Abstracts: 2005-2007
2007
Accepted for presentation
Gender Alters the Responsiveness of Multiple Cardiovascular Disease Risk Factors to a Lifestyle Management and Risk Reduction Program in Participants With Prehypertension
Neil F. Gordon, MD, PhD, MPH, Chief Medical and Science Officer, Nationwide Better Health and INTERxVENT USA, Inc.; Richard D. Salmon, DDS, MBA, Executive Vice President, INTERxVENT USA, Inc.; Kevin S. Reid, Consultant, INTERxVENT USA, Inc.
Rationale: Prehypertension is associated with the presence of other cardiovascular disease (CVD) risk factors and with excess morbidity and mortality. In this study, we evaluated the effect of gender on the responsiveness of multiple CVD risk factors to a lifestyle management/risk reduction program in individuals with prehypertension.
Methodology: Subjects were 666 men and 1,812 women with prehypertension who were not taking antihypertensive medications and did not have known CVD, diabetes, or chronic kidney disease. Subjects were evaluated at baseline and after ~ 6 months of participation in a lifestyle management/risk reduction program. Lifestyle intervention included exercise training, nutrition, weight management, and smoking cessation interventions. Although participants did not receive antihypertensive medication, they were referred to their physicians for consideration of medication changes for the modification of other risk factors in accordance with national guidelines.
Results: For participants with abnormal baseline risk factors, clinically relevant improvements were observed for multiple variables in men and women, as follows (p <0.05): systolic/diastolic blood pressure (Males, -6/-5 mmHg; Females, -8/-6 mmHg); LDL cholesterol (Males, -21 mg/dl; Females, -13 mg/dl); HDL cholesterol (Males, 2 mg/dl; Females, 3 mg/dl); triglycerides (Males, -73 mg/dl; Females, -36 mg/dl); and weight (Males, -7.1 lbs; Females, -5.1 lbs). Whereas blood pressure was reduced to a greater degree (p <0.05) in females, LDL cholesterol, triglycerides, and weight were reduced to a greater degree (p <0.05) in males. In participants with a baseline 10-year Framingham coronary heart disease risk score >10%, the score decreased (p <0.05) by 15.5% in males and 19.3% in females (p=NS for males versus females).
Conclusions: This study is the first, to our knowledge, to show that while both males and females with prehypertension derive favorable improvements in multiple CVD risk factors by participating in a lifestyle management/risk reduction program, there are gender-related differences in therapeutic responsiveness.
Accepted for publication
Effect of Gender on Effectiveness of Therapeutic Lifestyle Changes in Men and Women With Prediabetes
Richard D. Salmon, DDS, MBA, Executive Vice President, INTERxVENT USA, Inc.; Neil F. Gordon, MD, PhD, MPH, Chief Medical and Science Officer, Nationwide Better Health and INTERxVENT USA, Inc.; William E. Saxon Jr., ASRT, Director, Information Technology, INTERxVENT USA, Inc.
Rationale: Prediabetes affects an estimated 54 million Americans. Prediabetes is a precursor of diabetes and a predictor of excessive risk for cardiovascular disease. Recent research has documented gender-related differences in the responsiveness of multiple cardiovascular disease risk factors to lifestyle and pharmacologic interventions. In this study of 967 men (n = 399; age = 56.9+11.5 years) and women (n =568; age = 55.4+11.4 years) with prediabetes, we evaluated the effect of gender on the effectiveness of therapeutic lifestyle changes (TLC) in normalizing fasting plasma glucose without using drug therapy.
Methodology: At baseline, all participants met the American Diabetes Association’s criteria for prediabetes (i.e., fasting plasma glucose = 100 to 125 mg/dl). Participants were evaluated at baseline and after an average of ~ 4 months of TLC. TLC included exercise training, nutrition, weight management, and smoking cessation interventions.
Results: In male participants, baseline fasting plasma glucose 108+6 mg/dl decreased by 5+13 mg/dl (p <0.001) with TLC. Similarly, baseline fasting plasma glucose 107+6 mg/dl decreased by 5+13 mg/dl (p <0.001) with TLC in female participants. Based on American Diabetes Association criteria, 172 (43.1%) men and 250 (44.0%) women normalized their fasting plasma glucose (i.e., fasting plasma glucose below 100 mg/dl) with TLC. Thus, both the magnitude of reduction in fasting plasma glucose and the percentage of participants who normalized their fasting plasma glucose with TLC did not differ significantly for male versus female participants.
Conclusions: The present study adds to previous research by reporting on the effectiveness (rather than the efficacy) of TLC in men and women with prediabetes. The data show that many individuals with prediabetes can normalize their fasting plasma glucose with TLC and, in contrast to certain other cardiovascular disease risk factors, there do not appear to be gender-related differences in responsiveness to TLC.
Accepted for presentation
Evaluation of a Novel Heart Rate Monitor: Comparison With Telemetry Electrocardiography
Richard Salmon, DDS; William Saxon, Jr, ASRT; Tiana Speight, BS; Ami Drimmer, PhD, Julie Blakely, BS; Megan Zamora, BS; Chip Faircloth, MHA; and Neil Gordon, MD. St. Joseph’s/Candler Health System, Savannah, GA and INTERxVENT Coordinating Center, Savannah, GA
Rationale: Heart rate is widely used as an index of intensity when prescribing exercise training for healthy individuals and, especially, cardiac patients. Accurate measurement is critical when using target heart rates to prescribe exercise intensity. Many commercially available heart rate monitors are limited by the need to wear a strap-like device around the chest.
Objectives: In this study of 10 participants in a phase 2 cardiac rehabilitation program and 10 non-cardiac rehabilitation participants, we evaluated the accuracy of a heart rate monitor (HRM) that uses blue LED technology to monitor heart rate with a finger- rather than a chestsensor device.
Methodology: Subjects were 20 male and female volunteers (age = 54+18 years; males = 11; females = 9). Subjects exercised for 20 minutes on a treadmill, at a speed and gradient that were individually regulated to achieve a perceived exertion rating of between 11 and 15 (Borg 6-20 scale), while wearing the HRM watch (Seiko-Epson Corporation, Japan) on their wrist and sensor device on their index finger. Heart rates were continually monitored during exercise using the HRM and telemetry electrocardiography (Scott Care, United States). Comparisons were made of heart rates recorded using the HRM and telemetry electrocardiography at 5, 10, 15, and 20 minutes of treadmill exercise.
