Clinical Care/Education/Nutrition

O R I G I N A L A R T I C L E

The Impact of Outpatient Diabetes

Management on Serum Lipids in Urban
African-Americans With Type 2 Diabetes
DIANE M. ERDMAN, PHARMD1 GINA J. RYAN, PHARMD4

D
iabetes is recognized as an indepen-
CURTISS B. COOK, MD2 DANIEL L. GALLINA, MD2 dent risk factor for cardiovascular
KURT J. GREENLUND, PHD3 DAVID C. ZIEMER, MD2 disease (CVD) (1), and cardiovas-
WAYNE H. GILES, MD3 VIRGINIA G. DUNBAR, BS1 cular outcomes are less favorable than
IMAD EL-KEBBI, MD2 LAWRENCE S. PHILLIPS, MD2 in those without diabetes (2– 6). How-
ever, little progress has been made in re-
ducing heart disease mortality in diabetic
patients when compared with the nondi-
abetic U.S. population (7). The pathogen-
OBJECTIVE — Treating dyslipidemia in diabetic patients is essential, particularly among
minority populations with increased risk of complications. Because little is known about the
esis of heart disease in individuals with
impact of outpatient diabetes management on lipid outcomes, we examined changes in lipid diabetes is complex, but serum lipids are
profiles in urban African-Americans who attended a structured diabetes care program. frequently abnormal and likely contribute
to the increased risk of CVD (8,9). Be-
RESEARCH DESIGN AND METHODS — A retrospective analysis of initial and 1-year cause use of medications that improve
follow-up lipid values was conducted among patients selected from a computerized registry of an lipid profiles can also reduce CVD risk
urban outpatient diabetes clinic. The independent effects of lipid-specific medications, glycemic among individuals with diabetes (10 –
control, and weight loss on serum total cholesterol, LDL cholesterol, HDL cholesterol, and 12), aggressive intervention is recom-
triglyceride levels were evaluated by analysis of covariance and multiple linear regression. mended when dyslipidemia is detected
(13).
RESULTS — In 345 patients (91% African-American and 95% with type 2 diabetes), HbA1c
Recent data indicate that recom-
decreased from 9.3% at the initial visit to 8.2% at 1 year (P ⬍ 0.001); total and LDL cholesterol
and triglyceride levels were significantly lower, and HDL cholesterol was higher. After stratifying mended clinical targets for lipids are not
based on use of lipid-specific therapy, different outcomes were observed. In 243 patients not being achieved among patients at high
taking dyslipidemia medications, average total cholesterol, LDL cholesterol, and triglyceride risk for CVD (14). Structured diabetes
concentrations at 1 year were similar to initial values, whereas in 102 patients receiving phar- programs have been shown to improve
macotherapy, these lipid levels were all lower at 1 year relative to baseline (P ⬍ 0.001). Mean glycemic control, but there is actually lit-
HDL cholesterol increased regardless of lipid treatment status (P ⬍ 0.001). After adjusting for tle information about the impact of such
other variables, changes in LDL cholesterol concentration were associated only with use of programs on the severity of dyslipidemia
lipid-specific agents (P ⫽ 0.003), whereas improved HbA1c and weight loss had no independent in type 2 diabetes, particularly in popula-
effect. Lipid therapy, improved glycemic control, and weight loss were not independently related tions enriched in ethnic groups at in-
to changes in HDL cholesterol and therefore could not account for the positive changes observed.
Use of lipid-directed medications, improvement in glycemic control, and weight loss all resulted
creased risk of diabetes-related CVD
in significant declines in triglyceride levels but only improved HbA1c and weight loss had an mortality (15–19).
