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Home , Hypercholesterolemia

Clinical Care/Education/Nutrition ORIGINAL ARTICLE

Has Control of Hypercholesterolemia and in Type 1 Improved Over Time?

1 JANICE C. ZGIBOR, PHD While primary and secondary pre- 2 ROBB R. WILSON, MA vention of complications should be para- 1 TREVOR J. ORCHARD, MD mount, reports of suboptimal levels of treatment and control of these risk factors are abundant in the literature. The pro- portion of hypertensive individuals OBJECTIVE — To determine the extent to which patients’ awareness, treatment, and control treated and controlled in the general pop- of hypertension and hypercholesterolemia have changed over time and to examine factors ulation range from 10 to 41% (4,5), while associated with awareness and treatment in a type 1 diabetes population. for people with diabetes, rates range from 11 to 23% (6–9). For hypercholesterol- RESEARCH DESIGN AND METHODS — Data from six examinations conducted over 10 years from the Pittsburgh Epidemiology of Diabetes Complications Study, a prospective study emia, reports indicate that 18–37% of of subjects with childhood-onset (Ͻ17 years of age) type 1 diabetes diagnosed between 1950 and those treated and at high risk for an event 1980 and followed since 1986, were analyzed. Hypertension and hypercholesterolemia were in the general population are controlled defined according to the concurrent Joint National Committee and National Edu- (10), while 16–35% of those with diabe- cation Program Adult Treatment Panel criteria, respectively. tes are controlled (8,9). Reasons for inad- equate control are often centered on lack RESULTS — Results demonstrated that awareness of both conditions has improved; however, of access to health care, yet 90% of people control is not optimal (e.g., only 32.1 and 28% of those with hypertension in 1986–1988 and with diabetes have access to a health care 1996–1998 were controlled, while for hypercholesterolemia, the rates were 0 and 5.5%, respec- Ͼ provider and have health insurance (8), tively). Stratified by age-group (18–29, 30–39, and 40 years), the youngest subjects with demonstrating a “missed opportunity” for hypercholesterolemia were least likely to be treated and controlled to goal levels. Older age and physician contact were correlates of awareness and treatment of hypertension at baseline, while preventive care. presence of renal or coronary complications was also associated with awareness and treatment of Over the past two decades, effective both hypertension and hypercholesterolemia at the 10-year follow-up. treatment options and more aggressive treatment guidelines have been intro- CONCLUSIONS — There is a considerable treatment gap, particularly for hypercholester- duced; however, little is known about the olemia. Improved treatment of both hypertension and hypercholesterolemia are clearly needed, impact of these efforts on the level of particularly hypercholesterolemia in younger age-groups who have not yet experienced long- treatment and control of hypertension term complications. and hypercholesterolemia, particularly in Diabetes Care 28:521–526, 2005 type 1 diabetes. It was our objective to determine the extent to which patients’ awareness, treatment, and control of hy- ypertension and hypercholesterol- risk factors can directly impact the occur- pertension and hypercholesterolemia has emia are important risk factors for rence of both new (1) and repeat (2) changed over time and to examine factors H the development of micro- and ma- events. Additionally, data suggest that associated with awareness and treatment crovascular complications in people with people with type 1 diabetes and renal dis- in a type 1 diabetes population. diabetes. Studies examining cardiovascu- ease may experience remission or regres- lar events among people with type 2 dia- sion of their renal disease with aggressive RESEARCH DESIGN AND betes demonstrate that controlling these antihypertensive treatment (3). METHODS — The Pittsburgh Epide- ●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●● miology of Diabetes Complications Study