Results: Perceived exertion ratings were 11+1, 12+1, 13+3, and 13+1 at 5, 10, 15, and 20 minutes of treadmill exercise, respectively. Heart rates were as follows:
| Time (mins) | Telemetry | HRM | P | R |
|---|---|---|---|---|
| 5 | 116 + 14 | 116+15 | NS | 0.990 |
| 10 | 126 + 21 | 129 + 21 | NS | 0.996 |
| 15 | 134 + 22 | 132 + 22 | NS | 0.989 |
| 20 | 136 + 25 | 134 + 24 | NS | 0.997 |
Conclusions: The present study documents the high degree of accuracy during treadmill exercise of a novel HRM that does not require the use of a chest device.
ACC Annual Meeting
Effect of Gender and Ethnicity on Effectiveness of Therapeutic Lifestyle Changes in Patients With Prehypertension
Venkata V. Bavikati, MBBS, MPH; Laurence S. Sperling, MD; Richard D. Salmon, DDS; George C. Faircloth, MHA; Terri L. Gordon; Barry A. Franklin, PhD; and Neil F. Gordon, MD. Emory University School of Medicine, Atlanta, GA and INTERxVENT Coordinating Center, Savannah, GA
Rationale: Although national clinical guidelines promulgate therapeutic lifestyle changes (TLC) as a cornerstone in the management of prehypertension, recent research has focused on the use of pharmacotherapy due to the perceived ineffectiveness of TLC.
Background: In this study of 2,478 ethnically diverse (African Americans, n = 448; Caucasians, n = 1,881) men (n = 666) and women (n =1,812) with prehypertension who were not taking antihypertensive medications (age = 48+10 years), we evaluated the clinical effectiveness of TLC in normalizing their blood pressure (BP) without using drug therapy.
Methodology: Subjects were evaluated at baseline and after an average of 6 months of participation in a community-based program of TLC. At baseline, all subjects met the criteria for prehypertension as defined by the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7). Subjects did not have known atherosclerotic heart disease, diabetes, or chronic kidney disease. TLC included exercise training, nutrition, weight management, and smoking cessation interventions.
Results: Baseline BP 125+8/79+3 mmHg decreased by 6+12/3+3 mmHg (p <0.001) with TLC. In subjects with a baseline systolic BP of 120-139 mmHg (n=2,082), systolic BP decreased by 7+12 mmHg (p <0.001) with TLC. In subjects with a baseline diastolic BP of 80-89 mmHg (n=1,504), diastolic BP decreased by 6+3 mmHg (p <0.001) with TLC. Based on JNC 7 criteria, 952 (39%) subjects normalized their BP with TLC (p <0.001). The magnitude of reduction in BP was similar in African Americans 7+12/5+3 mmHg and Caucasians 7+12/6+3 mmHg. In contrast, the magnitude of reduction in BP was greater (p <0.001) in women 8+12/6+3 mmHg versus men 6+11/5+3 mmHg.
Conclusions: The present study adds to previous research by reporting on the effectiveness (rather than the efficacy) of TLC in an ethnically diverse group of men and women with prehypertension. Although further research is warranted, these data show that while many patients with prehypertension can normalize their BP, there are gender-related differences in BP responsiveness to TLC.
The Definition for Risk Factors has a Significant impact on the Prevalence ff the Metabolic Syndrome
Thomas A Draper, Melvyn Rubenfire, University of Michigan Health System, Ann Arbor, MI; Richard Salon, Kevin Reid, William Saxon, George Faircloth, Brenda Wright, Richard Leighton, Barry Franklin, Neil Gordon, St. Joseph’s/Candler Health System and INTERxVENT Coordinating Center, Savannah, GA
Background: The metabolic syndrome (MS) is a constellation of interrelated cardiovascular disease (CVD) risk factors of metabolic origin. The AHA and NHLBI jointly recently revised the criteria to diagnose MS with changes in criteria for reduced HDL-C, hypertension, elevated glucose, and elevated triglycerides. Objective: To determine the impact the revision of the criteria had on the prevalence of MS.
Methods: The prevalence of MS was assessed in 19,097 individuals who had data for all 5 MS risk factors using both the AHA/NHLBI revised and nonrevised criteria. Subjects were 4,411 consecutive adult (age = 66±11 years) males (70.8%) and females who enrolled in a phase 2 cardiac rehabilitation program (Group A; CVD = 94.8%) and 14,686 consecutive adult (age = 48.9±12 years) males (25.9%) and females who enrolled in a national comprehensive lifestyle management/CVD risk reduction program (Group B; CVD = 10.1%). For the non-revised prevalence determinations for MS and its 5 individual components, MS risk factors were defined in accordance with the original ATP III Guidelines, with the exception of a fasting glucose 100 mg/dl rather than 110 mg/dl. The revised prevalence determinations included each parameter and medication use.
Results: The prevalence of MS in cardiac rehabilitation patients increased by about 25% using the revised criteria but remained at about 1/3rd of participants in the lifestyle/CVD risk reduction program.
Conclusion: 1) Whether the AHA/NHLBI ATP III revised or non-revised criteria are used, MS is commonly present at entry into lifestyle management/CVD risk reduction programs (especially a phase 2 cardiac rehabilitation program); 2) the implication of the AHA/NHLBI’s recent revisions depends on the precise population under evaluation; 3) the findings are particularly relevant to expectations from and comparing Results of programs, and when developing comprehensive risk reduction interventions with an emphasis on nutrition and exercise.
| Group | Prevalence of MS – Non-revised Criteria | Prevalence of MS – Revised Criteria | % Relative Increase in Prevalence |
|---|---|---|---|
| Group A | 48.7% (n = 2,105) | 59.6 % (n = 2,628) | 24.8% (p<0.001) |
| Group B | 31.6% (n = 4,641) | 34.1% (n = 5,004) | 7.8% (p<0.001) |
Self Reported Depression is Associated With Decreased but Considerable Benefit From Phase 2 Cardiac Rehabilitation
Melvyn Rubenfire, Thomas Draper, Katherine Smith, University of Michigan Health System, Ann Arbor, MI; Richard Salmon, Kevin Reid, William Saxon, George Faircloth, Brenda Wright, Richard Leighton, Barry Franklin, Neil Gordon, St. Joseph’s/Candler Health System and INTERxVENT Coordinating Center, Savannah, GA
Background: Depressed patients with cardiovascular disease (CVD) are less likely to take prescribed medications and adhere to appropriate lifestyle changes.
