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ONLINE=20
FIRST
Systematic=20
Review of Early Cardiometabolic Outcomes of the First =
Treated=20
Episode of Psychosis
Debra=20
L. Foley, PhD; Katherine I. Morley, PhD=20
Arch Gen=20
Psychiatry. Published online February 7, 2011.=20
doi:10.1001/archgenpsychiatry.2011.2
ABSTRACT=20
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Context =20
The increased mortality associated with schizophrenia =
is=20
largely due to cardiovascular disease. Treatment with=20
antipsychotics is associated with weight gain and =
changes=20
in other cardiovascular risk factors. Early=20
identification of modifiable cardiovascular risk =
factors=20
is a clinical imperative but prospective longitudinal=20
studies of the early cardiometabolic adverse effects =
of=20
antipsychotic drug treatment other than weight =
gain have=20
not been previously reviewed.
Objectives To assess the methods and =
reporting of=20
cardiometabolic outcome studies of the first =
treated=20
episode of psychosis, review key findings, and =
suggest=20
directions for future research.
Data Sources PsycINFO, MEDLINE, and Scopus =
from=20
January 1990 to June 2010.
Study Selection Subjects were experiencing =
their=20
first treated episode of psychosis. Subjects were =
antipsychotic naive or had been exposed to =
antipsychotics=20
for a short known period at the beginning of the =
study.=20
Cardiometabolic indices were assessed. Studies =
used a=20
longitudinal design.
Data Extraction Sixty-four articles were =
identified=20
describing 53 independent studies; 25 studies met =
inclusion criteria and were retained for detailed =
review.
Data Synthesis Consolidated Standards of =
Reporting=20
Trials and Strengthening the Reporting of =
Observational=20
Studies in Epidemiology checklists were used to =
assess=20
the methods and reporting of studies. A =
qualitative=20
review of findings was conducted.
Conclusions Two key hypotheses were =
identified based=20
on this review: (1) in general, there is no =
difference in=20
cardiovascular risk assessed by weight or =
metabolic=20
indices between individuals with an untreated =
first=20
episode of psychosis and healthy controls and (2) =
cardiovascular risk increases after first exposure to =
any=20
antipsychotic drug. A rank order of drugs can be =
derived=20
but there is no evidence of significant class =
differences.=20
Recommended directions for future research =
include=20
assessing the effect on cardiometabolic outcomes =
of=20
medication adherence and dosage effects, =
determining the=20
therapeutic window for antipsychotic use in =
adults and=20
youth, and testing for moderation of outcomes by=20
demographic factors, including sex and age, and =
clinical=20
and genetic factors.
INTRODUCTION=20
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Top |
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Introduction |
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Methods |
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Results |
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Comment |
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Author=20
information |
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References |
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Twenty-five=20
years after diagnosis, individuals with schizophrenia=20
have a mortality risk that is 3 times that of the =
general=20
population.1=20
Although risk of suicide is increased 18-fold over 25 =
years,1=20
the very low base rate for suicide in the wider =
community=20
means that the major cause of mortality and morbidity=20
among individuals with schizophrenia is actually =
natural=20
causes, predominantly cardiovascular =
disease.1-2=20
Antipsychotic drugs, such as clozapine, can save =
lives by=20
reducing the impulsiveness and aggression that =
can lead=20
to suicide3-4=20
but they can also alter risk for cardiovascular =
disease=20
by causing weight gain5-6=20
and possibly hypertension and lipid and glucose=20
abnormalities.7=20
The risk for cardiovascular disease appears to be =
increasing among individuals with =
schizophrenia,1=20
creating an ever-widening gap between the life =
expectancy=20
of the seriously mentally ill and the broader=20
community.8=20
Determining if antipsychotic drugs reduce or increase=20
overall mortality associated with schizophrenia or =
other=20
psychoses is therefore a pressing issue9-10=20
and the identification of, and intervention =
directed at,=20
modifiable risk factors for cardiovascular =
disease among=20
the seriously mentally ill, a clinical imperative. =
Research is needed to understand the nature and magnitude =
of=20
the cardiovascular risk factors associated with=20
schizophrenia and other psychoses in the early =
phase of=20
illness to track the effects of different drug =
treatments=20
for psychosis on key risk factors for =
cardiovascular=20
disease. Distinguishing pretreatment status from=20
treatment effects is important for understanding =
the=20
source of cardiovascular disease associated with =
psychosis=20
and to inform decisions regarding medication review =
and=20
other interventions. This distinction can only be =
made at=20
the very beginning of treatment in patients with =
a first=20
episode of psychosis who have not previously been =
exposed=20
to antipsychotic drugs or who have been exposed =
for a=20
short known period.11=20
First-episode psychosis is an intermediate =
diagnosis used=20
in the early phase of psychotic illness until the =
clinical picture stabilizes.12=20
Most first episodes of psychosis will eventually be=20
diagnosed as schizophrenia in younger cohorts, or =
as=20
schizophrenia, bipolar disorder, or major =
depression with=20
psychotic features in samples unselected for age =
at=20
onset.13=20
The aims of this report are to:
- Identify prospective longitudinal treatment studies of =
the=20
first episode of psychosis that include =
assessment of=20
cardiometabolic outcomes. These include body =
weight and=20
central obesity and associated biomarkers,=20
hyperglycemia and hyperinsulinemia, dyslipidemia,=20
hypertension, and inflammatory markers (Table).=20
- Summarize the methods and quality of =
reporting of=20
identified studies.
