Naproxen and omeprazole combination effective in preventing bladder cancer

The anti-inflammatory class of drugs NSAIDs have shown great promise in preventing cancers including colon, esophagus and skin. However, they can increase the risks of heart attacks, ulcers and rare but potentially life-threatening bleeds.

A new study suggests there may be ways to reduce these dangerous side effects. Collaborators from the University of Michigan, the National Cancer Institute and the University of Alabama looked at naproxen, which is known to have a lower cardiovascular risk than other NSAIDs. Naproxen, like most NSAIDs and aspirin, does increase the risk for gastric ulcers or bleeding. Here, the researchers used the proton pump inhibitor omeprazole, a commonly used acid inhibitor, in combination with naproxen and tested its effects on cancer prevention in a rat model of bladder cancer.

They found that naproxen reduced the incidence of bladder cancer by 75 percent in rats. Omeprazole by itself did not affect the development of cancer but it also did not interfere with the effect of naproxen at preventing tumors. The rats who received naproxen alone or naproxen with omeprazole developed cancer at similarly low rates, while all rats receiving omeprazole alone or no treatment developed bladder cancer.

Clinical data in humans has previously shown combining omeprazole plus naproxen reduced gastric toxicity roughly 70 percent.

The authors also found that intermittent dosing with naproxen (three weeks on the drugs, followed by three weeks off) was highly effective and likely to reduce gastric toxicity. However, it does not have the clear clinical data supporting reduced gastric toxicity associated with naproxen and omeprazole.

"Our study shows that naproxen works just as well with a proton pump inhibitor as without. This provides proof of principle that this could be a valuable cancer prevention strategy and one hopes it can advance quickly to a clinical trial for those at high risk of colon, esophageal, squamous cell skin cancer or potentially other cancers," says lead study author Ronald A. Lubet, Ph.D., a scientist with the Chemopreventive Agent Development Research Group at the National Cancer Institute.

Naproxen and omeprazole combination effective in preventing bladder cancer

FDA Approves Konvomep (omeprazole and sodium bicarbonate for oral suspension) for Gastric Ulcer and Reduction of Risk of Gastrointestinal Bleeding in Critically Ill Patients

 

 

 In continuation of my update on omeprazole

Azurity Pharmaceuticals, Inc., a pharmaceutical company focused on developing innovative dose-forms and formulations of products to serve the needs of overlooked patients, announced the U.S. Food and Drug Administration (FDA)   approval of  Konvomep (omeprazole and sodium bicarbonate for oral suspension). Konvomep is approved for the treatment of active benign gastric ulcer and reduction of risk of upper gastrointestinal bleeding in critically ill patients.

“We are very pleased that patients will soon have access to this FDA-approved oral liquid formulation option of a commonly prescribed proton pump inhibitor¹,” said Richard Blackburn, CEO of Azurity Pharmaceuticals. “Patients are our priority, and our purpose is to bring them new formulations that help them benefit from established medicines. Konvomep™ may give patients, particularly patients with difficulty swallowing pills or capsules, an option for treatment tailored to their needs.”

“Patients who struggle with taking solid oral dosage forms may be overlooked and have historically had limited FDA-approved treatment options available as liquid formulations,” said Olga Hilas, PharmD, MPH, BCPS, BCGP, Professor, Clinical Health Professions, St. John’s University College of Pharmacy & Health Sciences, Queens, New York.

 

Ref : https://en.wikipedia.org/wiki/Omeprazole

 

FDA Approves Talicia (omeprazole magnesium, amoxicillin and rifabutin) for the Treatment of H. pylori Infection in Adults

In continuation of my update on omeprazole and amoxicillin   

RedHill Biopharma Ltd. (Nasdaq: RDHL) (Tel-Aviv Stock Exchange: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company primarily focused on the development and commercialization of proprietary drugs for the treatment of gastrointestinal diseases,  announced that the U.S. Food and Drug Administration (FDA) has approved Talicia (omeprazole magnesium, amoxicillin and rifabutin) delayed-release capsules 10 mg1/250 mg/12.5 mg for the treatment of Helicobacter pylori (H. pylori) infection in adults. RedHill expects to launch Talicia1 in the U.S. in the first quarter of 2020 with its dedicated sales force.