1 2 (EDC) is an observational prospective co- From the Department of Epidemiology, University of Pittsburgh, Pittsburgh, Pennsylvania; and the Center hort study of type 1 diabetic subjects that for Biomedical Informatics, University of Pittsburgh, Pittsburgh, Pennsylvania. Address correspondence and reprint requests to Janice C. Zgibor, PhD, 601.7 Kaufmann Building, 3471 has been previously described (11). Fifth Ave., Pittsburgh, PA 15213. E-mail: [email protected]. Briefly, study participants were diagnosed Received for publication 30 June 2004 and accepted in revised form 14 December 2004. between 1950 and 1980 and seen within T.J.O. has received consulting fees from AstraZeneca and Merck Schering Plough and has received grant 1 year of diagnosis at Children’s Hospital support from Merck Schering Plough. Abbreviations: CAD, ; DSP, distal symmetric polyneuropathy; EDC, Pittsburgh of Pittsburgh. Although this population is Epidemiology of Diabetes Complications Study; LEAD, lower-extremity arterial disease; ON, overt nephrop- clinic based, it has been shown to be epi- athy; PR, proliferative retinopathy. demiologically representative of the type A table elsewhere in this issue shows conventional and Syste`me International (SI) units and conversion 1 diabetes population of Allegheny factors for many substances. County, Pennsylvania (12). A total of 658 © 2005 by the American Diabetes Association. The costs of publication of this article were defrayed in part by the payment of page charges. This article must therefore be hereby subjects participated in the baseline exam marked “advertisement” in accordance with 18 U.S.C. Section 1734 solely to indicate this fact. (1986–1988). While attendance at Chil-

DIABETES CARE, VOLUME 28, NUMBER 3, MARCH 2005 521 Hypercholesterolemia and hypertension control

Table 1—Definitions for hypertension and hypercholesterolemia during the 10-year follow-up period in the EDC