- Conduct a review of the early cardiometabolic outcomes =
of=20
treated psychosis and report key =
findings.=20
- Suggest directions for future =
research.=20
View=20
this table:
[in=20
this window]
[in a new =
window]
[as=20
a PowerPoint slide]
=20
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| Table.=20
Cardiometabolic Indices Assessed by the =
Studies=20
Reviewed Herein and Their Association With =
Cardiovascular Outcomes
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METHODS=20
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Top |
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Introduction |
| =95 |
Methods |
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Results |
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Comment |
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Author=20
information |
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References |
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DATA=20
SOURCES
Two search strings were used to identify studies: ["first =
episode psychosis" AND metabolism] and [psychosis =
AND=20
naive AND "glucose OR insulin OR cholesterol OR=20
triglycerides OR blood pressure OR weight"]. The =
search=20
was limited to English-language publications and =
was=20
conducted using MEDLINE (via PubMed), PsycINFO, and=20
Scopus for the period from January 1, 1990, through =
June=20
15, 2010. The reference lists of identified =
articles were=20
also hand searched.
STUDY =
SELECTION
Studies were included if (1) subjects had a first episode =
of=20
psychosis; (2) subjects were antipsychotic drug naive =
or=20
only recently exposed to antipsychotics for a =
short known=20
period at the initiation of the study; and (3) a=20
prospective longitudinal study design was =
implemented.=20
File audits, cohort studies, and drug trials =
(blind or=20
open) were all eligible. Medical record file =
audits were=20
considered only if they used data from clinics =
that=20
conducted routine monitoring of all patients.
DATA=20
EXTRACTION
Items from the Consolidated Standards of Reporting Trials =
(CONSORT)14-15=20
and Strengthening the Reporting of Observational =
Studies=20
in Epidemiology (STROBE)16-17=20
checklists were used to assess the methods and =
quality of=20
reporting (eTable=20
1). We added 4 additional fields=97industry=20
sponsorship, assessment of medication compliance, =
follow-up psychiatric diagnosis, and if tests for =
differences in cardiometabolic outcomes across =
different=20
antipsychotics were conducted.
RESULTS=20
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Top |
| =95 |
Introduction |
| =95 |
Methods |
| =95 |
Results |
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Comment |
| =95 |
Author=20
information |
| =95 |
References |
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PROSPECTIVE=20
LONGITUDINAL TREATMENT STUDIES OF THE FIRST EPISODE OF=20
PSYCHOSIS
Sixty-four articles were identified describing 53=20
independent studies; 25 studies met inclusion =
criteria=20
and were retained for detailed review (eTable=20
1). Studies were excluded because they did =
not=20
consist solely of patients with first-episode psychosis =
(n =3D 21), patients were not antipsychotic =
drug=20
naive at entry to the study and recent brief =
exposure was=20
not explicitly specified (n =3D 5), or =
exposure=20
was not brief (ie, at least 6 months)=20
(n =3D 2).
METHODS AND=20
QUALITY OF REPORTING
Industry=20
Sponsorship
Ten studies received support from the pharmaceutical=20
industry (eTable=20
1).
Study =
Design=20
and Hypotheses
Studies reviewed comprised 10 randomized trials, 5=20
nonrandomized trials, and 10 observational cohort =
studies=20
(eTable=20
1). One randomized trial, 1 nonrandomized =
trial, and=20
4 cohort studies included healthy controls to =
conduct a=20
cross-sectional case-control comparison of =
baseline=20
cardiometabolic indices.18-24=20
Cardiometabolic outcomes (predominantly weight) =
were a=20
primary outcome measure in 16 studies18-21,23-34;=20
the primary outcome was treatment efficacy or =
all-cause=20
medication discontinuation, with cardiometabolic =
measures=20
a secondary outcome, in the remaining studies (eTable=20
2).
Sample=20
Ascertainment and Subject Participation
Two studies described in detail the population from which =
subjects were ascertained and both appear to have =
ascertained samples representative of the broader =
population of patients.35-36=20
All studies provided information on eligibility =
criteria.=20
Four randomized trials, 1 nonrandomized trial, =
and 4=20
cohort studies excluded subjects who used =
recreational=20
drugs,28=20
had recent alcohol or drug abuse,37=20
or a substance use disorder.18-20,25,=20
33,=20
36,=20
38=20
The drugs were not specified. Six studies excluded =
individuals=20
with any cardiometabolic abnormality at =
baseline.18-19,25,=20
28,=20
30-31=20
Only 2 studies reported the number of potential =
subjects=20
who met eligibility criteria. Four studies reported =
the=20
percentage of eligible individuals approached who =
subsequently consented to participate in the =
study (eTable=20
1) (for Addington et al,27=20
no participation rate is recorded because it was a=20
retrospective medical file audit study). All =
others=20
reported that their sample consisted of all =
consecutive=20
admissions at 1 or more treatment centers. =
Drug-Naive=20
Status and Medication
Patients were either antipsychotic naive or had been =
exposed=20
to antipsychotics for between 9 days and 16 weeks. All =
studies described the medication administered, =
but only 4=20
formally assessed medication compliance, using =
pill=20
counts,35,=20
39=20
prescription counts,20=20
or patient report.40=20
Selection of=20
Control Subjects
Eight studies included controls (eTable=20
1). Controls were recruited from hospital=20
staff,19,=20
24=20
universities, and the general community21,=20
24=20
and an anonymous workplace health screening program.18=20
The other studies provided no information on how =
controls=20
were recruited. No study provided any information =
on how=20
many controls were initially approached or any=20
differences between control participants and=20
nonparticipants in the study. All but 1 study21=20
attempted to match controls to cases on at least some =
pertinent=20
characteristics such as age, sex, and ethnicity. =
