Efficacy

PROTONIX is the original brand-name pantoprazole, researched and clinically proven to help manage erosive GERD for nearly 20 years.1

PROTONIX Delayed-Release Tablets were used in the following clinical trials:

In Adult Patients
Erosive Esophagitis (EE) Associated With Gastroesophageal Reflux Disease (GERD)1
Significantly Greater Healing Rates Than Placebo
Table 1: Erosive Esophagitis Healing Rates (Per Protocol)

Week

4

8

PROTONIX

10 mg daily
(n=153)

20 mg daily
(n=158)

40 mg daily
(n=162)

45.6%

66.0%

58.4%†‡

83.5%†‡

75.0%‡§

92.6%‡§

Placebo (n=68)

14.3%

39.7%

  • (P<0.001) PROTONIX vs placebo
  • (P<0.05) vs 10 mg PROTONIX
  • §(P<0.05) vs 10 mg or 20 mg PROTONIX

See study design

  • In this study, all PROTONIX treatment groups had significantly greater healing rates than the placebo group. This was true regardless of H. pylori status for the 40-mg and 20-mg PROTONIX treatment groups. The 40-mg dose of PROTONIX resulted in healing rates significantly greater than those found with either the 20-mg or 10-mg dose.
  • A significantly greater proportion of patients taking PROTONIX 40 mg experienced complete relief of daytime and nighttime heartburn and the absence of regurgitation, starting from the first day of treatment, compared with placebo. Patients taking PROTONIX consumed significantly fewer antacid tablets per day than those taking placebo.

Significantly Superior Rates of Healing Compared to Nizatidine1
Table 2: Erosive Esophagitis Healing Rates (Per Protocol)

Week

4

8

PROTONIX

20 mg daily
(n=72)

40 mg daily
(n=70)

61.4%

79.2%

64.0%

82.9%

Nizatidine 150 mg twice daily (n=70)

22.2%

41.4%

  • (P<0.001) PROTONIX vs nizatidine

See study design

  • Once-daily treatment with PROTONIX 40 mg or 20 mg resulted in significantly superior rates of healing at both 4 and 8 weeks compared with twice-daily treatment with 150 mg of nizatidine. For the 40-mg treatment group, significantly greater healing rates compared to nizatidine were achieved regardless of the H. pylori status.
  • A significantly greater proportion of the patients in the PROTONIX treatment groups experienced complete relief of nighttime heartburn and regurgitation, starting on the first day and of daytime heartburn on the second day, compared with those taking nizatidine 150 mg twice daily. Patients taking PROTONIX consumed significantly fewer antacid tablets per day than those taking nizatidine.

PROTONIX 40 mg and 20 mg Were Significantly Superior to Ranitidine at Every Timepoint and 40 mg Was Superior to All Other Treatments Studied1
Table 3: Long-term Maintenance of Healing of Erosive Gastroesophageal Reflux Disease (GERD): Percentage of Patients Who Remained Healed

Study 1
PROTONIX
Ranitidine 150 mg
twice daily (n=75)
20 mg daily
(n=75)
40 mg daily
(n=74)
Month 1 91 99 68
Month 3 82 93†‡ 54
Month 6 76 90†‡ 44
Month 12 70 86†‡ 35

Study 2
PROTONIX
Ranitidine 150 mg
twice daily (n=84)
20 mg daily
(n=74)
40 mg daily
(n=88)
Month 1 89 92†‡ 62
Month 3 78 91†‡ 47
Month 6 72 88†‡ 39
Month 12 72 83 37

Note: PROTONIX 10 mg was superior (P<0.05) to ranitidine in Study 2, but not Study 1.

  • (P<0.05) vs ranitidine
  • (P<0.05) vs PROTONIX 20 mg

See study design


PROTONIX 40 mg Was Superior to Ranitidine in Reducing the Number of Daytime and Nighttime Heartburn Episodes1
Table 4: Number of Episodes of Heartburn (mean ± SD)

 

Month 1

Month 12

 

Daytime

Nighttime

Daytime

Nighttime

PROTONIX
40 mg daily

5.1 ± 1.6

3.9 ± 1.1

2.9 ± 1.5

2.5 ± 1.2

Ranitidine 150 mg twice daily

18.3 ± 1.6

11.9 ± 1.1

17.5 ± 1.5

13.8 ± 1.3

  • (P<0.001) vs ranitidine, combined data from the 2 US studies
  • PROTONIX 40 mg was superior to ranitidine in reducing the number of daytime and nighttime heartburn episodes from the 1st through the 12th month of treatment

See study design

PROTONIX Successfully Controlled Gastric Acid Secretion in Patients With Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome1

In a multicenter, open-label trial of 35 patients with pathological hypersecretory conditions, such as Zollinger-Ellison syndrome, with or without multiple endocrine neoplasia-type I, PROTONIX successfully controlled gastric acid secretion. Doses ranging from 80 mg daily to 240 mg daily maintained gastric acid output below 10 mEq/h in patients without prior acid-reducing surgery and below 5 mEq/h in patients with prior acid-reducing surgery.

Doses were initially titrated to the individual patient needs, and adjusted in some patients based on the clinical response with time. PROTONIX was well tolerated at these dose levels for prolonged periods (greater than 2 years in some patients).

Pediatric Patients Ages 5 Years Through 16 Years1

The efficacy of PROTONIX in the treatment of EE associated with GERD in pediatric patients ages 5 years through 16 years is extrapolated from adequate and well-conducted trials in adults, as the pathophysiology is thought to be the same. Four pediatric patients with endoscopically diagnosed EE were studied in multicenter, randomized, double-blind, parallel-treatment trials. Children with endoscopically diagnosed EE (defined as an endoscopic Hetzel-Dent score ≥2) were treated once daily for 8 weeks with one of two dose levels of PROTONIX (20 mg or 40 mg). All 4 patients with EE were healed (Hetzel-Dent score of 0 or 1) at 8 weeks.


Table 1: Erosive Esophagitis Healing Rates (Per Protocol)

A US multicenter, double-blind, placebo-controlled study of PROTONIX 10-mg, 20-mg, or 40-mg once daily was conducted in 603 patients with reflux symptoms and endoscopically diagnosed EE of grade 2 or above (Hetzel-Dent scale). In this study, approximately 25% of enrolled patients had severe EE of grade 3, and 10% had grade 4.


Table 2: Erosive Esophagitis Healing Rates (Per Protocol)

PROTONIX 40-mg and 20-mg once daily were also compared with nizatidine 150-mg twice daily in a US multicenter, double-blind study of 243 patients with reflux symptoms and endoscopically diagnosed EE of grade 2 or above.


Tables 3 & 4: Long-term Maintenance of Healing of Erosive Gastroesophageal Reflux Disease (GERD Maintenance): Percentage of Patients Who Remained Healed

Two independent, multicenter, randomized, double-blind, comparator-controlled trials of identical design were conducted in adult GERD patients with endoscopically confirmed healed erosive esophagitis to demonstrate efficacy of PROTONIX in long-term maintenance of healing. The two US studies enrolled 386 and 404 patients, respectively, to receive either 10-mg, 20-mg, or 40-mg of PROTONIX Delayed-Release Tablets once daily or 150-mg of ranitidine twice daily.