Coronary Heart Disease

The Safety of Rosuvastatin as Used in Common

Clinical Practice
A Postmarketing Analysis
Alawi A. Alsheikh-Ali, MD; Marietta S. Ambrose, MD; Jeffrey T. Kuvin, MD; Richard H. Karas, MD, PhD

Background—Statins are currently the mainstay of dyslipidemia management for the primary and secondary prevention
of cardiovascular disease. Controversial concerns about the safety of the newly marketed statin rosuvastatin have been
raised on the basis of premarketing studies and a few postmarketing reports.
Methods and Results—We reviewed rosuvastatin-associated adverse events reported to the US Food and Drug
Administration over its first year of marketing. On the basis of prescription data obtained from IMS Health, rates of
adverse event reports (AERs) per million prescriptions were calculated. Rates of rosuvastatin-associated AERs over its
first year of marketing were compared with those seen with atorvastatin, simvastatin, and pravastatin over the concurrent
timeframe and during their respective first years of marketing. Comparison was also made to the first year of marketing
of cerivastatin. The primary analysis examined the composite end point of AERs of rhabdomyolysis, proteinuria,
nephropathy, or renal failure. With either timeframe comparison, rosuvastatin was significantly more likely to be
associated with the composite end point of rhabdomyolysis, proteinuria, nephropathy, or renal failure AERs. Reported
cases of rhabdomyolysis, proteinuria, or renal failure tended to occur early after the initiation of therapy and at relatively
modest doses of rosuvastatin. The increased rate of rosuvastatin-associated AERs relative to other widely used statins
was also observed in secondary analyses when other categories of AERs were examined, including adverse events with
serious outcomes, liver toxicity, and muscle toxicity without rhabdomyolysis.
Conclusions—The present analysis supports concerns about the relative safety of rosuvastatin at the range of doses used
in common clinical practice in the general population. (Circulation. 2005;111:0000-0000.)
Key Words: cholesterol 䡲 complications 䡲 drugs 䡲 lipids 䡲 population

I nhibitors of 3-hydroxy-3-methylglutaryl coenzyme A

(HMG-CoA) reductase (statins) are currently the mainstay
of dyslipidemia management for the primary and secondary
withdrawal from the global market, it is essential to assess the
postmarketing safety of rosuvastatin relative to other widely
used drugs in this class. Such assessment either can serve to
prevention of cardiovascular disease.1 Their widespread use alleviate concerns about the safety of rosuvastatin and hence
is driven by a robust body of evidence supporting their encourage its appropriate use in patients who need it or can
efficacy in preventing cardiovascular events.1 Recent data detect an adverse safety profile that was not fully appreciated
have shown that more intensive lipid lowering with high-dose in premarketing trials.14
statins offers additional benefit.2– 6 This finding has intensi- In the present analysis, using a methodology we have
fied interest in more potent statins that could better achieve previously used to assess postmarketing safety of lipid-
the more aggressive LDL cholesterol (LDL-C) targets. altering drugs,15–18 we reviewed adverse event reports
(AERs) to the US Food and Drug Administration (FDA) to
See p ●●● determine the frequency of rosuvastatin-associated events
Of the currently available statins, rosuvastatin has the relative to other commonly used statins.
greatest effect on LDL-C.7 Although its potency can be an
advantage, controversial concerns have been raised about its Methods
safety, particularly in terms of rhabdomyolysis and renal Using a computer-based search engine (DrugLogic, QED Solutions),
we reviewed AERs to the FDA in which rosuvastatin was listed as a
failure, on the basis of premarketing studies and a few suspect in causing the adverse event. The search engine includes 2
postmarketing reports.8 –13 Given previous concerns about the FDA databases, the Spontaneous Reporting System (1969 –1997)
safety of the potent statin cerivastatin that eventually led to its and the Adverse Events Reporting System (1997 on), both of which

Received April 15, 2005; revision received April 29, 2005; accepted May 2, 2005.
From the Molecular Cardiology Research Institute and Division of Cardiology, Department of Medicine, Tufts-New England Medical Center, and Tufts
University School of Medicine, Boston, Mass.
Reprint requests to Richard H. Karas, MD, PhD, Molecular Cardiology Research Institute, Box 80, Tufts-New England Medical Center, 750
Washington St, Boston, MA 02111. E-mail rkaras@tufts-nemc.org
© 2005 American Heart Association, Inc.
Circulation is available at http://www.circulationaha.org DOI: 10.1161/CIRCULATIONAHA.105.555482

