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BACKGROUND: Heartburn is the most common symptom of gastroesophageal reflux disease (GERD). This study compared 4 pharmacologic strategies using the proton pump inhibitor (PPI) lansoprazole (Prevacid) and the H2-receptor antagonist ranitidine (Zantac) in the treatment of moderate to severe heartburn.
POPULATION STUDIED: This study included 593 men and women older than 18 years who experienced heartburn on at least 50% of days during a 7- to 10-day screening period, including at least one moderate to severe episode. Patients were excluded if they had coexisting systemic disease affecting the esophagus, active gastrointestinal bleeding, Zollinger-Ellison syndrome, esophageal varices, significant disease of major organs, abnormal laboratory values, current alcohol or illegal drug use, use of a PPI in the previous 3 months, or use of anticholinergic or prokinetic drugs during the screening period.
STUDY DESIGN AND VALIDITY: This was a double-blind controlled multicenter trial in which patients were randomized to 1 of 4 treatment groups. The subjects received one of the following: (1) lansoprazole 30 mg daily for 20 weeks; (2) ranitidine 150 mg twice daily for 20 weeks; (3) step-down therapy consisting of lansoprazole 30 mg daily for 8 weeks followed by ranitidine 150 mg twice a day for 12 weeks; or (4) a step-up approach of ranitidine 150 mg twice daily for 8 weeks followed by lansoprazole 30 mg once daily for 12 weeks.
OUTCOMES MEASURED: Two outcome measurements were reported, including the median severity of heartburn using a scale of 0 (no heartburn), 1 (mild heartburn), 2 (moderate heartburn), or 3 (severe heartburn) and the percentage of 24-hour heartburn-free days. Outcomes measurements were based on self-report in daily diaries. Antacid use was also reported.
RESULTS: All patients, regardless of treatment, reported a marked clinically relevant decline in the intensity of their heartburn symptoms. The median heartburn severity decreased from 1.88 to 0.46 in the ranitidine group, from 1.75 to 0.25 in the lansoprazole group, from 1.75 to 0.35 in the step-up group, and from 1.70 to 0.44 in the step-down group (P <.05 for lansoprazole vs the other groups). The lansoprazole group also had a significantly higher percentage of 24-hour heartburn-free days (median=81.4%; P <.01) than the ranitidine (66.6%), step-up (66.9%), and step-down (73.6%) groups. In the step-up and step-down groups, heartburn was less severe, and percentages of 24-hour heartburn-free days were higher during lansoprazole treatment regardless of treatment sequence (P <.001). Over the 20 weeks of treatment, antacid use was required on a significantly higher percentage of days in the ranitidine (median=18.7%; P <.001), step-up (12.3%; P <.05), and step-down (18.5%; P <.001) groups than in the lansoprazole group (8.6%).
Most patients with moderate to severe heartburn will experience relief with either H2-receptor antagonist or PPI therapy. Results in this study were better when patients started and stayed on regular doses of lansoprazole. Heartburn severity was also less with lansoprazole but minimally different. This study did not address cost issues, although a recent study in primary care patients with heartburn symptoms found that omeprazole (Prilosec) provided greater resolution of symptoms than ranitidine, with no significant differences in total outpatient costs between the groups.1 Although step-down and step-up therapies are often recommended to decrease total costs, they were less effective than continuous-dose therapy in this study.
BACKGROUND: Heartburn is the most common symptom of gastroesophageal reflux disease (GERD). This study compared 4 pharmacologic strategies using the proton pump inhibitor (PPI) lansoprazole (Prevacid) and the H2-receptor antagonist ranitidine (Zantac) in the treatment of moderate to severe heartburn.
POPULATION STUDIED: This study included 593 men and women older than 18 years who experienced heartburn on at least 50% of days during a 7- to 10-day screening period, including at least one moderate to severe episode. Patients were excluded if they had coexisting systemic disease affecting the esophagus, active gastrointestinal bleeding, Zollinger-Ellison syndrome, esophageal varices, significant disease of major organs, abnormal laboratory values, current alcohol or illegal drug use, use of a PPI in the previous 3 months, or use of anticholinergic or prokinetic drugs during the screening period.
STUDY DESIGN AND VALIDITY: This was a double-blind controlled multicenter trial in which patients were randomized to 1 of 4 treatment groups. The subjects received one of the following: (1) lansoprazole 30 mg daily for 20 weeks; (2) ranitidine 150 mg twice daily for 20 weeks; (3) step-down therapy consisting of lansoprazole 30 mg daily for 8 weeks followed by ranitidine 150 mg twice a day for 12 weeks; or (4) a step-up approach of ranitidine 150 mg twice daily for 8 weeks followed by lansoprazole 30 mg once daily for 12 weeks.
OUTCOMES MEASURED: Two outcome measurements were reported, including the median severity of heartburn using a scale of 0 (no heartburn), 1 (mild heartburn), 2 (moderate heartburn), or 3 (severe heartburn) and the percentage of 24-hour heartburn-free days. Outcomes measurements were based on self-report in daily diaries. Antacid use was also reported.
