oembolism (VTE) (HR 0.64, 0.39—1.06, p = 0.08) and total mortality (0.83, 0.64—1.07, p = 0.15), and a 28% increase in diabetes (1.28, 1.07—1.54, p = 0.01). In patients with no major diabetes risk factor, treatment with rosuvastatin was associated with a 52% reduction in the primary endpoint (HR 0.48, 95% CI 0.33—0.68, p = 0.0001), nonsignificant reductions in VTE (HR 0.47, 0.21—1.03, p = 0.05) and total mortality (HR 0.78, 0.59—1.03, p = 0.08), and no increase in diabetes (HR 0.99, 0.45—2.21, p = 0.99). For those at high risk for developing diabetes, 134 total cardiovascular events or deaths were avoided for every 54 new cases of diabetes diagnosed. In those without major risk factors, 86 total cardiovascular events or deaths were avoided with no excess new cases of diabetes diagnosed.
ADVERSE REACTIONS
Severe
immune-mediated necrotizing myopathy / Delayed / 0-1.0
rhabdomyolysis / Delayed / 0-0.5
atrial fibrillation / Early / Incidence not known
renal tubular obstruction / Delayed / Incidence not known
myoglobinuria / Delayed / Incidence not known
cholecystitis / Delayed / Incidence not known
hepatic necrosis / Delayed / Incidence not known
pancreatitis / Delayed / Incidence not known
hepatic failure / Delayed / Incidence not known
cirrhosis / Delayed / Incidence not known
anaphylactoid reactions / Rapid / Incidence not known
angioedema / Rapid / Incidence not known
Stevens-Johnson syndrome / Delayed / Incidence not known
erythema multiforme / Delayed / Incidence not known
vasculitis / Delayed / Incidence not known
toxic epidermal necrolysis / Delayed / Incidence not known
hemolytic anemia / Delayed / Incidence not known
lupus-like symptoms / Delayed / Incidence not known
Moderate
elevated hepatic enzymes / Delayed / 0.7-3.6
myopathy / Delayed / 0-0.5
cataracts / Delayed / Incidence not known
gastritis / Delayed / Incidence not known
edema / Delayed / Incidence not known
constipation / Delayed / Incidence not known
myasthenia / Delayed / Incidence not known
jaundice / Delayed / Incidence not known
cholestasis / Delayed / Incidence not known
hyperbilirubinemia / Delayed / Incidence not known
hepatitis / Delayed / Incidence not known
cholelithiasis / Delayed / Incidence not known
anemia / Delayed / Incidence not known
thrombocytopenia / Delayed / Incidence not known
leukopenia / Delayed / Incidence not known
eosinophilia / Delayed / Incidence not known
dyspnea / Early / Incidence not known
depression / Delayed / Incidence not known
memory impairment / Delayed / Incidence not known
amnesia / Delayed / Incidence not known
peripheral neuropathy / Delayed / Incidence not known
confusion / Early / Incidence not known
hyperglycemia / Delayed / Incidence not known
diabetes mellitus / Delayed / Incidence not known
impotence (erectile dysfunction) / Delayed / Incidence not known
Mild
headache / Early / 5.8-5.8
infection / Delayed / 3.6-3.6
diarrhea / Early / 2.8-2.8
influenza / Delayed / 2.3-2.3
musculoskeletal pain / Early / 2.3-2.3
rash (unspecified) / Early / 0.6-0.6
pruritus / Rapid / 0.5-0.5
myalgia / Early / 3.6
vertigo / Early / Incidence not known
sinusitis / Delayed / Incidence not known
arthralgia / Delayed / Incidence not known
pharyngitis / Delayed / Incidence not known
cough / Delayed / Incidence not known
abdominal pain / Early / Incidence not known
dyspepsia / Early / Incidence not known
asthenia / Delayed / Incid |
