Jun 10 2009
New Treatment Option for People Living with Gastroesophageal Reflux Disease
(ARA) — Nearly 19 million Americans currently live with Gastroesophageal Reflux Disease (GERD), commonly known as acid reflux disease, and suffer from painful and uncomfortable symptoms such as frequent and persistent heartburn.
The Food and Drug Administration (FDA) recently approved KAPIDEX (TM) (dexlansoprazole) delayed release capsules for the once-daily, oral treatment of heartburn associated with symptomatic non-erosive GERD, the healing of erosive esophagitis (EE) and the maintenance of healed EE. KAPIDEX (30 mg and 60 mg) is the first PPI with a Dual Delayed Release (TM) (DDR) formulation that provides two separate releases of medication.
GERD is a chronic condition that can occur when the valve at the lower end of the esophagus does not work properly, causing stomach contents to back up into the esophagus repeatedly. If the esophagus is continually exposed to stomach contents, damage to the lining of the esophagus such as breaks or lesions can occur, a condition known as erosive esophagitis (EE).
GERD can affect both men and women, and its symptoms are often triggered by certain foods, stress, or pressure on the stomach.
“Clinical studies have shown that KAPIDEX has the ability to provide up to 24-hour heartburn relief in patients with GERD,” said Charles Baum, M.D., executive medical director at Takeda Pharmaceuticals North America, Inc. “KAPIDEX is the first PPI that provides two separate releases of medication.”
About KAPIDEX (dexlansoprazole) delayed release capsules
KAPIDEX (dexlansoprazole) delayed release capsules, previously known by the development code TAK-390MR, is a proton pump inhibitor (PPI), which decreases acid production by turning off many of the acid pumps in the stomach, thus helping to protect the esophagus from acidic reflux so that esophageal inflammation can heal. KAPIDEX combines an enantiomer of lansoprazole with a Dual Delayed Release (TM) (DDR) formulation designed to provide two separate releases of medication. KAPIDEX, taken once-daily, is approved for the healing of all grades of erosive esophagitis (EE) for up to eight weeks, maintaining healing of EE for up to six months, and treating heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD) for four weeks.
Important Safety Information
KAPIDEX is contraindicated in patients with known hypersensitivity to any component of the formulation. Symptomatic response with KAPIDEX does not preclude the presence of gastric malignancy. The most commonly reported treatment-emergent adverse reactions (?2%): diarrhea, abdominal pain, nausea, upper respiratory tract infection, vomiting, and flatulence. KAPIDEX should not be co-administered with atazanavir. KAPIDEX may interfere with the absorption of drugs for which gastric pH is important for bioavailability (e.g., ampicillin esters, digoxin, iron salts, ketoconazole). Patients taking concomitant warfarin may require monitoring for increases in international normalized ratio (INR) and prothrombin time.
Please see the complete prescribing information and visit the KAPIDEX Web site at www.kapidex.com.
KAPIDEX is a product of Takeda Pharmaceuticals North America, Inc. To learn more about the product, speak with your healthcare provider.
Courtesy of ARAContent
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I have lived with GERD for the past twenty years, have history of grade four lesions in my esophagus plus strictures. Had recent severe exacerbation of heartburn that went on for five weeks after taking an antibiotic which obviously irritated my esophagus. Tried everything, zegerid, prilosec, gaviscon, carafate. was living off grits,oatmeal and mashed potatoes. pain exttremely severe and unrelenting. constantly drinking ice water only thing that gave relief. Gastro doc placed me on Kapidex two weeks ago and the heartburn immediately ceased, wonderful relief of pain and symptoms. The only problem is my previously controlled high blood pressure has now gone haywire. been spiking blood pressures in the 190’s over 100 along with rapid heartrate & severe headaches since starting kapidex. don’t know if there is any connectrion with my starting on kapidex and blood pressure suddenly getting out of control. but looked up prescribing info on kapidex and high blood pressure is listed as a possible serious side effect. don’t know what I am going to do if I have to get off kapidex guess I am left with the nissan fundoplication surgery as my last resort. Problem is I am on plavix and aspirin daily for previous heart blockages and stent placements. cardiologist will not approve my coming off these blood thinners long enough to have surgery. Has anyone else on kapidex experienced a rise in blood pressure?
I have had high blood pressure readings at my last 2 MD appts (the last one was so high the physician recommended me going to an urgent care facility if it didn’t come down significantly within a couple of hours). I have always had very LOW blood pressure. The only change in the last month or so has been a switch from another reflux drug to Kapidex.
Frances, I am fascinated to see your comment. I have been on Kapidex for two and a half months and have also gotten relief from some very difficult symptoms of heartburn brought on by a drug. I also tried Gaviscon, cerafate, nexium, aciphix but all that seemed to help was Kapidex.
But unfortunately, my blood pressure has been out of control for this same period, so much so that I started a blood pressure medicine two weeks ago for the first time in my life. I am stunned to see that it has done absolutely nothing to bring my blood pressure down. So it has to be the kapidex causing this problem because nothing else is different. Like you, I absolutely do not want to do the nissen fundoplication surgery, but I am unsure what to do next. I am going to see another gastroenterologist in two weeks for more advice. This is a tough situation to be in.
Good luck to you.
Hi Frances,
Although I haven’t experienced high blood pressure from taking Kapidex,
I believe it has damaged my heart’s electrical system. I took Kapidex for gastritis for 5 weeks until I began experiencing strong heart palpitations and chest pressure – so severe in fact that I sought medical treatment and also had to go the emergency room. During this time, I also gained ten lbs and had severe depression. I stopped the medication, lost the weight within the month, and the depression went away within a few days. Unfortunately, it’s been over six months and the heart arrythmia and chest pressure have not gone away and I have to take a beta blocker. I never had any heart issues before Kapidex.
I hope things will work out for you.