Objective: We sought to determine how depression impacts the benefit of a contemporary Phase 2 cardiac rehabilitation program (CRehab).
Methods: 14,007 participants in 37 centers in North America were stratified by self reported current or previous depression to compare the effect of CRehab on classic CVD risk factors. Risk factors were evaluated at baseline and after an average of 12 weeks of participation.
Results: Depression was present in 2,767 patients (19.75%) (mean age 64.2±11.5 years) and 11,240 had no depression (age 66.5±11.6 years). Those with depression at baseline were less likely to complete the exit evaluation (depression, 41.7% completion; no depression, 47.9% completion; P<.05). On exit from CRehab, improvements (each P<.05) in classic CVD risk factors were observed for participants with and without a self-reported history of depression who had abnormal baseline values based on national guidelines. Although highly relevant and significant, the magnitude of benefit in those with depression was less for reduction in total and LDL cholesterol, triglycerides, and diastolic BP. Patients with depression were more often current cigarette smokers at program entry (depression, 10.6%; no depression, 5.7%; P<.05); however, both groups of patients were equally successful in quitting (depression, 17.8% of smokers quit; no depression, 19.3% of smokers quit; p = NS).
Conclusions: Patients with self-reported current and previous depression may derive less, but still gain considerable benefit from contemporary Phase 2 CRehab. The effect of depression on long term compliance with the principles of CRehab needs to be determined.
| History of Depression (Change in Value from Baseline) | No History of Depression (Change in Value from Baseline) | P Value between groups | |
|---|---|---|---|
| Total Cholesterol | -36 mg/dl | -47 mg/dl | P <.05 |
| LDL Cholesterol | -26 mg/dl | -32 mg/dl | P <.05 |
| HDL Cholesterol | 4 mg/dl | 4 mg/dl | NS |
| Triglycerides | -37 mg/dl | -49mg/dl | P <.05 |
| Fasting Glucose | -18 mg/dl | -15mg/dl | NS |
| Systolic BP | -10 mmHg | -10 mmHg | NS |
| Diastolic BP | -10 mmHg | -11 mmHg | P <.05 |
| Weight | -3.7 lbs | -3.9 lbs | NS |
| Quitting Smoking | 17.8% | 19.3% | NS |
2006
AACVPR Annual Meeting
Clinical Effectiveness of Therapeutic Lifestyle Changes in Patients With Prehypertension
Venkata V. Bavikati, MBBS; Laurence S. Sperling, MD; Richard D. Salmon, DDS; George C. Faircloth, MHA; Richard F. Leighton, MD; Barry A. Franklin, PhD; and Neil F. Gordon, MD. Emory University School of Medicine, Atlanta, GA, St. Joseph’s/Candler Health System, Savannah, GA, and INTERxVENT Coordinating Center, Savannah, GA
Rationale: Prehypertension is a precursor of hypertension and an established predictor of excessive cardiovascular risk. Although national clinical guidelines promulgate therapeutic lifestyle changes (TLC) as a cornerstone in the management of prehypertension, recent research has focused on the use of pharmacotherapy due to the perceived ineffectiveness of TLC in daily clinical practice.
Objectives: In this study of 2,478 ethnically diverse (African Americans, n = 448; Caucasians, n = 1,881) men (n = 666) and women (n =1,812) with prehypertension who were not taking antihypertensive medication (age = 48+10 years), we evaluated the clinical effectiveness of TLC in helping patients normalize their blood pressure (BP) without using drug therapy.
Methodology: Subjects were evaluated at baseline and after an average of approximately 6 months of participation in a community-based lifestyle management program (the INTERxVENT program). At baseline, all subjects met the criteria for the diagnosis of prehypertension as defined by the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7), namely, a systolic BP of 120-139 mmHg and a diastolic BP < 89 mmHg or a diastolic BP of 80-89 mmHg and a systolic BP <139 mmHg. Subjects did not have known atherosclerotic cardiovascular disease, diabetes, or chronic kidney disease at baseline. TLC included exercise training, nutrition, weight management, stress management, and smoking cessation interventions. All subjects remained off antihypertensive medications throughout the study.
Results: Baseline systolic BP (125+8 mmHg) decreased by 6+12 mmHg (p <0.001) and baseline diastolic BP (79+3 mmHg) decreased by 3+3 mmHg (p <0.001) with TLC. In subjects with a baseline systolic BP of 120-139 mmHg (n=2,082), systolic BP decreased by 7+12 mmHg (p <0.001) with TLC. In subjects with a baseline diastolic BP of 80-89 mmHg (n=1,504), diastolic BP decreased by 6+3 mmHg (p <0.001) with TLC. Based on JNC 7 criteria, 952 (39%) subjects normalized their BP (i.e., achievement of both a systolic BP <120 mmHg and a diastolic BP <80 mmHg) with TLC (p <0.001).
Conclusions: The present study adds to previous research by reporting on the effectiveness (i.e., extent to which TLC works in actual practice) rather than on the efficacy (i.e., determining whether TLC can work when administered in a clinical trial) of TLC in patients with prehypertension. Although further research is warranted, these data clearly show that many patients with prehypertension can normalize their BP with TLC. The data have important clinical and cost-containment implications for physicians and their patients
Prevalence of the Metabolic Syndrome and its Component Risk Factors On Entry Into a Comprehensive Lifestyle Management/Cardiovascular Risk Reduction Program
Neil Gordon, MD; Thomas Draper, MBA; Melvyn Rubenfire, MD; Richard Salmon, DDS; Kevin Reid, MA; William Saxon, ASRT; George Faircloth, MHA; Brenda Wright, PhD; Richard Leighton, MD; and Barry Franklin, PhD. St. Joseph’s/Candler Health System and INTERxVENT Coordinating Center, Savannah, GA.
Rationale: The metabolic syndrome (MS) is a constellation of interrelated risk factors of metabolic origin (MS risk factors) that are strongly influenced by lifestyle.
