geriatricsphilippines.org Blog

Authors: Silvina Levis, MD; Nancy Strickman-Stein, PhD; Parvin Ganjei-Azar, MD; Ping Xu, MPH; Daniel R. Doerge, PhD; Jeffrey Krischer, PhD

Journal: Arch Intern Med. 2011;171(15):1363-1369. doi:10.1001/archinternmed.2011.330

A 2- year randomized trial found no significant difference in bone loss or menopausal symptoms between women taking soy tablets or placebo.

Patients were women age 45-60 years, within 5 years of menopause and without osteoporosis.

Subjects were were randomly assigned, in equal proportions, to receive daily soy isoflavone tablets, 200 mg, or placebo.

Results
After 2 years, no significant differences were found between the participants receiving soy tablets (n = 122) and those receiving placebo (n = 126) regarding changes in bone mineral density in the spine (–2.0% and –2.3%, respectively), the total hip (–1.2% and –1.4%, respectively), or the femoral neck (–2.2% and –2.1%, respectively).

A significantly larger proportion of participants in the soy group experienced hot flashes and constipation compared with the control group. No significant differences were found between groups in other outcomes.

Authors’ Conclusions
In this population, the daily administration of tablets containing 200 mg of soy isoflavones for 2 years did not prevent bone loss or menopausal symptoms

FDA approves injectable gel to treat fecal incontinence

For Immediate Release: May 27, 2011
Media Inquiries: Amanda Sena, 301-796-0393, amanda.sena@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

The U.S. Food and Drug Administration today approved a sterile, injectable gel to treat fecal incontinence in patients for whom other therapies such as diet change, fiber therapy or anti-motility medications failed.

Fecal incontinence is the involuntary loss of bowel control. It can have different causes including nerve damage, weakened anal sphincter associated with aging, or rectum muscle damage. According to the National Institutes of Health, there are more than 5.5 million Americans with fecal incontinence.

The Solesta gel is injected into a layer of tissue beneath the anus lining and may help build tissue in that area. By growing the surrounding tissue, the opening of the anus narrows and the patient may be able to better control those muscles.

“Fecal incontinence is difficult to treat,” said Christy Foreman, director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health. “This approval provides a minimally invasive treatment option for patients with fecal incontinence that does not respond to conservative therapies.”

The FDA based its approval on results from a clinical study of 206 patients. In the primary study, most patients received two treatments, consisting of four injections each, for a total of eight injections. After six months, more than half of the patients injected with Solesta experienced a 50 percent reduction in the number of fecal incontinence episodes. However, one-third of patients who received no Solesta in the study also experienced a similar reduction. Overall, a greater proportion of patients treated with Solesta experienced improvements, indicating the gel provides benefit.

Solesta is approved for use in patients ages 18 and up. It should not be used in patients who have active inflammatory bowel disease, immunodeficiency disorders, previous radiation treatment to the pelvic area, significant rectal prolapse, active infections, bleeding, tumors or malformations in the anorectal area, rectal distended veins, an existing implant in the anorectal region, or allergy to hyaluronic acid based products.

The most common side effects associated with Solesta include injection area pain and bleeding. Infection and inflammation of anal tissue are more serious risks, but are less common.

Solesta is manufactured by Oceana Therapeutics Inc. of Edison, N.J.

Other treatments for fecal incontinence include dietary modification, antidiarrheal medication, and exercises to strengthen the sphincter. If those conservative therapies don’t work, some patients undergo surgical treatments including sphincteroplasty or sphincter repair, implantation of an artificial bowel sphincter, radiofrequency ablation of the tissue of the anal canal and ileostomy/colostomy surgical repair.

For more information:

Gastroenterology-Urology Devices Panel Advisory Committee Meeting Transcript from Dec. 2nd1 and Dec. 3rd2, 2010.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Developed by:
American College of Cardiology Foundation Task Force on Clinical Expert Consensus Documents American Academy of Neurology American Geriatrics Society American Society for Preventive Cardiology American Society of Hypertension, American Society of Nephrology Association of Black Cardiologists European Society of Hypertension

Clinical Evaluation

Note: The reader should view the expert consensus document as the best attempt of the ACCF and document cosponsors to inform and guide clinical practice in areas where rigorous evidence may not yet be available or evidence to date is not widely applied to clinical practice.

Aside from a good and targeted history and physical examination, guidelines on laboratory testing were presented. The diagnosis is established with at least 3 blood pressure readings in at least 2 clinic visits.

