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  • Atorvastatin calcium: SAFETY(2)

In the placebo controlled clinical trials, the general incidence of adverse events in patients receiving atorvastatin was not significantly different from that seen in patients receiving placebo (Table 7) . Analysis of data from these studies showed no consistent dose-related increase in frequency or type of adverse event.

TABLE 7 Associated adverse events reported in 1% or more of patients in placebo controlled clinical trials with atorvastatin

Placebo % Atorvastatin %
Adverse event (n=270) (n=1122 )
Constipation 1 1
Diarrhea 1 1
Dyspepsia 2 1
Flatulence 2 1
Nausea 0 1
Headache 2 1
Pain <1 1
Myalgia 1 1
Asthenia <1 1

Reprinted from reference 39

There were no notable differences in the frequency or types of adverse events among atorvastatin-treated patients when stratified by age, sex or hyperlipidemia phenotype . The overall safety profile of atorvastatin was similar among patients treated for one or two years, including in patients treated with 80 mg/day . In 20 patients, atorvastatin treatment resulted in LDL-C levels of 1.3 mmol/L or less being maintained for up to two years . Safety analysis showed no difference in the adverse event profile of these patients compared with other patients.

Elevations in liver enzymes are associated with this class of cialis professional. In the clinical studies with atorvastatin, an overall analysis showed that clinically significant transaminase elevations (persistent levels greater than three times the upper limit of normal) were reported for 0.7% of patients receiving atorvastatin . This is consistent with reported data for other HMG-CoA reductase inhibitors and with the reported incidence in the individual comparative clinical studies with atorvastatin. The incidence reported with ator-vastatin80 mg/day (2.3%) is similar to that reported for lovastatin 80 mg/day (1.9%) . In the atorvastatin studies, examination of transaminase elevations by age, sex, alcohol consumption and body mass index did not reveal any association with persistent transaminase elevations . Most of the persistent elevations in transaminase levels were self-limiting. Upon reducing or discontinuing the dose of ator-vastatin, the elevations improved or resolved, and no patient experienced any clinical sequelae. However, as is consistent with established clinical practice for other HMG-CoA reductase inhibitors, liver function tests should be performed before initiation of treatment and periodically thereafter.

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