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A multi-center study of a pill that combines two drugs appropriate for hypertension shows significant benefit to go to people with
despotic-to-in check high blood persuade. The study, conducted at the University of Maryland Votaries of Pharmaceutical and 118 other
sites, was focused on bringing down systolic blood pressure, the top number in a blood pressure reading, which is the more
difficult number to submit down. The results of the study, called the INCLUSIVE trial, will be presented at the American
Society in the direction of Hypertension talk in San Francisco on Tuesday, May 17, 2005.

“The percentage of patients whose blood pressure was controlled in this observe was much higher compared to other combination
psychoanalysis trials,” says one of the study’s two principal investigators, Elijah Saunders, M.D., professor of nostrum at the
University of Maryland Middle school of Panacea and a cardiologist and hypertension expert at the University of Maryland Medical
Center.

“This was the first large-escalade hypertension study to include such a broad range of patient groups,” says Dr. Saunders. “We
found that this combination psychotherapy reduced systolic blood persuasion to a desirable elevation in 77 percent of the patients, and
83 percent of the patients in our study achieved an pleasing diastolic blood pressure. These results are significant,” he
adds.

The ruminate on began with a all-out of 1,005 participants with high blood pressure. A chick choice of people participated in the
reflect on in terms of life-span and ethnicity. Half of them were women. All were given a diuretic alone for two weeks at the start of
the trial. Nearly 30 percent of participants responded to this song analgesic, so they were eliminated from extra participation.
The remaining 736 people were given the combination pill of irbesartan (an angiotensin II receptor blocker) and a diuretic,
hydrochlorothiazide, in increasingly stronger doses until their blood sway reached a choice goal. At the betwixt of 18
weeks, the participants’ systolic blood pressure (the top number) dropped an mean of 21.5 points, from 154.4 to 132.9
points. Their diastolic blood compressing (the bottom number) fell an average of 10.4 points, from 91.3 to 80.9.

Current national guidelines exhort that blood pressure be kept below 140/90 millimeters of mercury for the sweeping
population, and less than 130/80 for people with diabetes or chronic kidney virus. Hypertension increases the peril of
coronary heart disease, insensitivity attack and stroke.

The study included at least 100 hypertensive patients in indicated subgroups: those age 65 and older, African-Americans,
Hispanic/Latinos, and people with Type 2 diabetes. Patients with several risk factors because cardiovascular disease were also
included, such as obesity, abnormal glucose permissiveness, high triglycerides and low high-density lipoprotein, the so-called
“good” cholesterol. According to Dr. Saunders, all of these subgroups represent a large pull apart of the hypertensive population
in the U.S. They may require two or more medicines to reach a pleasing blood arm-twisting goal.

Dr. Saunders says the medication was the only factor being tested in the study. There was no stab to adjust slim or
employ, which can also guide blood pressure. “It is so so to say that this subdue was almost solely in arrears to the drug
treatment,” says Dr. Saunders.

The patient subgroups in the writing-room showed similar results. Exchange for example, in the older band of people age 65 and over,
the intermediate systolic blood pressure at the start of the trial was 157. At the end of ten weeks, average systolic blood burden
was down 14.9 points. At the conclusion of the on at week 18, after patients had received a higher dose of the combination
medicament, their systolic readings had dropped an unexceptional of 23 points, to 134.
In the African-American subgroup, blood pressure dropped 20.7 points by the end of the muse about to an average systolic
reading of 135.2.

The Hispanic/Latino subgroup had a drop in systolic blood pressure from an ordinary of 154.5 to 131.8 by the end of
the study. Patients with Type 2 diabetes showed an average drop of 18.2 points. The customarily systolic blood pressure of the
women enrolled in the work dropped from 153.9 to 131.

“We believe this aggregation will be advantageous for many people who have not been able to accomplish their blood pressure
below control,” says Dr. Saunders, who adds that there is a major want for bigger therapies since simply at hand entire-third of
people with hypertension are able to talk about it under control.

The look at was funded by the Bristol-Myers Squibb/Sanofi-Synthelabo Partnership. They are makers of AVALIDE®, the
irbesartan-hydrochlorothiazide conjunction medicine used in the observe.

UNIVERSITY OF MARYLAND MEDICAL NEWS

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The “thick political wall” that pharmaceutical companies have established in all directions from US medication prices “is showing cracks” after former…. FDA Commissioner David Kessler on Tuesday testified at a Senate Healthfulness, Upbringing, Labor and Pensions Panel hearing that remedy drug reimportation “can’t be stopped,” according to a Los Angeles Times editorial. However, a “crack in the wall is not a go,” and those who have opposed legislation to legalize reimportation — such as a gang of congressional Republicans — or called because more study of the pursuit — such as President Bush — “now may go to a fallback, momentous for ‘compromise’ bills designed to be circumscribed and ineffective,” the editorial states. In addition, although reimportation legislation has the stand of a number of lawmakers, such bills “seldom surface to a attest to at all” in Congress, the editorial states. But, the leader states, reimportation legislation likely would pass if congressional leaders allowed a vote. The article adds, “If Bordello leaders decline to haversack a settled House-Senate congress council with importation enemies,” a “good irrefutable bill pass on be sent to the president’s desk,” and Bush conceivable would not emanate the first veto of his presidency to “keep drug prices violent.” According to the op-ed article, the legalization of reimportation likely would usher to reduced prescription drug prices, and pharmaceutical companies would “have to figure entirely the premium that U.S. consumers would be willing (not forced) to takings in the interest the convenience of buying American” (Los Angeles Times, 4/22).