Ambulatory BP monitoring (ABPM) is indicated when hypertension diagnosis or response to therapy is unclear from office visits, when syncope or hypotensive disorders are suspected, and for evaluation of vertigo and dizziness. The case for using out-of-office BP readings in the elderly, particularly home BP measurements, is strong due to potential hazards of excessive BP reduction in older people and better prognostic accuracy versus office BP.

The most important role for testing in an elderly patient
with hypertension is to assess for organ damage and modifiable
CVD risk factors, including tobacco smoking, hypercholesterolemia,
diabetes mellitus, and excessive alcohol intake.

Information on the following laboratory tests should be available:
1. Urinalysis to look for any evidence of renal damage,
especially albuminuria/microalbuminuria
2. Blood chemistry to assess electrolytes and renal function, especially potassium and creatinine with eGFR
3. Total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, and triglycerides, preferably fasting levels
4. Fasting blood sugar and, if there are concerns about diabetes mellitus, hemoglobin A1c
5. ECG

Lifestyle Modification

Weight reduction, salt reduction, DASH diet, regular physical activity and moderation in alcohol consumption are recommended.

The general recommended BP goal in uncomplicated hypertension is 140/90 mm Hg. However, this target for elderly hypertensive patients is based on expert opinion rather than on data from randomized controlled trials (RCTs). It is unclear whether target SBP should be the same in patients 65 to 79 years of age as in patients 80 years of age.

Drug Treatment and other details may be viewed thru this link to the Journal of the American College of Cardiology Expert Consensus Document on Hypertension in the Elderly 2011

The Alzheimer’s Association USA released the following Alzheimer’s Disease Facts and Figures 2011.
Go to the link to access the following information:

• Overall number of Americans with Alzheimer’s disease nationally and for each state
• Proportion of women and men with Alzheimer’s and other dementias
• Estimates of lifetime risk for developing Alzheimer’s disease
• Number of family caregivers, hours of care provided, economic value of unpaid care nationally and for each state, and the impact of caregiving on caregivers
• Use and costs of health care, long-term care and hospice care for people with Alzheimer’s disease and other dementias
• Number of deaths due to Alzheimer’s disease nationally and for each state, and death rates by age

Alzheimer’s is the sixth-leading cause of death in United States and the only cause of death among the top 10 in the United States that cannot be prevented, cured or even slowed. Based on mortality data from 2000-2008, death rates have declined for most major diseases while deaths from Alzheimer’s disease have risen 66 percent during the same period.

The conclusions in this report reflect currently available data on Alzheimer’s disease. They are the interpretations of the Alzheimer’s Association.

Details are available in the website Alzheimer’s Association

The DSM-5 Task Force and Work Group members (American Psychiatric Association) are working to develop criteria for diagnoses that not only reflect new advances in the science and conceptualization of mental disorders, but also reflect the needs of our patients.

The Neurocognitive Disorders Work Group has been responsible for addressing these disorders. Among the Work Group’s proposals is the recommendation that the category be divided into three broad syndromes: Delirium, Major Neurocognitive Disorder, and Mild Neurocognitive Disorder. The Neurocognitive Disorders Work Group has posted the draft criteria for the Alzheimer Disease Subtype as an illustration of how they propose to organize other subtypes. They are inviting comment on the general approach. Work on other subtypes is currently in progress, and the Work Group is in consultation with various expert groups that work in those areas (e.g. vascular cognitive impairment and dementia, frontotemporal lobar degeneration, dementia with Lewy bodies, Huntington’s disease, Parkinson’s disease, traumatic brain injury, etc.).

While they welcome comments and suggestions on any and all aspects of the proposal, they are particularly interested in obtaining input regarding the following issues:

1) Removing the term “Dementia” and adding “Major Neurocognitive Disorders”,

2) Adding a category of “Mild Neurocognitive Disorders”,

3) Categorizing behavioral disturbances, particularly the syndromes of psychosis and depression, associated with Neurocognitive Disorders, and

4) Selecting specific domains as well as measures of severity of cognitive functional impairment

Please Click this link to DSM 5 Delirium, Dementia, Amnestic, and Other Cognitive Disorders

The U.S. Food and Drug Administration (FDA) is informing the public that prescription proton pump inhibitor (PPI) drugs may cause low serum magnesium levels (hypomagnesemia) if taken for prolonged periods of time (in most cases, longer than one year). In approximately one-quarter of the cases reviewed, magnesium supplementation alone did not improve low serum magnesium levels and the PPI had to be discontinued.

