sodium-bicarbonate and Peptic-Ulcer

Santarus Inc., is developing an immediate-release formulation of omeprazole in combination with an antacid (sodium bicarbonate) as a powder for suspension, known as Acitrel [SAN 05], and also as Rapinex powder for oral suspension. Acitrel is based on technology licensed from the University of Missouri. Santarus have also licensed technology from Tulane and North Carolina Universities relating to potential treatments for GI diseases. Santarus have licensed exclusive, worldwide rights to patent applications covering specific combination-formulations of proton pump inhibitors and antacids for treating various upper GI diseases and disorders. Santarus plans to license development, distribution and marketing rights of Rapinex Powder for oral suspension 20mg outside the US, to one or more well established pharmaceutical companies. The US FDA has requested that Santarus pursue a name other than Rapinex for the product. Santarus is currently discussing potential alternative names for the product with the FDA. Santarus announced positive results, in August 2003, from a phase III trial comparing oral Acitrel (Rapinex 40mg) to intravenous cimetidine in preventing upper GI bleeding in 359 critically ill adult patients. Santarus has also completed an open-label clinical trial in 243 patients, including 97 patients with gastric ulcers, evaluating the safety of Rapinex 40mg for an 8-week period. In connection with the NDA for Rapinex 40mg, Santarus provided notice to the NDA holder for Prilosec delayed-release capsules and related patent owners that Rapinex 40mg does not infringe currently listed patents for Prilosec or that those patents are invalid.

Topics: Administration, Oral; Anti-Ulcer Agents; Clinical Trials, Phase III as Topic; Drug Combinations; Humans; Omeprazole; Peptic Ulcer; Sodium Bicarbonate; Suspensions

Santarus Inc. is developing an immediate-release formulation of omeprazole in combination with an antacid (sodium bicarbonate) as a powder for suspension, known as Acitreltrade mark [SAN 05] and also as Rapinex powder for oral suspension. This omeprazole powder suspension will be used to treat gastrointestinal haemorrhage, gastro-oesophageal reflux disease, heartburn and peptic ulcers. Acitreltrade mark is based on technology licensed from the University of Missouri. Santarus have also licensed technology from Tulane and North Carolina Universities relating to potential treatments for gastrointestinal (GI) diseases. Santarus has licensed exclusive, worldwide rights to patent applications covering specific combination formulations of proton pump inhibitors (PPIs) and antacids for treating various upper GI diseases and disorders. Santarus plans to license the development, distribution and marketing rights of omeprazole powder for oral suspension 20 mg outside the US, to one or more well established pharmaceutical companies. The US FDA has requested that Santarus pursue a name other than Rapinex for the product. Santarus is currently discussing potential alternative names for the product with the FDA. Santarus announced positive results in August 2003 from a phase III trial comparing oral Acitrel (Rapinex 40 mg) with intravenous cimetidine in preventing upper GI bleeding in 359 critically ill adult patients. Santarus has also completed an open-label clinical trial in 243 patients, including 97 patients with gastric ulcers, evaluating the safety of this omeprazole 40 mg powder suspension for an 8-week period. In connection with the NDA for omeprazole powder suspension 40 mg, Santarus provided notice to the NDA holder for Prilosec delayed-release capsules and related patent owners that omeprazole powder suspension 40 mg does not infringe currently listed patents for Prilosec or that those patents are invalid.

