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Heart disease researchers nationwide gathered recently in Atlanta to share the latest findings in heart disease management with their peers at the 72nd Annual American Heart Association (AHA) Scientific Session. Heart disease remains one of this aging nation’s most costly killers. The studies summarized below offer case managers valuable information on how to achieve better outcomes for their patients.
A glimmer of HOPE
Researchers released data from the HOPE (Heart Outcomes Prevention Evaluation) Study, which clearly show that the antihypertensive drug ramipril could prevent cardiovascular deaths, heart attacks, and stroke in 22% of patients at risk for cardiovascular disease.
"We consider these results amazing," says Salim Yusuf, MD, HOPE Study chairman and professor of medicine at McMaster University in Hamilton, Ontario, Canada. "Based on the findings of HOPE, we believe that if ramipril is used in the appropriate patients we could prevent more than 1 million premature deaths, heart attacks, and strokes each year. This news gives great hope to everyone with heart disease or those at risk for heart disease, particularly those with diabetes."
The study was conducted in 267 centers in 19 countries over four-and-half years and included more than 9,500 patients with a history of coronary artery disease, peripheral vascular disease, or individuals with diabetes who are at high risk for cardiovascular problems. The study examined ramipril, an angiotensin-converting-enzyme inhibitor vs. placebo in reducing cardiovascular events. It also examined the use of vitamin E versus placebo on heart disease and cancer. The vitamin E arm of the study will continue for several more years.
The numbers speak
Study findings include:
• The combined rate of heart attack, stroke, and cardiovascular death was 13.9% in the ramipril treatment group and 17.5% for the placebo group, with a 22% relative risk reduction. The individual relative risk reductions in this composite endpoint were: 25% reduction in cardiovascular death, 20% reduction in nonfatal heart attacks, and 32% reduction in nonfatal strokes.
• The rate of revascularization procedures, such as coronary angioplasty, coronary artery bypass graft, and peripheral angioplasty, was 15% lower in patients receiving ramipril.
• Significantly fewer people in the ramipril group developed diabetes compared to those in the placebo group.
• The rate of new and worsening congestive heart failure was 7.4% in the ramipril group and 9.4% in the placebo group, with a 22% risk reduction.
Ramipril is marketed in the United States under the brand name Altace, manufactured by Monarch Pharmaceuticals in Bristol, TN.
Researchers released findings from the second heart failure study comparing the high blood pressure medicine losartan potassium to captopril, an ACE inhibitor. ACE inhibitors are currently considered the standard in heart failure treatment.
The 3,152-patient study was designed to eval uate whether losartan potassium, the first and most widely prescribed angiotensin-II antagonists (AIIAs) for hypertension was superior to captopril at reducing deaths in patients with heart failure. The study also assessed whether losartan potassium was better tolerated than captopril.
The study, called ELITE II, was conducted after results of a smaller trial known as ELITE showed superior survival benefits and tolerability for patients taking losartan potassium compared to patients taking captopril. Neither losartan potassium nor any other AIIA is currently approved for the treatment of heart failure in the United States.
"ELITE II did not confirm the survival advantage seen for Cozaar [losartan potassium] over captopril in the earlier ELITE study," said Bertram Pitt, MD, professor of medicine in the department of internal medicine at the University of Michigan in Ann Arbor, who presented the study findings in Atlanta. "In both studies, however, Cozaar was better tolerated than the ACE inhibitor, with significantly fewer patients stopping therapy due to adverse experiences such as persistent cough."
Cozaar is manufactured in the United States for Merck & Co. in West Point, PA, by DuPont Pharma in Wilmington, DE. Based on the results of ELITE II, Merck will not seek regulatory approval for Cozaar in heart failure in the United States. Merck will request removal of first-line indication in any country where Cozaar is approved for first-line use in heart failure.
Study findings showed no statistically significant difference between Cozaar and captopril in reducing overall deaths or in reducing sudden cardiac deaths or resuscitated cardiac arrest. Findings include:
• 250 patients, or 15.9% of the 1,574 patient captopril group died during the two-year trial, vs. 280 patients or 17.7% of the Cozaar group.