PPIs work by reducing the amount of acid in the stomach and are used to treat conditions such as gastroesophageal reflux disease (GERD), stomach and small intestine ulcers, and inflammation of the esophagus.

Prescription PPIs include Nexium (esomeprazole magnesium), Dexilant (dexlansoprazole), Prilosec (omeprazole), Zegerid (omeprazole and sodium bicarbonate), Prevacid (lansoprazole), Protonix (pantoprazole sodium), and AcipHex (rabeprazole sodium). Vimovo is a prescription combination drug product that contains a PPI (esomeprazole magnesium and naproxen). Over-the-counter (OTC) PPIs include Prilosec OTC (omeprazole), Zegerid OTC (omeprazole and sodium bicarbonate), and Prevacid 24HR (lansoprazole).

For Medical Professionals:
# Consider obtaining serum magnesium levels prior to initiation of prescription PPI treatment and checking levels periodically thereafter for patients expected to be on prolonged treatment or who take PPIs with medications such as digoxin or drugs that may cause hypomagnesemia (e.g., diuretics).
# Hypomagnesemia occurs with both loop diuretics (furosemide, bumetanide, torsemide, and ethacrynic acid) and thiazide diuretics (chlorothiazide, hydrochlorothiazide, indapamide, and metolazone). These agents can cause hypomagnesemia when used as a single agent or when combined with other anti-hypertensives (e.g., beta-blockers, angiotensin receptor blockers and/or ACE inhibitors).
# Advise patients to seek immediate care from a healthcare professional if they experience arrhythmias, tetany, tremors, or seizures while taking PPIs. These may be signs of hypomagnesemia.
# Consider PPIs as a possible cause of hypomagnesemia, particularly in patients who are clinically symptomatic.
# Patients who develop hypomagnesemia may require PPI discontinuation in addition to magnesium replacement.
# Be aware that consumers either on their own, or based on a healthcare professional’s recommendation, may take OTC PPIs for periods of time that exceed the directions on the OTC label. This is considered an off-label (unapproved) use. Healthcare professionals should communicate the risk of hypomagnesemia to patients if they are recommending prolonged use of an OTC PPIs.

Learn more by clicking this link to USFDA

Screening for Osteoporosis: U.S. Preventive Services Task Force Recommendation Statement

From the U.S. Preventive Services Task Force, Rockville, Maryland.

Abstract

Description: Update of the 2002 U.S. Preventive Services Task Force (USPSTF) recommendation on screening for osteoporosis.

Methods: The USPSTF evaluated evidence on the diagnostic accuracy of risk assessment instruments for osteoporosis and fractures, the performance of dual-energy x-ray absorptiometry and peripheral bone measurement tests in predicting fractures, the harms of screening for osteoporosis, and the benefits and harms of drug therapy for osteoporosis in women and men.

Recommendations: The USPSTF recommends screening for osteoporosis in women aged 65 years or older and in younger women whose fracture risk is equal to or greater than that of a 65-year-old white woman who has no additional risk factors. (Grade B recommendation)

The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for osteoporosis in men. (I statement)

Osteoporosis Screening Table USPSTF

Patient Population Under Consideration

This recommendation applies to older adults in the general U.S. population who do not have a history of an osteoporotic fracture, osteoporosis secondary to another condition, or other specific clinical indications for bone measurement testing. The USPSTF did not define a specific upper age limit for screening in women because the risk for fractures continues to increase with age and treatment harms remain no greater than small. Clinicians should take into account the patient’s remaining lifespan when deciding whether to screen patients with significant illness. In the Fracture Intervention Trial (1), the benefit of treatment emerged 18 to 24 months after initiation of treatment.

The quantity and quality of data on osteoporotic fracture risk other than hip fracture are much less for Asian, American Indian or Alaska Native, Hispanic, and black women than for white women. The USPSTF’s recommendation to screen women aged 65 years or older for osteoporosis applies to all racial and ethnic groups because the harms of the screening tests are no greater than small, the consequences of failing to identify and treat women who have low bone mineral density (BMD) are considerable, and the optimal alternative age at which to screen nonwhite women is uncertain.