Exams 1–4 (1986–1993) Exams 5 and 6 (1994–1998) Hypertension Case definition Ͼ140/90 mmHg or treatment with antihypertensive 130/85 mmHg or treatment with antihypertensive * medication* Goal for treatment Ͻ140/90 mmHg Ͻ130/85 mmHg Hypercholesterolemia Case definition Above LDL cholesterol goal or treatment with anihyperlipidemic medication† Goal for treatment ● LDL cholesterol Ͻ160 mg/dl if less than two risk factors‡ ● Ͻ160 mg/dl if less than two risk factors§ ● Initiate medication therapy if Ͼ190 mg/dl ● Initiate medication therapy if Ͼ190 mg/dl or or ● LDL cholesterol Ͻ130 mg/dl if CAD or two or more risk factors‡ ● Ͻ130 mg if two or more risk factors ● Initiate medication therapy if Ͼ160 mg/dl ● Initiate medication therapy if Ͼ160 mg/dl or ● Ͻ100 mg /dl if CAD ● Initiate medication therapy if Ͼ130 mg/dl *Antihypertensive include ACE inhibitors, ␤-blockers, calcium channel blockers, diuretics, and other antihypertensives. Subjects also had to indicate that the reason for taking the medication was hypertension. If the reason was not hypertension, subjects were not considered to be taking an antihypertensive medication. If no reason was listed, the presumption was antihypertensive use. †-lowering medications include HMG-COA reductase inhibitors, fish oil (more than six capsules per day), resins, probucol, and Ն750 mg/day. ‡Male sex, smoker, hypertension, family history of premature coronary disease, HDL cholesterol Ͻ35 mg/dl, diabetes, cerebrovascular or peripheral vascular disease, and BMI Ͼ45 kg/m2. §Male age Ͼ45 years, female age Ͼ55 or postmenopausal without hormone replacement therapy, family history of premature coronary heart disease, smoker, hypertension, HDL cholesterol Ͻ35 mg/dl, and diabetes. dren’s Hospital was one of the eligibility Hypercholesterolemia and level of control bumin excretion rate Ͼ200 ␮g/min on criteria, the EDC participants subse- were defined for the time period studied two of three timed urine samples or, in the quently received their diabetes care in the according to the concurrent National absence of urine, serum creatinine Ͼ2 general community, with ϳ50% receiv- Cholesterol Education Program Adult mg/dl, renal failure, or transplant. Distal ing care from diabetes specialists (13). Treatment Panel (22,23), as outlined in symmetric polyneuropathy (DSP) was The present cross-sectional analyses rep- Table 1. considered present if on examination, ac- resent data available for adults (age Ͼ18 Patient awareness of hypertension cording to the Diabetes Control and Com- years) followed for the first 10 years (six was defined by a positive response to the plications Trial protocol (25), the examination periods) of the EDC. question “has a physician ever told you participant had at least two of the follow- that you had high blood pressure?” Pa- ing: symptoms consistent with DSP, de- Primary outcomes tient awareness of hypercholesterolemia creased or absent deep reflexes, Blood pressure was measured with a ran- was defined by a positive response to the and signs of sensory loss. At the 4-year dom zero sphygmomanometer, accord- question “has a physician ever told you that follow-up exam and thereafter (i.e., for ing to the Hypertension Detection and you had high cholesterol/?” 101 of 108 incident subjects), DSP was Follow-up Program protocol (14). Case confirmed (CDSP) by the presence of a definition of hypertension and level of Data collection and variable vibratory threshold above the age-specific control were defined for the time period definitions studied according to the concurrent Joint Before their scheduled clinic visit, partic- normal range using the Vibratron II tester National Committee (15,16) recommen- ipants were sent questionnaires to docu- (Physitemp instruments, Clifton, NJ). dations as outlined in Table 1. ment demographic, health care, self-care, Coronary artery disease (CAD) was deter- HDL cholesterol was determined by a lifestyle characteristics, and medical his- mined by EDC physician-diagnosed an- precipitation technique (heparin and tory information. Complication status gina or , confirmed manganese chloride) with a modification was determined using a standardized pro- by Q waves on electrocardiogram or hos- (17) of the Lipid Research Clinics method tocol throughout the study period and de- pital records (Minnesota codes 1.1 or (18). Cholesterol and triglycerides were fined as follows: Proliferative retinopathy 1.2), or by angiographic Ͼ50%, measured enzymatically (19,20). LDL (PR) was determined by stereo fundus coronary artery bypass surgery, angio- cholesterol levels were calculated from photography (classified by the Arlie plasty, or ischemic electrocardiogram measurements of the levels of total cho- House System) (24) or a history of laser (non–Q wave) (Minnesota codes 1.3, 4.1, lesterol, triglycerides, and HDL choles- therapy for proliferative disease. Overt 4.2, 5.1, 5.2, and 7.1). Lower-extremity terol using the Friedewald equation (21). nephropathy (ON) was defined as an al- arterial disease (LEAD) was determined