Talicia is the only rifabutin-based therapy approved for the treatment of H. pylori infection and is designed to address the high resistance of H. pylori bacteria to current clarithromycin-based standard-of-care therapies. It is estimated that H. pylori resistance to clarithromycin more than doubled between 2009-2013.

Professor David Y. Graham, MD, MACG, Professor of Medicine, Molecular Virology and Microbiology at Baylor College of Medicine, Houston and Lead Investigator of the Talicia Phase 3 studies, said: “Talicia offers patients a much-needed new treatment option for H. pylori with an excellent safety and efficacy profile that is not compromised by clarithromycin or metronidazole resistance. The clinical studies for Talicia demonstrated high efficacy in eradication of H. pylori. Studies with Talicia found zero resistance to rifabutin and showed 17% resistance to clarithromycin, a current standard-of-care macrolide antibiotic, consistent with current data showing that clarithromycin-containing therapies fail in approximately 25-40% of cases.”

Colin W. Howden, MD, AGAF, FACG, Hyman Professor of Medicine & Chief of the Division of Gastroenterology, University of Tennessee Health Science Center, added: “H. pylori is a major cause of peptic ulcer and gastritis. It is also carcinogenic and is the leading cause of gastric cancer. Treatment of H. pylori infection has become increasingly difficult due to growing bacterial resistance and the lack of advances in treatment options over the past decade. Talicia offers a new effective treatment option to overcome bacterial resistance and provide optimal efficacy and I believe it could become a recommended first-line standard-of-care treatment for H. pylori infection.”

“The FDA’s approval of Talicia demonstrates our unwavering dedication to patients suffering from gastrointestinal diseases. We thank the patients, researchers and clinical staff who participated in the studies of Talicia and the RedHill team and vendors for this important milestone achieved by their commitment and hard work,” said Dror Ben-Asher, Chief Executive Officer of RedHill Biopharma. “We are working to expand our sales force to approximately 140 representatives who will promote Talicia, Aemcolo and other gastrointestinal-focused products in our basket.”

Pernix Therapeutics introduces Omeclamox-Pak® for the treatment of H. pylori infection and duodenal ulcer disease

Pernix Therapeutics introduces Omeclamox-Pak® for the treatment of H. pylori infection and duodenal ulcer disease: Pernix Therapeutics Holdings, Inc., a specialty pharmaceutical company,  announced the introduction of Omeclamox-Pak®, a ten-day therapy of omeprazole (below 1st) delayed-release capsules (20 mg), clarithromycin (below 2nd) tablets (500 mg) and amoxicillin (below 3rd) capsules (500 mg) for the treatment of Helicobacter pylori (H. pylori) infection and duodenal ulcer disease (active or one-year history) to eradicate H. pylori in adult patients...

Antacid medicines improve overall survival in patients with head and neck cancer

Patients with head and neck cancer who used antacid medicines to control acid reflux had better overall survival, according to a new study from the University of Michigan Comprehensive Cancer Center.

-Prevacid  Nexium

 Prilosec 

Reflux can be a common side effect of chemotherapy or radiation treatment for head and neck cancer. Doctors at the University of Michigan frequently prescribe two types of antacids - proton pump inhibitors or histamine 2 blockers - to help treat this side effect.

The researchers looked at 596 patients who were treated for head and neck cancer. More than two-thirds of the patients took one or both types of antacid medication after their diagnosis.

Patients who were taking antacids had significantly better overall survival than those who did not take them. Proton pump inhibitors, which include drugs such as Prilosec, Nexium and Prevacid, had the biggest effect: a 45 percent decreased risk of death, compared to patients who did not take antacids. Patients taking histamine 2 blockers, such as Tagamet, Zantac or Pepcid, saw a 33 percent decreased risk of death.

"We had suspicions that these medications somehow had a favorable impact on patient outcomes. This led us to review our large cohort of patients and screen them for common medications, focusing on antacids. In fact, our study did show that people taking antacids are doing better," says lead study author Silvana Papagerakis, M.D., Ph.D., research assistant professor of otolaryngology--head and neck surgery at the University of Michigan Medical School and an adjunct clinical assistant professor at the U-M School of Dentistry.

Results of the study are published in the December issue of Cancer Prevention Research.