Objectives: In this study, we determined the prevalence of MS and its component MS risk factors on entry into a national comprehensive lifestyle management/cardiovascular disease (CVD) risk reduction program (the INTERxVENT program) specifically designed to function outside of a formal/traditional cardiac rehabilitation program setting.
Methodology: Subjects were 20,304 consecutive adult (age = 49 + 12 years) males (26.5%) and females (73.5%) who completed an initial evaluation as part of the INTERxVENT program. MS risk factors were evaluated using standardized procedures and entered into an electronic medical record. MS and its 5 individual component MS risk factors were defined in accordance with the National Cholesterol Education Program Adult Treatment Panel III Guidelines, with the exception that a fasting glucose >100 mg/dl rather than > 110 mg/dl was used. Electronic medical records were analyzed to categorize MS status as follows: MS present (i.e., presence of >3 MS risk factors), MS absent (i.e., definite absence of >3 MS risk factors), or MS indeterminate (i.e., not possible to definitively identify or exclude MS due to incomplete data). In individuals with MS and data on all 5 individual MS risk factors, data were further analyzed to determine the number and percentage of individuals with 3, 4, or 5 MS risk factors and the prevalence of each of the individual MS risk factors.
Results: Of the study subjects, 89.4 % did not have a diagnosis of known CVD. MS status could be determined in 17,169 (84.6 %) individuals. In these subjects, MS was present in 5,398 (31.4 %) and absent in 11,771 (68.6 %) individuals. Results for individuals (n = 4,641) with MS and data on all 5 MS risk factors are shown in the table.
| MS Risk Factors | Number of Individuals | % | Rank |
|---|---|---|---|
| 3 MS Risk Factors | 2,574 | 55.5% | |
| 4 MS Risk Factors | 1,540 | 33.2% | |
| 5 MS Risk Factors | 527 | 11.4% | |
| Positive waist | 4,054 | 87.4% | 1 |
| Positive triglyceride | 3,004 | 64.7% | 4 |
| Positive HDL | 3,176 | 68.4% | 3 |
| Positive BP | 3,395 | 73.2% | 2 |
| Positive glucose | 2,888 | 62.2% | 5 |
Conclusion: These data indicate that MS and multiple MS risk factors are very commonly present at entry into a comprehensive lifestyle management/CVD risk reduction program. Our findings are particularly relevant when designing and prioritizing components of programs to foster comprehensive lifestyle management and CVD risk reduction outside of a formal cardiac rehabilitation setting.
Multi-Center Study of the Prevalence of the Metabolic Syndrome and its Component Risk Factors On Entry Into a Phase 2 Cardiac Rehabilitation Program
Thomas Draper, MBA; Melvyn Rubenfire, MD; Richard Salmon, DDS; Kevin Reid, MA; William Saxon, ASRT; George Faircloth, MHA; Brenda Wright, PhD; Richard Leighton, MD; Barry Franklin, PhD; and Neil Gordon, MD. University of Michigan, Ann Arbor, MI, St. Joseph’s/Candler Health System, Savannah, GA, and INTERxVENT Coordinating Center, Savannah, GA.
Rationale: The metabolic syndrome (MS) is a constellation of interrelated coronary heart disease (CHD) risk factors of metabolic origin (MS risk factors) that influence first and subsequent cardiovascular event rates. No comprehensive, multi-center data are available on the prevalence of MS and its component MS risk factors on entry into a contemporary phase 2 cardiac rehabilitation (CR) program.
Objectives: In this multi-center study, we determined the prevalence of MS and its component MS risk factors on entry into a contemporary phase 2 CR program.
Methodology: Subjects were 15,714 consecutive male (69.6%) and female (30.4%) patients (age = 66±12 years) who enrolled in a phase 2 CR program in 37 sites in North America. MS and its 5 individual component MS risk factors were defined in accordance with the National Cholesterol Education Program Adult Treatment Panel III Guidelines, with the exception that a fasting glucose >100 mg/dl rather than > 110 mg/dl was used. Electronic medical records were analyzed to categorize MS status as follows: MS present (i.e., presence of 3 MS risk factors), MS absent (i.e., definite absence of 3 MS risk factors), or MS indeterminate (i.e., incomplete data). In patients with MS and data on all 5 individual component MS risk factors, data were further analyzed to determine the number and percentage of patients with 3, 4, or 5 MS risk factors and the prevalence of each of the individual MS risk factors.
Results: MS status could be determined in 7,590 (48.3 %) of patients. In these patients, MS was present in 3,512 (46.3 %) and absent in 4,078 (53.7 %) patients. Results for patients (n = 2,105) with MS and data on all 5 MS risk factors are shown in the table.
| MS Risk Factors | Number of Patients | % | Rank |
|---|---|---|---|
| 3 MS Risk Factors | 1,104 | 52.4% | |
| 4 MS Risk Factors | 764 | 36.3% | |
| 5 MS Risk Factors | 237 | 11.3% | |
| Waist | 1,598 | 75.9% | 3 |
| Triglyceride | 1,410 | 67.0% | 4 |
| HDL | 1,649 | 78.3% | 2 |
| BP | 1,162 | 55.2% | 5 |
| Glucose | 1,734 | 82.4% | 1 |
2005
AHA CVD Epidemiology and Prevention Conference
Health Risk Appraisal Only Vs. Targeted Disease Management for Worksite Cardiovascular Risk Reduction
David J. Maron, Barbara L. Forbes, Jay R. Groves, Vanderbilt University Medical Center, Nashville, TN; Mary S. Dietrich, Vanderbilt University, Nashville, TN; Patrick Sells, Belmont University, Nashville, TN; Andres G. DiGenio, Pfizer Inc., Groton, CT
Objective: To evaluate the effectiveness of health risk appraisal (HRA) only compared with health risk appraisal followed by targeted disease management (DM) among employees at increased risk for cardiovascular disease.
Methods: We randomized 133 high-risk employees to HRA and DM conditions. Subjects randomized to DM received individualized counseling for nutrition, exercise, smoking cessation, and weight control. This intervention was delivered using a commercial, evidence-based cardiovascular disease risk reduction program. When indicated by national guidelines, medications for control of hypertension and high cholesterol were recommended to DM subjects and their physicians. The primary endpoint of the study was the mean change, compared with baseline, of the Framingham Risk Score at one year of follow-up in each group.
