn severity during the 2-week treatment period. No statistically significant differences were observed between the lansoprazole 30mg and esomeprazole 40mg treatment groups in heartburn relief parameters on day 1 or during the first 3 days, the first week or the 2-week treatment period after adjusting for differences in baseline heartburn severity. Both treatments were well tolerated. Significantly higher percentages of patients treated with esomeprazole as compared with those treated with lansoprazole reported treatment-emergent dry mouth (0.5% vs 0.1 %, p = 0.021) and vomiting (0.5% vs 0.1%, p = 0.038). The most common treatment-related adverse events were diarrhoea (lansoprazole 1.4%, esomeprazole 1.8%), flatulence (lansoprazole 0.7%, esomeprazole 1.0%) and abdominal pain (lansoprazole 1.1%, esomeprazole 1.3%). Lansoprazole 30mg once daily or esomeprazole 40mg once daily for 2 weeks effectively increase the percentage of days and nights patients with symptomatic GERD are without heartburn and reduce the average severity of daytime and night-time heartburn.

Effectiveness and Tolerability of Rabeprazole 20mg as Once-Daily Monotherapy in Treatment of Erosive or Ulcerative Gastro-Oesophageal Reflux Disease

Rabeprazole, a new proton pump (H+, K+-ATPase) inhibitor, is a consistently effective treatment for patients with gastro-oesophageal reflux disease (GORD). Most of the data, however, has been obtained from controlled trials. The present study was carried out to assess the effectiveness and tolerability of rabeprazole in actual conditions of use in everyday clinical practice. This was a multicentre, observational, noncomparative, open-label, short-term study conducted in the outpatient clinics of 11 hospitals from a single country (Brazil). Male and female patients over 18 years of age with endoscopically confirmed erosive/ulcerative oesophagitis (Savary-Miller classification) and moderate to severe heartburn as the predominant symptom were eligible. Patients received rabeprazole 20mg once daily in the morning for 4 or 8 weeks. Patients with endoscopically documented healing at week 4 exited the study at that point. 92 patients were included in the intention-to-treat (ITT) group and 68 in the per-protocol (PP) group. At the end of the 4-week treatment period, daytime heartburn was present in 16.2% of patients, as compared with 97.1% at baseline (p < 0.001) and night-time heartburn in 10.3%, as compared with 77.9% at baseline (p < 0.001). All other symptoms of GORD (acid regurgitation, dysphagia, eructation, fullness, nausea, vomiting, epigastric pain) improved significantly after 4 weeks of rabeprazole treatment. The healing rate of erosive/ulcerative oesophagitis was 70.6% in the PP analysis and 69.6% in the ITT analysis after 4 weeks of treatment. At 4 or 8 weeks, the healing rate in the PP group was 78.3% for grade I oesophagitis, 91.7% for grade II, 60% for grade III, and 40% for grade IV. According to diary card information, most patients obtained marked relief of heartburn within the first 3 days of treatment and reduction in the need for supplemental antacids within the first 5 days. A total of 18 adverse events occurred in 17 (18.5%) patients, with a ‘possible’ relationship to the use of rabeprazole in only four cases. Withdrawal of the medication because of adverse events was not necessary. In this non-comparative, open-label, short-term study, rabeprazole 20mg once daily has shown clinical effectiveness in healing oesophageal lesions and in reducing the frequency and intensity of heartburn associated with erosive/ ulcerative oesophagitis in patients with GORD. Rabeprazole was also well tolerated.

Evidence for Therapeutic Equivalence of Lansoprazole 30mg and Esomeprazole 40mg in the Treatment of Erosive Oesophagitis

To compare the effectiveness of lansoprazole 30mg once daily and esomeprazole 40mg once daily on healing and symptom relief in patients with erosive oesophagitis. Phase IV, randomised, double-blind, active-controlled, multicentre study. 284 patients with endoscopically confirmed erosive oesophagitis (grade ≥2). Patients were randomised to treatment with lansoprazole or esomeprazole. The primary efficacy endpoint was the healing of erosive oesophagitis (defined as grade 0 or 1) at week 8. Healing rates at week 4 and the percentages of patients reporting no daytime or night-time heartburn after 1 day, 3 days and 1 week of treatment, as well as the rate of healing or improvement of oesophagitis by two grades, were also analysed. Healing rates and 95% confidence intervals (CIs) at week 8 were 91.4% (85.4, 95.5%) for lansoprazole 30mg once daily and 89.1% (82.7, 93.8%) for esomeprazole 40mg once daily, respectively. For any baseline grade, greater than 90% of lansoprazole-treated and 81% of esomeprazole-treated patients exhibited healing or improvement of erosive oesophagitis by two grades from baseline to week 8. Healing rates at week 4 were also comparable: 77.0% (95% CI 69.1, 83.7%) for lansoprazole 30mg and 78.3% (95% CI 70.4, 84.8%) for esomeprazole 40mg. The percentages of heartburn-free patients after 1 day, 3 days and 1 week of treatment were slightly higher for lansoprazole compared with esomeprazole, although the differences did not reach statistical significance (p > 0.05). Both treatments were well tolerated. In erosive oesophagitis, lansoprazole 30mg once daily and esomeprazole 40mg once daily are equally effective in healing erosions and relieving heartburn.