Sample Size and=20
Follow-up
Sample size varied (n =3D 9-555) but most =
studies=20
were small. Only 4 studies ascertained more than =
200=20
patients. One study provided an explicit =
description of=20
how subjects were followed up for postbaseline=20
assessments.28=20
For 3 studies, it could be inferred that =
follow-up of=20
subjects was routinely conducted because subjects =
appeared to have been inpatients for the duration =
of the=20
study.30-31,39=20
Others did not provide any information on how =
subjects=20
were tracked through the course of the study, how =
and=20
where follow-up assessments were conducted, and methods =
used to try to find subjects lost to follow-up. Nine=20
studies provided information about the reasons =
that=20
follow-up assessments could not be =
conducted21,=20
23,=20
30-31,35-36,40-42=20
(simply stating that patients were discharged =
from the=20
hospital or dropped out of the study was not =
considered=20
sufficient). The average follow-up time across =
studies=20
was 31.7 weeks (median, 52 weeks) but ranged from =
4=20
weeks34=20
to 2.5 years23=20
(3 years including the additional follow-up study =
by=20
Addington et al43).=20
Analytical=20
Methods Including Missing Data Handling
Subgroup analyses or tests of interaction were generally =
not=20
well described or justified. The methods used for =
handling=20
missing data were described in only 6 studies. =
For 3=20
others, it could be inferred that a complete case =
analysis was conducted.27,=20
29,=20
40=20
Subject=20
Characteristics
Four studies did not provide information on =
diagnoses,21,=20
26-27,33=20
and 1 provided incomplete information.29=20
All studies provided some demographic information =
on=20
subjects, such as proportion of males and =
females,=20
average age, socioeconomic status, and ethnicity. =
Most=20
studies did not tabulate the number of participants =
with=20
missing data for each variable, making it difficult to=20
determine numbers of subjects in different =
analyses.=20
Tested for Drug=20
Differences
Nineteen studies administered multiple =
antipsychotics.18-21,23-24,27-29,32-36,38,=20
40-42,44=20
Nine studies analyzed data for all drugs =
combined.19,=20
21,=20
23,=20
27,=20
29,=20
32-34,44=20
Ten studies tested for drug differences in=20
cardiometabolic outcomes.18,=20
20,=20
24,=20
28,=20
35-36,38,=20
40-42=20
Six studies administered a single =
antipsychotic25-26,30-31,37,=20
45;=20
5 administered olanzapine,25-26,30-31,45=20
some to test if the mode of administration45=20
or adjunct treatments minimized weight =
gain.30-31=20
Case-Control=20
Comparisons
Seven studies tested if patients were different from=20
controls at baseline with regard to weight and =
fat=20
distribution and diet; indices of diabetes risk; =
and=20
biochemical indices such as triglyceride, =
cholesterol,=20
and cortisol levels (eTable=20
1). Four studies recruited patients who were=20
antipsychotic naive18-19,24,=20
46:=20
1 included patients within 72 hours of first=20
exposure,22=20
1 included patients with up to 2 weeks' lifetime =
exposure=20
but no more than 3 doses in the month prior to=20
recruitment,20=20
and another recruited patients with up to 16 =
weeks of=20
recent exposure.21=20
RESEARCH=20
FINDINGS
Case-Control=20
Findings
At baseline, patients had a higher waist to hip ratio =
than=20
controls in 3 studies,18-19,24=20
a higher saturated fat intake,24=20
and, in a study that matched on body mass index =
(BMI), 3=20
times more intra-abdominal fat,24=20
but there was no elevation of intra-abdominal fat =
in=20
another study that did not report matching.19=20
There were no other significant weight-related=20
differences. At baseline, patients did not have =
more=20
total body fat,24=20
abdominal subcutaneous fat,19,=20
24=20
unsaturated fat intake,24=20
or a higher weight,19,=20
21,=20
46=20
BMI,19-21,24,=20
46=20
or waist circumference46=20
than controls.
Patients had a higher prevalence of prediabetes (elevated =
fasting glucose21=20
or insulin19=20
level) than controls in 2 studies but 1 of these =
included=20
patients exposed to antipsychotics for up to 16=20
weeks.21=20
Another study reported a 10-fold higher prevalence =
of=20
diabetes in patients (5%) than controls (0.5%),22=20
which may be largely independent of weight or =
low-density=20
lipoprotein (LDL) cholesterol given that the =
relevant=20
controls were significantly more likely to have =
elevated=20
LDL cholesterol levels and to be overweight or =
obese (52%=20
vs 27%, in their corrected Table 1) compared with =
patients. Patients did not differ from controls =
on=20
trigylceride21;=20
total, LDL,22=20
or high-density lipoprotein (HDL) =
cholesterol21-22;=20
insulin21;=20
adiponectin; leptin; interleukin 6; vascular cell =
adhesion molecule 1; or E-selectin21=20
levels. One study found an elevated waist to hip =
ratio=20
and elevated fasting insulin level relative to =
controls=20
only in female patients.19=20
Two studies used controls to test if change over time was =
due to factors other than treatment.20,=20
46=20
One study matched hospitalized cases and controls =
by sex,=20
age, exercise and diet (basal metabolic rate), =
race, and=20
socioeconomic status to match for possible =
confounders of=20
natural weight gain over time.46=20
Concomitant drugs that could potentially affect =
weight=20
were not permitted. Patients had significantly =
elevated=20
weight (4 kg) and BMI (2 kg) after 6 weeks of=20
double-blind, randomized treatment with =
haloperidol,=20
risperidone, or olanzapine compared with controls =
after 6=20
weeks of unmedicated follow-up. After 12 months of =
treatment=20
with haloperidol, risperidone, olanzapine, or=20
perphenazine, cases had a significantly greater =
increase=20
in BMI (2 kg) than controls matched only for =
age.20=20
To control for progressive weight gain in cases over =
time,=20
independent of medication, 1 study included a =
second=20
control group of patients (n =3D 7) who =
refused=20
antipsychotic drug treatment for longitudinal =
comparison=20
with treated patients and healthy controls.20=20
The mean weight gain was 17 kg across 1 year for =
olanzapine,=20
8 kg for risperidone, 4 kg for haloperidol, 1 kg for=20
perphenazine, 1 kg for patients who refused=20
antipsychotics, and 1 kg for age- and sex-matched =
controls with no history of psychosis.