“Reprinted with leniency from kaisernetwork.org kaisernetwork.org. You can way of thinking the entire Kaiser Daily Well-being Policy Report, search the archives, or sign up to email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Vigour Tactics Reveal is published for kaisernetwork.org, a vacant handling of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights guarded.

A study of ankylosing spondylitis (AS) patients treated with Abbott’s HUMIRA® showed a decrease in the rate of uveitis flares by generally half compared to patients treated with placebo. Ankylosing spondylitis is an rebellious infection of the spine, and may also be associated with other inflammatory diseases of the skin, eyes, and intestines. Uveitis, or sore of the eye, occurs in up to 40 percent of people with AS, and can lead to plain and painful symptoms, including scrutinize devastation and blindness. These data were presented at the American College of Rheumatology Annual Scientific Meeting in Boston.

The RHAPSODY (Review of safe keeping and effectiveness witH Adalimumab in Patients with animated ankylosing SpOnDYlitis) trial was designed to pump the effectiveness of HUMIRA in treating the signs and symptoms of AS in patients with active condition despite previous standard treatment. The 1,250 case trial also included a subset of patients (n=274) with uveitis. Results of the trial suggested that the number of uveitis flares was reduced in patients with active AS treated with HUMIRA.

In the incipient, multi-national, start-peg trial, adult patients with bustling AS who had insufficient responses to prior non-steroidal anti-inflammatory pharmaceutical (NSAID) analysis received open-label HUMIRA 40 mg subcutaneously every other week as 12 weeks. Patients with symptomatic uveitis at baseline and/or in the previous year received the changeless regimen for the sake of a total of 20 weeks. Evaluations of treatment effects were measured at weeks 2, 6, 12 and week 20, if applicable.

This breakdown measured the number of ingenious flares during treatment with HUMIRA both because of all patients in the bad and in the interest patients with pre-known history of uveitis. The rate was calculated as flares per 100-pertinacious-years (100-PYs), which set forth the number of flares that would materialize in 100 patients observed or treated for one year. The classify of uveitis flares was reduced by generally half during treatment with HUMIRA compared with the rate prior to the venture (15 flares/100-PY to 7.4 flares/100-PY in the in one piece trial population, 68.4 flares/100-PY to 28.9 flares/100-PY in the subset with a history of uveitis).

Complete, 27 adverse events of uveitis were reported on 25/1,250 patients. Two of the 25 patients experienced an attack of uveitis for the treatment of the first time. In both patients, the accepted AS disease pursuit was high at time of the anterior uveitis instalment.

“Uveitis is a fairly common and potentially straight-faced complication of ankylosing spondylitis,” said Martin Rudwaleit, M.D., of the Charité University Hospital in Germany and inveigle author of the contest. “This study is an example of the research needed to better understand this equip and the collide with it has on these patients.”

About RHAPSODY

RHAPSODY (Review of safety and effectiveness witH Adalimumab in Patients with active ankylosing SpOnDYlitis) is a future, multi-governmental, munificent-characterization trial designed to vet the effectiveness of HUMIRA in treating the signs and symptoms of the disease in a large number of patients (n=1,250) with active AS despite previous standard treatment, including patients with uveitis (n=274), in real-life clinical practices.

About Uveitis

There are three different types of uveitis based on the function of the eyeball involved, including anterior, tail or intermediate. Intense anterior uveitis occurs in up to 40 percent of patients with AS. Symptoms include anguish, gentle tender-heartedness, blurry vision or reduced vision; severe complications may include extraordinary eye persuade, cataracts, or glaucoma, which can do the groundwork to perpetual loss of vision.

About Ankylosing Spondylitis

Ankylosing spondylitis (AS) is a category of arthritis that primarily causes inflammation of the spine. Ankylosing means “stiff or rigid” and spondylitis means “inflammation of the vertebrae.” Advanced AS can lead to advanced bone formation on the barb causing the barb to fuse in a anchored position. Typically, the first symptoms of AS are gradual and can allow for frequent vexation and stiffness in the lower back and buttocks. In addition to back pain, other symptoms can group sore of joints or tendons, weight loss, fatigue, and eye redness (uveitis).

AS affects an estimated 129 out of 100,000 people in the United States and commonly develops between the ages of 15 and 40. Men are three times more likely than women to develop AS. Although the course and severity of AS varies from woman to person, some patients with step by step AS can develop spinal deformities matchless to valuable impairment.

The source of AS is not known, albeit genetics may fidget with a role: 90 percent of people with AS share a joint genetic marker, but having this genetic marker does not capital a bodily will evolve the disease.

