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Internal Medicine News - Standard digoxin nomogram can lead to deadly overdoses in HF

admin — Sun, 11 Jan 2009 22:55:21 +0000

MUNICH — Patients with heart failure who are treated with digoxin administered according to the standard nomogram risk getting an overdose that might kill them.
“We recommend treating patients who get digoxin with half the dose from the nomogram,” said Kirkwood F. Adams, Jr., M.D., at the annual congress of the European Society of Cardiology.
Half the standard dosage gives most patients a serum level of 0.5-0.9 ng/mL. A post hoc analysis of data collected in the landmark Digitalis Investigation Group (DIG) trial showed that patients with a serum level in this range had a 15%-20% reduced risk of death during follow-up, compared with patients who did not receive digoxin, reported Dr. Adams, a cardiologist at the University of North Carolina in Chapel Hill.

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In contrast, patients who had serum levels of 1.2-1.5 ng/mL had a death rate that was 33% higher than that of matched placebo patients.
This risk is believed to be due to the neurohormonal effects of a relatively high serum level of the drug. At lower serum levels, digoxin probably has a small inotropic effect that is safe and beneficial, Dr. Adams told this newspaper.
In the DIG trial, conducted from 1991 to 1995, the 6,800 patients with stable heart failure were randomized to treatment with digoxin or placebo on top of what was standard heart failure treatment at that time.
The primary finding of the study was that digoxin treatment had no effect on mortality compared with placebo, but it did reduce the hospitalization rate (N. Engl. J. Med. 1997;336:525-33).
The post hoc analysis by Dr. Adams and his associates focused on the 1,843 patients in the digoxin arm of the study who had their serum level of the drug checked after they had been on treatment for 4 weeks, an indicator of their steady-state level of the drug. Of the patients who had this test done and entered into their records, 1,458 had a detectable level of drug.
The relationship between serum levels of digoxin after 4 weeks of treatment and mortality was similar in men and women.
The standard nomogram for calculating a digoxin dosage dates to 1974 and takes into account a patient’s body mass index and renal function.
But there can be substantial variability in the actual serum level that individual patients maintain from a particular dosage. With the nomogram, most patients receive a dosage of 0.25 mg/day. A better dosage based on these findings would be 0.125 mg/day, Dr. Adams said.
All patients with heart failure who receive digoxin should have their serum level checked after 4 weeks and then have their dosage modified if the level is outside of the 0.5-0.9 ng/mL range, he added.
BY MITCHEL L. ZOLER
Philadelphia Bureau
COPYRIGHT 2005 International Medical News Group
COPYRIGHT 2008 Gale, Cengage Learning

SciTech Book News - Concepts in Clinical Pharmacokinetics, 4th ed

admin — Sat, 10 Jan 2009 00:36:03 +0000

Concepts in clinical pharmacokinetics, 4th ed.
Ed. by Joseph T. DiPiro et al.
Am.Soc./Health-Sys.Pharmacists
2005
230 pages
$99.00
Paperback
RM301
The 15 lessons in this pharmacy textbook define the time course of drug absorption and metabolism in the human body, examine the relationship between drug concentration at the site of action and the resulting effect, and present brief patient case studies with aminoglycosides, theophylline, vancomycin, digoxin, and phenytoin. The fourth edition adds an appendix of pharmacokinetic equations.

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([c]20062005 Book News, Inc., Portland, OR)
COPYRIGHT 2006 Book News, Inc.
COPYRIGHT 2008 Gale, Cengage Learning

Internal Medicine News - Cochrane review finds role for digoxin in heart failure

admin — Tue, 06 Jan 2009 19:52:03 +0000

VANCOUVER, B.C. — The latest Cochrane systematic review of digoxin for treatment of heart failure patients in sinus rhythm paints a picture of a more than 200-year-old drug that’s still clinically useful, although it has no effect on mortality, William B. Hood Jr., M.D., said at a meeting sponsored by the International Academy of Cardiology.
“It’s probably not first-line therapy. It’s not very powerful. But it’s available for patients who are not fully responsive to other agents that have become first-line treatments, such as the ACE inhibitors, [beta]-blockers, spironolactone, and the angiotensin receptor blockers,” added Dr. Hood, lead author of the recent Cochrane review and a cardiologist at the University of Washington, Seattle.