Lansoprazole for maintenance of remission of erosive oesophagitis.

Gastro-oesophageal reflux disease, which is experienced daily by a significant proportion of individuals, may result in serious sequelae such as erosive oesophagitis. Short-term treatment with acid antisecretory therapy (a proton pump inhibitor or a histamine H(2) receptor antagonist) is highly effective in healing the erosive oesophagitis lesion. However, numerous studies confirm that unless maintenance therapy is initiated virtually all patients will experience oesophagitis relapse within 1 year, as well as an increasing severity of oesophagitis and risk for complications such as Barrett's oesophagus and adenocarcinoma. Studies evaluating the efficacy of proton pump inhibitor and H(2) antagonist maintenance therapy have found that only the proton pump inhibitors significantly reduce the incidence of oesophagitis relapse. Pharmacoeconomic studies have also confirmed that proton pump inhibitor maintenance therapy is cost effective, by virtue of the ability of these agents to reduce the incidence of relapse as well as prolong the time to relapse and increase the number of weeks per year that patients are without symptoms. Lansoprazole, a member of the proton pump inhibitor class of agents, has been extensively studied in the treatment of patients with a variety of acid-related disorders. Among those with erosive oesophagitis, maintenance therapy with lansoprazole 15 or 30mg once daily is highly effective in preventing relapse. Studies have documented that lansoprazole 15 and 30mg once daily for six months prevents oesophagitis relapse in up to 81 and 93% of patients, respectively, with comparable percentages of patients remaining in remission after 1 year of treatment. These high rates of remission have also been observed in studies of patients with lesions that were difficult to heal at baseline (resistant to healing with at least 3 months of H(2) antagonist therapy). Moreover, lansoprazole produces high remission rates regardless of the grade of erosive oesophagitis before acute healing. Among symptomatic patients with heartburn, lansoprazole provides rapid and effective relief of daytime and night-time heartburn and prevents relapse of symptoms. Lansoprazole has a wide margin of safety and is well tolerated when administered as monotherapy in short- and long-term clinical trials. Taken together these data suggest that proton pump inhibitor therapy represents the preferred and ideal long-term management strategy for the patient with erosive oesophagitis. Lansoprazole is a well-established member of this class of agents and, as such, has an extensive body of literature that supports its safety, tolerability and clinical efficacy in preventing relapse in these patients.

Comparing lansoprazole and omeprazole in onset of heartburn relief: results of a randomized, controlled trial in erosive esophagitis patients

OBJECTIVE:This randomized, double-blind, multicenter study was conducted to confirm a previous finding that lansoprazole relieves heartburn faster than omeprazole in patients with erosive esophagitis.METHODS:A total of 3510 patients with erosive esophagitis and at least one episode of moderate to very severe daytime and/or nighttime heartburn during the 3 days immediately before the screening visit were randomized to lansoprazole 30 mg once daily or omeprazole 20 mg once daily for 8 wk. Patients recorded the presence and severity of daytime and nighttime heartburn in daily diaries. On treatment days 1–4, patients were telephoned to confirm the completion of their daily diary. The primary efficacy parameters were the percentage of heartburn-free days and heartburn-free nights, as well as the average severity of daytime and nighttime heartburn.RESULTS:During treatment day 1 and all evaluation time points including the entire 8-wk treatment period, significantly (p < 0.05) higher percentages of patients treated with lansoprazole than those treated with omeprazole did not experience a single episode of heartburn. Onset of heartburn relief was more rapid in lansoprazole-treated versus omeprazole-treated patients: on day 1, 33% versus 25% of lansoprazole- versus omeprazole-treated patients were heartburn-free. The percentages of heartburn-free days and heartburn-free nights were also significantly (p < 0.01) greater for patients treated with lansoprazole at all evaluation time points. Heartburn severity was significantly less among those treated with lansoprazole compared with omeprazole. Both treatments were safe and well tolerated.CONCLUSIONS:Over 8 wk, lansoprazole 30 mg once daily relieved heartburn symptoms faster and more effectively than omeprazole 20 mg once daily in patients with erosive esophagitis.