Change in=20
Cardiometabolic Risk Factors After Treatment With=20
Antipsychotics
Studies that administered multiple antipsychotics but=20
analyzed data for all drugs combined19,=20
21,=20
23,=20
27,=20
29,=20
32-34,44=20
found that changes in weight, BMI, and waist=20
circumference were evident after 1 month.34=20
There was a significant increase in interleukin =
12 after=20
6 weeks47=20
and a significant increase in subcutaneous and=20
intra-abdominal fat, a 3-fold increase in leptin level, =
and a significant increase in total and LDL =
cholesterol,=20
triglyceride, and nonfasting glucose levels after =
10=20
weeks.19=20
Total body weight increased by 10% to 12% after 6 =
to 12=20
months.27,=20
29=20
Most of that weight change occurred in the first =
6=20
months. At baseline, 36% to 42% were overweight =
or=20
obese21,=20
27=20
(like the broader community); after 6 months, 58% =
to 71%=20
were overweight or obese.21,=20
27=20
There was a significant change in total,21,=20
29,=20
44=20
LDL,21,=20
44=20
and HDL cholesterol,29=20
triglyceride,29,=20
44=20
fasting insulin and glucose, leptin, E-selectin, =
and=20
adiponectin levels by 6 months.21=20
Weight gain continued for at least 3 years.43=20
Those who had taken antipsychotics continuously =
over 2.5=20
years had nonsignificantly more weight gain (13 =
kg) than=20
those who had not (7 kg).23=20
Genotype may also play a role. The wild-type =
variant of=20
the 5HT2C receptor gene regulatory region was =
associated=20
with significantly more weight gain after 10 =
weeks taking=20
risperidone or chlorpromazine than the =96759 C/T =
polymorphism in a Han Chinese cohort.32=20
This finding was replicated in a Spanish cohort treated =
with=20
a different combination of antipsychotics and in the=20
subset of those given olanzapine.33=20
In studies that administered multiple antipsychotics and=20
tested for differences in cardiometabolic =
outcomes across=20
drugs,18,=20
20,=20
24,=20
28,=20
35-36,38,=20
40-42=20
the combination of drugs studied and the =
follow-up=20
interval varied (eTable=20
1), which is important because the trajectory =
of=20
weight gain varies across different drugs. We =
therefore=20
summarize results by follow-up point to better =
show the=20
pattern of findings that emerges across studies.
By 6 =
to 8=20
Weeks. Weight gain was significant. =
The=20
average weight gain after 6 to 8 weeks taking =
olanzapine=20
was 5 to 6 kg,18,=20
26,=20
45=20
which was significantly higher than the average =
weight=20
gained while taking risperidone (4 kg) or =
haloperidol (3=20
kg).18=20
In another study, means were not reported but the =
rank=20
order of weight gain by drug administered was the =
same.36=20
There was a significant increase in fasting and=20
postprandial blood glucose levels and the =
incidence of=20
diabetes after 6 weeks in male patients.39=20
The largest effects were seen for olanzapine, then=20
risperidone and haloperidol. At 8 weeks, there =
was a=20
significant increase in insulin level, insulin=20
resistance, and glucose, cholesterol, =
triglyceride, and C=20
peptide levels across clozapine, olanzapine, =
risperidone,=20
and sulpiride combined but no significant difference=20
between drugs.28=20
By 3 =
to 4=20
Months. Olanzapine was associated with =
significantly more weight gain (7-9 kg)26,=20
41,=20
48=20
than haloperidol (3-4 kg)41,=20
48=20
but not risperidone (6 kg).48=20
Risperidone was associated with significantly more =
weight=20
gain than haloperidol (5 kg vs 3 kg).38=20
Other results were less consistent. A significant =
increase in cholesterol and fasting insulin =
levels was=20
found after 3 to 4 months taking olanzapine in 1=20
study26=20
but not another.25=20
No significant increase was found in fasting=20
triglyceride, glucose,26=20
or leptin25=20
levels but there was a significant increase in =
absolute=20
fat mass; percentage of body fat and waist to hip =
ratio,=20
suggesting central deposition of body fat; and C =
peptide=20
level while taking olanzapine.25=20
By 6=20
Months. Gain in intra-abdominal fat =
was=20
nonsignificantly higher with risperidone (27=20
cm2) than olanzapine (18 cm2).24=20
By 1=20
Year. There was no significant =
difference in=20
weight gain across different =
antipsychotics.20,=20
35,=20
38,=20
40,=20
48=20
Two studies did not report pairwise drug =
comparisons,=20
just 4- and 5-way comparisons.20,=20
40=20
The rank and range of average weight gain reported =
after=20
1 year taking antipsychotics for each drug across=20
informative studies is olanzapine, 11 to 14 to 17 =
kg20,=20
40,=20
48;=20
amisulpride, 10 kg40;=20
clozapine, 10 kg35;=20
quetiapine fumarate, 10 kg40;=20
risperidone, 8 to 9 kg20,=20
48=20
and at 2 years, 7 kg38;=20
haloperidol, 4 to 7 to 11 kg20,=20
40,=20
48=20
and at 2 years, 6 kg38;=20
chlorpromazine, 6 kg35;=20
ziprasidone hydrochloride, 5 kg40;=20
and perphenazine, 1 kg.20=20
This ranking of antipsychotics was reflected in other=20
weight-related changes, such as 4-kg or more =
weight=20
increase,36=20
7% or more weight increase,42,=20
46=20
increasing BMI,41,=20
48=20
and the incidence of metabolic syndrome,49=20
but not for intra-abdominal fat.24=20
Orally disintegrating tablets of olanzapine were=20
associated with significantly less weight gain =
than=20
standard tablets,45=20
as was adjunctive reboxetine31=20
but not fluoxetine.30=20
At 12 months, there was a significant increase in insulin =
level, insulin resistance, and total and LDL =
cholesterol,=20
triglyceride, leptin, and ghrelin levels,40,=20
50-51=20
an elevation in fasting glucose level in 1 =
study40=20
but not in 2 others,35,=20
50=20
and weight gain significantly correlated with =
insulin and=20
leptin levels.51=20
No significant differences were found across =
haloperidol,=20
olanzapine, or risperdione.51=20
No significant differences were found across =
haloperidol,=20
amisulpride, olanzapine, quetiapine, or=20
ziprasidone.40=20