independent effect. In our setting, which serves primarily
African-Americans with type 2 diabetes,
CONCLUSIONS — Among urban African-Americans, diabetes management led to favor- patients typically have LDL cholesterol
able changes in HDL cholesterol and triglyceride levels, but improved glycemic control and levels that fall outside of American Diabe-
weight loss had no independent effect on LDL cholesterol concentration. Initiation of pharma- tes Association (ADA) clinical targets,
cologic therapy to treat high LDL cholesterol levels should be considered early in the course of with an average value of 140 mg/dl at pre-
diabetes management to reach recommended targets and reduce the risk of cardiovascular sentation (20). Low HDL cholesterol is
complications in this patient population. less common, and only a low percentage
Diabetes Care 25:9 –15, 2002
of patients have hypertriglyceridemia
(20). Therefore, interventions directed
● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ●
at lowering LDL cholesterol and raising
From the 1Grady Health System Atlanta, and the 2Division of Endocrinology and Metabolism, Department HDL cholesterol should take priority in
of Medicine, Emory University School of Medicine; the 3Division of Adult and Community Health, National
Center for Chronic Disease Prevention and Health Promotion, the Centers for Disease Control and Preven-
decisions about the choice of therapy
tion; and the 4Department of Pharmacy Practice, Mercer University, Atlanta, Georgia. for dyslipidemia. To determine the im-
Address correspondence and reprint requests to Curtiss B. Cook, MD, Diabetes Unit, Emory University pact of diabetes care on serum lipids in
School of Medicine, 69 Butler St., S.E., Atlanta, GA 30303. E-mail: cbcook@emory.edu. this population, we examined the inde-
Received for publication 12 April 2001 and accepted in revised form 21 September 2001. pendent effects of lipid-directed phar-
Abbreviations: ADA, American Diabetes Association; ANCOVA, analysis of covariance; CVD, cardiovas-
cular disease; HMG, hydroxymethylglutaryl. macotherapy, glycemic control, and
A table elsewhere in this issue shows conventional and Système International (SI) units and conversion weight loss on lipid outcomes after 1
factors for many substances. year of treatment.

DIABETES CARE, VOLUME 25, NUMBER 1, JANUARY 2002 9

Diabetes care and lipids in African-Americans
RESEARCH DESIGN AND
METHODS
Overview of treatment program
The diabetes treatment program has been
described previously (17,18). Briefly, in-
tensive education in lifestyle modifica-
tion, self-management training, and diet,
coupled with intensification of medical
therapy when needed to control hyper-
glycemia, have been integral parts of our
structured care program. The overall
treatment approach has been shown to
result in significantly lower HbA1c levels
(17,18).
Patient selection
Patients who initially presented to the
program between 1991 and 1998 were
selected from a computerized registry if
they had a 1-year (52 ⫾ 10 weeks) fol-
low-up visit and if serum total cholesterol,
HDL cholesterol, LDL cholesterol, and
triglyceride levels were measured at both
the initial (baseline) and 1-year visits. We
chose a 1-year follow-up because we be-
lieved this would be a sufficient amount
of time to expect life-style and pharmaco-
logic interventions to take effect or be ini-
tiated. Data on lipid-specific medications
for these patients were obtained from the
computerized Pharmacy and Drug Infor-
mation system maintained by the health
system.
Laboratory studies and
measurements
Serum total cholesterol, HDL cholesterol,
and triglyceride levels were determined
on fasting blood samples using standard
techniques as described previously (21).
Because LDL cholesterol levels were de-
termined using the Friedewald equation,
patients with triglyceride levels ⱖ400
mg/dl were not included in the analysis
(22); only ⬃4% of African-American pa-
tients in our setting have triglyceride lev-
els ⬎400 mg/dl (20).
Analyses
Patients were stratified into individuals re-
ceiving medical therapy for dyslipidemia
at 1 year (pharmacotherapy group) and
individuals not receiving lipid-directed
therapy (nonpharmacotherapy group),
and lipid outcomes were examined sepa-
rately for each category. Pharmacother-
apy patients included individuals in
whom medication was maintained or in-
creased during the 1-year follow-up as
10
well as individuals for whom therapy was
initiated. Statistical differences between
groups were tested on log-transformed
data using either paired or unpaired Stu-
dent’s t tests, and ␹2 analysis was used for
proportions.
To evaluate the impact of care on
reaching lipoprotein targets, we exam-
ined LDL cholesterol, HDL cholesterol,
and triglyceride distributions using ADA
clinical guidelines applicable to the time
encompassed by the data set. Before
1998, the recommended goal for LDL
cholesterol was ⬍130 mg/dl, and drug
treatment was suggested for values ⱖ160
mg/dl. The proportion of patients meet-
ing the ADA definition of an HDL choles-
terol level at high risk for CVD was also
determined, using sex-specific criteria
(⬍35 mg/dl in men and ⬍45 mg/dl in
women). Finally, we determined the per-
centage of patients at goal (⬍200 mg/dl)
for triglyceride levels (23).