Assessment of Risk

Multiple instruments to predict risk for low BMD and fractures have been developed and validated for use in postmenopausal women, but few have been validated for use in men. To predict fracture risk, the area under the receiver-operating characteristic curve ranges from 0.48 to 0.89 (2). Less complex instruments (that is, those with fewer variables) seem to perform as well as more complex ones (3). The USPSTF found no studies that assessed the effect on patient outcomes of using risk prediction instruments alone or in combination with bone measurement tests.

The USPSTF used the FRAX (Fracture Risk Assessment) tool (World Health Organization Collaborating Centre for Metabolic Bone Diseases, Sheffield, United Kingdom), available at www.shef.ac.uk/FRAX/, to estimate 10-year risks for fractures because this tool relies on easily obtainable clinical information, such as age, body mass index (BMI), parental fracture history, and tobacco and alcohol use; its development was supported by a broad international collaboration and extensively validated in 2 large U.S. cohorts; and it is freely accessible to clinicians and the public. The FRAX tool includes questions about previous DXA results but does not require this information to estimate fracture risk.

Based on the U.S. FRAX tool, a 65-year-old white woman with no other risk factors has a 9.3% 10-year risk for any osteoporotic fracture. White women between the ages of 50 and 64 years with equivalent or greater 10-year fracture risks based on specific risk factors include but are not limited to the following persons: 1) a 50-year-old current smoker with a BMI less than 21 kg/m2, daily alcohol use, and parental fracture history; 2) a 55-year-old woman with a parental fracture history; 3) a 60-year-old woman with a BMI less than 21 kg/m2 and daily alcohol use; and 4) a 60-year-old current smoker with daily alcohol use. The FRAX tool also predicts 10-year fracture risks for black, Asian, and Hispanic women in the United States. In general, estimated fracture risks in nonwhite women are lower than those for white women of the same age.

Although the USPSTF recommends using a 9.3% 10-year fracture risk threshold to screen women aged 50 to 64 years, clinicians also should consider each patient’s values and preferences and use clinical judgment when discussing screening with women in this age group. Menopausal status is one factor that may affect a decision about screening in this age group.

Considerations for Practice Regarding the I Statement

When deciding whether to screen men for osteoporosis, clinicians should consider the following factors.

Potential Preventable Burden

Bone measurement tests may potentially detect osteoporosis in a large number of men and prevent a substantial part of the burden of fractures and fracture-related illness in this population. The aging of the U.S. population is likely to increase this potentially preventable burden in future years.

Potential Harms

Potential harms of screening men are likely to be small and consist primarily of opportunity costs.

Current Practice

Routine screening of men currently is not a widespread practice.

Costs

Many additional DXA scanners may be required to screen sizeable populations of men for osteoporosis; DXA machines range in cost from $25 000 to $85 000.

Assuming that the relative benefits and harms of therapy in men are similar to those in women, the men most likely to benefit from screening would have 10-year risks for osteoporotic fracture equal to or greater than those of 65-year-old white women who have no additional risk factors. However, current evidence is insufficient to assess the balance of benefits and harms of screening for osteoporosis in men.

Screening Tests

The most commonly used bone measurement tests used to screen for osteoporosis are DXA of the hip and lumbar spine and quantitative ultrasonography of the calcaneus. Quantitative ultrasonography is less expensive and more portable than DXA and does not expose patients to ionizing radiation. Quantitative ultrasonography of the calcaneus predicts fractures of the femoral neck, hip, and spine as effectively as DXA. However, current diagnostic and treatment criteria for osteoporosis rely on DXA measurements only, and criteria based on quantitative ultrasonography or a combination of quantitative ultrasonography and DXA have not been defined.

Screening Intervals

The potential value of rescreening women whose initial screening test did not detect osteoporosis is to improve fracture risk prediction. A lack of evidence exists about optimal intervals for repeated screening and whether repeated screening is necessary in a woman with normal BMD. Because of limitations in the precision of testing, a minimum of 2 years may be needed to reliably measure a change in BMD; however, longer intervals may be necessary to improve fracture risk prediction. A prospective study of 4 124 women aged 65 years or older found that neither repeated BMD measurement nor the change in BMD after 8 years was more predictive of subsequent fracture risk than the original measurement (4).

Treatment

In addition to adequate calcium and vitamin D intake and weight-bearing exercise, multiple drug therapies are approved by the U.S. Food and Drug Administration to reduce fractures, including bisphosphonates, parathyroid hormone, raloxifene, and estrogen. The choice of therapy should be an individual one based on the patient’s clinical situation and the tradeoff between benefits and harms. Clinicians should provide patient education on how to use drug therapies to minimize adverse effects. For example, esophageal irritation from bisphosphonate therapy can be reduced by taking the medication with a full glass of water and by not lying down for at least 30 minutes afterward.