Results: The difference noted between groups in baseline Framingham Risk Scores was not statistically significant (p=0.279). The DM group had a significant decrease in the mean Framingham Risk Score (-1.33, decrease of 22.6%), while the HRA group had a non-significant rise in the mean Framingham Risk Score from baseline to one year (+0.20, increase of 4.3%). The difference between DMand HRA groups in the mean changes in risk scores from baseline was statistically significant (p=0.017).
Conclusions: Among employees with increased cardiovascular risk, a targeted DM program is more effective.
AACVPR Annual Meeting
Multi-Center Study of Risk Factor Status on Completion of a Contemporary Phase 2 Cardiac Rehabilitation Program: Male Versus Female Patients
Diane Vogel, RN, BS; Barry A. Franklin, PhD; Richard D. Salmon, DDS; Kevin S. Reid, MA; William E. Saxon, ASRT; George C. Faircloth; Brenda S. Wright, PhD; Richard F. Leighton, MD; and Neil Gordon, MD. Bryan LGH Medical Center, Lincoln, NE, St. Joseph’s/Candler Health System, Savannah, GA, and INTERxVENT Coordinating Center, Savannah, GA
Rationale: No comprehensive gender-specific data are available on the percentage of participants who are still not at recommended cardiovascular disease (CVD) risk factor goal levels on completion of a contemporary phase 2 cardiac rehabilitation (CR) program and, therefore, in need of additional intervention.
Objectives: In this multi-center study, we compared the percentage of participants not at goal for select risk factors in male versus female patients on exit from a phase 2 CR program. Methodology: Subjects were 4,873 consecutive male Group A; n=3,511; age=66+/-11 years and female Group B; n=1,362; age=68+/-11 years patients who enrolled in a phase 2 CR program at 30 centers in the United States after May 16, 2001 (i.e., the publication date of the National Cholesterol Education Program Adult Treatment Panel III Guidelines) and subsequently completed an exit evaluation on program completion. Risk factors were evaluated using standardized procedures.
Results: Results are shown in the table.
| CVD Risk Factor | Goal (Based on National Clinical Guidelines) | % Not At Goal, Group A | % Not At Goal, Group B | P (Group A versus Group B) |
|---|---|---|---|---|
| Cigarette smoking | Smoking cessation | 4.1 | 3.6 | NS |
| Systolic BP | <120 mm Hg | 54.2 | 55.0 | NS |
| Diastolic BP | <80 mm Hg | 22.6 | 17.9 | <0.001 |
| LDL cholesterol | <100 mg/dl | 26.6 | 37.5 | <0.001 |
| HDL cholesterol | >39 mg/dl | 46.6 | 18.1 | <0.001 |
| Triglycerides | <150 mg/dl | 33.0 | 42.2 | <0.001 |
| Body Mass Index | <25 kg/m2 | 79.3 | 69.2 | <0.001 |
| Fasting glucose | <100 mg/dl | 59.3 | 49.5 | <0.02 |
| Sedentary lifestyle | >149 min/wk | 48.8 | 53.7 | <0.01 |
Conclusion: These data indicate that multiple CVD risk factors are often inadequately controlled on exit from a contemporary phase 2 CR program. Our findings further indicate that gender-specific differences exist for multiple risk factors. These data emphasize the urgent need for ongoing risk reduction interventions in post-phase 2 CR program participants.
Effect of Gender on Clinical Responsiveness to Therapeutic Lifestyle Changes
Marlene Sigler, RN, MS; Richard D. Salmon, DDS; Terri L. Gordon; George C. Faircloth, MHA; Brenda S. Wright, PhD; Richard F. Leighton, MD; Barry A. Franklin, PhD; and Neil Gordon, MD. New Hanover Regional Medical Center, Wilmington, NC, St. Joseph’s/Candler Health System, Savannah, GA, and INTERxVENT Coordinating Center, Savannah, GA
Rationale: Emerging data have displayed important gender-based differences in the response to cardiovascular disease (CVD) therapies. Although national clinical guidelines promulgate therapeutic lifestyle changes (TLC) as a cornerstone in CVD risk reduction in both men and women, scarce comprehensive data are available on the effect of gender on responses to TLC.
Objectives: In this study, we compared the clinical effectiveness of TLC in 2,144 consecutive men n=543; age=47+/-10 years and women n=1,601; age=46+/-10 years with an elevated blood pressure, LDL cholesterol, and/or fasting plasma glucose level who were not taking medication for hypertension, hyperlipidemia, or diabetes.
Methodology: Subjects were evaluated at baseline and after approximately 12 weeks of participation in a community-based lifestyle management program. TLC included exercise training, nutrition, weight management, stress management, and smoking cessation interventions. All subjects remained off antihypertensive, antilipemic, and antidiabetic medications throughout the study.
Results: Among subjects with abnormal baseline CVD risk factors (based on national guidelines), clinically relevant improvements (p <0.05) were observed for multiple variables, including: systolic/diastolic blood pressure (Men, -7/-6 mmHg; Women, -10/-7 mmHg; p <0.05 for Men versus Women); LDL cholesterol (Men, -18 mg/dl; Women, -11 mg/dl; p <0.05 for Men versus Women); HDL cholesterol (Men, 2 mg/dl; Women, 4 mg/dl; p=NS for Men versus Women); triglycerides (Men, -55 mg/dl; Women, -49 mg/dl; p=NS for Men versus Women); fasting glucose (Men, -10 mg/dl; Women, -9 mg/dl; p=NS for Men versus Women); and weight (Men, -7 lbs; Women, -5 lbs; p<0.05 for Men versus Women). In subjects with a calculated Framingham 10-year coronary heart disease risk score >10% at baseline, the score decreased significantly (p<0.05) in men (-18.8%) and women (-18.9%); p=NS for Men versus Women.
Conclusions: These data demonstrate the similar clinical effectiveness of TLC in men and women with an elevated blood pressure, LDL cholesterol, and/or fasting plasma glucose level.
ACSM Annual Meeting
Multi-Center Study of Risk Factor Status on Entry Into Cardiac Rehabilitation: Elderly Versus Younger Patients
Amy L. Fowler, Barry A. Franklin, FACSM, Adam T. deJong, Richard D. Salmon, Ivan Levinrad, George C. Faircloth, Brenda S. Wright, Kevin S. Reid, William E. Saxon, Neil F. Gordon, FACSM. William Beaumont Hospital, Royal Oak, MI; INTERxVENT Coordinating Center, Savannah, GA; St. Joseph’s/Candler Health System, Savannah, GA.
