RELIEF OF HEARTBURN AND ASSOCIATED SYMPTOMS

In nonerosive GERD patients...
ACIPHEX® Effectively Reduced Symptom Severity
Study design: Randomized, double-blind, placebo-controlled study in nonerosive adult GERD patients with moderately severe heartburn symptoms (N=203). Efficacy was assessed in patients who received ACIPHEX® 20 mg once a day or placebo for 4 weeks (Total ITT: ACIPHEX®, n=67; placebo, n=68).1,2 This study also assessed the efficacy of ACIPHEX®
10 mg, a nonapproved dosing strength.

A combined analysis of this study and another clinical study with identical design showed ACIPHEX® 20 mg significantly improved heartburn and other GERD-associated symptoms (regurgitation and belching) by week 4 compared with placebo (all P values <0.005). Results varied across the 2 studies.
Primary endpoint: Median time to first 24-hour heartburn-free period was significantly shorter with ACIPHEX® vs placebo1,2
  • 4.5 days with ACIPHEX® 20 mg (n=67) vs 21.5 days with placebo (n=68; P≤0.004)


 Click for symptom data:
HEARTBURN REGURGITATION BELCHING
Key secondary endpoint—Heartburn

ACIPHEX® significantly reduced daytime and nighttime heartburn
severity scores from baseline at week 41

Key secondary endpoint-Heartburn chart
Based on these results, mean symptom severity scores were reduced
from baseline:
Daytime Heartburn Daytime Heartburn Nighttime Heartburn Nighttime Heartburn
*Symptom severity scores were recorded daily (0=none; 1=mild; 2=moderate; 3=severe; 4=very severe).
†Percentages not based on statistical analysis. Statistical comparisons were not conducted.
Key secondary endpoint—Regurgitation

ACIPHEX® significantly reduced regurgitation severity scores
from baseline at week 41

Key secondary endpoint-Regurgitation chart
Based on these results, mean symptom severity scores were reduced
from baseline:
Mean symptom severity scores for Regurgitation  
*Symptom severity scores were recorded daily (0=none; 1=mild; 2=moderate; 3=severe; 4=very severe).
†Percentages not based on statistical analysis. Statistical comparisons were not conducted.
Key secondary endpoint—Belching

ACIPHEX® significantly reduced belching severity scores
from baseline at week 41

Key secondary endpoint-Belching chart
Based on these results, mean symptom severity scores were reduced
from baseline:
Mean symptom severity scores for belching  
*Symptom severity scores were recorded daily (0=none; 1=mild; 2=moderate; 3=severe; 4=very severe).
†Percentages not based on statistical analysis. Statistical comparisons were not conducted.


Adverse Events in the Clinical Trial
Adverse events occurring in ≥2% of patients and with a frequency greater than placebo
  ACIPHEX® 20 mg (n=68) Placebo (n=70)
 Headache 4.4% 4.3%
 Rash 2.9% 0%
 

 
INDICATIONS
  • In adults (≥18 years of age), ACIPHEX® 20 mg is indicated for: treatment of daytime and nighttime heartburn and other symptoms associated with GERD; short-term, up to 4 weeks, treatment in the healing and symptomatic relief of duodenal ulcers; short-term, 4 to 8 weeks, treatment in the healing and symptomatic relief of erosive GERD; and maintenance of healing and reduction in relapse rates of heartburn symptoms in erosive GERD (controlled maintenance studies do not extend beyond 12 months)
  • In adolescent patients 12 years of age and above, ACIPHEX® 20 mg is indicated for: short-term, up to 8 weeks, treatment of daytime and nighttime heartburn and other symptoms associated with GERD
IMPORTANT SAFETY INFORMATION
Contraindications:
  • ACIPHEX® is contraindicated in patients with known hypersensitivity to rabeprazole, substituted benzimidazoles, or to any component of the formulation
Warnings and Precautions:
  • Symptomatic response to therapy does not preclude the presence of gastric malignancy
  • As with all PPIs, patients treated concomitantly with warfarin may need to be monitored for increases in INR and prothrombin time. Increases in INR and prothrombin time may lead to abnormal bleeding and even death
  • Long-term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine
  • Hypomagnesemia has been reported rarely with prolonged treatment with PPIs. Serious adverse events include tetany, arrhythmias, and seizures. Consider monitoring magnesium levels in patients on prolonged PPI therapy or concomitant medications such as digoxin or medications that may cause hypomagnesemia (eg, diuretics)
Adverse Events:
  • In adolescents, the related reported adverse reactions that occurred in ≥2% of patients were headache and nausea. The adverse reactions reported without regard to relationship to ACIPHEX® that occurred in ≥2% of patients were headache, diarrhea, nausea, vomiting, and abdominal pain
  • In adults, clinical trials revealed the following adverse reactions appearing in ≥2% of ACIPHEX® patients and with a frequency greater than placebo: pain, pharyngitis, flatulence, infection, and constipation
Drug Interactions:
  • ACIPHEX® inhibits gastric acid secretion and may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (eg, ketoconazole, iron salts and digoxin)
  • ACIPHEX® may reduce the plasma levels of atazanavir
  • Rabeprazole has been shown to inhibit cyclosporine metabolism in vitro

For more information about ACIPHEX®, see full Prescribing Information.

Click here to view full Prescribing Information for ACIPHEX®.

References: 1. Data on file, Eisai Inc. 2. Miner P Jr, Orr W, Filippone J, Jokubaitis L, Sloan S. Rabeprazole in nonerosive gastroesophageal reflux disease: a randomized placebo-controlled trial. Am J Gastroenterol. 2002;97(6):1332-1339.

 
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