Global Dialysis

Dialysis industry news

Stories from the dialysis comunity across the globe.

Edarbyclor (azilsartan medoxomil and chlorthalidone) Head-to ... - MarketWatch (press release)

DEERFIELD, Ill., June 19, 2012 /PRNewswire via COMTEX/ -- Results of a 12-week, head-to-head, phase 3 study published online in the American Heart Association journal Hypertension found systolic blood pressure (SBP) reductions of a fixed-dose combination of azilsartan medoxomil and chlorthalidone 40/25 mg were statistically superior to those of the fixed-dose combination of olmesartan medoxomil-hydrochlorothiazide 40/25 mg. This fixed-dose combination (azilsartan medoxomil and chlorthalidone) is currently marketed as Edarbyclor in the United States. It is the first and only hypertension medication to combine an angiotensin II receptor blocker (ARB) with chlorthalidone, a diuretic, in a once-daily, single tablet.

"Hypertension and its impact on cardiovascular health have long been studied; the goal of this particular study was to determine whether a fixed-dose combination of a well-established yet underutilized diuretic paired with a new angiotensin II receptor blocker would provide an effective option to help control hypertension," said study co-author Michael Weber, M.D., professor of medicine, State University of New York, Downstate College of Medicine, Brooklyn, N.Y. "The data showed that Edarbyclor exhibited superior blood pressure reductions compared to a commonly used combination treatment."

Results after 12 weeks of treatment showed that the fixed-dose combination of azilsartan medoxomil and chlorthalidone 40/25 mg reduced clinic SBP by 42.5 mm Hg from baseline. The reductions were statistically significantly (P

"Takeda has a long history in exploring new approaches for the management of chronic diseases," said Ali Hariri, M.D., medical director of medical & scientific affairs at Takeda. "Edarbyclor is a good example of rethinking existing therapies in an effort to create a new treatment option for patients."

The published data was a 12-week, randomized, double-blind study that compared blood pressure reductions of azilsartan medoxomil and chlorthalidone to olmesartan medoxomil-hydrochlorothiazide among 1,071 patients with mean baseline clinic SBPs ranging from 160 to 190 mm Hg and diastolic blood pressures equal to or lower than 119 mm Hg. Two azilsartan medoxomil and chlorthalidone fixed-dose combination groups were force titrated from 20/12.5 mg and 40/12.5 mg to 40/25 mg and 80/25 mg, respectively. In the olmesartan medoxomil-hydrochlorothiazide fixed-dose combination group, patients were force titrated from 20/12.5 mg to 40/25 mg, the highest approved dose. The primary endpoint was change from baseline to week 12 in trough (measured about 24 hours after the last treatment dose) clinic SBP with changes in 24-hour ambulatory blood pressure monitoring as secondary endpoints.

After 12 weeks, azilsartan medoxomil and chlorthalidone lowered blood pressure more effectively than olmesartan medoxomil-hydrochlorothiazide at each hour of the 24-hour period between doses. Adverse events leading to permanent drug discontinuation occurred in 7.9 percent of patients taking azilsartan medoxomil and chlorthalidone 40/25 mg and 7.1 percent of patients taking olmesartan medoxomil-hydrochlorothiazide 40/25 mg.

About Hypertension

Hypertension, or high blood pressure, is a chronic medical condition in which blood pressure is elevated to levels of 140 mm Hg or greater systolic and/or 90 mm Hg or greater diastolic. Hypertension impacts approximately 76 million Americans, or nearly one in three adults. It is estimated that nearly one billion people are affected by hypertension worldwide, and this figure is predicted to increase to 1.5 billion by 2025. Hypertension typically has no symptoms. Adults of all ages and backgrounds can develop hypertension; however, the risk of developing the condition increases with age, with more than half of people over age 60 affected in the U.S.

Elevated systolic or diastolic pressure increases cardiovascular risk, and lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and heart attacks. The absolute risk increase per mm Hg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit.