522 DIABETES CARE, VOLUME 28, NUMBER 3, MARCH 2005 Zgibor, Wilson, and Orchard

Table 2—Characteristics of the study population (EDC) aged >18 years at baseline (1986– Hypertension 1988) and exam 6 (1996–1998) Over time, improvements in awareness and control were observed during exams Baseline Exam 6 3 and 4, but control and awareness wors- ened during the 5th and 6th exam peri- n 592 402 ods. Control was best at 48% in exam 3 Age (years) 29.1 Ϯ 6.8 37.4 Ϯ 8.0 but worsened to 28% at exam 6. As results Duration (years) 20.4 Ϯ 7.1 29.1 Ϯ 7.6 may differ by age-group, results for exams Sex (% male) 49.2 (291) 50.6 (206) 1 and 6 were repeated and stratified by Income (% Ͼ$20,000) 81.6 (386) 79.6 (300) age-groups (18–29, 30–39, and Ͼ40 Education (% more than high school) 63.2 (354) 69.4 (121) years). The proportion of patients un- Saw physician in previous year (% yes) 82.1 (449) 91.6 (340) aware of their hypertension increased be- Health insurance (% yes) 92.5 (371) 94.2 (376) tween exams 1 and 6 in all age-groups and Hypertension (% positive)* 18.8 (106) 35.3 (140) increased the most in the oldest age- Age 18–29 years 10.3 (32) 13.4 (10) group (6.7 to 21.5%, P ϭ 0.10). The pro- Age 30–39 years 28.4 (59) 32.4 (57) portion untreated decreased in the 18–29 Age Ͼ40 years 34.1 (59) 49.3 (73) and 30–39 age-group but increased in Mean systolic blood pressure (mmHg) 114.9 Ϯ 16.2 118.1 Ϯ 18.2 those Ͼ40 years of age although not sig- Mean diastolic blood pressure (mmHg) 73.7 Ϯ 11.0 70.7 Ϯ 10.9 nificantly. The proportion controlled was Hypercholesterolemia (% positive)* 26.3 (135) 39.8 (142) relatively stable in 18–29 year olds Age 18–29 years 17.3 (51) 29.2 (19) (15.6–20.0%, P ϭ 0.87) and 30–39 year Age 30–39 years 37.1 (69) 32.7 (52) olds (37.3 to 35.1%, P ϭ 0.96) but de- Age Ͼ40 years 36.6 (15) 53.4 (71) creased in those Ͼ40 years of age (46.7 to Mean LDL cholesterol (mg/dl) 118.3 Ϯ 35.1 117.6 Ϯ 32.2 23.3%, P ϭ 0.13). Complications (% positive) CAD 8.3 (49) 22.1 (90) Hypercholesterolemia LEAD 8.0 (47) 14.4 (57) Figure 1B represents the level of aware- PR 34.8 (203) 51.0 (204) ness, treatment, and control of hypercho- ON 28.7 (170) 23.3 (95) lesterolemia. Patient awareness of DSP 31.4 (185) 36.4 (146) hypercholesterolemia increased between Data are percent (n) or means Ϯ SD. *See Table 1 for definitions. exams 1 and 6 as did the proportion of patients untreated. No patients had their LDL cholesterol levels controlled to goal by history of amputation, or , the 30- to 39-year age-group. As noted in levels during the first two exam periods, or ankle brachial index Ͻ0.9 at rest. Table 2, mean diastolic blood pressure and only 1–5.6% had achieved control and LDL cholesterol were also lower at during exams 3 and 6, respectively. When Statistical analyses exam 6 than at baseline. Applying base- stratified by age, the proportion of sub- Prevalence, level of awareness, treatment, line criteria to exam 6, the prevalence of jects unaware of their hypercholesterol- and control of hypertension and hyper- hypercholesterolemia remained un- emia decreased in all age-groups from cholesterolemia were evaluated for each changed; however, the prevalence of exam 1 to exam 6: 80.4 to 68.4%, P ϭ of the six examination periods, overall hypertension was lower (28.5%). Fur- 0.45 (18–29 years of age); 87.0 to 63.5%, and by specific age strata (18–29, 30–39, thermore, because the prevalence of risk P ϭ 0.005 (30–39 years of age); and 93.3 and Ͼ40 years). All univariate compari- factors was determined at one time point, to 57.7%, P ϭ 0.02 (Ͼ40 years of age). sons were conducted using the Student’s t we examined the proportion of subjects However, the proportion untreated in- test or ␹2 test for proportions. with hypertension and hypercholesterol- creased across all age-groups, although emia for two consecutive exams. When ex- differences were not statistically signifi- RESULTS ams 1 and 2 were combined, 15.7% had cant. The proportion treated and con- hypertension and 22.5% had hypercho- trolled increased for the older two groups: Demographic data lesterolemia. We also repeated the analy- 0–7.7% (P ϭ 0.03) and 0–5.6% (P ϭ Demographic and clinical characteristics ses for exams 5 and 6 combined and 0.79) for ages 30–39 and Ͼ40 years, re- of the population from the baseline and found 19.4% had hypertension and spectively, while no one in the youngest sixth exams are presented in Table 2. The 22.2% had hypercholesterolemia. group was treated and controlled at either mean age and diabetes duration at base- Figure 1A and B describe the level of exam period. line were 29.1 and 20.4 years, respective- awareness, treatment, and control of hy- ly. The prevalence of both hypertension pertension and hypercholesterolemia in Correlates of awareness and and hypercholesterolemia (defined by prevalent cases during exams 1–6 using treatment concurrent national criteria for the exam concurrent definitions (Table 1). We do To determine the correlates of awareness period) increased from exam 1 to exam 6, not present the proportion of patients by and treatment of hypertension and hyper- overall and within each age-group with cut point or using mean values as these do cholesterolemia, analyses were performed the exception of hypercholesterolemia in not consider treatment. for baseline and exam 6 data. At baseline,