We next determined the independent
effects of lipid-directed therapy, im-
proved glycemic control, and weight loss
on changes in LDL cholesterol, HDL cho-
lesterol, and triglyceride concentrations
using both analysis of covariance (AN-
COVA) and multiple linear regression.
For the ANCOVA, patients were stratified
according to lipid therapy status (therapy
versus no therapy), whether they had a
reduction in HbA1c level (HbA1c im-
proved versus not improved), and by
weight loss (weight loss versus no weight
loss). HbA1c was defined as “improved” if
there was a decrease of ⬎0.5% at 1 year;
the “HbA1c not improved” group was ex-
pected to include individuals in whom
HbA1c values were similar or higher than
baseline. Weight loss was defined as a de-
crease of ⬎1.0 kg at 1 year; it was antici-
pated that the “no weight loss” category
would incorporate individuals whose
weight was either unchanged or increased
compared with their initial visit. A change
in lipoprotein concentration relative to
baseline was considered significant if the
95% CI did not cross zero. Statistical dif-
ferences in the changes in lipid levels be-
tween categories were tested after
adjusting for patient age, duration of dia-
betes, sex, race, baseline lipid levels,
mode of treatment for hyperglycemia,
and year of initial visit.
Using multiple linear regression
models, we separately evaluated the inde-
pendent effect of lipid therapy, weight
DIABETES CARE, VOLUME 25, NUMBER 1, JANUARY 2002
change, and HbA1c change on change in
LDL cholesterol, HDL cholesterol, and
triglyceride levels (all defined as year mi-
nus baseline values). Analyses were ad-
justed as for the ANCOVA.
RESULTS
Patient characteristics
We identified 345 patients in whom total
cholesterol, LDL cholesterol, HDL choles-
terol, and triglyceride levels were mea-
sured at the initial and 1-year visits. At
presentation, the mean age of this study
group was 57 years, mean weight was
89.6 kg, and mean BMI was 32.6 kg/m2;
68% were women, 91% were African-
American, and 95% had type 2 diabetes.
The mean duration of diabetes was 5.4
years. Average HbA1c declined from 9.3
to 8.2% (P ⬍ 0.001) by 1 year in the study
group. Patients not included in the anal-
yses (n ⫽ 5,728) were slightly younger
(52 years, P ⬍ 0.001) at presentation, had
a similar duration of diabetes (5.4 years),
had a comparable weight (88.0 kg) but
slightly lower BMI (31.6 kg/m2, P ⫽
0.019), and similar HbA1c (9.3%) relative
to those studied. The proportion of
women and African-Americans were sim-
ilar.
Among study patients, there were de-
creases in total cholesterol (219 to 212
mg/dl, P ⬍ 0.001), LDL cholesterol (148
to 139 mg/dl, P ⬍ 0.001), and triglyceride
(148 to 142 mg/dl, P ⫽ 0.007) concentra-
tions and an increase in HDL cholesterol
level (47 to 50 mg/dl, P ⬍ 0.001). Com-
pared with the study patients at the initial
visit, those not analyzed had lower total
cholesterol, LDL cholesterol, and HDL
cholesterol values (207, 136, and 46 mg/
dl, respectively; P ⬍ 0.04) and higher but
not significantly different triglyceride lev-
els (167 mg/dl, P ⫽ 0.94). Subsequent
analyses focused on those in the study
group.
Lipid profiles in
nonpharmacotherapy patients
The mean HbA1c level of nonpharmaco-
therapy patients (n ⫽ 243) declined sig-
nificantly (P ⬍ 0.001) relative to the
initial visit, with an average decrease of
1.0% (Table 1). Despite the improvement
in HbA1c, the total cholesterol, LDL cho-
lesterol, and triglyceride concentrations
at 1 year were comparable to levels found
at the initial visit (all P ⱖ 0.28).
LDL cholesterol distributions of non-

Table 1—HbA1c , weight, and lipid profiles, according to dyslipidemia therapy status
No pharmacotherapy
(n ⫽ 243)
Initial
HbA1c (%) 9.2 (2.7)
Weight (kg) 89.6 (21.8)
BMI (kg/m2) 32.8 (8.1)
Lipids (mg/dl)
Total cholesterol 208 (47)
LDL 138 (43)
HDL 48 (16)
Triglycerides 141 (69)
Data are means (SD). *Significant difference between 1-year and initial visit; †significant difference between
therapy groups at initial visit.
pharmacotherapy patients are shown in
Fig. 1. The LDL cholesterol distribution
improved only minimally at 1 year, with a
slight increase in the proportion of indi-
viduals with levels from 100 to 129 mg/dl
category and a modest decrease in the
percentage with levels from 130 to 159
mg/dl (Fig. 1). In addition, 25% had an
LDL cholesterol value ⱖ160 mg/dl (pre-
1998 treatment threshold) at 1 year ver-
sus 26% at the initial visit; 48% had
1-year levels ⬍130 mg/dl (pre-1998 goal)
compared with 43% at baseline.
