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| |  Nearly 19 Million Hypertensive Patients May Have Significant Drug-Tolerability Problems ATLANTA, GA -- November 10, 1999 -- A national antihypertensive medication survey released in a symposium sponsored by the Association of Black Cardiologists, Inc. (ABC), revealed that nearly four out of every 10 patients (38 percent) being treated for high blood pressure may stop taking their medication due to drug tolerability problems. The survey also found that 95 percent of patients believe that their blood pressure is under control yet, 35 percent of these patients reported elevated or uncontrolled systolic blood pressure above 140 mm Hg, suggesting that elevated systolic blood pressure -- the leading cause of cardiovascular morbidity and mortality -- is misunderstood among patients.
"This survey highlights the extent of the tolerability problem in hypertension which is widespread among all patient populations and underscores the need for the medical community to continue searching for pharmacological alternatives," says Dr. Frank James, President of the Association of Black Cardiologists, Inc. "Surprisingly, the survey also presents some new challenges in treating high blood pressure because the findings show that elevated systolic blood pressure is not being controlled to the recommended levels." The survey, released by ABC, demonstrates that among patients being treated for hypertension, 36 percent have changed medications at least once because of the severity of side effects. Also, 13 percent of respondents stated that their current medication dosage had to be adjusted, at least once, because of adverse events. The most commonly reported side effects were fatigue (22 percent), and dizziness (21 percent). African American respondents were significantly more likely to experience the side effects of headache, potassium loss and weakness compared to Caucasian respondents. The survey also finds that younger patients (ages 25-54) are significantly more likely than their older counterparts (age 55 and up) to characterize side effects as having a significant impact on their life. The ABC survey confirms recent trends from the Third National Health and Nutrition Examination Survey (NHANES-III) that demonstrate a downward trend in hypertension awareness, treatment, and control among patients. Phase 2 of the NHANES (1991-1994) revealed that among high blood pressure patients, there is a decrease in awareness of hypertension (68 percent in 1994 vs. 73 percent in 1991). Similarly, treatment rates have declined from 65 percent in 1991 to 54 percent in 1994 and high blood pressure control (achieving target measurements within the normal range) has declined from 29 percent in 1991 to 27 percent in 1994. The survey reports that on average, 30 percent of patients have been diagnosed with isolated systolic hypertension (ISH) per physician practice. ISH -- a condition that exists when the systolic pressure is higher than 140 mm Hg with a diastolic pressure that is less than 90 mm Hg -- is the most common form of high blood pressure in older Americans. ISH affects more than three million people over the age of 60. More than half of physicians surveyed (52.5 percent) believe that controlling systolic pressure is the most important goal in treating elderly hypertensives. Conversely, nearly 20 percent believe that diastolic control is the most important goal of therapy. The ABC survey also found that 44 percent of African Americans vs. 31 percent of Caucasians reported systolic readings > 140 mm Hg. Similarly nearly 40 percent of the diabetic patient population reported a reading above 140 mm Hg. "Systolic blood pressure is a major predictor of cardiovascular diseases and this survey underscores the need to do a better job at controlling systolic blood pressure in key patient groups," says Dr. Domenic Sica, chairman of Clinical Pharmacology and Hypertension at the Medical College of Virginia of Virginia Commonwealth University. "Clearly, these new results also indicate a greater need to educate patients on what constitutes elevated hypertension, including systolic blood pressure." A study conducted in 1991, called the Systolic Hypertension in the Elderly Program (SHEP), reported a significant reduction in stroke and coronary events with successful lowering of systolic blood pressure to below 140 mm Hg through drug therapy. SHEP proved that ISH is not a normal part of the aging process, but a strong indicator of increased cardiovascular risk. The physician component of the survey also confirmed that the tolerability problem extends beyond side effects. Seventy-five percent of treating physicians reported that drug-drug interactions are a common problem with their patients. Conversely, 88 percent of respondents in the patient arm of the study stated that they had little drug-drug interaction problems. "Physicians are very concerned about drug-drug interactions, while patients are generally not aware of the significant problems that concomitant drug regimens can create," added Dr. James. "The ABC survey reinforces that the tolerability problem extends beyond common side effects or adverse reactions in the hypertensive patient." In addition to their hypertension treatments, the research revealed that most hypertensive patients take 2 or more additional medications. Forty-six percent take two to three other medications while 36 percent take three to five other medications. Because of this drug-drug prevalence, 95 percent of physicians reported that the method of elimination is an important consideration in their selection of anti-hypertensive medication. Most drugs are either eliminated through the liver or the kidney. Those that have a dual elimination process are often preferred because they lower the likelihood of toxicity if one or the other organ is functionally impaired. Combination therapy is the most common treatment regimen. Physicians who were surveyed indicated that, on average, 39 percent of their patients receive combination therapy. The most commonly prescribed class of medication is the ACE inhibitors (prescribed to 31 percent of patients). ARBs are the least commonly prescribed treatment class (prescribed to 11 percent of patients). Cardiologists are, however, more likely to prescribe ARBs than general practitioners (14 percent vs. 9 percent respectively). Most physicians surveyed reported having to switch a patient's medication at least once to address efficacy. According to the survey, diuretics (46.5 percent) are the most likely to be changed because of efficacy problems, followed by beta blockers (21.8 percent), calcium channel blockers (15.8 percent), ACE inhibitors (9.9 percent) and ARBs (5.9 percent). Interestingly, almost one quarter of the physicians believe that ARBs are the most likely medication to be stopped because of adverse events or side effects. However, these same physicians reported the fewest efficacy problems and lowest level of drug interactions with ARBs. According to Dr. Sica this is not necessarily a contradiction. "ARBs are a relatively new classification of hypertensive drugs," says Sica. "Many physicians have not used them long enough to understand them. If an adverse event occurs when patients are being treated with a new drug, physicians will likely assume it is caused by the new treatment even if the reaction is unrelated. However, numerous clinical studies have showed us that ARBs have a tolerability profile similar to or better than placebo; therefore, it is necessary to translate this knowledge into clinical practice." Physicians also indicated the percentage of patients in their practice that experience the most common and specific side effect in conjunction in each drug class*: -- Of patients treated with beta-blockers, the average percentage of patients having fatigue as a side effect is 34 percent. -- Of patients treated with diuretics, the average percentage of patients experiencing electrolyte imbalance as a side effect is 30 percent. -- Of patients treated with calcium channel blockers, the average percentage of patients having edema as a side effect is 26 percent. -- Of patients treated with ACE inhibitors, the average percentage of patients having cough as a side effect is 21 percent. -- Of patients treated with ARBs, the average percentage of patients having cramping as a side effect is 7 percent.
The study was comprised of two audiences, patients and physicians, and utilized two key research methods, qualitative and quantitative, with each audience. The patient research consisted of a small-scale, telephone-based, qualitative study with 20 clinically diagnosed, hypertensive patients. Findings from the qualitative research were used to design a more in-depth The physician audience primarily consisted of primary care physicians and cardiologists. Again, a two-phase research approach was utilized. The qualitative research consisted of 12 telephone interviews with physicians. Following the completion of the qualitative research, a structured questionnaire was conducted among 101 physicians representing five physician groups (cardiology, internal medicine, family/general practice, nephrology and geriatrics). * Based on clinical standards, placebo-related side effects are generally found between 4 percent to 7 percent of patients. These findings should be interpreted in this context.
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