Purpose: According to the American Heart Association, cardiac rehabilitation programs should provide comprehensive cardiovascular disease (CVD) risk reduction interventions aimed at the control of multiple risk factors. Published guidelines are available on goals for each CVD risk factor. However, no comprehensive data are available on the percentage of participants who are not already at recommended goal risk factor levels on entry into a contemporary phase 2 cardiac rehabilitation program. In this multi-center study, we compared the percentage of participants not at goal for select CVD risk factors in elderly (>65 years) versus younger (<65 years) patients at entry into a phase 2 cardiac rehabilitation program.
Methods: Subjects were 12,083 consecutive elderly (Group A; n=5,103; age=74+/-6 years; males=66%) and younger (Group B; n=6,980; age=51+/-10 years; males=52%) patients enrolled in phase 2 cardiac rehabilitation programs at 30 centers in the United States. CVD risk factors were evaluated on program entry using standardized procedures.
Results: Results are shown in the table.
| CVD Risk Factor | Goal (Based on National Clinical Guidelines) | % Not At Goal, Group A | % Not At Goal, Group B | P (Group A versus Group B) |
|---|---|---|---|---|
| Cigarette smoking | Smoking cessation | 3.3 | 9.2 | <0.001 |
| Systolic BP | <120 mm Hg | 67.0 | 54.7 | <0.001 |
| Diastolic BP | <80 mm Hg | 25.3 | 37.6 | <0.001 |
| LDL cholesterol | <100 mg/dl | 40.9 | 57.3 | <0.001 |
| HDL cholesterol | >39 mg/dl | 38.0 | 33.8 | <0.001 |
| Triglycerides | <150 mg/dl | 40.5 | 38.2 | <0.05 |
| Body Mass Index | <25 kg/m2 | 72.5 | 80.7 | <0.001 |
| Fasting glucose | <100 mg/dl | 60.8 | 38.8 | <0.001 |
| Sedentary lifestyle | >149 min/wk | 81.1 | 79.8 | NS |
Conclusion: These data indicate that multiple CVD risk factors are often inadequately controlled at entry into a contemporary phase 2 cardiac rehabilitation program, especially body mass index and a sedentary lifestyle. Our findings further indicate that differences exist between elderly and younger patients for multiple CVD risk factors. These data may be relevant to cardiac rehabilitation programs when prioritizing, designing, and developing comprehensive CVD risk reduction interventions for elderly and younger participants.
Clinical Effectiveness of a Comprehensive Lifestyle Management and Cardiovascular Risk Reduction Program in Cancer Survivors
Neil F. Gordon, FACSM, Richard D. Salmon, Ivan Levinrad, George C. Faircloth, Brenda S. Wright, Kevin S. Reid, William E. Saxon, Richard F. Leighton, Adam T. deJong, Barry A. Franklin, FACSM. St. Joseph’s/Candler Health System, Savannah, GA; INTERxVENT Coordinating Center, Savannah, GA; William Beaumont Hospital, Royal Oak, MI.
Purpose: Recent research indicates that cancer survivors have poorer long-term health outcomes than do similar individuals without cancer across multiple burden of illness measures. This study is the first, to our knowledge, to evaluate the clinical effectiveness of a community-based comprehensive lifestyle management and cardiovascular disease (CVD) risk reduction program in cancer survivors and to make a comparison to individuals without a personal history of cancer.
Methods: Subjects were 3,761 consecutive men and women with (Group A; n=254) and without (Group B; n=3,507) a personal history of cancer. Subjects were evaluated at baseline and after approximately 1 year of participation in a community-based lifestyle management and CVD risk reduction program. Lifestyle management included exercise training, nutrition, weight management, stress management, and smoking cessation interventions. Participants were referred to their personal physicians for consideration of medication changes in accordance with national clinical guidelines.
Results: Among subjects with abnormal baseline CVD risk factors (based on national guidelines), clinically relevant improvements (p <0.05) were observed in both groups for multiple variables, including: systolic/diastolic blood pressure (Group A, -14/-9 mmHg; Group B, -17/-12 mmHg); LDL cholesterol Group A, -21 mg/dl; Group B, -17 mg/dl; HDL cholesterol Group A, 6 mg/dl; Group B, 4 mg/dl; triglycerides Group A, -33 mg/dl; Group B, -34 mg/dl; fasting glucose Group A, -12 mg/dl; Group B, -26 mg/dl; and weight (Group A, -7 lbs; Group B, -6 lbs). With the exception of diastolic blood pressure (greater reduction in Group B versus Group A, p <0.05), no statistically significant differences were observed for Group A versus B. Among cigarette smokers, 30.4 % (p <0.05) of Group A and 21.7 % (p <0.05) of Group B subjects quit smoking; p=NS for Group A versus B. In subjects with a calculated Framingham 10-year coronary heart disease risk score >10% at baseline, the score decreased significantly (p<0.05) in Group A (-20.5 %) and in Group B (-21.7 %); p=NS for Group A versus B.
Conclusions: These data demonstrate that cancer survivors derive substantial improvements in multiple CVD risk factors during participation in a comprehensive lifestyle management and CVD risk reduction program.
Multicenter Study of Effect of Cardiac Rehabilitation on Self-Reported Health Status: Elderly Versus Younger Patients
Adam deJong, Barry A. Franklin, FACSM, Richard D. Salmon, Ivan Levinrad, George C. Faircloth, Brenda S. Wright, Kevin S. Reid, William E. Saxon, Neil F. Gordon, FACSM. William Beaumont Hospital, Royal Oak, MI. INTERxVENT Coordinating Center, Savannah, GA. St. Joseph’s/Candler Health System, Savannah, GA.
Purpose: Improved survival of patients with cardiovascular disease (CVD) and the aging of America have created a large population of elderly patients (>65 years of age) eligible for cardiac rehabilitation. No comprehensive data are currently available on the effect of a contemporary phase 2 cardiac rehabilitation program on multiple indices of self-reported health status in elderly versus younger patients. In this multicenter study, we investigated the effect of a contemporary phase 2 cardiac rehabilitation program on self-reported health status in 5,418 consecutive patients >65 years of age Group A; n=2,526; age=74+/-6 years and <65 years of age Group B; n=2,892; age=52+/-10 years.