Mean HDL cholesterol increased in
nonpharmacotherapy individuals at 1
year (P ⬍ 0.001, Table 1). The HDL cho-
lesterol distribution also improved; the
proportion with a high-risk HDL choles-
terol concentration decreased from 41%
at baseline to 30% at 1 year. For triglyc-
erides, 82% had levels ⬍200 mg/dl at
both time points (data not shown).
Lipid profiles in pharmacotherapy
patients
Compared with the nonpharmacotherapy
group, pharmacotherapy patients (n ⫽
102) were older (59 vs. 56 years, P ⫽
0.011) and had a longer duration of dia-
betes (6.8 vs. 4.7 years, P ⫽ 0.03). Most
patients (94%) were using hydroxymeth-
ylglutaryl (HMG)-CoA reductase inhibi-
tors (average dose 22 mg). There were no
differences between lipid therapy classes
in the percentage who were women, who
had type 2 diabetes, or who were African-
American.
There was a significant decrease in
HbA1c in those on drug therapy, and the
average decline (1.3%) was similar (P ⫽
0.40) to that detected in the nonpharma-
cotherapy group (Table 1). At the initial
DIABETES CARE, VOLUME 25, NUMBER 1, JANUARY 2002
Erdman and Associates
proportion with LDL cholesterol levels
ⱖ160 mg/dl decreased from 60% at the
Pharmacotherapy initial visit to 30% at 1 year, whereas the
(n ⫽ 102) number with values ⬍130 mg/dl in-
creased from 21 to 39%.
1 Year Initial 1 Year
Like the nonpharmacotherapy group,
8.2 (2.4)* 9.8 (2.5)† 8.2 (2.2)* HDL cholesterol concentration increased
90.6 (22.0)* 89.5 (22.7) 89.4 (20.9) in pharmacotherapy patients (P ⬍ 0.001)
33.2 (7.6) 32.6 (7.6) 32.6 (7.5) at 1 year (Table 1), and the percentage
with levels in the high-risk category de-
210 (49) 247 (55)† 219 (53)* creased from 37% at the initial visit to
137 (45) 174 (50)† 145 (45)* 24% at 1 year. Finally, 82% had triglycer-
50 (17)* 47 (13) 50 (12)* ide levels of ⬍200 mg/dl at both the initial
140 (76) 164 (71)† 146 (69)* and 1-year visits (data not shown).
Evaluating the independent effects of
lipid therapy, glycemic control, and
weight loss
visit, pharmacotherapy patients had a Of the 345 patients, 56% had improved
higher HbA1c level (P ⫽ 0.017) than non- HbA1c levels after 1 year; among these in-
pharmacotherapy individuals and similar dividuals, HbA1c decreased an average of
weight (P ⫽ 0.99). In contrast to the non- 3.1% (from 10.5 to 7.4%, P ⬍ 0.001). For
pharmacotherapy patients, the pharma- individuals who did not show improve-
cotherapy group experienced no ment in glycemic control, HbA 1c in-
significant weight change. Pharmacother- creased an average of 1.6% (from 7.7 to
apy patients had higher total cholesterol, 9.3%, P ⬍ 0.001). A total of 29% of pa-
LDL cholesterol, and triglyceride levels tients experienced a ⬎1-kg weight loss,
(P ⬍ 0.001) at baseline compared with with an average decrease of 5.6 kg (from
nonpharmacotherapy patients. Use of 92.5 to 86.9 kg, P ⬍ 0.001); patients with
lipid therapy led to significant decreases no weight loss gained an average of 4.0 kg
in all three lipoprotein concentrations by (from 86.6 to 90.5 kg, P ⬍ 0.001).
1 year (all P ⬍ 0.001). We used ANCOVA to determine
A shift to a more favorable LDL cho- whether lipid-directed therapy, improved
lesterol distribution was evident among glycemic control, and weight loss had in-
pharmacotherapy patients (Fig. 2). The dependent effects on change in individual
Figure 1—LDL cholesterol distribution for patients not on lipid pharmacotherapy at 1 year.