Other Approaches to Prevention

The USPSTF has updated its evidence review on falls prevention in older adults (2) and plans to issue an updated recommendation; in future months, the USPSTF also will issue a separate statement on the preventive effects of vitamin D and calcium supplements on osteoporotic fractures. When complete, these documents will be made available at www.uspreventiveservicestaskforce.org.

Useful Resources

The 10-year risk for osteoporotic fractures can be calculated for individuals by using the FRAX tool and could help to guide screening decisions for women younger than 65 years.

Summary guides for clinicians and patients on fracture prevention treatments for postmenopausal women who have osteoporosis are available from the Agency for Healthcare Research and Quality at http://effectivehealthcare.ahrq.gov. The recommendations in these guides may differ from those of the USPSTF because they were based on a systematic review that pooled data from trials that included women who had previous clinical fractures.

Other Considerations
Research Needs and Gaps

Given the absence of direct evidence that screening for osteoporosis reduces fracture-related morbidity or mortality, studies of long-term health outcomes of screened and nonscreened population groups are important. Research is needed to test the effectiveness of drug therapies for osteoporosis in men who do not have a history of fractures. The results of ongoing randomized trials of bisphosphonates for fracture prevention in men at high risk for fractures could help to assess whether these drugs are effective in men. Research to evaluate the outcome of screening women during periods of rapid bone loss (for example, during menopause) also should be supported.

Further research that would inform clinical decisions about screening for osteoporosis include studies to establish parameters for treatment using quantitative ultrasonography as a primary screening test for osteoporosis, studies that ascertain the true incidence of major osteoporotic fractures in nonwhite ethnic groups in the United States, studies clarifying optimal screening intervals, and studies of the effect of clinical and subclinical vertebral fractures on health-related quality of life.

Link to Full Article:
Ann Intern Med E-309published ahead of print January 17, 2011

The 32-year relationship between cholesterol and dementia from midlife to late life. Neurology. November 23, 2010 75:1862-1863
Authors: Mielke, Zandi, Shao, et al

Methods:
The Prospective Population Study of Women, consisting of 1,462 women without dementia aged 38–60 years, was initiated in 1968–1969 in Gothenburg, Sweden. Follow-ups were conducted in 1974–1975, 1980–1981, 1992–1993, and 2000–2001. All-cause dementia was diagnosed according to DSM-III-R criteria and AD according to National Institute of Neurological and Communicative Disorders and Stroke–Alzheimer’s Disease and Related Disorders Association criteria. Cox proportional hazards regression examined baseline, time-dependent, and change in cholesterol levels in relation to incident dementia and AD among all participants. Analyses were repeated among participants who survived to the age of 70 years or older and participated in the 2000–2001 examination.

Results:
Higher cholesterol level in 1968 was not associated with an increased risk of AD (highest vs lowest quartile: hazard ratio [HR] 2.82, 95% confidence interval [CI] 0.94–8.43) among those who survived to and participated in the 2000–2001 examination. While there was no association between cholesterol level and dementia when considering all participants over 32 years, a time-dependent decrease in cholesterol over the follow-up was associated with an increased risk of dementia (HR 2.35, 95% CI 1.22–4.58).

Conclusion:
These data suggest that midlife cholesterol level is not associated with an increased risk of AD. However, there may be a slight risk among those surviving to an age at risk for dementia. Declining cholesterol levels from midlife to late life may better predict AD risk than levels obtained at one timepoint prior to dementia onset. Analytic strategies examining this and other risk factors across the lifespan may affect interpretation of results.

They pointed to animal and cell culture studies suggesting a causal link with high cholesterol leading to amyloid-beta deposition characteristic of Alzheimer’s disease. However, cholesterol declines in older age, “perhaps as a function of underlying subclinical pathology, sarcopenia, or change in appetite,” Haan explained. The study was also limited by loss of participants due to death or refusal, possible undiagnosed dementia, lack of genotyping for high-risk alleles, and unknown generalizability to men and populations outside of Sweden, the researchers noted.

In the study “Effect of rivastigmine as an adjunct to usual care with haloperidol on duration of delirium and mortality in critically ill patients: a multicentre, double-blind, placebo-controlled randomised trial” , authors Maarten MJ, Roes, Honing et al concluded that Rivastigmine did not decrease duration of delirium and might have increased mortality.