DIABETES CARE, VOLUME 28, NUMBER 3, MARCH 2005 523 Hypercholesterolemia and hypertension control

Figure 1—A: Level of awareness, treatment, and control of hypertension: EDC 10-year follow-up. B: Level of awareness, treatment, and control of hypercholesterolemia; EDC 10-year follow-up. older age (33.9 vs. 30.4 years, P Ͻ 0.01) At exam 6, only the presence of ON or were not conducted. At exam 6, the pres- and seeing a physician in the previous CAD was significantly associated with ence of ON or CAD were associated with year (96.3 vs. 68.2%, P Ͻ 0.001) were awareness (66.0 vs. 44.2%, P Ͻ 0.05). awareness (72.7 vs. 49.4%, P Ͻ 0.01) and significantly associated with both aware- For hypercholesterolemia, there were treatment (82.4 vs. 55.2%, P Ͻ 0.05), as ness and treatment of hypertension no significant associations with awareness were other complications (PR, CDSP, and (age 34.2 vs. 31.5 years, P Ͻ 0.05; phy- at the baseline exam. Only two subjects LEAD) (88.9 vs. 73.8%, P Ͻ 0.05; 100.0 sician contact 96.9 vs. 79.0%, P Ͻ 0.01). were treated at baseline; thus, analyses vs. 76.9%, P Ͻ 0.05, respectively).