11
Diabetes care and lipids in African-Americans
Figure 2—LDL cholesterol distribution for patients on lipid pharmacotherapy at 1 year.
lipid levels (Table 2). Use of lipid-directed
therapy was associated with a significant
decline in LDL cholesterol level, which
was statistically greater than that detected
in individuals not given lipid-directed
therapy (P ⫽ 0.003). Improved HbA1c
was also associated with a significant de-
crease in LDL cholesterol, but this was not
different from that in individuals with no
improvement in HbA1c (P ⫽ 0.47). Los-
ing ⬎1 kg body weight was not associated
with a significant decrease in LDL choles-
terol concentration, and changes were
comparable between weight-loss catego-
ries (P ⫽ 0.86). Therefore, only use of
lipid-directed therapy was independently
associated with decrease in LDL choles-
terol levels.
HDL cholesterol concentrations in-
creased significantly in most categories,
but changes were similar regardless of
lipid therapy status (P ⫽ 0.80), HbA1c
outcome (P ⫽ 0.44), or weight loss (P ⫽
0.82). Lipid therapy, improvement in
HbA1c, and weight loss were all associated
with significant decreases in triglyceride
levels, but only weight loss demonstrated
an independent effect (P ⫽ 0.035) (Table
2). Results of ANCOVA analyses were
comparable if stricter definitions were
used for improvement in HbA1c (⬎1.0%)
or weight loss (decrease ⬎2.5 kg) (not
shown).
Using multiple linear regression, re-
12
exception to the ANCOVA results was
that change in HbA1c was significantly re-
lated to change in triglyceride level (P ⫽
0.027).
After 1994, our program became
more aggressive in intensifying therapy
for hyperglycemia, which resulted in bet-
ter HbA1c outcomes compared with ear-
lier years (24). Therefore, we performed
the above analyses on the subset of pa-
tients seen between 1995 and 1998. The
1-year HbA1c outcome for 1995–1998
was 7.9%, compared with 8.6% for
1991–1994 (P ⫽ 0.013). Despite the bet-
ter HbA1c outcome for 1995–1998, re-
peat ANCOVA and multiple linear
regression analyses of this patient subset
showed the relationships between HbA1c,
weight, and lipid medications with lipid
levels the same as for the whole study pe-
riod of 1991–1998 (data not shown).
CONCLUSIONS — The 345 patients
in this study had significant reductions in
levels of HbA1c, total cholesterol, LDL
cholesterol, and triglycerides as well as an
sults mostly agreed with the ANCOVA. increase in HDL cholesterol, which is ev-
Lipid therapy was significantly associated idence that the diabetes management pro-
(P ⫽ 0.028) with change in LDL choles- gram improved both glycemic control
terol, whereas change in HbA 1c and and serum lipids. However, lipid out-
weight had no independent effect (both comes were not affected uniformly by tra-
P ⫽ 0.43); HbA1c, use of lipid therapy, ditional program components such as
and weight did not significantly impact glycemic control, weight loss, and lipid-
HDL cholesterol (all P ⬎ 0.50). Weight directed pharmacotherapy.
change was related to change in triglycer- We detected significant reductions in
ides (P ⫽ 0.0085), whereas use of lipid LDL cholesterol only in patients given lip-
therapy had no effect (P ⫽ 0.76). The only id-directed pharmacotherapy. Patients
Table 2—Effect of lipid therapy, glyemic control, and weight loss on LDL cholesterol, HDL
cholesterol, and triglyceride changes (mg/dl)
Change Change Change in
in LDL in HDL triglycerides
Lipid pharmacotherapy at 1 year
No ⫺2 (⫺7 to 3) ⫹3 (1–5)† ⫺1 (⫺9 to 8)
Yes ⫺27 (⫺38 to ⫺16)*† ⫹2 (0–5) ⫺17 (⫺31 to ⫺3)†
HbA1c at 1 year
Not improved ⫺6 (⫺13 to 0) ⫹2 (⫺1 to 4) 1 (⫺9 to 12)
Improved (decrease ⬎0.5%) ⫺12 (⫺20 to ⫺5)† ⫹3 (1–5)† ⫺11 (⫺20 to ⫺1)†
Weight change at 1 year
No weight loss ⫺11 (⫺17 to ⫺4)† ⫹2 (1–4)† ⫺1 (⫺10 to 8)
Lost weight (decrease ⬎1.0 kg) ⫺8 (⫺15 to 0) ⫹3 (1–6)† ⫺14 (⫺26 to ⫺3)†‡
Data are means (95% CI). Changes in lipids defined as 1 year minus initial values. Negative changes denote
a decrease and positive changes an increase in lipid concentration compared with initial visit. Analyses were
conducted by ANCOVA and were adjusted for other variables in the table plus patient age, duration of
diabetes, race (African-American versus other), sex, hyperglycemia treatment (diet, oral agents, insulin), year
of initial visit, and initial lipid values. *Significantly different from those not on therapy (P ⫽ 0.003);
†significantly different from baseline (CI does not cross zero); ‡significantly different from those without
weight loss (P ⫽ 0.035).