Hypertension is also costly to the nation's health care system. The American Heart Association recently estimated that direct and indirect expenses associated with hypertension cost the nation more than $73 billion in 2009.

About Edarbyclor

Azilsartan medoxomil and chlorthalidone (currently marketed as Edarbyclor) is a fixed-dose combination therapy in a single tablet for the treatment of hypertension. Edarbyclor is indicated for the treatment of hypertension to lower blood pressure and may be used in patients not adequately controlled with monotherapy and as an initial therapy if a patient is likely to need multiple drugs to help achieve blood pressure goals. The recommended starting dose in adults is 40/12.5 mg taken orally once daily. The maximum recommended dose is 40/25 mg. Chlorthalidone is a diuretic that reduces the amount of salt and water in the body by increasing the flow of urine, which helps lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and heart attacks. There are no controlled trials demonstrating risk reduction with Edarbyclor, but trials with chlorthalidone and at least one pharmacologically similar drug to azilsartan medoxomil have demonstrated such benefits.

Important Safety Information WARNING: FETAL TOXICITY See full Prescribing Information for complete boxed warning. When pregnancy is detected, discontinue EDARBYCLOR as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.

EDARBYCLOR is contraindicated in patients with anuria.

Fetal Toxicity: Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. When pregnancy is detected, discontinue EDARBYCLOR as soon as possible. Thiazides cross the placental barrier and appear in cord blood and may be associated with adverse reactions, including fetal or neonatal jaundice and thrombocytopenia.

In patients with an activated renin-angiotensin-aldosterone system (RAAS), such as volume- and/or salt-depleted patients, EDARBYCLOR can cause excessive hypotension. Correct volume or salt depletion prior to administration of EDARBYCLOR.

Monitor for worsening renal function in patients with renal impairment. In patients whose renal function may depend on the activity of the renin-angiotensin system, treatment with ACE inhibitors and ARBs has been associated with oliguria or progressive azotemia and rarely with acute renal failure and death. In patients with renal artery stenosis, EDARBYCLOR may cause renal failure. In patients with renal disease, chlorthalidone may precipitate azotemia. Consider withholding or discontinuing EDARBYCLOR if progressive renal impairment becomes evident.

Hypokalemia is a dose-dependent adverse reaction that may develop with chlorthalidone. Coadministration of digitalis may exacerbate the adverse effects of hypokalemia. EDARBYCLOR attenuates chlorthalidone-associated hypokalemia.

Hyperuricemia may occur or frank gout may be precipitated in certain patients receiving chlorthalidone or other thiazide diuretics.

Adverse Reactions (AEs): AEs that occurred at an incidence of greater-than or equal to 2% of EDARBYCLOR-treated patients and greater than azilsartan medoxomil or chlorthalidone were dizziness (8.9%) and fatigue (2.0%). Incidence of consecutive elevations of creatinine (greater-than or equal to 50% from baseline and >ULN) was 2% and were typically transient, or nonprogressive and reversible, and associated with large blood pressure reductions.

Drug Interactions: Renal clearance of lithium is reduced by diuretics, such as chlorthalidone, increasing the risk of lithium toxicity. Monitor renal function periodically in patients receiving EDARBYCLOR and NSAIDs who are also elderly, volume-depleted (including those on diuretics), or who have compromised renal function due to potential reversible deterioration of renal function. NSAIDs may interfere with antihypertensive effect.

For further information, please click here for complete Edarbyclor Prescribing Information.

Indication and Usage

EDARBYCLOR is an angiotensin II receptor blocker (ARB) and a thiazide-like diuretic combination product indicated for the treatment of hypertension to lower blood pressure. EDARBYCLOR may be used if a patient is not adequately controlled on monotherapy or as initial therapy if multiple drugs are needed to help achieve blood pressure goals. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. There are no controlled trials demonstrating risk reduction with EDARBYCLOR, but trials with chlorthalidone and at least one pharmacologically similar drug to azilsartan medoxomil have demonstrated such benefits.

Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals.

EDARBYCLOR may be used with other antihypertensive agents.

Takeda Pharmaceuticals U.S.A., Inc. and Takeda Global Research & Development Center, Inc.

Based in Deerfield, Ill., Takeda Pharmaceuticals U.S.A., Inc. and Takeda Global Research & Development Center, Inc. are subsidiaries of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. The respective companies currently market oral diabetes, insomnia, rheumatology, gastroenterology, and cardiovascular treatments and seek to bring innovative products to patients through a pipeline that includes compounds in development for metabolic and cardiovascular disease, gastroenterology, neurology and other conditions. To learn more about these Takeda companies, visit www.tpna.com .

Contacts:Jocelyn GerstCorporate Communications Takeda Pharmaceuticals U.S.A., This e-mail address is being protected from spambots. You need JavaScript enabled to view it

Ashleigh This e-mail address is being protected from spambots. You need JavaScript enabled to view it

SOURCE Takeda Pharmaceuticals U.S.A., Inc.

...

Life on MARS: Emory Offers Lifesaving Liver Dialysis System for ... - PR Web (press release)

Emory Healthcare

Atlanta, GA (PRWEB) June 19, 2012

For many patients with acute liver failure, the only hope for treatment is a liver transplant. With transplant, waiting for an organ to become available can take a long time – time the patient does not have.

Emory is only one of five centers in the U.S. and the only one in the Southeast to offer the Molecular Adsorbents Recirculating System (MARS), a liver dialysis system recently approved by the U.S. Food and Drug Administration (FDA) to treat select patients with acute liver failure due to drugs or toxins. MARS can be used either as a bridge to transplant or spontaneous recovery, and highlights Emory’s institutional commitment to providing comprehensive, state-of-the-art liver critical care.

Says transplant hepatologist and intensivist Ram Subramanian, assistant professor at Emory University School of Medicine, “We have long had kidney dialysis to stabilize patients in renal failure, but until now, we have not had a corresponding method of treatment for patients in acute liver failure. MARS is a potential game changer for patients who either don’t qualify for transplant or who don’t have the time that is critical to wait for a liver transplant.”

Acute liver failure does not allow patients to clear certain toxins from their systems. The MARS system works by drawing blood from patients and cleansing it with a solution containing albumin. Albumin is produced by healthy livers and binds to certain medications and other bodily substances to transports them throughout the body while protecting the body from their toxic effects. This cleansed blood is returned to the patient’s circulatory system to attract more toxins.

MARS is the only FDA approved treatment of acute liver failure, but is currently under clinical trial investigation to treat forms of chronic liver illness.

“Several studies in Europe have demonstrated that MARS is effective in treating chronic liver failure as well,” says Subramanian. “My hope is that it becomes another tool for us in offering hope to patients who are dealing with all kinds of liver failure.”

Learn more about the MARS liver dialysis system in a video interview with Ram Subramanian, MD.

...

Life on MARS: Emory Offers Lifesaving Liver Dialysis System for ... - DigitalJournal.com (press release)

Atlanta, GA (PRWEB) June 19, 2012

MARS is the only FDA approved treatment of acute liver failure, but is currently under clinical trial investigation to treat forms of chronic liver illness.

Learn more about the MARS liver dialysis system in a video interview with Ram Subramanian, MD.

Read the full story at http://www.prweb.com/releases/2012/6/prweb9615939.htm

...

Urologist, Radiologist Blame Each Other for Patient's Untimely Death - Renal and Urology News

Who is to blame when a patient suffers a fatal adverse reaction to a diagnostic test—the urologist who ordered it or the radiologist who carried it out?

The case involved a 41-year-old man, Mr. E, who was admitted to the emergency department (ED) of the local community hospital. Mr. E had been suffering from severe pain in the right flank that had persisted for more than an hour. A urinalysis revealed microscopic hematuria. An abdominal x-ray showed moderate intestinal obstruction, but overlying bowel gas made it impossible to determine if a kidney stone was present.

