When was protonix introduced

This cannot be considered a true comparison of effectiveness. In the study comparing esomeprazole with omeprazole, esomeprazole did better. Well, that's no surprise—esomeprazole is the active isomer of omeprazole, and the study authors used a dosage four times that of omeprazole. Breaking this down, they used 40 mg of active drug esomeprazole versus 10 mg of active drug omeprazole the dosage is actually 20 mg, but since omeprazole is a racemic mixture, that is only 10 mg of active drug , and guess what?

The drug not going off patent did better! And who sponsored the study? Astra-Zeneca, the manufacturer. Bob : I knew you would jump on the inappropriate comparison of esomeprazole with omeprazole. Another problem with this comparison is that a true clinical end point is not being measured. But I have the same complaints as I did with the GERD studies regarding the use of unequal dosages and using endoscopic cure rates as the end point.

And do I even have to do the H. Sixteen studies with no differences noted among any PPIs. Bob : Meta-analysis can be tricky. A series of principles needs to be followed for the results to be valid. In this study, the authors appropriately identified a clear study question, performed a fairly comprehensive review of available databases although they did not include any abstracts from presentations at symposia or obtain unpublished clinical trials from the FDA or the drug companies , and used clear end points to determine cure or failure—so far, so good.

The most obvious faux pas the authors made was not grading the quality of the studies they incorporated in this meta-analysis.

They did, however, redeem them-selves slightly by incorporating only randomized prospective trials. Mark : This faux pas is a problem. How do we know that the studies they included were any good? We don't. I like their conclusions and I am sure they are correct, but they need to grade the papers included in their analysis; other-wise, we have no assurance that they were any good. Bob : I feel comfortable saying there are no differences in efficacy among any PPIs for the above conditions. It also has been suggested that PPIs are associated with increased rates of community-acquired pneumonia 1 and Clostridium difficile colitis.

Andrea : There are no differences among PPIs except cost, so go with the cheapest. However, the cheapest is not what ends up in our sample cabinet.

Mark : I agree—save your patient some cash and go for the less expensive drug. Main Points. Make sure that any article that evaluates treatments uses equipotent dosages of the drugs being compared. As a corollary, a placebo-controlled trial should not typically change your practice; any drug comparison should be against a known effective therapy, if one exists.

First is publication bias—only positive trials are usually published. Pharmaceutical companies are permitted to provide financial support for CME programs, but they are not permitted to use CME programs as promotional vehicles for off-label indications. These grants invariably included promises that Wyeth would not attempt to influence the content of the program in any way.

Attorney Carmen M. This case was litigated by Assistant U. The claims settled by this agreement are allegations only, allegations which Pfizer denies; there has been no determination of liability.

Pfizer acquired Wyeth in October Alterations in renal function have no effect on esomeprazole's pharmacokinetics, while patients with liver cirrhosis will have a small delay in the time-to-peak plasma concentration 2 vs 1. Mild-to-moderate hepatic dysfunction has no effect on the pharmacokinetics of esomeprazole.

This is similar to the previously available PPIs. The most common adverse events reported in the clinical trials were diarrhea, abdominal pain, flatulence, gastritis, nausea, and headache. Drug interactions reported with omeprazole have included prolonged elimination of diazepam, warfarin, and phenytoin.

Isolated reports of changes in elimination have been reported with cyclosporine, disulfiram, and other benzodiazepines. See Table 3. No drug-drug interactions were found between esomeprazole and phenytoin, R-warfarin, quinidine, amoxicillin, oral contraceptives, and clarithromycin. Esomeprazole may interfere with the elimination of other drugs metabolized by CYP2C Changes in gastric pH can affect the bioavailability of some medications.

Examples of medications where the bioavailability of the medication may be decreased with profound and long-lasting inhibition of gastric acid secretion are ketoconazole and iron salts. See table 4. The recommended dose of esomeprazole is 20 mg or 40 mg once daily for 4 to 8 weeks for the treatment of erosive esophagitis, 20 mg once daily for maintenance of healed erosive esophagitis studies lasted up to 6 months , 20 mg once daily for symptomatic GERD for 4 weeks, and as part of a day triple drug regimen for eradication of H.