The authors do not recommend use of rivastigmine to treat delirium in critically ill patients.

Delirium is frequently diagnosed in critically ill patients and is associated with adverse outcome. Impaired cholinergic neurotransmission seems to have an important role in the development of delirium. The study’s aim was to establish the effect of the cholinesterase inhibitor rivastigmine on the duration of delirium in critically ill.

Patients (aged ≥18 years) who were diagnosed with delirium were enrolled from six intensive care units in the Netherlands, and treated between November, 2008, and January, 2010. Patients were randomised (1:1 ratio) to receive an increasing dose of rivastigmine or placebo, starting at 0•75 mL (1•5 mg rivastigmine) twice daily and increasing in increments to 3 mL (6 mg rivastigmine) twice daily from day 10 onwards, as an adjunct to usual care based on haloperidol. The trial pharmacist generated the randomisation sequence by computer, and consecutively numbered bottles of the study drug according to this sequence to conceal allocation.

The primary outcome was the duration of delirium during hospital admission. Analysis was by intention to treat. Duration of delirium was censored for patients who died or were discharged from hospital while delirious. Patients, medical staff, and investigators were masked to treatment allocation. Members of the data safety and monitoring board (DSMB) were unmasked and did interim analyses every 3 months.

Findings
Although a sample size of 440 patients was planned, after inclusion of 104 patients with delirium who were eligible for the intention-to-treat analysis (n=54 on rivastigmine, n=50 on placebo), the DSMB recommended that the trial be halted because mortality in the rivastigmine group (n=12, 22%) was higher than in the placebo group (n=4, 8%; p=0•07). Median duration of delirium was longer in the rivastigmine group (5•0 days, IQR 2•7—14•2) than in the placebo group (3•0 days, IQR 1•0—9•3; p=0•06).

Interpretation
Rivastigmine did not decrease duration of delirium and might have increased mortality so we do not recommend use of rivastigmine to treat delirium in critically ill patients.

This trial is registered with ClinicalTrials.gov, number NCT00704301.

Funding
ZonMw, the Netherlands Brain Foundation, and Novartis.

Source
The Lancet, Volume 376, Issue 9755, Pages 1829 - 1837, 27 November 2010

Background
Patients with cirrhosis in Child–Pugh class C or those in class B who have persistent bleeding at endoscopy are at high risk for treatment failure and a poor prognosis, even if they have undergone rescue treatment with a transjugular intrahepatic portosystemic shunt (TIPS). This study evaluated the earlier use of TIPS in such patients.
Methods
Random assignment, within 24 hours after admission, a total of 63 patients with cirrhosis and acute variceal bleeding who had been treated with vasoactive drugs plus endoscopic therapy to treatment with a polytetrafluoroethylene-covered stent within 72 hours after randomization (early-TIPS group, 32 patients) or continuation
of vasoactive-drug therapy, followed after 3 to 5 days by treatment with propranolol or nadolol and long-term endoscopic band ligation (EBL), with insertion of a TIPS if needed as rescue therapy (pharmacotherapy–EBL group, 31 patients).
Results
During a median follow-up of 16 months, rebleeding or failure to control bleeding occurred in 14 patients in the pharmacotherapy–EBL group as compared with 1 patient in the early-TIPS group (P = 0.001). The 1-year actuarial probability of remaining free of this composite end point was 50% in the pharmacotherapy–EBL group versus 97% in the early-TIPS group (P<0.001). Sixteen patients died (12 in the pharmacotherapy–EBL group and 4 in the early-TIPS group, P = 0.01).

The 1-year actuarial survival was 61% in the pharmacotherapy–EBL group versus 86% in the early-TIPS group (P<0.001)

Seven patients in the pharmacotherapy–EBL group received TIPS as rescue therapy, but four died. The number of days in the intensive care unit and the percentage of time in the hospital during follow-up were significantly higher in the pharmacotherapy–EBL group than in the early-TIPS group. No significant differences were observed between the two treatment groups with respect to serious adverse events.
Conclusions
In these patients with cirrhosis who were hospitalized for acute variceal bleeding and at high risk for treatment failure, the early use of TIPS was associated with significant reductions in treatment failure and in mortality. (Current Controlled Trials number, ISRCTN58150114.)
Downloaded from www.nejm.org on June 24, 2010 .