• 228 patients, or 14.5% of the captopril group discontinued therapy due to an adverse experience during the trial, compared to 149 patients, or 9.4% of the Cozaar group.
Survey shows need for education
A national antihypertensive medication survey released by the Association of Black Cardiologists reveals that nearly four out of every 10 patients being treated for high blood pressure may stop taking their medication due to drug tolerability problems. Researchers also told attendees at the recent Atlanta meeting that 95% of patients believe that their blood pressure is under control, yet 35% of patients report elevated or uncontrolled systolic blood pressure, suggesting that this leading cause of cardiovascular morbidity and mortality is poorly understood by many patients.
Researchers surveyed both patients and physicians. Both qualitative and quantitative research methods were used with each audience. The patient research consisted of a small-scale, telephone-based, qualitative study of 20 clinically diagnosed, hypertensive patients. Findings from that research were used to design a more in-depth telephone questionnaire. The survey gathered information from 314 patients for the quantitative questionnaire.
The physician audience included primary care physicians and cardiologists. The qualitative phase included telephone interviews with 12 physicians. The resulting structured questionnaire was completed by 101 physicians.
• 36% of patients treated for hypertension reported changing their medications at least once because of the severity of side effects.
• 13% of patients reported their current medication dosage had to be adjusted at least once due to adverse events.
• Younger patients, defined as those under age 54, are more likely than their older counterparts to report that side effects have a significant impact on their life.
• 44% of African-American patients, compared to 31% of Caucasian patients, reported systolic reading greater than 140 mm Hg.
• More than 50% of physicians surveyed reported believing that controlling systolic pressure is the most important goal in treating elderly hypertensives compared to roughly 20% who reported that controlling diastolic pressure is the most important goal of therapy.
Researchers noted that systolic pressure is a major predictor of cardiovascular disease and concluded that there is a great need to do a better job controlling systolic pressure in key patient groups. They also noted that the survey indicates a need to better educate both patients and physicians about what constitutes elevated hypertension.
When questioned about treatment regimen, physicians reported the following:
• Thirty-nine percent of patients receive combination therapy.
• The most commonly prescribed class of medication is the ACE inhibitor, prescribed to 31% of patients.
• Of patients treated with beta-blockers, the average percentage of patients experiencing fatigue as a side effect is 34%.
• Of patients treated with diuretics, the average percentage of patients having electrolyte imbalance as a side effect is 30%.
• Of patients treated with calcium channel blockers, the average percentage of patients having edema as a side effect is 26%.
• Of patients treated with ACE inhibitors, the average percentage of patients having cough as a side effect is 21%.
Toprol-XL increases survival
Adding the beta-blocker Toprol-XL manufactured by AstraZeneca in Wayne, PA, to standard treatment in patient with congestive heart failure who participated in the Metropolol CR/XL Randomized Intervention Trial in Heart Failure (MERIT-HF) reduced all-cause mortality and hospitalizations for heart failure by 31%, researchers told their colleagues at the AHA meeting.
Toprol-XL also reduced the combined endpoint of death and the number of patients requiring heart transplantation by 32%.
Nearly 4,000 patients with moderate-to-severe heart failure from 14 countries participating in the MERIT-HF study were randomized to once-daily doses of placebo or Toprol-XL.
• 34% reduction in overall death rate;
• 41% reduction in sudden deaths;
• 49% reduction in heart failure deaths.
The study found that the addition of Toprol-XL benefited patients regardless of the severity of the disease, with similar response patterns for patients in New York Heart Association (NYHA) classes II, II, and IV. In addition, patients in the Toprol group improved significantly in both NYHA class and self-reported quality of life.
Studies find enoxaparin sodium saves lives
Results of two multicenter studies reported found that patients hospitalized in the United States with medical illnesses including acute heart failure benefit from treatment with the blood thinner Enoxaparin sodium (enoxaparin sodium) injection to prevent life-threatening blood clots.