A comparison of olanzapine, risperidone, and =
quetiapine=20
in another of the larger samples did find significant=20
differences at 12 months: olanzapine and quetiapine =
were=20
associated with a greater elevation in =
triglyceride level=20
and systolic blood pressure than risperidone; =
olanzapine=20
was associated with a greater elevation in =
diastolic=20
blood pressure than risperidone; quetiapine was=20
associated with a greater elevation in cholesterol =
level=20
than risperidone; and olanzapine was associated with a=20
greater reduction in HDL cholesterol level than =
quetiapine=20
or risperidone.42=20
This is consistent with the earlier-mentioned =
ranking for=20
weight, with olanzapine over quetiapine over =
risperidone.=20
Baseline=20
Predictors of Cardiometabolic Outcomes
Lower pretreatment BMI,20,=20
44,=20
46=20
younger age,20,=20
44=20
triglyceride level,44=20
more negative symptoms,20=20
and more co-medications and =
antidepressants20=20
predicted weight gain after antipsychotic =
treatment. In 1=20
study, women (but not men) starting with a normal =
BMI=20
gained a significantly higher percentage of body weight =
(mean, 18%) than those starting with an overweight BMI =
(mean, 2%).27=20
COMMENT=20
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| =95 |
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| =95 |
Methods |
| =95 |
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| =95 |
Author=20
information |
| =95 |
References |
| |
|
| |
Drawing=20
definitive conclusions about the impact of =
antipsychotics=20
on cardiovascular risk factors in patients with a =
first=20
episode of treated psychosis is not currently =
possible.=20
Some drug comparisons are entirely lacking, and =
others=20
appear underpowered. Sample sizes varied widely =
but most=20
were small. Only 4 studies ascertained more than =
200=20
patients. Most studies do not describe their patient =
or=20
control samples well enough to gauge =
representativeness.=20
Medication compliance is rarely assessed and never=20
explicitly factored into analyses, even in formal =
treatment trials. Dropout rates in the longer =
trials were=20
as high as 80% to 90%,41,=20
52=20
which limits conclusions about longer-term outcomes. =
Given=20
the sparseness of cardiometabolic outcome data =
beyond 1=20
year, a commonly used method for handling missing =
data=20
(last observation carried forward) may =
underestimate=20
weight gain and associated parameters in patients =
compliant with antipsychotic use for much longer =
than=20
average periods by as much as 50%.52=20
The results of the studies reviewed herein point toward 2 =
important hypotheses that need further =
research:=20
- In general, there is no difference in cardiometabolic=20
indices between patients and controls prior to=20
treatment with antipsychotic drugs. Caveat: =
Prior to=20
first exposure to antipsychotics, patients may =
have a=20
higher waist to hip ratio and more intra-abdominal =
fat=20
relative to BMI than controls but adequate control =
matching=20
may be required to detect these early =
differences.=20
- Risk for cardiovascular disease, indexed by =
weight=20
and other metabolic indices, =
increases after=20
first exposure to any antipsychotic. Caveat: =
After 1=20
year of antipsychotic drug treatment, a rank =
order of=20
drugs can be derived across all studies reviewed =
herein=20
but there is no evidence of significant differences=20
between first- and second-generation =
antipsychotics.=20
Weight gain after 1 year taking risperidone, =
for=20
example, was very similar to weight gain after =
1 year=20
taking haloperidol or chlorpromazine. Variance =
in=20
adverse cardiometabolic effects within each class=20
indexes the most meaningful source of variance. =
Weight=20
gain while taking olanzapine, for example, was =
much=20
higher than weight gain while taking =
ziprasidone.=20
SUGGESTIONS FOR=20
FUTURE DIRECTIONS
Weight gain may be the most visible of the adverse=20
cardiometabolic effects of antipsychotic drugs =
but=20
tracking less visible risk factors is just as =
important.=20
Elevated LDL cholesterol level is the main target =
for=20
primary prevention of heart disease2=20
but it is not clear whether changes in LDL or HDL=20
cholesterol, triglyceride, or serum glucose =
levels or=20
insulin resistance in the first treated episode =
of=20
psychosis are independent of weight changes. More =
research in this area is needed to determine =
which=20
cardiometabolic indices are most strongly affected by=20
which antipsychotics and what the long-term =
consequences=20
of this are.
As many as 39% of patients are nonadherent and 20%=20
inadequately adherent53=20
in their first year of antipsychotic drug treatment =
but=20
many studies do not assess or analyze medication =
compliance.=20
Assessment of serum levels of antipsychotics is =
important=20
because compliance with a prescription does not =
ensure a=20
therapeutic dose and that is ultimately the point =
of=20
tracking adherence with prescribed medication in =
relation=20
to outcomes. Some antipsychotics do not even have =
a known=20
therapeutic window, especially for youth.54=20
This is an important unsolved problem. Dosage effects =
on=20
the efficacy of antipsychotics for psychotic symptom =
reduction=20
and the emergence or exacerbation of cardiometabolic =
risk=20
factors, and their relationship, should be =
tested.=20
Comorbidity, sex, age, and genetic makeup may all affect=20
treatment efficacy and adverse effects. Exclusion =
criteria in drug trials often include substance =
abuse and=20
depression or other medical conditions, even =
minor=20
cardiometabolic abnormalities. Recreational drug =
use,=20
drug abuse, and depression are all common in cohorts =
of=20
patients with a first treated episode of psychosis55-57=20
and increase risk for cardiovascular =
disease,58-59=20
but we do not know if they moderate =
cardiovascular risk=20
during treatment with antipsychotics.