Important Cover Information

Serious infections, sepsis, tuberculosis (TB) and opportunistic infections, including fatalities, have been reported with the handling of TNF-blocking agents, including HUMIRA. Many of these serious infections force occurred in patients also taking other immunosuppressive agents that in annex to their underlying disease could predispose them to infections. Infections have also been reported in patients receiving HUMIRA alone. Treatment with HUMIRA should not be initiated in patients with animated infections. TNF-blocking agents, including HUMIRA, have been associated with reactivation of hepatitis B (HBV) in patients who are dyed in the wool carriers of this virus. Some cases deliver been fatal. Patients at jeopardy for HBV infections should be evaluated for previously to basis of HBV infections before initiating HUMIRA. The combination of HUMIRA and anakinra is not recommended and patients using HUMIRA should not admit live vaccines.

More cases of malignancies oblige been observed amidst patients receiving TNF blockers, including HUMIRA, compared to hold sway over patients in clinical trials. These malignancies, other than lymphoma and non-melanoma skin cancer, were similar in type and digit to what would be expected in the sweeping population. There was an roughly 3.5 fold higher rate of lymphoma in combined controlled and uncontrolled outspread-marker portions of HUMIRA clinical trials. The the right stuff role of TNF- blocking therapy in the development of malignancies is not known. TNF-blocking agents, including HUMIRA, include been associated in rare cases with demyelinating illness and severe allergic reactions. Infrequent reports of serious blood disorders take been reported with TNF-blocking agents.

Worsening congestive heart fizzle (CHF) has been observed with TNF-blocking agents, including HUMIRA, and new hit CHF has been reported with TNF-blocking agents. Treatment with HUMIRA may fruit in the production of autoantibodies and rarely, in development of a lupus-equal to syndrome.

The most attend regularly adverse events seen in the placebo-controlled clinical trials in adults with rheumatoid arthritis (HUMIRA vs. placebo) were injection site reactions (20 percent vs. 14 percent), more elevated respiratory infection (17 percent vs. 13 percent), injection plot pain (12 percent vs. 12 percent), headache (12 percent vs. 8 percent), ill-considered (12 percent vs. 6 percent) and sinusitis (11 percent vs. 9 percent). Discontinuations due to adverse events were 7 percent for HUMIRA and 4 percent destined for placebo. As with any treatment program, the benefits and risks of HUMIRA should be carefully considered in the forefront initiating psychoanalysis.

In HUMIRA clinical trials for ankylosing spondylitis, psoriatic arthritis and Crohn’s disease, the safety clear for of age patients treated with HUMIRA was similar to the safety profile seen in adult patients with rheumatoid arthritis.

About HUMIRA

HUMIRA is approved for the treatment of adults with rheumatoid arthritis, psoriatic arthritis (PsA), ankylosing spondylitis (AS) and Crohn’s contagion in the Combined States and in Europe. HUMIRA resembles antibodies normally institute in the richness. It works by blocking tumor necrosis factor alpha (TNF-α), an inflammatory protein that, when produced in excess, plays a key job in the inflammatory responses of autoimmune diseases.

Earlier this year, HUMIRA received FDA good of facts in the Clinical section of the label regarding the long-come to contribution of efficacy to 5 years with respect to clinical reaction, woman function and radiographic response in patients with rheumatoid arthritis. To date, HUMIRA has been approved in 67 countries and more than 190,000 people worldwide are currently being treated with HUMIRA. Clinical trials are currently under distance evaluating the potential of HUMIRA in other immune-mediated diseases.

In the U.S., HUMIRA is approved by the FDA for reducing signs and symptoms, inducing foremost clinical response, inhibiting the progression of structural bill, and improving physical take the role in grown up patients with sort of to severely animated RA. HUMIRA is indicated after reducing the signs and symptoms of vigorous arthritis, inhibiting the succession of structural damage and improving natural function in patients withp soriatic arthritis. HUMIRA can be used desolate or in solution with methotrexate or other disease-modifying anti-rheumatic drugs (DMARDs). HUMIRA is also approved for reducing signs and symptoms in patients with active AS.

Earlier this year, HUMIRA was approved for reducing the signs and symptoms and inducing and maintaining clinical abatement in adults with to a degree to severely active Crohn’s disease who have had an inadequate response to conventional therapy, and reducing the signs and symptoms and inducing clinical deliverance in these patients if they have also lost response to or are intolerant to infliximab.

Abbott’s Commitment to Immunology

Abbott is focused on the discovery and development of innovative treatments for immunologic diseases. The Abbott Bioresearch Center, founded in 1989 in Worcester, Massachusetts, Mutual States, is a world-class determining and basic investigating facility supporting scrutinize and improvement of biologic treatments. Abbott Biotechnology Limited, which opened April 10, 2007, in Barceloneta, Puerto Rico, is the electric cable television facility for HUMIRA.

About Abbott

Abbott is a far-reaching, broad-based health care guests devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals and devices. The company employs 65,000 people and markets its products in more than 130 countries

Abbott

http://www.abbott.com

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