Topics: Antacids; Anti-Ulcer Agents; Chemistry, Pharmaceutical; Clinical Trials, Phase III as Topic; Drug Combinations; Humans; Omeprazole; Peptic Ulcer; Powders; Sodium Bicarbonate; Suspensions; United States; United States Food and Drug Administration

Antacid ingestion may lead to side-effects related to their chemical composition. Aluminum hydroxide may cause the phosphate depletion syndrome even during short-term administration of high doses in patients at high risk, such as alcoholics. Long-term intake may lead to bone demineralization and to osteomalacia. Fluoride complexing in the gut and prevention of fluoride absorption may be an additional factor. The clinical relevance of aluminum absorption in patients with normal renal function is not clear. In contrast, in patients with renal failure, aluminum hydroxide ingestion may contribute to an increasing hyperaluminemia. Hyperaluminemia and tissue deposition of aluminum in these patients may contribute to the dialysis-associated encephalopathy. Magnesium hydroxide causes an alkalinization of the urine due to magnesium absorption and urinary excretion. Thus, in renal insufficiency, a life-threatening hypermagnesemia may develop if magnesium-aluminum-containing antacids are prescribed. The milk-alkali syndrome, rarely observed nowadays, may be caused by calcium carbonate- and sodium bicarbonate-containing antacids. Hypercalciuria and alkaluria predispose to nephrolithiasis. The possibility that these disturbances in mineral metabolism will develop in patients with normal renal function is unlikely unless there is an abuse of these "over the counter" antacids.

Topics: Aluminum Hydroxide; Antacids; Bicarbonates; Calcium Carbonate; Drug Combinations; Humans; Magnesium; Magnesium Hydroxide; Magnesium Silicates; Minerals; Peptic Ulcer; Phosphorus; Silicic Acid; Sodium Bicarbonate

Both proton pump inhibitor drug treatment and Helicobacter pylori infection cause hypergastrinaemia in man.. To determine whether eradicating H pylori is a means of reducing hypergastrinaemia during subsequent proton pump inhibitor treatment.. Patients with H pylori were randomised to treatment with either anti-H pylori or symptomatic treatment. One month later, all received four weeks treatment with omeprazole 40 mg/day for one month followed by 20 mg/day for six months. Serum gastrin concentrations were measured before and following each treatment.. In the patients randomised to anti-H pylori treatment, eradication of the infection lowered median fasting gastrin by 48% and meal stimulated gastrin by 46%. When gastrin concentrations one month following anti-H pylori/symptomatic treatment were used as baseline, omeprazole treatment produced a similar percentage increase in serum gastrin in the H pylori infected and H pylori eradicated patients. Consequently, in the patients in which H pylori was not eradicated, median fasting gastrin concentration was 38 ng/l (range 26-86) at initial presentation and increased to 64 ng/l (range 29-271) after seven months omeprazole, representing a median increase of 68% (p < 0.005). In contrast, in the patients randomised to H pylori eradication, median fasting gastrin at initial presentation was 54 ng/l (range 17-226) and was unchanged after seven months omeprazole at 38 ng/l (range 17-95).. Eradicating H pylori is a means of reducing the rise in gastrin during subsequent long term omeprazole treatment. In view of the potential deleterious effects of hypergastrinaemia it may be appropriate to render patients H pylori negative prior to commencing long-term proton pump inhibitor treatment.

Topics: Adult; Alginates; Aluminum Hydroxide; Amoxicillin; Antacids; Anti-Ulcer Agents; Drug Combinations; Drug Therapy, Combination; Esophagitis; Female; Gastrins; Gastroscopy; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Omeprazole; Organometallic Compounds; Peptic Ulcer; Silicic Acid; Sodium Bicarbonate

Simpler, effective therapies to treat Helicobacter pylori infection are greatly needed. Omeprazole co-therapy apparently enhances effectiveness of some antimicrobials. Our objective in this study was to determine whether the apparent additional benefit provided by omeprazole to amoxicillin therapy could be equaled by a high dose of ranitidine plus sodium bicarbonate.. In a prospective randomized trial, we tested 1 g amoxicillin b.i.d. with either omeprazole 20 mg b.i.d., or high dose ranitidine (900 and 1800 mg) plus sodium bicarbonate tablets 650 t.i.d. (with meals) for 14 day.. Fifty-two patients with documented H. pylori infection and peptic ulcer completed therapy. The cure rate with omeprazole and amoxicillin was poor (46%), with the 95% confidence interval (CI) = 25-67%. Ranitidine plus sodium bicarbonate was also poor (39% cure) with the 95% CI = 21.5-59% (p > 0.57). Average compliance was more than 92% for all three groups. Side effects were experienced in only two patients (stomatitis and mild diarrhea).. Neither the omeprazole nor ranitidine plus bicarbonate plus amoxicillin therapies used here can be recommended for treatment of H. pylori infection.