The age distribution in cohorts of patients with a first=20
treated episode of psychosis varies by sex =
because of sex=20
differences in the age at onset of =
psychosis.13=20
Patients with first-episode psychosis are =
composed of=20
younger men and older women unless artificially=20
constrained to ascertain a specific age range via =
a youth=20
service. This means that the prevalence of =
schizophrenia=20
in first-episode cohorts will be much higher in youth =
and=20
young adults than in those unselected for =
age.13=20
Tests for sex differences should therefore =
control for=20
age effects60=20
and all studies should report any age limits on=20
ascertainment and intake/outcome diagnosis. =
Diagnosis is=20
important because large population-based studies =
have=20
shown that different psychosis subtypes index partly =
distinct=20
risk factors,61=20
which may prove to be related to comorbidity with =
physical disease. There is no a priori reason to assume =
that treatment effects are unrelated to risk factors =
for=20
psychosis or cardiovascular disease.
Women may be more sensitive to the effects of=20
antipsychotics60=20
and their increased risk for central obesity may be =
evident=20
early.19=20
After 3 to 6 months of treatment, women had waist =
circumference=20
measures in the high-risk range.29=20
Hypoadiponectinemia induced by visceral fat =
accumulation=20
may be a strong risk factor for metabolic and=20
cardiovascular diseases and some cancers.62=20
Central obesity early in the course of treated =
illness=20
may therefore predict later physical disease. =
Efforts to=20
evaluate interventions that target emerging =
central=20
obesity, especially in women, should be a =
clinical=20
research priority.
Adoption of both the CONSORT guidelines for randomized=20
controlled trials and the STROBE guidelines for=20
observational (cohort) studies will increase the =
accuracy=20
of reporting and interpretation of future studies =
of=20
cardiometabolic outcomes of the first treated =
episode of=20
psychosis. Beyond the implementation of these =
guidelines=20
we recommend future studies:
- Provide a more detailed characterization of the =
primary=20
exposure=97medication=97by assessing and =
analyzing=20
medication compliance by identifying the =
therapeutic=20
window for antipsychotic drugs in adults and =
youth and=20
by evaluating dosage effects.
- Undertake a comprehensive assessment of=20
cardiometabolic risk factors following, at =
the=20
very least, recommended monitoring=20
guidelines.63=20
Long-term follow-up will be required to =
accurately=20
document the emergence of some outcomes, =
such as=20
diabetes.
- Examine whether cardiovascular outcomes are =
moderated by (1) demographic characteristics =
(sex=20
and age at a minimum); (2) clinical=20
characteristics; and (3) genetic factors.=20
CLINICAL=20
IMPLICATIONS
Individuals treated with antipsychotics should be =
assessed=20
before (or very soon after) first exposure to=20
antipsychotics to determine baseline =
cardiovascular risk.=20
Regular monitoring is then recommended using =
consensus=20
guidelines.63=20
Any clinically significant changes should be =
dealt with=20
following recommended protocols and referral to a =
primary=20
care physician or appropriate specialist.64=20
Information from monitoring should guide the =
selection=20
(and switching) of antipsychotic agents,63=20
but in practice, regular monitoring is rarely=20
conducted.65=20
We have found that general nurses can conduct =
monitoring=20
in a first-episode psychosis service,66=20
but in other settings, and outside of the =
rigorous=20
protocols of research studies, cardiometabolic =
monitoring=20
is still not routinely implemented.67=20
This is an important failure of care.
LIMITATIONS
There are many unresolved issues. Contrary to =
expectations,=20
in all but 1 of the largest studies,42=20
cardiometabolic outcomes were not significantly =
different=20
across different antipsychotics at study end =
points. This=20
may reflect low power to detect true differences =
given=20
currently attainable sample sizes relative to the =
number=20
of antipsychotics administered. A recent meta-analysis =
of=20
weight gain following first exposure to antipsychotics =
in=20
the absence of any concomitant medications that may =
affect=20
weight did not find any significant differences =
across=20
antipsychotics5=20
because, the authors concluded, there were insufficient =
data.=20
Different second-generation antipsychotics are =
associated=20
with significantly different cardiometabolic =
profiles in=20
samples that are not restricted to the first =
treated=20
episode.68=20
Olanzapine causes more weight gain than all other =
second-generation antipsychotics except =
clozapine.=20
Clozapine causes more weight gain than risperidone,=20
risperidone more than amisulpride, and sertindole more =
than risperidone. Olanzapine elevates cholesterol =
level=20
more than aripiprazole, risperidone, and =
ziprasidone but=20
not amisulpride, clozapine, and quetiapine. =
Quetiapine=20
elevates cholesterol level more than risperidone =
and=20
ziprasidone. Olanzapine elevates blood glucose =
level more=20
than amisulpride, aripiprazole, quetiapine, =
risperidone,=20
and ziprasidone but not clozapine. Key unanswered=20
questions concern the strength of the association =
between=20
antipsychotic exposure and adverse =
cardiometabolic=20
effects for each antipsychotic, which can only be =
estimated with previously antipsychotic-naive =
patients,=20
the timing of the emergence of these effects, and =
their=20
trajectory, not if they eventually occur. An observed=20
temporal relationship does not prove a causal =
relationship=20
exists, and lifestyle factors associated with =
psychosis=20
may play a part, but systematic differences in =
the=20
pattern and timing of the adverse cardiometabolic =
outcomes of different antipsychotics in =
randomized trials=20
are consistent with a causal link. Possible =
modifiers of=20
the observed association, its effect size and =
trajectory,=20
are important to evaluate because treatment is =
correlated=20
with length and severity of illness. Longitudinal =
investigation of patients who refuse =
antipsychotics or=20
become noncompliant is therefore required to test =
if risk=20
is concentrated in those who are compliant with =
their=20
antipsychotic medication.
AUTHOR=20
INFORMATION
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| =95 |
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| =95 |
Introduction |
| =95 |
Methods |
| =95 |
Results |
| =95 |
Comment |
| =95 |
Author=20
information |
| =95 |
References |
| |
|
| |
Correspondence:=20
Debra L. Foley, PhD, Orygen Youth Health Research =
Centre,=20
35 Poplar Rd, Parkville, VIC 3052, Australia (dfoley{at}unimelb.edu.au
).
Submitted for Publication: June 28, 2010; final =
revision=20
received November 3, 2010; accepted December 16,=20
2010.