PGI8: RAPID IMPACT OF RABEPRAZOLE ON SYMPTOM DISTRESS AMONG PATIENTS WITH GASTROESOPHAGEAL REFLUX DISEASE

OBJECTIVES: Gastroesophageal reflux disease (GERD) is a common condition associated with a variety of symptoms, particularly heartburn. The purpose of this study was to assess patient-reported symptom distress in a randomized trial of rabeprazole (RAB), a proton pump inhibitor. METHODS: Symptom distress was measured using the Distress subscale of the GERD Symptom Assessment Scale (GSAS) that asks patients about the degree of bother they experience for 15 symptoms. Patients completed the GSAS at baseline and week 4. We evaluated the impact of treatment (RAB 10mg, RAB 20mg, or placebo) on mean change in GSAS Distress scores using an ANCOVA model. We also conducted a relative variability analysis using ANOVA models to determine which of 5 clinical indicators are most useful to explain changes in GSAS Distress scores. Mean change was assessed as a function of baseline daytime heartburn severity, baseline nighttime heartburn severity, time to first 24 hours without heartburn symptoms, complete daytime heartburn relief, and complete nighttime heartburn relief. RESULTS: The sample consisted of 169 patients (RAB10mg = 55, RAB 20mg = 56, placebo = 58). Overall, a significant difference in mean change in GSAS Distress scores was observed across treatment groups (p = 0.0007). Both the RAB 10mg and RAB 20mg groups reported significantly greater improvements in GSAS Distress scores than the placebo group (p = 0.0036 and p = 0.0004, respectively). Of the 5 clinical indicators examined, time to first 24 hours without heartburn explained the greatest amount of variability in GSAS Distress scores. Achieving complete daytime and complete nighttime heartburn relief also were significant factors. CONCLUSIONS: In clinical studies, RAB provided fast and consistent (both daytime and nighttime) heartburn relief. Given that speed of heartburn relief as well as achieving complete heartburn relief were significant factors explaining variability in patient-reported symptom distress, the positive impact of RAB on the GSAS distress scale was consistent with its clinical efficacy.

Management of heartburn in a large, randomized, community-based study: comparison of four therapeutic strategies

OBJECTIVE: Our objective was to compare four management strategies for heartburn: therapy with an H2-receptor antagonist (ranitidine), therapy with a proton pump inhibitor (lansoprazole), crossover from ranitidine to lansoprazole (“step-up” therapy), and crossover from lansoprazole to ranitidine (“step-down” therapy). METHODS: This was a controlled, double-blind, multicenter trial comprising 593 adults with heartburn, randomized to one of four groups for 20 wk. Subjects received either ranitidine 150 mg b.i.d. for 20 wk, or lansoprazole 30 b.i.d. for 8 wk followed by lansoprazole 30 mg once daily for 12 wk (“step-up”), or lansoprazole 30 mg once daily for 8 wk followed by ranitidine 150 mg b.i.d. for 12 wk (“step-down”). Outcome measures were based on self-reports in daily diaries of 24-h heartburn severity, measured by maximum daytime and nighttime severity, and percentage of 24-h heartburn-free days measured by absence of both daytime and nighttime heartburn. RESULTS: Median heartburn severity was significantly lower ( p < 0.05) for lansoprazole (0.25) than the other groups (0.46 ranitidine, 0.44 “step-up,” 0.35 “step-down”). The lansoprazole group had a significantly higher percentage of 24-h heartburn-free days (median 81.4%, p < 0.01) than other groups (66.6, 66.9, and 73.6%, respectively). In the “step-up” and “step-down” groups, heartburn was less severe, and percentages of 24-h heartburn-free days were higher during lansoprazole treatment regardless of treatment sequence. CONCLUSION: Proton pump inhibitor treatment provides more consistent heartburn relief than an H2-receptor antagonist, or “step-up” or “step-down” therapy.

Nighttime heartburn is an underappreciated clinical problem that impacts sleep and daytime function

Nighttime heartburn is an underappreciated clinical problem that impacts sleep and daytime function

Nighttime heartburn is an underappreciated clinical problem that impacts sleep and daytime function

Nighttime heartburn is an underappreciated clinical problem that impacts sleep and daytime function