DIABETES CARE, VOLUME 25, NUMBER 1, JANUARY 2002

classified as “improved HbA1c ” had a sub-
stantial decrease in HbA1c and achieved
an average level of 7.4% after 1 year and a
value close to national standards (13).
Individuals classified as “not improved”
had an increase in HbA1c, but the change
in LDL cholesterol was comparable re-
gardless of final glycemic status. Simi-
larly, patients with “weight loss” lost an
average of 5.6 kg, whereas individuals
classified as “no weight loss” gained 4.0
kg, and changes in LDL cholesterol were
also comparable between groups. This is
consistent with findings from another
study, in which intensive versus nonin-
tensive lifestyle modification resulted in
similar declines in LDL cholesterol among
African-American patients with type 2 di-
abetes (25). Our results suggest that al-
though glycemic control and weight
management are cornerstones of diabetes
therapy, neither intervention may play a
major role in improving LDL cholesterol
in populations comparable to ours. Life-
style modification must continually be
emphasized and reinforced in overall di-
abetes care and may lower cardiovascular
risk through factors not examined here.
Our finding that LDL cholesterol declined
even among individuals who did not ex-
perience HbA1c improvement or weight
loss may be explained by other manage-
ment elements such as lifestyle modifica-
tion (changes in diet composition and/or
physical activity). Because we do not cap-
ture data on exercise or dietary habits, we
are unable to retrospectively assess the ef-
fects of these interventions on lipid pro-
files. Because the decrease in LDL
cholesterol was highly associated with use
of lipid-specific pharmacotherapy, our re-
sults indicate that early introduction of
lipid-modifying agents into the treatment
program should be given strong consid-
eration for patients with high LDL choles-
terol levels.
Recent data indicate that detection
and treatment of high LDL cholesterol of-
ten falls short of national recommenda-
tions (14,26,27). Although this study was
not designed to examine practice pat-
terns, our data also indicate that providers
were not sufficiently aggressive in their
management when high LDL cholesterol
concentrations were found. Guidelines
operating during 1998 and earlier sug-
gested institution of pharmacotherapy for
an LDL cholesterol value ⱖ160 mg/dl
(23), but in our study, 25% of the un-
treated patients had levels higher than
DIABETES CARE, VOLUME 25, NUMBER 1, JANUARY 2002
this threshold and remained without
therapy at 1 year. Moreover, nearly one-
third of treated patients still had LDL
cholesterol levels ⱖ160 mg/dl at 1 year,
implying delayed or insufficient inten-
sification of therapy. Since 1998, a more
stringent clinical target for LDL choles-
terol in diabetes, with a goal of ⬍100
mg/dl, has been suggested by the ADA,
and it is a goal now recommended by the
National Cholesterol Education Program
(28). It is not yet known whether practi-
tioners have responded to the recom-
mended lower targets for LDL cholesterol
with more aggressive use of medication
therapy.
We have defined previously clinical
inertia as a failure to intensify therapy
when such action is needed and not oth-
erwise contraindicated. Studying the ba-
sis for clinical inertia and implementing
measures to overcome it can result in ad-
ditional improvement in glycemic control
of a population (24). Successful diabetes
management requires attention to multi-
ple metabolic parameters. When practi-
tioners are focused on a single health
problem, other processes of care may not
be delivered (29). It is possible that the
intense concentration on treating hy-
perglycemia may have detracted from
aggressively managing dyslipidemia. Ex-
amination of potential barriers in the
management of dyslipidemia requires
further investigation and is underway
(30).