1
2 Circulation June 14, 2005

TABLE 1. Demographic Characteristics of Individuals With AERS of Rhabdomyolysis,

Proteinuria/Nephropathy, or Renal Failure (COMPOSITE AERS) Associated With Rosuvastatin,
Simvastatin, Pravastatin, or Atorvastatin and Received by the US FDA Between October 1,
2003, and September 30, 2004
Rosuvastatin Simvastatin Pravastatin Atorvastatin
(n⫽145) (n⫽381) (n⫽52) (n⫽315)
Prescriptions, in millions 5.2 29.8 15.0 72.9
Age, y 59.6⫾1.3 65.3⫾0.8† 66.3⫾1.5‡ 62.1⫾0.9
Male, % 55 63 69 46
Statin dose, mg 16.7⫾1.2 53.1⫾2.8† 18.8⫾2.0 21.8⫾1.4*
Duration of therapy, d 69.8⫾7.8 731.3⫾68.4† 744.7⫾228.7† 368.8⫾46.0†
Other concomitant medications, n 4.2⫾0.3 5.0⫾0.4 6.2⫾0.8* 5.7⫾0.4
Outcome, %
Death 2 6 15‡ 10‡
Hospitalization 72 76 83 66
No hospitalization 26 18 2† 24
Continuous variables are presented as mean⫾SE. Some reports listed both hospitalization and death as an
outcome.
*P⬍0.05, †P⬍0.001, ‡P⬍0.01 for pairwise comparison versus rosuvastatin.

rely on reports generated by health professionals, consumers, and concomitant use of a fibric acid derivative or other drugs that can
manufacturers. potentially interact with statins.
For comparative purposes, we evaluated 4 other statins: atorva-
statin, simvastatin, pravastatin, and cerivastatin (during the time Secondary Analyses
period when it was available). In doing so, we compared the Comparisons pertaining to the following categories of AERs were
postmarketing safety profile of rosuvastatin with other statins, the 3 performed as secondary analyses: (1) reports of any adverse event
most widely used with broadly acceptable safety profiles (atorvasta- (ALL AERs); (2) reports of serious adverse events, defined as fatal,
tin, simvastatin, and pravastatin) and 1 with an unfavorable safety considered life-threatening by the reporter, or resulting in hospital-
profile that eventually led to its withdrawal from the global market ization (SERIOUS AERs); (3) reports of adverse events affecting the
(cerivastatin). liver (LIVER AERs); (4) reports of adverse events affecting muscle
Two comparative analyses were performed. For the first analysis, (myalgia, myopathy, elevated creatine-phosphokinase) without frank
AERs were tabulated for the first year during which rosuvastatin was rhabdomyolysis (MUSCLE–NO-RHABDO AERs); (5) reports of
available in the United States (October 1, 2003, the first quarter after rhabdomyolysis (RHABDO AERs); (6) reports of proteinuria or
launch of rosuvastatin in the United States, to September 30, 2004, nephropathy (PROTEINURIA AERs); and (7) reports of renal
the last quarter for which data were available through the search failure (RENAL FAILURE AERs).
engine) and over this concurrent time period for the other statins.
This is referred to as “concurrent time period analysis.” The second Statistical Analysis
approach was undertaken to control for the potential of preferential We used ␹2 tests (with appropriate degrees of freedom) to compare
reporting of adverse events with newly marketed drugs.19 For the rates of AERs among the various statins. For each specific adverse
second analysis, referred to as “first year of marketing analysis,” event category, within-group differences (ie, among all the statins
rates of rosuvastatin-associated AERs were compared with those examined) were first sought. If within-group differences were not
observed during the first year of marketing for atorvastatin (1997), statistically significant, no further analysis was undertaken for that
simvastatin (1992), pravastatin (1992), and cerivastatin (1998). adverse event category. If within-group differences were statistically
The number of AERs to the FDA was tabulated for each of the significant, subsequent pairwise analyses were performed with ␹2
statins. Corresponding prescription data over the time periods of tests. For all analyses, a value of P⬍0.01 was considered statistically
interest were obtained from IMS Health for each of the statins significant to account for the multiple comparisons made. For the
evaluated. Using the tabulated number of AERs and the prescription data in Table 1, continuous variables were compared by use of
data, we calculated rates of AERs per 1 million prescriptions for ANOVA on ranks test for within-group comparisons and the
various categories of AERs associated with each of the statins. Mann-Whitney rank-sum test for pairwise comparisons to allow for
unequal variance among the groups. Categorical variables were
Primary Analysis compared by use of the ␹2 test. All statistical analyses were
AERs were categorized according to the specific reaction reported to performed with SigmaStat 3.10 (Systat Software Inc).
the FDA. The primary analysis focused on the prespecified, com-
posite end point of AERs of rhabdomyolysis, proteinuria, nephrop- Results
athy, or renal failure (COMPOSITE AERs). The rate of rosuvastatin-
associated COMPOSITE AERs was compared with the rates of such Primary Analysis
events with the other statins. These specific adverse events were In the concurrent time period analysis, the rate of
chosen for the primary analysis because they were identified as the rosuvastatin-associated COMPOSITE AERs (rhabdmoyoly-
primary areas of concern in previous safety analyses of rosuvastatin. sis, proteinuria/nephropathy, or renal failure) was higher than
For the concurrent time period analysis, the following character- simvastatin (P⬍0.001), pravastatin (P⬍0.001), and atorva-
istics of COMPOSITE AERs were noted: subject age and gender,
statin dose and duration of therapy, and outcome of the adverse event statin (P⬍0.001; Figure 1A). A similar pattern was observed
classified as death, hospitalization, or no hospitalization. In addition, with the first year of marketing analysis (Figure 1B). The rate
we noted the number of other concomitant medications and the of rosuvastatin-associated COMPOSITE AERs was not sig-
 Alsheikh-Ali et al Postmarketing Safety of Rosuvastatin 3