The ED physician called the consulting urologist, Dr. R, 70, who recommended that excretory urography be performed to confirm the presence of the stone, locate the point of urinary obstruction, and evaluate the degree of dilation of the proximal ureter and renal collecting system. The ED physician conveyed the request for the urography to the radiologist, who immediately called Dr. R on the phone.

Procedural differences

“It's the policy of the radiology department to use an unenhanced CT scan of the pelvis in this sort of case rather than a urogram,” the radiologist said. “It's preferable because CT will provide more clinical information than urography and won't subject the patient to the risk of a reaction from the IV contrast.”

“I've been ordering excretory urograms on patients with suspected stones for 40 years with satisfactory results,” Dr. R replied. “I see no need to change that practice now.”

The radiologist tried again: “The CT has really become the standard of care now,” he said. “Why subject the patient to unnecessary risk?”

“Which one of us is going to be ultimately treating this patient,” the urologist replied, “you, or me?”

The radiologist, faced with what he perceived to be an unyielding attitude on the part of Dr. R and fearing the loss of future referrals, reluctantly agreed.

The patient was taken to the radiology department where the radiologist administered an IV of the contrast solution. Within five minutes, Mr. E went into anaphylactic shock. Attempts to revive him failed, and Mr. E was pronounced dead a half hour later.

Four months later, the family of the patient filed a medical malpractice lawsuit naming as co-defendants the ED physician, the urologist, the radiologist, and the hospital. The lawsuit alleged that the defendants had acted with gross negligence in performing an excretory urography that required the use of contrast solution, “known to be associated with a high incidence of serious reactions including death, rather than the superior, risk-free alternative diagnostic test known as helical CT scanning.”

Each physician was assigned a defense attorney and the discovery process began. During depositions, the plaintiff's attorney brought in a radiologist as expert witness. He testified that unenhanced CT had completely replaced excretory urography in assessing patients with suspected urinary tract stones because of the diagnostic superiority and absence of risk of adverse reactions. The expert further testified that the use of contrast solution was associated with a small but definite risk of bodily harm and death. The expert then went on the criticize the defendant radiologist's actions, stating that he was a board-certified professional who was responsible for making independent judgments that would provide the best care for his patient. He should not have functioned a mere “technologist,” doing what he was ordered.

The defense attorney for the radiologist on call, introduced an older, semiretired radiologist who testified that he had used excretory urography for years in similar situations without any complications. He was, however, unable to refute the argument that unenhanced CT had essentially replaced excretory urography in most situations. The defense expert did say, though, that having been “ordered” by the urologist, the radiologist essentially had been coerced, and that the urologist should bear ultimate responsibility for the outcome to the patient.

The ED physician testified that he had very limited knowledge of the various imaging modalities and would always defer to the “superior knowledge of the radiologist.”

Dr. R, the urologist, testified that although he had requested that the radiologist obtain a urogram, he nonetheless would have gone along with the radiologist's recommendations for a CT scan had the radiologist explained why it was important.

The attorney for the plaintiff was unable to provide testimony to support the charges of negligence against the ED physician or the hospital, but did call a urology expert who was critical of Dr. R, but who acknowledged that the radiologist ultimately had final say in determining which imaging tool was used was clearly .

The defense—realizing that chances of winning in court were slim—entered into settlement discussions with the plaintiff's attorneys. The case was settled for $1 million, 90% of which was paid by the radiologist's insurance company and 10% of which was attributed to the urologist.

Legal background

The purpose of discovery, which involves deposition and the exchange of evidence such as medical records and notes, is to allow each side to assess the strength of the case and gather evidence. Quite often, this process reveals that one party isn't likely to prevail at trial, and this spurs settlement negotiations between the parties, and often (as in this case) representatives of the malpractice liability provider. Settlements are often worked out that take into consideration the limits of the parties' malpractice insurance.

