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Table 4 Efficacy findings for paliperidone ER and risperidone dose groups (change from baseline to end point)

From: Paliperidone ER and oral risperidone in patients with schizophrenia: a comparative database analysis

 

Paliperidone ER

6-12 mg/day

n = 179

Risperidone

2-4 mg/day

n = 113

Risperidone

4-6 mg/day

n = 126*

Pooled Placebo

n = 186*

PANSS

    

Total score, adjusted mean change (SE)

-18.4 (1.7)

-11.6 (2.2)

-18.7 (2.0)

-6.4 (1.7)

   Mean difference (estimated SE)

    

Active-PBO

-12.0 (2.4)

-5.4 (2.8)

-12.0 (2.6)

NA

PALI-RIS 2-4 mg

-6.7 (2.8)§

NA

NA

NA

PALI-RIS 4-6 mg

0.2 (2.6)

NA

NA

NA

Negative factor, adjusted mean change (SE)

-4.7 (0.5)

-2.5 (0.6)

-3.8 (0.5)

-2.1 (0.4)

   Mean difference (estimated SE)

    

Active-PBO

-2.6 (0.6)

-0.5 (0.8)

-1.7 (0.7)§

NA

PALI-RIS 2-4 mg

-2.1 (0.8)§

NA

NA

NA

PALI-RIS 4-6 mg

-0.9 (0.7)

NA

NA

NA

Positive factor, adjusted mean change (SE)

-6.2 (0.5)

-4.5 (0.7)

-6.3 (0.7)

-2.3 (0.5)

   Mean difference (estimated SE)

    

Active-PBO

-4.0 (0.8)

-2.2 (0.9)§

-4.1 (0.8)

NA

PALI-RIS 2-4 mg

-1.7 (0.9)

NA

NA

NA

PALI-RIS 4-6 mg

0.1 (0.8)

NA

NA

NA

Anxiety/depression, adjusted mean change (SE)

-2.3 (0.3)

-1.7 (0.3)

-2.5 (0.3)

-1.4 (0.3)

   Mean difference (estimated SE)

    

Active-PBO

-0.9 (0.4)§

-0.3 (0.4)

-1.1 (0.4) §

NA

PALI-RIS 2-4 mg

-0.6 (0.4)

NA

NA

NA

PALI-RIS 4-6 mg

0.2 (0.4)

NA

NA

NA

Disorganized thoughts, adjusted mean change (SE)

-3.5 (0.4)

-2.3 (0.5)

-4.2 (0.5)

-1.1 (0.4)

   Mean difference (estimated SE)

    

Active-PBO

-2.4 (0.6)

-1.3 (0.7)

-3.2 (0.7)

NA

PALI-RIS 2-4 mg

-1.1 (0.7)

NA

NA

NA

PALI-RIS 4-6 mg

0.8 (0.7)

NA

NA

NA

Uncontrolled hostility/excitement, adjusted mean change (SE)

-1.4 (0.3)

-0.6 (0.4)

-2.0 (0.4)

0.6 (0.3)

   Mean difference (estimated SE)

    

Active-PBO

-2.0 (0.5)

-1.2 (0.5)§

2.6 (0.5)

NA

PALI-RIS 2-4 mg

-0.8 (0.5)

NA

NA

NA

PALI-RIS 4-6 mg

0.6 (0.5)

NA

NA

NA

CGI-S, adjusted mean change (SE)

-0.9 (0.1)

0.0 (0.2)

-0.1 (0.2)

-0.2 (0.1)

   Mean difference (estimated SE)

    

Active-PBO

-0.7 (0.1)

0.2 (0.2)

0.0 (0.3)

NA

PALI-RIS 2-4 mg

-0.9 (0.2)

NA

NA

NA

PALI-RIS 4-6 mg

-0.8 (0.3)§

NA

NA

NA

Response, % #

55.1

40.7

51.6

28.1

Active-PBO

26.9§

28.5§

23.4§

NA

PALI-RIS 2-4 mg

14.4§

NA

NA

NA

PALI-RIS 4-6 mg

3.5

NA

NA

NA

  1. Separate models were run for comparison of risperidone 2-4 mg/day and risperidone 4-6 mg/day against paliperidone ER 6-12 mg/day and pooled placebo groups. Adjusted means for the pooled placebo group are presented from the model comparing paliperidone ER with risperidone 4-6 mg/day. Data are nearly identical to those for the model comparing paliperidone ER with risperidone 2-4 mg/day. p values are from ANCOVA models with factor treatment and covariate baseline score for continuous variables and chi-square test for categorical variables.
  2. *Not all subjects had a PANSS assessment.
  3. A negative sign indicates greater improvement vs comparator.
  4. p < 0.0001; §p < 0.05.
  5. Numbers of subjects assessed were 179, 53, 69 and 167 for the paliperidone ER, risperidone 2-4 mg/day, risperidone 4-6 mg/day and pooled placebo groups, respectively.
  6. #Response was defined as ≥30% decrease in total PANSS score from baseline.
  7. PANSS = Positive and Negative Syndrome Scale; PALI = paliperidone ER; RIS = risperidone PBO = placebo; CGI-S = Clinical Global Impressions—Severity; NA = not applicable.