Published Online: February 7, 2011.=20
doi:10.1001/archgenpsychiatry.2011.2
Financial Disclosure: None reported.
Funding/Support: Dr Foley was supported by the =
Colonial=20
Foundation (Australia) and is a recipient of =
grant=20
G09M4402 from the Heart Foundation (Australia). =
Dr Morley=20
was supported by Public Health Fellowship 520452 =
from the=20
Australian National Health and Medical Research=20
Council.
Author=20
Affiliations: Applied Genetics and Biostatistics, Orygen =
Youth=20
Health Research Centre (Dr Foley), and Centres for Youth =
Mental=20
Health (Dr Foley) and Molecular, Environmental, Genetic, and =
Analytic Epidemiology, School of Population Health (Dr =
Morley), the=20
University of Melbourne, Parkville, Victoria, Australia; and =
Wellcome Trust Sanger Institute, Wellcome Trust Genome =
Campus,=20
Hinxton, Cambridge, England (Dr Morley).
REFERENCES=20
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| =95 |
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References |
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psychosis.=20
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Yap HL, Mahendran R, Lim D, Liow PH, Lee A, Phang S, Tiong =
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.ARCHPSYCSecondLevel P {
MARGIN-TOP: 0px
}
.ARCHPSYCSecondLevel UL {
MARGIN-TOP: 0px; MARGIN-BOTTOM: 1em
}
.ARCHPSYCSecondLevel OL {
MARGIN-TOP: 0px; MARGIN-BOTTOM: 1em
}
* HTML .ARCHPSYCSecondLevel #MainNav UL LI A {
HEIGHT: 2.6em
}
* HTML .ARCHPSYCSecondLevel #nav_home A {
WIDTH: 50px
}
* HTML .ARCHPSYCSecondLevel #nav_current-issue A {
WIDTH: 98px
}
* HTML .ARCHPSYCSecondLevel #nav_past-issues A {
WIDTH: 84px
}
* HTML .ARCHPSYCSecondLevel #nav_collections A {
WIDTH: 128px
}
* HTML .ARCHPSYCSecondLevel #nav_cme A {
WIDTH: 32px
}
* HTML .ARCHPSYCSecondLevel #nav_careernet A {
WIDTH: 105px
}
* HTML .ARCHPSYCSecondLevel #nav_submit A {
WIDTH: 52px
}
* HTML .ARCHPSYCSecondLevel #nav_subscribe A {
WIDTH: 75px
}
* HTML .ARCHPSYCSecondLevel #nav_help A {
WIDTH: 39px
}
.ARCHPSYCSecondLevel FORM {
PADDING-BOTTOM: 0px; MARGIN: 0px; PADDING-LEFT: 0px; PADDING-RIGHT: =
0px; PADDING-TOP: 0px
}
.ARCHPSYCSecondLevel INPUT {
VERTICAL-ALIGN: middle
}
.ARCHPSYCSecondLevel SELECT {
VERTICAL-ALIGN: middle
}
.ARCHPSYCSecondLevel SELECT {
FONT-SIZE: 100%
}
.ARCHPSYCSecondLevel#LayoutWrapper {
FONT-FAMILY: 'Lucida Grande', arial, helvetica, sans-serif; COLOR: =
#000; FONT-SIZE: 68.75%
}
.ARCHPSYCManuscript #HeaderWrapper {
MIN-WIDTH: 975px
}
* HTML .ARCHPSYCManuscript #PageWrapper {
; WIDTH: expression( (document.body.clientWidth > 975) ? 100 + "%" : =
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}
* HTML .ARCHPSYCManuscript #HeaderWrapper {
; WIDTH: expression( (document.body.clientWidth > 975) ? 100 + "%" : =
975 + "px" )
}
.ARCHPSYCManuscript#LayoutWrapper {
FONT-FAMILY: 'Lucida Grande', arial, helvetica, sans-serif; COLOR: #000
}
.ARCHPSYCManuscript #ArchivesNav LABEL {
MARGIN-TOP: 3px; DISPLAY: block
}
.ARCHPSYCManuscript IMG {
BORDER-BOTTOM: medium none; BORDER-LEFT: medium none; BORDER-TOP: =
medium none; BORDER-RIGHT: medium none
}
.ARCHPSYCManuscript A IMG {
BORDER-BOTTOM: medium none; BORDER-LEFT: medium none; BORDER-TOP: =
medium none; BORDER-RIGHT: medium none
}
.ARCHPSYCManuscript H1 {
PADDING-BOTTOM: 0px; MARGIN: 0px 0px 0.5em; PADDING-LEFT: 0px; =
PADDING-RIGHT: 0px; PADDING-TOP: 0px
}
.ARCHPSYCManuscript H2 {
PADDING-BOTTOM: 0px; MARGIN: 0px 0px 0.5em; PADDING-LEFT: 0px; =
PADDING-RIGHT: 0px; PADDING-TOP: 0px
}
.ARCHPSYCManuscript H3 {
PADDING-BOTTOM: 0px; MARGIN: 0px 0px 0.5em; PADDING-LEFT: 0px; =
PADDING-RIGHT: 0px; PADDING-TOP: 0px
}
.ARCHPSYCManuscript H4 {
PADDING-BOTTOM: 0px; MARGIN: 0px 0px 0.5em; PADDING-LEFT: 0px; =
PADDING-RIGHT: 0px; PADDING-TOP: 0px
}
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.ARCHPSYCManuscript P {
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.ARCHPSYCManuscript UL {
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.ARCHPSYCManuscript OL {