Topics: Amoxicillin; Biopsy; Drug Administration Schedule; Drug Therapy, Combination; Female; Gastric Mucosa; Helicobacter Infections; Helicobacter pylori; Humans; Male; Middle Aged; Omeprazole; Peptic Ulcer; Prospective Studies; Ranitidine; Reproducibility of Results; Sodium Bicarbonate

Four antacid preparations have been studied in a stratified, randomized, double-blind trial to evaluate criteria which determine patients' acceptance of this type of therapy. There was a considerable range of judgements about palatability, but preference was determined not only by factors such as the smell, taste, texture and after-taste of the preparation, but also by the order in which the antacids were tested and by the age and sex of the patient. The preparations also differed considerably in acid-neutralizing capacity and ability to bind bile salts, as well as cost. We conclude that individuals requiring antacid therapy should be allowed to chose from among a range of preparations, in order to maximize compliance.

Topics: Adult; Aged; Alginates; Aluminum Compounds; Aluminum Hydroxide; Aluminum Silicates; Antacids; Bicarbonates; Clinical Trials as Topic; Dimethylpolysiloxanes; Double-Blind Method; Drug Combinations; Esophagitis; Female; Humans; Magnesium; Magnesium Compounds; Magnesium Hydroxide; Magnesium Oxide; Male; Middle Aged; Patient Acceptance of Health Care; Peptic Ulcer; Random Allocation; Silicates; Silicic Acid; Silicon Dioxide; Silicones; Simethicone; Sodium Bicarbonate

Topics: Aluminum Hydroxide; Bismuth; Clinical Trials as Topic; Drug Combinations; Duodenal Ulcer; Glycyrrhiza; Humans; Magnesium Hydroxide; Peptic Ulcer; Plant Extracts; Plants, Medicinal; Sodium Bicarbonate; Stomach Ulcer

Topics: Alginates; Aluminum Hydroxide; Antacids; Drug Combinations; Education, Medical, Continuing; Family Practice; Gastroenterology; Gastroesophageal Reflux; Germany; Humans; Peptic Ulcer; Silicic Acid; Sodium Bicarbonate

In a consecutive prospective series of 208 Swedish primary peptic ulcer patients, 146 gastric, 55 duodenal and 7 in both sites, gastroduodenitis was found in 97.6% of the cases. The mucosal inflammation was associated with CP in 87% and 91% of the gastric and duodenal ulcer cases respectively. No significant correlation was found between CP colonisation and the type or severity of mucosal inflammation. Gastric metaplasia was present in only 8% of 48 bulbar ulcer cases. Ulcer healing and eradication of CP was achieved in 52% of patients treated with bismuth subnitrate in combination with erythromycin or according to the triple approach.

Topics: Adult; Aged; Aged, 80 and over; Aluminum Hydroxide; Anti-Ulcer Agents; Bismuth; Campylobacter Infections; Drug Combinations; Female; Glycyrrhiza; Histamine H2 Antagonists; Humans; Magnesium Hydroxide; Male; Middle Aged; Peptic Ulcer; Pilot Projects; Plant Extracts; Prospective Studies; Sodium Bicarbonate; Sweden

Topics: Aluminum Hydroxide; Bismuth; Drug Combinations; Glycyrrhiza; Humans; Magnesium Hydroxide; Peptic Ulcer; Plant Extracts; Sodium Bicarbonate; Ulcer

Topics: Alkalosis; Bicarbonates; Kidney; Peptic Ulcer; Pharmaceutical Preparations; Sodium Bicarbonate