Although the diabetes care program
led to an increase in HDL cholesterol con-
centrations, an encouraging observation
indicating the benefit of the program on
this lipoprotein, definite variables that ac-
counted for this change were not identi-
fied. The therapies examined here
(glycemic control, weight loss, and lipid
pharmacotherapy) were not indepen-
dently associated with changes in HDL
cholesterol. Other components of the ed-
ucation and treatment paradigms may
have resulted in higher HDL cholesterol.
Nevertheless, despite improvement in the
HDL cholesterol profile after 1 year of
management, a substantial proportion of
patients still had levels that would confer
increased cardiovascular risk. In this anal-
ysis, there was a predominant use of
HMG-CoA reductase inhibitors, which
typically have only a modest effect on
HDL cholesterol levels (13,23). These ob-
servations suggest that HDL cholesterol
may have been underemphasized as an
Erdman and Associates
independent target of intervention when
practitioners made therapeutic decisions
and indicates a potential need to increase
awareness of the benefits of increasing
HDL cholesterol (31) during the course of
diabetes care.
Although use of lipid medication sig-
nificantly reduced triglyceride concentra-
tion relative to baseline, this effect was
statistically similar to the change seen
among patients not on lipid therapy. The
decrease in triglyceride level with im-
proved HbA1c was also significant com-
pared with baseline. Although the results
of the ANCOVA indicated that improved
HbA1c did not have an independent effect
on triglyceride change, multiple linear re-
gression confirmed the effect of glycemic
control on this lipoprotein. Weight loss
also independently affected triglyceride
levels; the average change in the weight-
loss category was significantly greater
than in the no–weight-loss group and in-
dicates that even the modest weight de-
crease detected here would likely be
beneficial in the management of hypertri-
glyceridemia.
Certain limitations to the study must
be noted. Because LDL cholesterol levels
tended to be high and triglyceride levels
tended to be low in our patient popula-
tion, LDL cholesterol was of primary in-
terest to us. Therefore, we retrospectively
selected patients according to whether
levels of this lipoprotein were available.
This led to statistical differences in some
characteristics between the study popula-
tion and those not included in the analy-
ses. Although the clinical significance of
these small differences is unclear, the
study sample size, although still informa-
tive about the results of care, may not re-
flect eventual changes in the lipid profiles
of the larger patient base. A recent study
supports findings from the Diabetes Con-
trol and Complications Trial that achiev-
ing glycemic control improves lipid status
among patients with type 1 diabetes
(32,33). Studies examining the relation-
ship between achieving normal blood
glucose levels and the effect it has on se-
rum lipids among patients with type 2 di-
abetes have yielded inconsistent results
(25,34). For instance, in contrast to other
data, our educational program resulted in
a significant improvement in HDL choles-
terol levels (25). The findings here might
be specific to our clinic population, which
is enriched in African-Americans, who
typically have a lipid profile different
13
Diabetes care and lipids in African-Americans
from that of Caucasians (20). Additional
studies are required to determine whether
our observations can be generalized to
other clinical settings and whether indi-
vidual lipoproteins remain at target over
longer follow-up periods. Studies focus-
ing on lipid levels rather than just glyce-
mic control as primary outcomes of care
are needed in diabetes.
Our analysis shows how serum lipids
are likely to respond within the context of
routine diabetes care. Standard ap-
proaches to managing diabetes will likely
benefit HDL cholesterol and triglyceride
levels, even without use of lipid-directed
medications, but glycemic control and
weight management may provide little
benefit in reducing high LDL cholesterol
levels. In accordance with what is becom-
ing recognized increasingly (35), our re-
sults indicate that patients with elevated
LDL cholesterol concentrations may need
early introduction of lipid-specific agents
into their treatment programs rather than
wait a long period to observe effects of
nonpharmacologic approaches. More-
over, education programs aimed at lipid-
related decision-making by providers
may be needed to increase attention to
management of all aspects of diabetic dys-
lipidemia— beyond improving LDL cho-
lesterol alone. Establishing the most
effective methods of achieving recom-
mended lipid targets will be needed to
reduce the morbidity and mortality of
CVD in diabetic patients at high risk.
Acknowledgments — This study was sup-
ported by awards from the Agency for Health-
care Research and Quality (HS-09722) and the
National Institutes of Health (DK-33475 and
DK-48124).
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