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The metaanalysis was restricted to randomized, double-blind, placebo-controlled trials involving adults followed for at least 7 weeks. A total of 13 trials involving nearly 7,900 patients qualified, including the largest of all digoxin studies: the 6,800-patient, 3-year Digitalis Investigation Group (DIG) trial (N. Engl. J. Med. 1997;336:525-33).
Why even bother doing a metaanalysis when one trial is so dominant in size? Dr. Hood explained that the smaller trials are helpful in that each consistently reached the same conclusion as DIG regarding the effect of digoxin on mortality–namely, there is none–thereby reinforcing the finding. The drug didn’t lessen mortality, nor did it significantly worsen it. Indeed, the odds ratio for mortality was 0.98 in heart failure patients randomized to digoxin, compared with placebo. In the DIG trial, however, there was a non-significant trend for fewer deaths from heart failure in digoxin-treated patients and a hint that the inotrope may have caused more arrhythmia deaths, although this wasn’t a prespecified study end point.
Digoxin’s effect on deterioration in clinical status was more clearcut in the metaanalysis. The odds ratio for that end point was 0.31, meaning patients randomized to digoxin were 69% less likely to show clinical deterioration than were control patients. The third end point used in the metaanalysis was hospitalization for worsening heart failure. Patients on digoxin were 32% less likely to experience it.
Two studies included in the metaanalysis were designed to learn whether concomitant ACE inhibitor therapy mattered in patients randomized to digoxin or placebo. Both showed that patients on an ACE inhibitor plus digoxin did better than those on an ACE inhibitor plus placebo.
However, the effects of digoxin in patients on other agents that have become first-line therapies in heart failure more recently than the ACE inhibitors, including [beta]-blockers and aldosterone antagonists, haven’t been systematically studied. For ethical reasons, such trials are highly unlikely to ever be done, Dr. Hood said.
BY BRUCE JANCIN
Denver Bureau
COPYRIGHT 2005 International Medical News Group
COPYRIGHT 2008 Gale, Cengage Learning

Internal Medicine News - Digoxin poses risk in women

admin — Mon, 05 Jan 2009 19:17:24 +0000

Digoxin appears to raise the risk of death in stable heart failure, but only in women, according a post hoc analysis of data from a clinical trial.
This finding is based on “robust evidence” and “provides sufficient grounds for a reexamination of the use of digoxin therapy for women with heart failure,” said Saif S. Rathore, a public health specialist at Yale University, New Haven, and associates.
In 1997 the Digitalis Investigation Group reported that digoxin decreased the rate of hospitalization for worsening heart failure, based on a clinical trial involving nearly 8,000 patients at 302 clinical centers. The American College of Cardiology the American Heart Association, and the Heart Failure Society of America then issued guidelines strongly endorsing the use of digoxin in patients with heart failure.

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The Yale researchers decided to reassess the data because the study had enrolled four men for every woman. The post hoc analysis showed a 5.8% absolute difference between men and women in the drug’s effect on mortality. Digoxin raised the rate of death from any cause, death from cardiovascular causes, and death from worsening heart failure only in women (N. Engl. J. Med. 347[18]:1403-11, 2002).
COPYRIGHT 2003 International Medical News Group
COPYRIGHT 2008 Gale, Cengage Learning

Southern Medical Journal - Early detection of digitalis-induced nonocclusive mesenteric ischemia using Doppler ultrasonography.(Letter to the editor)

admin — Sun, 04 Jan 2009 13:52:47 +0000

To the Editor: Acute mesenteric ischemia occurs in 1 of 1000 hospital admissions, and a nonocclusive mechanism makes up about 20% of these cases. (1) Nonocclusive mesenteric ischemia (NOMI) is a condition where the macrovasculature is patent, but the microvascular blood flow is inadequate to meet intestinal tissue demands leading to gangrene and disastrous consequences.