Methods: Self-reported health status was assessed at baseline and after an average of approximately 12 weeks of participation in a phase 2 cardiac rehabilitation program at 30 centers in the U.S. using the SF-36.
Results: On program exit, statistically significant improvements (p <0.05 for within group change from baseline) in SF-36 transformed scores were observed in both groups, as follows: physical functioning (Group A, 14; Group B, 11); role-physical (Group A, 36; Group B, 24); bodily pain (Group A, 17; Group B, 13); general health (Group A, 3; Group B, 5); vitality (Group A, 11; Group B, 9); social functioning (Group A, 19; Group B, 13); role-emotional (Group A, 14; Group B, 9); and mental health (Group A, 5; Group B, 6). Statistically significant (p<0.05) differences were observed for the magnitude of improvement from baseline in Group A versus Group B patients for physical functioning, role physical, bodily pain, vitality, social functioning, and role emotional (greater improvements in elderly patients), and for general health (greater improvement in younger patients).
Conclusions: These data indicate that both elderly and younger patients derive substantial improvements in multiple indices of self-reported functional status and well-being with participation in a contemporary phase 2 cardiac rehabilitation program. The data further suggest that, with the exception of general health and, possibly, mental health, the magnitude of improvement may be greater in elderly patients.
Clinical Effectiveness of Therapeutic Lifestyle Changes in Patients With Low-Density Lipoprotein Subclass Pattern B Versus A
Kirk D. Hendrickson, Barry A. Franklin, FACSM, Adam T. deJong, Richard D. Salmon, Ivan Levinrad, George C. Faircloth, Anil Verma, Richard F. Leighton, William C. Cromwell, Neil F. Gordon, FACSM. William Beaumont Hospital, Royal Oak, MI. INTERxVENT Coordinating Center, Savannah, GA. Liposcience, Inc., Raleigh, NC. St. Joseph’s/Candler Health System, Savannah, GA.
Purpose: Recent research suggests that persons with a predominance of small LDL particles (LDL pattern B) may respond differently to short-term therapeutic lifestyle changes (TLC) as compared to persons with a predominance of large LDL particles (LDL pattern A). However, scarce long-term data are available to substantiate or refute this possibility. In this study, we compared the effect of 1 year of TLC on plasma lipids and lipoproteins in participants with LDL pattern B (n=11; LDL size<20.6 nm) versus LDL pattern A (n=50; LDL size>20.5 nm), as determined using NMR spectroscopy.
Methods: TLC included counseling on a low fat (20% of daily calories)/high complex carbohydrate (60% of daily calories) diet and exercise training. Counseling was provided by healthcare professionals via telephone and the Internet. Participants were evaluated at baseline and after 1 year using standardized procedures. No changes in antilipemic medications occurred between evaluations.
Results: Body weight decreased to a similar degree in participants with LDL pattern B (-5.4 lbs, p<0.05) versus LDL pattern A (-5.2 lbs, p<0.05). In contrast, participants with LDL pattern B tended to derive more favorable changes in total cholesterol (-15 mg/dl, p<0.05 versus -3 mg/dl, p=NS; p<0.05 for pattern B versus A participants), LDL cholesterol (-11 mg/dl, p<0.05 versus – 6 mg/dl, p<0.05; p=NS for pattern B versus A participants), LDL particle number (-291 nmol/L, p<0.05 versus -91 nmol/L, p<0.05; p<0.05 for pattern B versus A participants), LDL particle size (0.5 nm, p<0.05 versus 0.1 nm, p=NS; p<0.05 for pattern B versus A participants), HDL cholesterol (6 mg/dl, p<0.05 versus 3 mg/dl, p<0.05; p=NS for pattern B versus A participants); large HDL cholesterol (4 mg/dl, p<0.05 versus 4 mg/dl, p<0.05; p=NS for pattern B versus A participants), triglycerides (-91 mg/dl, p<0.05 versus -3 mg/dl, p=NS; p<0.05 for pattern B versus A participants), and large VLDL cholesterol (-58 mg/dl, p=NS versus 6 mg/dl, p=NS; p<0.05 for pattern B versus A participants).
Conclusions: Although additional research is warranted, these data support the notion that individuals with LDL pattern B may be more responsive to a long-term program of TLC that includes a low fat/high complex carbohydrate diet and exercise training as compared to individuals with LDL pattern A.
Second Int Conference
Clinical Effectiveness of Therapeutic Lifestyle Changes in Pre-Menopausal Versus Post-Menopausal Women
Neil F. Gordon, Richard D. Salmon, Terri L. Gordon, Daniel Biggerstaff, William E. Saxon, Kevin S. Reid, George C. Faircloth, Ivan Levinrad, Brenda S. Mitchell, Richard F. Leighton, Anil Verma, St. Joseph’s/Candler Health System and INTERxVENT Coordinating Center, Savannah, GA; Laurence S. Sperling, Emory University, Atlanta, GA; Linda Hall, PhD, Forrest General Hospital; William L. Haskell, Stanford University, CA; Barry A. Franklin, William Beaumont Hospital, Royal Oak, MI
Background: The proportion of women living past the age of menopause has tripled during the past century. Although recent national clinical guidelines promulgate therapeutic lifestyle changes (TLC) as a cornerstone in cardiovascular disease (CVD) risk reduction in all women, no studies have evaluated the effect of menopausal status on responses to TLC.
Methods: In this study, we compared the clinical effectiveness of TLC in 1,601 consecutive pre-menopausal Group A; n=1,014; age=41+/-8 years and post-menopausal Group B; n=587; age=55+/-8 years women with an elevated blood pressure, LDL cholesterol, and/or fasting plasma glucose level who were not taking medication for hypertension, hyperlipidemia, or diabetes. Subjects were evaluated at baseline and after approximately 12 weeks of participation in a community-based lifestyle management program. TLC included exercise training, correct nutrition, weight management, stress management, and smoking cessation interventions. All women remained off antihypertensive, antilipemic, and antidiabetic medications throughout the study.