Figure 1. Rates of composite end point of AERs of rhabdomyolysis, proteinuria/nephropathy, or renal failure (COMPOSITE AERs) asso-
ciated with various statins. A, Rates over concurrent use period from October 1, 2003, to September 30, 2004; B, rates over respective
first postmarketing year for each statin. Rates are per 1 million prescriptions (Rx). †P⬍0.001 for pairwise comparison vs rosuvastatin.

nificantly different than simvastatin (P⫽0.02; not considered and tended to be comparable to or less than what was
statistically significant after Bonferroni’s correction) but was observed with the other statins (Table 2).
significantly higher than pravastatin (P⬍0.001) and atorva-
statin (P⬍0.001). Compared with what was observed with Secondary Analyses: Concurrent Time Period
cerivastatin during its first postmarketing year, rosuvastatin- Figure 2 depicts the concurrent time period secondary anal-
associated COMPOSITE AERs were less frequent (P⬍0.001; yses of rates of AERs from October 1, 2003, to September 30,
Figure 1B). 2004, for rosuvastatin, simvastatin, pravastatin, and atorva-
Demographic characteristics of individuals with COM- statin (cerivastatin was no longer available during this time
period). The rate of rosuvastatin-associated ALL AERs was
POSITE AERs are shown in Table 1. The reported adverse
higher than simvastatin, pravastatin, and atorvastatin
events tended to occur in relatively young individuals with no
(P⬍0.001 for each statin versus rosuvastatin; Figure 2A).
specific gender predominance and at relatively modest doses
Rosuvastatin-associated SERIOUS AERs, LIVER AERs, and
of statin. Indeed, 62% of the rosuvastatin-associated COM-
MUSCLE–NO-RHABDO AERs were also more common
POSITE AERs occurred at doses of ⱕ10 mg/d rosuvastatin. than each of these AERs associated with simvastatin, prava-
Interestingly, the rosuvastatin-associated COMPOSITE statin, or atorvastatin (Figure 2B, 2C, and 2D, respectively;
AERs occurred early after the initiation of therapy (within the P⬍0.001 for each statin versus rosuvastatin). Moreover, the
first 12 weeks) compared with the other statins. Although rate of rosuvastatin-associated RHABDO AERs was higher
fatal in only a minority of cases, most COMPOSITE AERs than RHABDO AERs associated with simvastatin (P⬍0.01;
listed hospitalization as an outcome. Table 2 lists the mean Figure 2E), pravastatin, and atorvastatin (P⬍0.001 for both
number of other concomitant medications and the percentage versus rosuvastatin; Figure 2E). Although reports of protein-
of COMPOSITE AERs in the concurrent time period analysis uria or nephropathy associated with rosuvastatin were rela-
reporting concomitant use of fibrates or other drugs that can tively rare (2.7 AERs per 1 million prescriptions), they were
potentially interact with statins. In general, the use of such significantly more frequent than what was observed with the
drugs was relatively rare with rosuvastatin-associated AERs other statins over the concurrent time period (Figure 2F). A