RESULTS: All patients, regardless of treatment, reported a marked clinically relevant decline in the intensity of their heartburn symptoms. The median heartburn severity decreased from 1.88 to 0.46 in the ranitidine group, from 1.75 to 0.25 in the lansoprazole group, from 1.75 to 0.35 in the step-up group, and from 1.70 to 0.44 in the step-down group (P <.05 for lansoprazole vs the other groups). The lansoprazole group also had a significantly higher percentage of 24-hour heartburn-free days (median=81.4%; P <.01) than the ranitidine (66.6%), step-up (66.9%), and step-down (73.6%) groups. In the step-up and step-down groups, heartburn was less severe, and percentages of 24-hour heartburn-free days were higher during lansoprazole treatment regardless of treatment sequence (P <.001). Over the 20 weeks of treatment, antacid use was required on a significantly higher percentage of days in the ranitidine (median=18.7%; P <.001), step-up (12.3%; P <.05), and step-down (18.5%; P <.001) groups than in the lansoprazole group (8.6%).
Most patients with moderate to severe heartburn will experience relief with either H2-receptor antagonist or PPI therapy. Results in this study were better when patients started and stayed on regular doses of lansoprazole. Heartburn severity was also less with lansoprazole but minimally different. This study did not address cost issues, although a recent study in primary care patients with heartburn symptoms found that omeprazole (Prilosec) provided greater resolution of symptoms than ranitidine, with no significant differences in total outpatient costs between the groups.1 Although step-down and step-up therapies are often recommended to decrease total costs, they were less effective than continuous-dose therapy in this study.
BACKGROUND: Heartburn is the most common symptom of gastroesophageal reflux disease (GERD). This study compared 4 pharmacologic strategies using the proton pump inhibitor (PPI) lansoprazole (Prevacid) and the H2-receptor antagonist ranitidine (Zantac) in the treatment of moderate to severe heartburn.
POPULATION STUDIED: This study included 593 men and women older than 18 years who experienced heartburn on at least 50% of days during a 7- to 10-day screening period, including at least one moderate to severe episode. Patients were excluded if they had coexisting systemic disease affecting the esophagus, active gastrointestinal bleeding, Zollinger-Ellison syndrome, esophageal varices, significant disease of major organs, abnormal laboratory values, current alcohol or illegal drug use, use of a PPI in the previous 3 months, or use of anticholinergic or prokinetic drugs during the screening period.
STUDY DESIGN AND VALIDITY: This was a double-blind controlled multicenter trial in which patients were randomized to 1 of 4 treatment groups. The subjects received one of the following: (1) lansoprazole 30 mg daily for 20 weeks; (2) ranitidine 150 mg twice daily for 20 weeks; (3) step-down therapy consisting of lansoprazole 30 mg daily for 8 weeks followed by ranitidine 150 mg twice a day for 12 weeks; or (4) a step-up approach of ranitidine 150 mg twice daily for 8 weeks followed by lansoprazole 30 mg once daily for 12 weeks.
OUTCOMES MEASURED: Two outcome measurements were reported, including the median severity of heartburn using a scale of 0 (no heartburn), 1 (mild heartburn), 2 (moderate heartburn), or 3 (severe heartburn) and the percentage of 24-hour heartburn-free days. Outcomes measurements were based on self-report in daily diaries. Antacid use was also reported.
RESULTS: All patients, regardless of treatment, reported a marked clinically relevant decline in the intensity of their heartburn symptoms. The median heartburn severity decreased from 1.88 to 0.46 in the ranitidine group, from 1.75 to 0.25 in the lansoprazole group, from 1.75 to 0.35 in the step-up group, and from 1.70 to 0.44 in the step-down group (P <.05 for lansoprazole vs the other groups). The lansoprazole group also had a significantly higher percentage of 24-hour heartburn-free days (median=81.4%; P <.01) than the ranitidine (66.6%), step-up (66.9%), and step-down (73.6%) groups. In the step-up and step-down groups, heartburn was less severe, and percentages of 24-hour heartburn-free days were higher during lansoprazole treatment regardless of treatment sequence (P <.001). Over the 20 weeks of treatment, antacid use was required on a significantly higher percentage of days in the ranitidine (median=18.7%; P <.001), step-up (12.3%; P <.05), and step-down (18.5%; P <.001) groups than in the lansoprazole group (8.6%).
Most patients with moderate to severe heartburn will experience relief with either H2-receptor antagonist or PPI therapy. Results in this study were better when patients started and stayed on regular doses of lansoprazole. Heartburn severity was also less with lansoprazole but minimally different. This study did not address cost issues, although a recent study in primary care patients with heartburn symptoms found that omeprazole (Prilosec) provided greater resolution of symptoms than ranitidine, with no significant differences in total outpatient costs between the groups.1 Although step-down and step-up therapies are often recommended to decrease total costs, they were less effective than continuous-dose therapy in this study.