Results: For subjects with abnormal baseline CVD risk factors (based on national guidelines), clinically relevant improvements (p <0.05) were observed for multiple variables, including: systolic/diastolic blood pressure Group A, -11/-7 mmHg; Group B, – 9/-8 mmHg; LDL cholesterol Group A, -12 mg/dl; Group B, -11 mg/dl; HDL cholesterol Group A, 3 mg/dl; Group B, 7 mg/dl; triglycerides Group A, -41 mg/dl; Group B, -59 mg/dl; fasting glucose Group A, -12 mg/dl; Group B, -6 mg/dl; and weight (Group A, -5 lbs; Group B, -6 lbs). With the exception of diastolic blood pressure (greater decrease in Group B), no significant differences were observed between the 2 groups. In women without coronary heart disease, the calculated Framingham 10-year coronary heart disease risk score decreased significantly (p<0.05) and by a similar magnitude in both groups.
Conclusions: These data are the first, to our knowledge, to demonstrate the similar clinical effectiveness of TLC in pre-menopausal and post-menopausal women.
ACC Annual Meeting
Clinical Effectiveness of Therapeutic Lifestyle Changes in African Americans Versus Caucasians
Neil F. Gordon, Richard D. Salmon, Kevin S. Reid, William E. Saxon, George C. Faircloth, Ivan Levinrad, Brenda S. Mitchell, Richard F. Leighton, Anil Verma, Martin R. Berk, Laurence S. Sperling, William L. Haskell, Barry A. Franklin, St. Joseph’s/Candler Health System, Savannah, GA, INTERxVENT Coordinating Center, Savannah, GA
Background: Despite impressive medical advances during the past century, striking differences remain in cardiovascular disease (CVD) mortality rates by race/ethnicity. Although national guidelines promulgate therapeutic lifestyle changes (TLC) as a cornerstone in CVD risk reduction, scarce data are available on the effectiveness of TLC in minority subpopulations in the U.S.
Methods: In this study, we compared the effectiveness of TLC in 1,967 consecutive, unmedicated, African American Group A; n=412; age=44+/-9 years and Caucasian Group B; n=1,555; age=47+/-11 years patients with an elevated blood pressure (BP), LDL cholesterol, and/or fasting plasma glucose level. Patients were evaluated at baseline and after ~12 weeks of participation in a community-based lifestyle management program. TLC included exercise training, nutrition, weight management, stress management, and smoking cessation interventions. All patients remained unmedicated throughout the study.
Results: Among patients with abnormal baseline risk factors (based on national guidelines), improvements were observed for multiple variables, as follows (p <0.05, unless otherwise noted): systolic BP (Group A, -9 mmHg; Group B, -10 mmHg; p=NS for Group A versus B); diastolic BP (Group A, -6 mmHg; Group B, -7 mmHg; p<0.05 for Group A versus B); total cholesterol (Group A, -20 mg/dl; Group B, -27 mg/dl; p=NS for Group A versus B); LDL cholesterol (Group A, -10 mg/dl; Group B, -15 mg/dl; p=NS for Group A versus B); HDL cholesterol (Group A, 5 mg/dl; Group B, 3 mg/dl; p=NS for Group A versus B); triglycerides (Group A, -10 mg/dl, p=NS; Group B, -55 mg/dl; p<0.05 for Group A versus B); fasting glucose (Group A, -3 mg/dl, p=NS; Group B, -11 mg/dl; p=NS for Group A versus B); and weight (Group A, -3 lbs; Group B, -7 lbs; p<0.05 for Group A versus B). In patients with a Framingham 10-year coronary heart disease risk score >10% at baseline, the score decreased significantly (p <0.05) in Group A (-13%) and Group B (-19.4%); p=NS for Group A versus B.
Conclusions: These data indicate that while both African Americans and Caucasians benefit substantially from TLC, the magnitude of benefit may be greater for Caucasians for certain CVD risk factors.
Multicenter Study of the Clinical Effectiveness of a Contemporary Cardiac Rehabilitation Program in Elderly Versus Younger Patients
Neil F. Gordon, Richard D. Salmon, Ivan Levinrad, George C. Faircloth, Richard F. Leighton, Martin R. Berk, Linda K. Hall, Laurence S. Sperling, William A. Dafoe, Melvyn Rubenfire, Diane Vogel, C. Noel Bairey Merz, William L. Haskell, Barry A. Franklin, St. Joseph’s/Candler Health System, Savannah, GA, INTERxVENT Coordinating Center, Savannah, GA
Background: The aging of the American population and improving survival of patients with cardiovascular disease (CVD) has created a large population of elderly patients (>65 years of age) eligible for cardiac rehabilitation. However, no comprehensive data are currently available on the effect of a contemporary phase 2 cardiac rehabilitation program on multiple CVD risk factors in elderly versus younger patients.
Methods: In this multicenter study, we investigated the effect of a contemporary phase 2 cardiac rehabilitation program on multiple CVD risk factors in 5,418 consecutive patients >65 years of age Group A; n=2,526; age=74+/-6 years and <65 years of age Group B; n=2,892; age=52+/-10 years. Outcome measures were evaluated at baseline and after approximately 12 weeks of participation in a phase 2 cardiac rehabilitation program at 30 centers in the U.S.
Results: On program exit, improvements (p <0.05) in multiple CVD risk factors were observed for both elderly and younger patients who had abnormal baseline risk factor values (based on national clinical guidelines), as follows: systolic blood pressure (Group A, -19 mmHg; Group B, -22 mmHg; p <0.05 for Group A versus Group B); diastolic blood pressure (Group A, -17 mmHg; Group B, -14 mmHg; p <0.05 for Group A versus Group B); LDL cholesterol (Group A, -28 mg/dl; Group B, -18 mg/dl; p <0.05 for Group A versus Group B); HDL cholesterol (Group A, 4 mg/dl; Group B, 4 mg/dl; p=NS for Group A versus Group B); triglycerides (Group A, -41 mg/dl; Group B, -43 mg/dl; p=NS for Group A versus Group B); fasting glucose (Group A, -14 mg/dl; Group B, -17 mg/dl; p=NS for Group A versus Group B); and weight (Group A, -4 lbs; Group B, -4 lbs; p=NS for Group A versus Group B).
Conclusion: To our knowledge, these are the first multicenter clinical trial data to demonstrate that elderly patients derive similar improvements in multiple CVD risk factors as compared to younger patients during participation in a contemporary phase 2 cardiac rehabilitation program. Increased efforts should be devoted to providing these important services to elderly patients.