TABLE 2. Percent of Statin-Associated COMPOSITE AERS (of Rhabdomyolysis, Proteinuria/Nephropathy, or

Renal Failure) Listing Concomitant Use of Other Drugs That Can Potentially Interact With Statins in the
Concurrent Time Period Analysis From October 1, 2003, to September 30, 2004
Rosuvastatin Simvastatin Pravastatin Atorvastatin
(n⫽145) (n⫽381) (n⫽52) (n⫽315)
No. of other concomitant medications, mean⫾SE 4.2⫾0.3 5.0⫾0.4 6.2⫾0.8* 5.7⫾0.4
Fibric acid derivative (gemfibrozil, fenofibrate, bezafibrate), % 7.6 18.4† 5.8 5.7
Macrolide antibiotic (erythromycin, azithromycin, clarithromycin), % 1.4 5.5 0 4.1
Azole antifungal (fluconazole, itraconazole, ketoconazole), % 0.7 0.8 0 0.6
Cyclosporin, % 1.4 7.9* 1.9 3.8
Calcium channel blocker (amlodipine, diltiazem, verapamil, nifedipine), % 17.2 25.7 30.8 30.2†
Amiodarone, % 2.8 7.3 3.8 2.9
*P⬍0.05, †P⬍0.01 for pairwise comparison versus rosuvastatin.
4 Circulation June 14, 2005

Figure 2. Rates of each category of AERs associated with various statins during concurrent use period from October 1, 2003, to Sep-
tember 30, 2004. A, ALL AERs; B, SERIOUS AERs; C, LIVER AERs; D, MUSCLE–NO-RHABDO AERs; E, RHABDO AERs; F, PROTEIN-
URIA AERs; G, RENAL FAILURE AERs. All rates are per 1 million prescriptions (Rx). Note specific scale on vertical axis for each cate-
gory of AERs. †P⬍0.001, ‡P⬍0.01 for pairwise comparison vs rosuvastatin.

similar trend was observed with renal failure reports, in which statins during their first full year of marketing, as described in
the rate of rosuvastatin-associated RENAL FAILURE AERs Methods. Compared with rates of ALL AERs associated with
was higher than simvastatin-associated RENAL FAILURE other statins in the first year of marketing analysis, the
AERs, pravastatin-associated RENAL FAILURE AERs, and difference was less marked than with the concurrent time
atorvastatin-associated RENAL FAILURE AERs (P⬍0.001 period analysis but was still significant. The rate of
for each versus rosuvastatin; Figure 2G). rosuvastatin-associated ALL AERs was higher than simva-
Secondary Analyses: First Year of Marketing statin, pravastatin, atorvastatin, and cerivastatin (P⬍0.001 for
Figure 3 depicts the rates of AERs during the first postmar- each statin versus rosuvastatin; Figure 3A). For SERIOUS
keting year for rosuvastatin compared with each of the other AERs, the rate for rosuvastatin-associated AERs was signif-
 Alsheikh-Ali et al Postmarketing Safety of Rosuvastatin 5

Figure 3. Rates of each category of AERs associated with various statins during respective first postmarketing year for each statin. A,
ALL AERs; B, SERIOUS AERs; C, LIVER AERs; D, MUSCLE–NO-RHABDO AERs; E, RHABDO AERs; F, PROTEINURIA AERs; G,
RENAL FAILURE AERs. All rates are per 1 million prescriptions (Rx). Note specific scale on vertical axis for each category of AERs.
†P⬍0.001, ‡P⬍0.01 for pairwise comparison vs rosuvastatin.