The MEDENOX (MEDical patients with ENOx aparin) trial included 1,102 patients and compared two regimens of the low-molecular-weight heparin enoxaparin sodium (20 mg and 40 mg given subcutaneously once daily) with placebo for prevention of venous thromboembolism (VTE) in acutely ill patients. The study demonstrated that 40 mg of enoxaparin sodium given subcutaneously once daily for six to 14 days significantly reduced the risk of VTE in patients with congestive heart failure as well as patients with other medical illnesses, including respiratory failure and infectious disease. Efficacy results indicate that at day 14, the overall incidence of VTE was 4% in the enoxaparin sodium group compared to 14.6% in the placebo group. The MEDENOX study found no reduction in the rate of VTE in the patients treated with 20 mg of enoxaparin sodium compared with placebo.
The PRINCE (Prevention IN Cardiopulmonary Disease with enoxaparin) trial 665 patients in two sub-studies (PRINCE I and PRINCE II) compared enoxaparin sodium 40 mg once daily with unfractionated, or standard, heparin for the prevention of VTE. The PRINCE I study included 332 patients hospitalized for respiratory disease. The PRINCE II study included 333 patients hospitalized for heart failure.
The PRINCE II investigators found that the incidence of VTE was 9.7% in enoxaparin sodium patients, compared to 16.1% in the standard heparin group. In addition only five patients in the enoxaparin sodium group experienced minor hemorrhage compared to 12 patients in the standard heparin group. The PRINCE I and II studies found that the incidence of VTE was 12.6% in heart failure patients compared to 6.5% in respiratory patients.
Add acetaminophen to your arsenal
Research from Baylor College of Medicine in Houston suggests that acetaminophen may help protect against atherosclerosis, or hardening of the arteries, adding an inexpensive new weapon to the war against heart disease in the United States. In a 12-week study of rabbits, the Baylor team found that acetaminophen exerts an anti-atherosclerotic effect when administered in doses therapeutically relevant to man.
"Last year, we reported findings in healthy human volunteers indicating that acetaminophen may have a potential antioxidant effect," Addison A. Taylor, PhD, professor of medicine and pharmacology and chief of the division of hypertension and clinical pharmacology at Baylor, told colleagues at the AHA conference. "We documented an association between the use of acetaminophen at recommended doses and a significant inhibition of the oxidation of certain low-density lipoprotein (LDL) components, which carry the form of cholesterol commonly described as bad cholesterol."
Taylor and his team induced above-normal levels of cholesterol in rabbits, half of which received doses of acetaminophen comparable to the recommended doses for humans. "At the end of the 12-week study, we examined the rabbits for evidence of fatty streaking in the aorta, an early manifestation of atherosclerosis. The rabbits that received acetaminophen had 50% less fatty streaking compared with controls," says Taylor.
Compliance causes costs to nosedive
Patients with untreated severe high blood pressure can run up an average of $14,582 annually in medical bills due to complications and illness. On the other hand, researchers who met in Atlanta report that it costs an average of $895 annually to effectively treat those patients.
The study examined an extensive pool of data from 2,500 patients at seven managed care and preferred provider organizations, as well as the Framingham Heart Study and other resource databases to calculate the average cost of treating hypertension. Researchers believe that the costs suggest the most successful practice for the treatment of hypertension will be to educate physicians, pharmacists, and patients on the importance of aggressive diagnosis, treatment, and therapy compliance.
The AHA has identified noncompliance as a national hidden health threat. The organization recently launched an aggressive compliance awareness and education program called the Compliance Action Program. The program targets physicians, allied health professionals, and patients. Two key elements of the program are a "Physician’s Compliance Tool Kit" and a new patient brochure, Knock Out America’s Hidden Health Threat.
The tool kit includes educational materials to help providers teach their patients how to follow a health regimen. The companion patient booklet contains consumer-friendly information on the benefits of compliance, compliance tips, an inventory of compliance tools, questions to ask their physician, and a wallet card to track prescription medications, cholesterol level, blood pressure and weight.
The materials are free. To order call (800) 242-8721. The compliance information is also available on the Internet at www.americanheart.org/CAP.