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January 11, 2013

Breakthroughs in Research and Clinical Practice Helping Patients

Patient Education
Pharmaceutical and medical device companies make significant breakthroughs in research to develop innovative treatments and technologies that have prolonged the lives of millions of Americans and made millions more live healthier, pain free lives.  Consequently, several recent articles have underscored the critical contributions such companies and their products have had on in several disease areas including Crohn’s disease, hypertension, and cholesterol. 

Crohn’s Disease 

A recent article from Med Page Today reported that “Patients with treatment-refractory Crohn's disease obtained long-term improvement when treated with the investigational agent vedolizumab, which selectively targets lymphocytes in the gut, according to results of a randomized, placebo-controlled trial.” 

Almost twice as many patients achieved clinical remission after 52 weeks of maintenance therapy with vedolizumab compared with placebo.  Additionally, 50% more patients treated with vedolizumab had at least a 100-point improvement in the Crohn's Disease Activity Index (CDAI), and twice as many achieved corticosteroid-free remission, as reported here at the American College of Gastroenterology meeting.  The study was supported by Millennium Pharmaceuticals. 

Hypertension, Blood Pressure 

A second article from Med Page Today reported that “Americans are using more antihypertensive drugs, and more drugs in combination, a trend that is paying off with better control of hypertension.”  In the first decade of the 21st century the number of patients using multiple agents jumped from 36.8% in 2001 to 47.7% in 2010 (P<0.01), according to Qiuping Gu, MD, PhD, of the CDC's National Center for Health Statistics in Hyattsville, Md., and colleagues. 

Compared with monotherapy, single-pill combinations and multiple-pill combinations were associated with 55% and 26% relative increases, respectively, in the likelihood of achieving blood pressure control (P<0.05 for both), the researchers reported online in Circulation: Journal of the American Heart Association

“The value of using multiple antihypertensive drugs [is that it] improves the overall efficacy of drugs, reduces dose-dependent side effects, and increases patients' adherence to medication regimens,” the authors wrote. 

Gu and colleagues analyzed data on 9,320 adults with hypertension who participated in one of the National Health and Nutrition Examination Survey (NHANES) cycles from 2001 to 2010, covering years both before and after publication of the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7) in 2003.

Hypertension was defined as a systolic blood pressure of 140 mm Hg or higher, a diastolic pressure of 90 mm Hg or higher, or an answer of yes to the question, “Because of your hypertension/high blood pressure are you now taking prescribed medicine?

Blood pressure control was defined as a systolic blood pressure of less than 130 mm Hg and a diastolic pressure of less than 80 mm Hg for patients with diabetes or chronic kidney disease or a systolic pressure of less than 140 mm Hg and a diastolic pressure of less than 90 mm Hg for others. 

Overall, the rate of antihypertensive medication use increased from 63.5% in 2001-2002 to 77.3% in 2009-2010 (P<0.01), primarily attributed to an increase in the percentage of patients taking more than one medication.  Use of thiazide diuretics, beta-blockers, ACE inhibitors, and angiotensin receptor blockers increased by a relative 23%, 57%, 31%, and 100%, respectively, whereas use of calcium channel blockers remained relatively steady. 

The rate of hypertension control increased overall (28.7% to 47.2%, P<0.01) and among those patients who were taking medications (44.6% to 60.3%, P<0.01).  Although the overall trends were positive, certain disparities remained at the end of the study period.

Mexican Americans, for example, had lower rates of medication use and blood pressure control, which has been seen historically.  “Their being less likely to be prescribed medicine when hypertension is present, their higher reliance on monotherapy when medicine is prescribed, and their nonpersistence with prescribed medication regimens may all contribute to the inadequate blood pressure control seen among Mexican Americans,” the authors wrote. 

In addition, older patients were more likely to use medications, but less likely to achieve blood pressure control compared with their younger counterparts.  And finally, treated but uncontrolled hypertension was more common among those with diabetes and chronic kidney disease. 

“More efforts are needed to close the gap between treatment and control and to maximize the public health and clinical benefits among those high-risk subpopulations,” the authors wrote. 

They acknowledged that the findings may have been influenced by the definition of medication users as those who had used a drug in the month before the survey; those who had used an antihypertensive more than a month before the survey were considered nonusers.  Also, blood pressure measurements in NHANES were performed at a single time point, possibly resulting in misclassification of hypertension status. 

Improving Cholesterol 

Finally, a blog post from the New York Times reported on findings published in The Journal of the American Medical Association (JAMA), which showed “that the nation had reached its 2010 goal of getting the average total cholesterol level in adults below 200 milligrams per deciliter.”  Researchers examined a nationally representative sample of tens of thousands of Americans over the last two decades and recorded a decline of 10 points in average total cholesterol — to 196 mg/dL from 206 mg/dL. 

While the so-called bad cholesterol decreased, there was a slight uptick in HDL cholesterol, higher levels of which are associated with a reduced risk of heart disease. Triglycerides, which are also linked to heart disease, initially rose 5 points to 123 mg/dL from 1994 to 2002, then dropped to 110 mg/dL by the end of 2010. 

The study’s authors said they were buoyed by their observations, but could not provide a solid explanation for them.  “The popularity of cholesterol-lowering drugs like statins was only part of the explanation, they said.  Their use more than quadrupled among adults during the study period, to 15.5 percent from 3.4 percent.  As many as 35 percent of men and women over 50 took them, the study found.” 

But the same improvements in cholesterol profiles were also seen in adults who were not taking them, said Margaret D. Carroll, the study’s lead author and a statistician with the National Health and Nutrition Examination Survey at the Centers for Disease Control and Prevention.  “It was somewhat of a surprise to us to see these favorable trends in people who were not on lipid-lowering medications,” she said. 

The study was observational, which means it could not prove what caused the decline in cholesterol levels.  “Dr. Carroll and her colleagues said, however, that exercise, obesity and saturated fat intake were unlikely to have been significant factors.  Average physical activity levels have not increased, more than a third of the adult population is obese, and the intake of saturated fat as a percentage of calories in the American diet is the same as it was over a decade ago.” 

Instead they suggested widespread public health campaigns to rid trans fats from foods might have had an impact.  “The notion of trans fat consumption contributing to the fall in cholesterol numbers, while intriguing, has not been proven, said Dr. James A. Underberg of the NYU Center for the Prevention of Cardiovascular Disease.”  Two other trends in the last decade may have also been factors, the researchers said: declines in smoking and a drop in carbohydrate consumption. 

Dr. David J. Frid, a cardiologist at the Cleveland Clinic, said the findings were unexpected given the high rates of obesity and Type II diabetes.  He pointed to research showing a recent 30 percent drop in deaths from heart disease nationwide, and said the cholesterol data might be related. 

Dr. Underberg said that standard measures of cholesterol could be deceiving.  People who are obese or have Type II diabetes can have seemingly normal levels of LDL, but also have high amounts of the small LDL particles that drive into artery walls and cause heart disease.

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