Protecting yourself

Dr. R could have protected himself in this case by listening to the advice of the radiologist, who is an expert in the field of imaging modalities. While Dr. R may have been older and more experienced generally, his hard line attitude about taking advice from the radiologist is what caused the death of the patient and brought him into court.

Likewise, the radiologist should have insisted that the urography decision go on record as being Dr. R's—under strong protest from him. The radiologist should have documented all conversations with Dr. R and had a third party witness sign off on the diagnostic treatment options discussed. Furthermore, Dr. R was not completely honest under oath when he let the radiologist take the blame for his catastrophic decision. By being intractable and pulling rank, Dr. R not only destroyed a life, but he significantly damaged the radiologist's career.

...

A loved one's journey into untreatable suffering - Vancouver Sun

My 86-year-old ad, Allan Yaffe, opted to kill himself during the second week of January last year rather than live one more week in a body he called "a bag of garbage."

Last Friday's B.C. Supreme Court ruling against the Criminal Code's prohibition of physician-assisted suicide took me back to the circumstances of his relatively quick death.

For at least a year before Dad faced down the nothingness he anticipated in death, he'd toyed with the notion of calling it quits.

He'd been living rather unhappily for about four years in a Vancouver nursing home - "a warehouse for the dying," he labelled it - and, wheelchair bound, began feeling tortured by his deteriorating physical condition.

Two years earlier my mother, living at the same home, had died of pneumonia. A year earlier, Dad had gone blind. His hearing, too, was failing.

He had been on kidney dialysis three times weekly for some six years - a ritual he positively detested.

He had lately developed chronic obstructive pulmonary disease and had to be hooked up to oxygen.

He also had problems with both his bladder and rectum.

Meanwhile, poor circulation left his legs below the knee, including his feet, perpetually infected; rotting for all practical purposes and forcing him to face the prospect of amputation.

He told me repeatedly that his life no longer was worth living, that he didn't want to have to keep coping with all the physical trauma being thrown his way, that he was prepared to go and it would be a relief.

The thing was, Dad always knew he had the power to order up his own death simply by curtailing his dialysis.

In that sense the Criminal Code discriminates against those who must rely on a helping hand to reach the Pearly Gates.

Three and a half days into my father's dialysis boycott - a briefer than anticipated period during which time morphine medication failed to fully diminish either his discomfort or acute awareness - Dad crossed to the other side in his brown leather La-Z-Boy.

Of course, I had no idea how to go about accompanying him on his final journey. I listened in those last days as he confided a few things about his life that I'd never known. I took him a takeout hotdog - his final food request, which he wound up not being able to get down.

In the year and a half since then, I've thought often, it was a mercy for him to pass on.

And it would be a similar mercy for other men-tally aware folks who, like my Dad, face a life of abject suffering and want a similar release but require a doc-tor's help.

Politicians dread dealing with such sensitive social issues that polarize the electorate. They know there will be little upside, in terms of popular appeal, for them in supporting the necessary Criminal Code change. But it's the humane thing for Parliament to do.

The fact physician-assisted suicide has become available in Oregon and the Netherlands should pro-vide a guide for the government in crafting the necessary safeguards to ensure any system of euthanasia is not abused, that mentally depressed individuals are not given free rein to just opt for suicide.

The Harper government has not yet determined whether it will appeal last Friday's court ruling. Rather than waste time on such an appeal, Conservatives should get on with the task of easing the way for those, like my father, seeking to escape their untreatable suffering.

This e-mail address is being protected from spambots. You need JavaScript enabled to view it

...

More Articles...

<< Start < Prev 551 552 553 554 555 556 557 558 559 560 Next > End >>

Page 551 of 4210

Share |

Empowering dialysis users and caregivers

Search for dialysis centres here

Jobs in dialysis

Procedural differences

Legal background

Protecting yourself

Dialysis travel

Dialysis information

Translate Global Dialysis

Dialysis centre search LOGIN HERE

Resources