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.ARCHPSYCManuscript FORM {
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.ARCHPSYCManuscript INPUT {
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.ARCHPSYCManuscript SELECT {
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.ARCHPSYCManuscript SELECT {
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@media Print =20
{
.AdWrapper {
DISPLAY: none
}
#MainNav {
DISPLAY: none
}
#ArchivesNav {
DISPLAY: none
}
#SiteSearch {
DISPLAY: none
}
#FooterNav {
DISPLAY: none
}
#UserToolbar {
DISPLAY: none
}
#HeaderWrapper {
MIN-WIDTH: 0px; MARGIN: 0px; WIDTH: auto; MAX-WIDTH: 100%
}
#BodyWrapper {
MIN-WIDTH: 0px; MARGIN: 0px; WIDTH: auto; MAX-WIDTH: 100%
}
#MainColumn {
MARGIN: 0px; WIDTH: auto
}
#archpsyc-logo {
MARGIN: 0px; DISPLAY: block; FLOAT: none
}
#HeaderWrapper {
MARGIN-BOTTOM: 1em; BACKGROUND: none transparent scroll repeat 0% 0%; =
BORDER-TOP: medium none
}
* HTML .ARCHPSYCHome #cover-image {
RIGHT: 0px
}
* HTML .ARCHPSYCHome #in-this-issue LI {
ZOOM: 1
}
.ARCHPSYCHome #top-content .Active {
MIN-HEIGHT: 0px
}
.ARCHPSYCHome #stay-connected .BoxFix {
PADDING-BOTTOM: 15px; PADDING-LEFT: 15px; PADDING-RIGHT: 15px; =
PADDING-TOP: 15px
}
.ARCHPSYCHome #call-for-papers .BoxFix {
PADDING-BOTTOM: 15px; PADDING-LEFT: 15px; PADDING-RIGHT: 15px; =
PADDING-TOP: 15px
}
.ARCHPSYCHome #explore-interact .Item H2 {
PADDING-BOTTOM: 0px; PADDING-LEFT: 0px; PADDING-RIGHT: 0px; =
PADDING-TOP: 0px
}
.ARCHPSYCHome #explore-interact .Item H2 A {
DISPLAY: block; HEIGHT: auto
}
}
.help_padding {
PADDING-BOTTOM: 15px; PADDING-LEFT: 10px; PADDING-RIGHT: 10px; =
PADDING-TOP: 15px
}
.container {
PADDING-BOTTOM: 0px; MARGIN: 0px; PADDING-LEFT: 0px; PADDING-RIGHT: =
0px; PADDING-TOP: 0px
}
H1.heading {
BORDER-BOTTOM: #76b2ea 1px solid; BORDER-LEFT: #76b2ea 1px solid; =
PADDING-BOTTOM: 4px; MARGIN-TOP: 0px; PADDING-LEFT: 12px; FONT-FAMILY: =
verdana,arial,helvetica,sans-serif; MARGIN-BOTTOM: 0px; COLOR: #003399; =
FONT-SIZE: 18px; BORDER-TOP: #76b2ea 1px solid; FONT-WEIGHT: bold; =
MARGIN-RIGHT: 10px; BORDER-RIGHT: #76b2ea 1px solid; PADDING-TOP: 4px
}
.content {
BORDER-LEFT: #76b2ea 1px solid; PADDING-BOTTOM: 12px; PADDING-LEFT: =
12px; PADDING-RIGHT: 12px; FONT-FAMILY: =
verdana,arial,helvetica,sans-serif; FLOAT: left; COLOR: #000; FONT-SIZE: =
13px; PADDING-TOP: 12px
}
.leftmargin {
MARGIN-LEFT: 10px
}
.ARCHPSYCHome #stay-connected UL.DotBullet_col_1 {
PADDING-BOTTOM: 0px; MARGIN: 0px; PADDING-LEFT: 10px; PADDING-RIGHT: =
20px; DISPLAY: inline-block; FLOAT: left; PADDING-TOP: 0px
}
.ARCHPSYCHome #stay-connected UL.DotBullet_col_2 {
PADDING-BOTTOM: 0px; MARGIN: 0px 0px 0.5em; PADDING-LEFT: 10px; =
PADDING-RIGHT: 20px; FLOAT: left; PADDING-TOP: 0px
}
.ARCHPSYCHome #stay-connected UL.DotBullet_col_1 LI {
LIST-STYLE-TYPE: none; PADDING-LEFT: 6px; MARGIN-BOTTOM: 0.5em; =
BACKGROUND: url(http://jama.ama-assn.org/icons/dot.79A8BE.gif) no-repeat =
0px 0.5em
}
.ARCHPSYCHome #stay-connected UL.DotBullet_col_2 LI {
LIST-STYLE-TYPE: none; PADDING-LEFT: 6px; MARGIN-BOTTOM: 0.5em; =
BACKGROUND: url(http://jama.ama-assn.org/icons/dot.79A8BE.gif) no-repeat =
0px 0.5em
}
.ARCHPSYCHome #stay-connected .clear_connected {
CLEAR: both
}
DIV.ifora .listcols {
WIDTH: 32%; FLOAT: left
}
DIV.ifora UL {
LIST-STYLE-TYPE: none
}
DIV.ifora LI.level2 {
FONT-WEIGHT: bold
}
DIV.ifora LI.level3 {
MARGIN-LEFT: 1em
}
DIV.ifora LI.level4 {
MARGIN-LEFT: 2em
}
DIV.ifora H2 {
COLOR: #003366; CLEAR: left; FONT-SIZE: 1em
}
DIV.ifora {
FONT-FAMILY: verdana,arial,helvetica,sans-serif; FONT-SIZE: 13px
}
DIV.ifora P.toplink {
FONT-SIZE: 0.7em
}
DIV.ifora .medline A {
TEXT-TRANSFORM: uppercase; MARGIN-LEFT: 5px; FONT-SIZE: 0.7em
}
DIV.ifora HR {
BORDER-BOTTOM: medium none; BORDER-LEFT: medium none; BACKGROUND-COLOR: =
#76b2ea; WIDTH: 90%; DISPLAY: block; HEIGHT: 1px; COLOR: #76b2ea; CLEAR: =
left; BORDER-TOP: medium none; BORDER-RIGHT: medium none
}
.subscript {
POSITION: relative; FONT-SIZE: 0.75em; VERTICAL-ALIGN: 0px; TOP: 0.25em
}
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