The researchers are not clear why these medications affect the cancer, although they have begun additional work to understand the mechanisms involved.

Antacid medicines improve overall survival in patients with head and neck cancer

LOAD - a better combination therapy against Helicobater pylori....

In continuation of my update on Helicobater pylori infection and its treatment, I found this info interesting to share with. Dr. Patrick Basu and his colleagues at Columbia University College of Physicians and Surgeons found that,  a shorter course of the four-drug combination (LOAD), seven days vs. a ten-day treatment, is equally effective. As per the claim by the researchers  Helicobater pylori, a bacteria implicated in peptic ulcers and gastritis, was eradicated in 95 percent patients who took a 7-day course of combination therapy with  levofloxacin (L), omeprazole (O), nitazoxanide (Alinia®) (A) and doxycycline  (D) (LOAD) compared to eradication in only 80.9 percent of patients on lansoprazole, amoxicillin and clarithromycin (LAC) for seven days.

The study included 135 patients with treatment naïve Helicobacter pylori infection, who were randomized to LOAD (7 or 10 days) vs. LAC (10 days). There was a total wash out period of six weeks from any prior antibiotic and PPI use prior to the initiation of therapy.

Ref : http://www.acg.gi.org/media/releases/09ACGReleaseLOADTherapyforHPylori.pdf

Acid reflux drug may cause heart disease, study suggests

In human tissue and mouse models, the researchers found PPIs (proton pump inhibitors) caused the constriction of blood vessels. If taken regularly, PPIs could lead to a variety of cardiovascular problems over time, including hypertension and a weakened heart. In the paper, the scientists call for a broad, large-scale study to determine whether PPIs are dangerous.

"The surprising effect that PPIs may impair vascular health needs further investigation," said John Cooke, M.D., Ph.D., the study's principal investigator. "Our work is consistent with previous reports that PPIs may increase the risk of a second heart attack in people that have been hospitalized with an acute coronary syndrome. Patients taking PPIs may wish to speak to their doctors about switching to another drug to protect their stomachs, if they are at risk for a heart attack."

Commonly used proton pump inhibitors in the United States are lansoprazole (below left) and omeprazole (below right), 

and these drugs are purchasable over the counter as brands or generics. The FDA estimates about 1 in 14 Americans has used them. In 2009, PPIs were the third-most taken type of drug in the U.S., accounting for $13 billion in sales. PPIs are used to treat a wide range of disorders, including gastroesophageal reflux disease, or GERD, infection by the ulcer-causing Helicobacter pylori, Zollinger-Ellison syndrome, and Barrett's esophagus.

Recent studies of proton pump inhibitors use by people who've already experienced severe cardiovascular events have raised concern about the anti-reflux drugs, at least for this subgroup of patients, said Cooke, chair of the Department of Cardiovascular Sciences and director of the Center for Cardiovascular Regeneration at Houston Methodist DeBakey Heart & Vascular Center.

PPIs are initially inert. After oral consumption, they are activated by specialized cells in the stomach. Once active, the molecules suppress the movement of protons into the intestine, which reduces the amount of acid present there and in the stomach.

In mouse models and cultures of human endothelial cells, Cooke and lead author Yohannes Ghebramariam, Ph.D., found that PPIs suppressed the enzyme DDAH, dimethylarginine dimethylaminohydrolase. That caused an increase in the blood levels of ADMA (asymmetric dimethylarginine), an important chemical messenger. They found ADMA in turn suppressed the production of another chemical messenger, nitric oxide, or NO, proven by 1998 Nobel Prize winners Furchgott, Ignarro, and Murad to impact cardiovascular function. Quantitative studies in mouse models showed animals fed PPIs were more likely than controls to have tense vascular tissue.

"We found that PPIs interfere with the ability of blood vessels to relax," said Ghebremariam, a Houston Methodist molecular biologist. "PPIs have this adverse effect by reducing the ability of human blood vessels to generate nitric oxide. Nitric oxide generated by the lining of the vessel is known to relax, and to protect, arteries and veins."

The researchers found PPIs led to an approximately 25 percent increase in ADMA in mouse and tissue cultures, and reduced the ability of mouse blood vessels to relax by over 30 percent on average.

Acid reflux drug may cause heart disease, study suggests