A comparison of simplified lansoprazole suspension administered nasogastrically and pantoprazole administered intravenously: effects on 24-h intragastric pH.

AIM: To compare the 24-h intragastric pH effects of simplified lansoprazole suspension, 30 mg, administered nasogastrically, with pantoprazole, 40 mg, administered intravenously. METHODS: Thirty-six healthy adults were enrolled and given simplified lansoprazole suspension, 30 mg (nasogastrically), or pantoprazole, 40 mg (intravenously), once daily for five consecutive days in a cross-over fashion. Intragastric pH was monitored at baseline and on Days 1 and 5 of each treatment period. The pharmacokinetic parameters of lansoprazole and pantoprazole were also determined on Days 1 and 5. RESULTS: No statistically significant changes in pharmacokinetic parameters occurred between Days 1 and 5 with either regimen, except for pantoprazole Cmax. On Days 1 and 5, significantly higher mean 24-h intragastric pH values were observed with 30 mg simplified lansoprazole suspension compared with 40 mg intravenous pantoprazole (Day 1, 3.13 vs. 2.67; Day 5, 3.95 vs. 3.61, respectively; P < 0.05). Additionally, 30 mg simplified lansoprazole suspension produced significantly (P < 0.05) higher percentages of time intragastric pH was above 3, 4, 5 or 6 as compared with 40 mg intravenous pantoprazole throughout Days 1 and 5. CONCLUSIONS: A 30 mg dose of simplified lansoprazole suspension administered nasogastrically was consistently more effective at controlling intragastric pH than pantoprazole, 40 mg, administered intravenously.

Comparative pharmacokinetics and pharmacodynamics of lansoprazole oral capsules and suspension in healthy subjects.

The pharmacokinetics and pharmacodynamics of lansoprazole suspension and lansoprazole capsules were studied. Thirty-six healthy males and females were randomized in a single-dose, open-label, two-period crossover study. Lansoprazole 30 mg was administered via a nasogastric tube as simplified lansoprazole suspension (in 8.4% sodium bicarbonate) or orally as the intact capsule after a minimum 12-hour fast and 5 hours before lunch. Ambulatory 24-hour intragastric pH was monitored at baseline and on day 1 of each treatment period to assess lansoprazole's pharmacodynamics. Blood samples were collected before drug administration and at predetermined intervals up to 24 hours after each dose to assess lansoprazole's pharmacokinetics. Both formulations effectively raised the mean 24-hour intragastric pH (mean 24-hour pH of 3.75 with suspension and 3.52 with intact capsule) and maintained it above threshold values of 3 and 4 for more than 40% of the 24-hour postdose period. The suspension was associated with a significantly shorter mean time to the maximum observed concentration (tmax) compared with the intact capsule. The mean maximum observed plasma concentration (Cmax) of the suspension was significantly higher and the mean area under the concentration-time curve from time zero to infinity (AUC infinity) was significantly lower than those of the intact capsule (879 versus 810 ng/mL and 1825 versus 2229 ng.hr/mL). The 90% confidence intervals obtained by two one-sided tests for both Cmax and AUC infinity were contained within the 0.80 to 1.25 range, confirming the bioequivalence of the two regimens. Simplified lansoprazole suspension effectively controls intragastric pH, is bioequivalent to the intact capsule, and represents an effective therapeutic option for patients who have difficulty swallowing or are unable to swallow lansoprazole capsules.

Superiority of lansoprazole vs ranitidine in healing nonsteroidal anti-inflammatory drug-associated gastric ulcers: results of a double-blind, randomized, multicenter study. NSAID-Associated Gastric Ulcer Study Group.

BACKGROUND: The usefulness of nonsteroidal anti-inflammatory drugs (NSAIDs) is limited by adverse gastrointestinal tract events. OBJECTIVE: To identify the optimal antisecretory therapy for healing of gastric ulcer in patients using NSAIDs and the impact of concurrent Helicobacter pylori infection on ulcer healing. DESIGN: Prospective, double-blind, multicenter, parallel-group study. SETTING: Gastroenterology practices in ambulatory and referral center settings. PATIENTS: Three hundred fifty-three patients with an active, nonmalignant gastric ulcer at least 5 mm in diameter confirmed by endoscopy and biopsy and who continued to receive stable doses of NSAIDs. INTERVENTION: Patients were randomized to receive ranitidine hydrochloride, 150 mg twice daily, or lansoprazole, 15 mg or 30 mg once daily, for 8 weeks. MEASUREMENTS: Healing was assessed by endoscopy at 4 and 8 weeks in an intent-to-treat population. Helicobacter pylori status was assessed by histological examination. RESULTS: After 8 weeks of treatment, healing was observed in 61 (53%) of 115, 81 (69%) of 118, and 85 (73%) of 117 patients receiving ranitidine lansoprazole, 15 mg, and lansoprazole, 30 mg, respectively (P<.05 for ranitidine vs both lansoprazole doses; 95% confidence interval, 3.2-28.0 for ranitidine vs lansoprazole, 15 mg, and 7.4-31.8 for ranitidine vs lansoprazole, 30 mg). The gastric ulcer healing rates were similar between H pylori-infected and -noninfected patients, with a statistically significant increase with the use of lansoprazole vs ranitidine. CONCLUSIONS: In patients who require continuous treatment with NSAIDs, lansoprazole is superior to ranitidine for healing of NSAID-associated gastric ulcers. Healing is not delayed by the presence of H pylori infection.