icantly lower than simvastatin (P⬍0.001) and cerivastatin cantly different from what was observed with cerivastatin
(P⬍0.01) but was significantly higher than what was ob- during its first postmarketing year (Figure 3C). The rate of
served with atorvastatin or pravastatin (P⬍0.001 for both rosuvastatin-associated MUSCLE-NO-RHABDO AERs was
versus rosuvastatin; Figure 3B). For LIVER AERs, the rate higher than what was observed with simvastatin, pravastatin,
for rosuvastatin was higher than what was observed with atorvastatin, and cerivastatin (P⬍0.001 for simvastatin, pra-
simvastatin, pravastatin, or atorvastatin (P⬍0.05 for simva- vastatin, and atorvastatin versus rosuvastatin; P⬍0.01 for
statin versus rosuvastatin, P⬍0.001 for pravastatin and ator- cerivastatin versus rosuvastatin; Figure 3D). Rosuvastatin
vastatin versus rosuvastatin; Figure 3C) but was not signifi- was also significantly more likely than simvastatin, pravasta-
6 Circulation June 14, 2005

tin, and atorvastatin to be associated with reports of rhabdo- mates of true adverse events with possible relative overrep-
myolysis (P⬍0.001 for each statin versus rosuvastatin; Figure resentation of serious events. Moreover, the retrospective
3E). However, compared with the first year of cerivastatin, nature of the analysis does not allow confirmation of causal-
the rate of rosuvastatin-associated RHABDO AERs was ity or control of potential confounders.
significantly less (P⬍0.001; Figure 3E). The rate of One potential confounder is the time period studied relative
rosuvastatin-associated PROTEINURIA AERs was not sig- to the life cycle of a drug, because providers tend to
nificantly different from what was observed with simvastatin, preferentially report adverse events associated with newly
pravastatin, and cerivastatin but was significantly higher than marketed drugs. In addition, certain adverse events may not
what was observed with atorvastatin (P⬍0.001 for atorvasta- be recognized as related to a particular class of drugs until
tin versus rosuvastatin; Figure 3F). Finally, the rate of later. For example, the very low rates of simvastatin- and
rosuvastatin-associated RENAL FAILURE AERs was signif- pravastatin-associated RHABDO AERs during their first
icantly greater than what was observed with pravastatin and postmarketing year (1992) may be the result of underrecog-
atorvastatin (P⬍0.001 for both versus rosuvastatin; Figure nition of this statin-related adverse event in an era predating
3G) but was comparable to what was observed with simva- the large landmark statin trials and the subsequent widespread
statin and tended to be lower than what was observed with use of these drugs. Postmarketing analyses can also be
cerivastatin (P⫽0.054; Figure 3G). influenced by the publicity, favorable or otherwise, surround-
ing the drug of interest. Hence, it is conceivable that some of
Discussion the negative publicity surrounding the safety profile of
We reviewed rosuvastatin-associated adverse events reported rosuvastatin and the accompanying heightened public aware-
to the US FDA over its first year of marketing and compared ness contributed to the increased rates of reported
the rates of such events with other statins over the concurrent rosuvastatin-associated adverse events. The extent to which
time frame and during their respective first year of marketing. that publicity contributed to our findings is uncertain. Other
We observed that with either comparison, rosuvastatin was time-dependent variables can potentially affect the assess-
several-fold more likely to be associated with the composite ment of postmarketing safety. For example, the relatively low
end point of rhabdomyolysis, proteinuria, nephropathy, or rate of atorvastatin-associated AERs during its first year of
renal failure AERs. The increased rate of rosuvastatin- marketing could be partially related to the availability of only
associated AERs relative to the 3 most widely used statins in the 10-mg dose during the first year, hence ameliorating the
the United States was also observed when other categories of preferential reporting often seen early after the release of a
AERs were examined, including serious adverse events and new drug. Therefore, in an effort to account for possible
reports of liver toxicity, as well as muscle toxicity without time-dependent effects, we present comparisons of
rhabdomyolysis. There were a few exceptions in which this rosuvastatin-associated AERs during its first year of market-
trend was not observed, such as the lower rate of serious ing with the other statins over the concurrent time frame and
AERs and a comparable rate of renal failure reports with during the respective first year of marketing of each statin.
rosuvastatin relative to the first year of marketing of simva- Although the first year of marketing analysis is limited by the
statin, as well as a relatively low incidence of proteinuria and use of two different time points, it has the advantage of using
nephropathy reports, comparable to what was observed dur- similar phases of the life cycle of each drug.
ing the first postmarketing year of simvastatin and pravasta- An additional limitation of our findings is the lack of
tin. We also observed that compared with first year of insight into the mechanism(s) that resulted in the higher rate
marketing of cerivastatin, the rate of rosuvastatin-associated of AERs with rosuvastatin. For example, it remains unclear
liver injury reports was not significantly different. whether the observed rate of rosuvastatin-associated AERs is
The approach we used in the present analysis takes due in part to its greater LDL-C–lowering effect compared
advantage of the “real-life” population exposure captured in with the other statins. If this were the case, then the rates of
the FDA AERs system. This overcomes the limitation of AERs with the other statins might also be higher if used at
controlled premarketing trials, which typically exclude pa- equivalent LDL-lowering doses. Despite this important ca-
tients who may be predisposed to a certain adverse event but veat, however, our findings remain clinically relevant be-
who nonetheless are likely to receive the drug after it is cause they reflect the AERs observed with each statin as it is
marketed. In addition, premarketing trials aimed at safety or commonly used in clinical practice. Similarly, we are unable
efficacy assessment are often underpowered to detect rela- to provide insight about any potential role of the distinct
tively rare adverse events. Hence, postmarketing assessments chemical structure of each statin or of differences in metab-
such as the one presented here are helpful in attempts to olism or dose response.
identify safety concerns that can potentially be missed early In conclusion, this comparative postmarketing analysis of
on. rosuvastatin-associated adverse events reported to the US
On the other hand, the findings we report should be FDA raises concerns about the safety of this drug at the range
interpreted within the context of the intrinsic limitations of of doses used in common clinical practice in the general
postmarketing adverse event analyses. The data used reflect population. The occurrence of rhabdomyolysis and renal
adverse event reporting rates, not actual adverse event rates. toxicity relatively early after initiation of therapy (within the
In clinical practice, adverse events tend to be underreported, first 12 weeks on average), suggests that vigilant surveillance
and serious events are more likely to be reported than milder for adverse effects during initiation of therapy may help
ones. Hence, the rates presented here are likely underesti- ameliorate the risk of toxicity when rosuvastatin is used.
 Alsheikh-Ali et al Postmarketing Safety of Rosuvastatin 7