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The pathophysiology of NOMI involves low blood flow states such as shock, heart failure, hemodialysis and direct splanchnic arteriolar vasoconstriction by drugs, eg, digoxin. (2,3) Angiography is the gold standard …

Read the rest of this article with a Free Trial at HighBeam Research.

Journal of Family Practice - Optimal digoxin range for men is 0.5 to 0.8 ng/mL

admin — Wed, 31 Dec 2008 10:49:08 +0000

Rathore SS, Curtis JP, Wang Y, Bristow MR, Krumholz, HM. Association of serum digoxin concentration and outcomes in patients with heart failure. JAMA 2003; 289:871-878.
* PRACTICE RECOMMENDATIONS
The optimal serum drug concentration for digoxin among men in sinus rhythm with stable heart failure is 0.5 to 0.8 ng/mL. This range is associated with decreased risk of hospitalization and mortality compared with placebo. Higher levels are associated with either no reduction, or an increased risk of hospitalization and mortality compared with placebo.
* BACKGROUND

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The Digitalis Investigation Group (DIG) trial of patients with heart failure found no effect on mortality from digoxin therapy at serum concentrations of 0.5 to 2.0 ng/mL, but did find that hospitalization due to worsening heart failure was modestly reduced. The original investigators did not evaluate the relative efficacy of different concentrations.
Other studies have demonstrated an association between serum drug concentrations 4 signs or symptoms of heart failure. Other medications known to benefit heart failure, such as angiotensin-converting enzyme inhibitors and diuretics, were continued. Patients using digoxin at the time of enrollment could be allocated to drug or placebo.
* STUDY DESIGN AND VALIDITY
This study is a post-analysis of data collected from the DIG study. The DIG study was a double-blind, placebo-controlled study of digoxin in the treatment of heart failure. Digoxin dosing was based on a published algorithm; serum digoxin levels were drawn 1 month after randomization. The present study is a subgroup analysis of men based on serum drug concentrations at 1 month of 0.5-0.8 ng/mL, 0.9-1.1 ng/mL, or [greater than or equal to] 1.2 ng/mL. These ranges have been used in previous studies of digoxin in the treatment of heart failure.
The study was sufficiently well done to draw conclusions about use of digoxin in treatment of heart failure. Patients and data investigators were blinded with respect to treatment, and cause of death was determined without knowledge of assigned treatment group. Digoxin levels were reported from the 1 month visit only. No subsequent levels were documented.
Generalizability to the general population is limited, as only men with heart failure in sinus rhythm and a left ventricular ejection fraction

HealthDay - 3 Common Drugs Trigger Most ER Visits by Seniors

admin — Mon, 29 Dec 2008 15:09:44 +0000

Side effects from just three drugs are responsible for a full third of all U.S. emergency room visits by senior citizens who had adverse reactions to medications, a new study found.
In 2004 and 2005, the blood thinner warfarin, the diabetes drug insulin and the heart drug digoxin caused about 58,000 emergency room visits a year in those 65 and older, the researchers found.
The major problem is that it’s hard to determine the correct dose for each drug, said study lead author Dr. Daniel Budnitz, a medical officer with the U.S. Centers for Disease Control and Prevention (CDC).
“It’s challenging,” he said, “and it takes work between the patient and physician to get the dose just right.”

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Budnitz and his colleagues undertook the study to determine the danger posed to senor citizens by a long list of drugs that have been deemed “potentially inappropriate” …

Read the full article with a Free Trial at MyWire.

Chain Drug Review - Lannett fills gap

admin — Sun, 28 Dec 2008 14:30:04 +0000

PHILADELPHIA — Lannett Co. is working to ensure a supply of the heart failure drug digoxin following a recall of another version of the drug. The FDA said that Digitek tablets may contain twice the amount of the active ingredient, which could put patients at risk, including the possibility of death.