524 DIABETES CARE, VOLUME 28, NUMBER 3, MARCH 2005 Zgibor, Wilson, and Orchard

CONCLUSIONS — In a representa- rope), rates of treatment and control were health care; however, we found no asso- tive cohort of people with type 1 diabetes 42.2 and 11.3%, respectively. Our treat- ciation between having health insurance receiving diabetes care in the general ment and control rates for the same time and hypertension control, similar to the community of health care providers, we period were 63 and 40%, respectively. findings of Hyman et al. (5). These data found an extremely low level of control of Several factors may account for these dif- demonstrate that both system and patient two major complication risk factors, with ferences. The EuroDiab study used a dif- factors need appropriate attention in or- little improvement observed over a 10- ferent definition for the concurrent time der to improve awareness, treatment, and year follow-up period. Only 27.8% of hy- period for control of hypertension of control of hypertension and hypercholes- pertensive individuals and 5.6% of those 130/85 mmHg, which is more conserva- terolemia (27). Our results also showed with hypercholesterolemia reached goal tive, thus resulting in lower rates of con- that having a physician visit in the previ- levels at the last exam period (1996– trol. Additionally, the EDC population ous year was a significant correlate of hy- 1998), demonstrating a considerable de- had a longer duration of diabetes and, pertension awareness and treatment at ficiency in complication risk factor thus, may have experienced more compli- the baseline exam. Despite a large propor- management. cations, which could lead to higher treat- tion of subjects having regular health care Results indicated that awareness, ment rates as both patients and health (at least one visit per year), control re- treatment, and control of hypertension care providers were more aware of their mained suboptimal throughout (5), were best at exam 3 and worsened pro- health status. Additionally, subjects in the which may represent a breakdown in gressively thereafter, perhaps due to the EDC and EuroDiab studies are treated un- communication between provider and stricter treatment goals introduced in the der different health systems, which could patient. Previous studies assessing type of fifth report of the Joint National Commit- influence results. Other studies of hyper- health care provider accessed by EDC tee on Detection, Evaluation and Treat- tension control also report lower rates; participants indicated that at exam 6, ment of High Blood Pressure (16), for however, these studies were conducted ϳ50% of the cohort reported receiving exams 5 and 6. When we stratified our on subjects with , or the care from a diabetes specialist (13,28); results according to age-group, the type of diabetes was not specified, making thus, it is unlikely that type of provider youngest group (18–29 years) had the comparisons difficult (8,9). played a significant role in the results. poorest treatment and control rates at For hypercholesterolemia, there ap- both exams 1 and 6. The prevalence of pears to be little data available on treat- Limitations hypercholesterolemia increased over time ment and control in type 1 diabetes. We defined both hypertension and hyper- as expected and could not be explained by Again, available studies do not specify cholesterolemia according to the guide- the more conservative definition of hy- type of diabetes or that the study popula- lines applicable at each exam period, percholesterolemia used in exams 5 and tion is exclusively type 2 diabetes (8). Our which became more conservative over the 6, as results did not change when the less data suggest that the abysmal rates of con- study period. As this could significantly aggressive criteria were applied (22). trol are likely due to the younger age of bias our results, these changes were taken Awareness improved during the fol- this population, despite their longer du- into account for both case definition and low-up period between exams 1 and 6 in ration of diabetes, compared with those level of control. To examine the effect of all age-groups; however, the proportion with type 2 diabetes. The impression by this change in criteria, data were analyzed aware but untreated increased across all health care providers and patients alike further, applying the definition used for categories. Disturbingly, no one in the may be that because of their younger age, exam 1 to the data from exam 6, and we youngest groups was treated and con- they may not be a high-risk group for the found no difference in the prevalence of trolled during either exam period. While development complications, particularly awareness, treatment, and control of hy- awareness of these risk factors is increas- . percholesterolemia. However, we did find ing, there has been little improvement in Our data demonstrate that older age a lower prevalence of hypertension, treatment or control, particularly in and the presence of any complications are which was accompanied by higher levels younger age-groups. These results likely correlates of awareness of hypercholester- of awareness, treatment, and control. An- reflect the lack of clear guidelines for the olemia and that the presence of ON or other limitation was that both blood pres- treatment of in young adults CAD was associated with awareness of sure and were measured at a single with type 1 diabetes, as the National Cho- hypertension at exam 6. For hypercholes- point in time for each exam and cannot be lesterol Education Program and American terolemia treatment, older age and com- considered diagnostic; thus, subjects may Diabetes Association guidelines are pri- plications are correlates of treatment. This have been misclassified. We investigated marily for type 2 diabetes. Because of this, may demonstrate a health system focus on this potential bias and found that the we have previously advocated vigorous secondary rather than primary prevention prevalence of hypertension and hyercho- intervention for hypertension and hyper- of diabetes complications. In the present lesterolemia at two consecutive time lipidemia for type 1 diabetes based on our analyses, those with complications were points was indeed lower. However, exam epidemiological risk observations (26). more likely to be aware of their risk fac- periods were 2 years apart, and it is pos- In our study, rates of treatment and tors, which supports the findings of Staf- sible that those who did not have the risk control of hypertension were somewhat ford et al. (27), who showed that factor at one exam may have developed it higher compared with those reported in comorbid conditions were associated at the subsequent exam. Blood pressures the literature (6). In the EuroDiab study (a with higher screening rates for hypercho- were measured using a random zero sphyg- prospective cohort study of people with lesterolemia. Health insurance is often momanometer, which may underrecord type 1 diabetes from 16 countries in Eu- considered the gateway to adequate blood pressure, particularly systolic. There-

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