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Acknowledgments Sopko G, Taylor AL, Walsh BW, Wenger NK, Williams CL.
Dr Karas was an Established Investigator of the American Heart Evidence-based guidelines for cardiovascular disease prevention in
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are grateful to Dr Inga Peter for consultation with regard to the 7. McTaggart F. Comparative pharmacology of rosuvastatin. Atheroscler
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Disclosure 9. Wolfe SM. Dangers of rosuvastatin identified before and after FDA
approval. Lancet. 2004;363:2189 –2190.
Dr Karas has received research grants from AstraZeneca and Kos 10. Cohen JS. Should rosuvastatin be withdrawn from the market? Lancet.
Pharmaceuticals; has served on the Speakers’ Bureaus of and/or 2004;364:1579; discussion 1579 –1580.
received honoraria from Kos, AstraZeneca, Merck, and Pfizer; and 11. Florentinus SR, Heerdink ER, Klungel OH, de Boer A. Should rosuv-
has served as a consultant to Kos. Dr Kuvin has received research astatin be withdrawn from the market? Lancet. 2004;364:1577; author
grants from AstraZeneca and has served on the Speakers’ Bureaus of reply 1578 –1579.
and/or received honoraria from Merck, Kos, and Pfizer. 12. Kastelein JJ. Should rosuvastatin be withdrawn from the market? Lancet.
We acknowledge that we have used QSCAN FDA, a product of 2004;364:1577–1578; author reply 1578 –1579.
DrugLogic, Inc. Any and all conclusions reached by the authors as 13. Olsson GO. Safety and efficacy of rosuvastatin. Lancet. 2004;364:135.
written in this article from the use of QSCAN FDA are those of the 14. Okie S. Safety in numbers: monitoring risk in approved drugs. N Engl
authors alone. DrugLogic makes no warranty nor accepts responsi- J Med. 2005;352:1173–1176.
bility or liability with respect to or in connection with the complete- 15. Abourjaily HM, Alsheikh-Ali AA, Karas RH. Comparison of the fre-
ness or accuracy of the QSCAN FDA data, the results obtained from quency of adverse events in patients treated with atorvastatin or simva-
its use, and conclusions reached by its users. statin. Am J Cardiol. 2003;91:999 –1002, A7.
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