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Independent on Sunday, The - NUMBERS

admin — Tue, 23 Dec 2008 22:41:38 +0000

$1 trillion
The interest America will have paid by 2017 on the money borrowed to finance the war in Iraq
13 billion
The number of plastic bags issued to shoppers every year in the UK
3
Number of drugs (warfarin, insulin and digoxin) that are responsible for a third of all serious adverse drug reactions among over-65s, according to a survey in the ‘Annals of Internal Medicine’
72%
Rise in the number of deaths linked to Clostridium difficile in the past year
5,000,000,000

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LegalView Reports of Woman Allegedly Fired For Expressing Concerns with Asbestos-Tainted Flooring At Her Workplace

admin — Sun, 21 Dec 2008 02:02:33 +0000

LegalView updated its mesothelioma blog with information of a woman who was allegedly fired for openly discussing her concerns with asbestos-tainted flooring. The woman, who works at a nursing home beauty salon, claims she was fired after she expressed anxiety with over her health because of potential asbestos exposure.

Denver, CO (PRWEB) May 23, 2008 — LegalView, the most comprehensive resource for everything legal on the Web, recently offered readers updated mesothelioma information through its mesothelioma blog. The story concerns a woman who was allegedly fired for expressing her concerns with asbestos-tainted flooring in her workplace. The woman, Mary Ann Gruzs, worked as a beautician in a York County, Penn., nursing home and claims she was fired in 2006 from her job after pointing out concerns with potential asbestos in the flooring, which may have put her health at risk as well as increase her chances of developing mesothelioma. Individuals who feel they too have been placed at risk with asbestos-tainted workplace environments should contact an experienced mesothelioma law firm to learn more about how to protect their health.

Mesothelioma is a deadly form of cancer that can remain dormant in the body for years, and, in most instances decades. It is caused when an individual has been exposed to asbestos fibers and asbestos dust. Those who believe they may have been previously exposed to asbestos should consult a medical professional immediately, as mesothelioma is often misdiagnosed and only through early treatment do individuals have a better chance of fighting the illness. Additionally, locating a mesothelioma lawyer may be advisable as well.

Asbestos, derived from the mineral vermiculite, was widely mined and used as insulation in buildings, ships and homes/apartments across the United States. It was considered an ideal insulator for its cheap production costs as well as its resistance to catching fire. However, after years of production and implementation across the country, the symptoms associated with mesothelioma and asbestos began to become apparent. Although its use was banned in the United States, it was not before thousands may have been exposed and continue to be at risk for exposure. It is advisable that individuals affected by this preventable form of cancer speak with a mesothelioma attorney to learn about developing mesothelioma litigation, which may provide them with monetary compensation for the costly bills associated with this disease.

LegalView also offers other information portals ranging from controversial prescription drugs, such as Chantix, Singulair and Digitek, to information on locating a brain injury lawyer to the latest on Nephrogenic Systemic Fibrosis (NSF).

Although lately, the prescription drug scandals have seemingly been on the rise and continue to do so around the country affecting millions of unsuspecting Americans. The Chantix side effects and Singulair risks are a prime example of this. Chantix is a smoking cessation drug that has been reportedly used by millions of Americans until the Food and Drug Administration (FDA) recently released a Public Health Advisory when hundreds of reports on unusual side effects including depression, moodiness, suicidal thoughts and behaviors, began to flood into FDA offices. Patients of Singulair - a treatment of asthma and allergies - began to report similar side effects ranging from erratic behavior to suicidal thoughts.

The most recent prescription drug recall involved Digitek digoxin. The Digitek brand of digoxin is a heart tablet used to treat heart beat irregularity conditions, however after a manufacturing defect resulted in pills with double the dosage, some patients began to report severe cardiac arrest, and some patients taking the drug may have even died because of the Digitek digoxin side effects. To learn more on this, visit http://digitek-digoxin.legalview.com/.

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