Ziprasidone Hydrochloride (Page 4 of 10)

Dyslipidemia

Undesirable alterations in lipids have been observed in patients treated with atypical antipsychotics. Pooled data from short-term, placebo-controlled studies in schizophrenia are presented in Tables 3 and 4.

Table 3: Lipid * Mean Change from Baseline in Short-Term (up to 6 weeks), Placebo-Controlled, Fixed-Dose, Oral Ziprasidone Monotherapy Trials in Adult Patients with Schizophrenia
*
“Random” lipid measurements, fasting/non-fasting status unknown

Mean Lipid Change from Baseline mg/dL (N)

Laboratory

Analyte

Ziprasidone

Placebo

5 mg BID

20 mg BID

40 mg BID

60 mg BID

80 mg BID

100 mg BID

Triglycerides

-12.9 (N = 45)

-9.6 (N = 181)

-17.3 (N = 146)

-0.05 (N = 120)

-16.0 (N = 104)

+0.8 (N = 85)

-18.6 (N = 260)

Total Cholesterol

-3.6 (N = 45)

-4.4 (N = 181)

-8.2 (N = 147)

-3.6 (N = 120)

-10.0 (N = 104)

-3.6 (N = 85)

-4.7 (N = 261)

Table 4: Lipid * Categorical Changes in Short-Term (up to 6 weeks), Placebo-Controlled, Fixed-Dose, Oral Ziprasidone Monotherapy Trials in Adult Patients with Schizophrenia
*
“Random” lipid measurements, fasting/non-fasting status unknown

Laboratory Analyte

Category Change (at least once) from Baseline

Treatment Arm

N

n (%)

Triglycerides

Increase by ≥ 50 mg/dL

Ziprasidone

681

232 (34.1%)

Placebo

260

53 (20.4%)

Normal to High (< 150 mg/dL to ≥ 200 mg/dL)

Ziprasidone

429

63 (14.7%)

Placebo

152

12 (7.9%)

Borderline to High (≥ 150 mg/dL and < 200 mg/dL to ≥ 200 mg/dL)

Ziprasidone

92

43 (46.7%)

Placebo

41

12 (29.3%)

Total Cholesterol

Increase by ≥ 40 mg/dL

Ziprasidone

682

76 (11.1%)

Placebo

261

26 (10.0%)

Normal to High (< 200 mg/dL to ≥ 240 mg/dL)

Ziprasidone

380

15 (3.9%)

Placebo

145

0 (0.0%)

Borderline to High (≥ 200 mg/dL and < 240 mg/dL to ≥ 240 mg/dL)

Ziprasidone

207

56 (27.1%)

Placebo

82

22 (26.8%)

In long-term (at least one year), placebo-controlled, flexible-dose studies in schizophrenia, the mean change from baseline in random triglycerides for ziprasidone 20 mg to 40 mg BID was +26.3 mg/dL (N = 15); for ziprasidone 60 mg to 80 mg BID was -39.3 mg/dL (N = 10); and for placebo was +12.9 mg/dL (N = 9). In long-term (at least 1 year), placebo-controlled, flexible-dose studies in schizophrenia, the mean change from baseline in random total cholesterol for ziprasidone 20 mg to 40 mg BID was +2.5 mg/dL (N = 14); for ziprasidone 60 mg to 80 mg BID was -19.7 mg/dL (N = 10); and for placebo was -28.0 mg/dL (N = 9).

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