Sertindole versus other atypical antipsychotics for schizophrenia

Katja Komossa; Christine Rummel‐Kluge; Heike Hunger; Sandra Schwarz; Franziska Schmid; Ruth Lewis; Werner Kissling; Stefan Leucht

doi:10.1002/14651858.CD006752.pub2

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Figure 1

Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies.

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Figure 2

Methodological quality summary: review authors' judgements about each methodological quality item for each included study.

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Analysis 1.1

Comparison 1 SERTINDOLE versus RISPERIDONE, Outcome 1 Leaving the study early.

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Analysis 1.2

Comparison 1 SERTINDOLE versus RISPERIDONE, Outcome 2 Global state: 1. No important change ‐ as defined by original study ‐ short term.

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Analysis 1.3

Comparison 1 SERTINDOLE versus RISPERIDONE, Outcome 3 Mental state: 1a. General ‐ no clinically important change (<50% PANSS total score reduction).

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Analysis 1.4

Comparison 1 SERTINDOLE versus RISPERIDONE, Outcome 4 Mental state: 1b. General ‐ average symptom score (PANSS total, high=poor).

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Analysis 1.5

Comparison 1 SERTINDOLE versus RISPERIDONE, Outcome 5 Mental state: 2. Specific ‐ average positive and negative symptom scores ‐ short term (PANSS subscore, high=poor).

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Analysis 1.6

Comparison 1 SERTINDOLE versus RISPERIDONE, Outcome 6 Functioning: Average score ‐ short term (GAF, high=poor).

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Analysis 1.7

Comparison 1 SERTINDOLE versus RISPERIDONE, Outcome 7 Adverse effects: 1a. General ‐ at least one adverse effect.

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Analysis 1.8

Comparison 1 SERTINDOLE versus RISPERIDONE, Outcome 8 Adverse effect/event: 1b. General ‐death.

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Analysis 1.9

Comparison 1 SERTINDOLE versus RISPERIDONE, Outcome 9 Adverse effects: 2. Specific ‐ A. Cardiac ‐ i. QTc prolongation.

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Analysis 1.10

Comparison 1 SERTINDOLE versus RISPERIDONE, Outcome 10 Adverse effects: 2. Specific ‐ A. Cardiac ‐ ii. QTc change from baseline (ms, high=poor)).

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Analysis 1.11

Comparison 1 SERTINDOLE versus RISPERIDONE, Outcome 11 Adverse effects: 2. Specific ‐ B. Central nervous system ‐ i. Sedation.

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Analysis 1.12

Comparison 1 SERTINDOLE versus RISPERIDONE, Outcome 12 Adverse effects: 2. Specific ‐ B. Central nervous system ‐ ii. Specific extrapyramidal movements ‐ binary outcomes.

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Analysis 1.13

Comparison 1 SERTINDOLE versus RISPERIDONE, Outcome 13 Adverse effects: 2. Specific ‐ B. Central nervous system ‐ ii. Specific extrapyramidal movements ‐ average scores.

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Analysis 1.14

Comparison 1 SERTINDOLE versus RISPERIDONE, Outcome 14 Adverse effects: 2. Specific ‐ C. Metabolic ‐ i. Cholesterol change from baseline (mg/dl, increase=poor).

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Analysis 1.15

Comparison 1 SERTINDOLE versus RISPERIDONE, Outcome 15 Adverse effects: 2. Specific ‐ C. Metabolic ‐ ii. Glucose change from baseline (mg/dl, iincrease=poor).

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Analysis 1.16

Comparison 1 SERTINDOLE versus RISPERIDONE, Outcome 16 Adverse effects: 2. Specific ‐ C. Metabolic ‐ iii. Weight ‐ significant gain.

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Analysis 1.17

Comparison 1 SERTINDOLE versus RISPERIDONE, Outcome 17 Adverse effects: 2. Specific ‐ C. Metabolic ‐ iii. Weight ‐ change from baseline (kg).

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Analysis 1.18

Comparison 1 SERTINDOLE versus RISPERIDONE, Outcome 18 Adverse effects: 2. Specific ‐ D. Sexual dysfunction.

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Table 1. Suggested design of future study

Methods	Allocation: randomised ‐ clearly described generation of sequence and concealment of allocation. Blinding: double ‐ described and tested. Duration: 6 months minimum.
Participants	Diagnosis: schizophrenia (operational criteria). N=2700.* Age: any. Sex: both. History: any.
Interventions	1. Sertindole: dose ˜ 12‐24 mg/day. N=300. 2. Amisulpride: dose ˜ 400‐800 mg/day. N=300. 3. Aripiprazole: dose ˜ 10‐30 mg/day. N=300. 4. Clozapine: dose ˜ 300‐800 mg/day. N=300. 5. Olanzapine: dose ˜ 10‐20 mg/day. N=300. 6. Quetiapine: dose ˜300‐800 mg/day. N=300. 7. Risperidone: dose ˜ 4‐8 mg/day. N=300. 8. Ziprasidone: dose ˜ 120‐160 mg/day. N=300. 9. Zotepine: dose ˜ 100‐300 mg/day. N=300.
Outcomes	Leaving study early (any reason, adverse events, inefficacy). Service outcomes: hospitalised, time in hospital, attending out patient clinics. Global impression: CGI**, relapse, healthy days. Mental state: PANSS. Adverse events: UKU, ECG. Functioning: employment. Satisfaction: family, patient.
* power calculation suggested 300/group would allow good chance of showing a 10% difference between groups for primary outcome. ** Primary outcome

Table 1. Suggested design of future study

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Comparison 1. SERTINDOLE versus RISPERIDONE

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Leaving the study early Show forest plot	2		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

1.1 any reason	2	508	Risk Ratio (M‐H, Random, 95% CI)	1.23 [0.94, 1.60]
1.2 adverse events	2	508	Risk Ratio (M‐H, Random, 95% CI)	1.38 [0.74, 2.57]
1.3 inefficacy	2	508	Risk Ratio (M‐H, Random, 95% CI)	1.32 [0.80, 2.18]
2 Global state: 1. No important change ‐ as defined by original study ‐ short term Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

2.1 no significant response	1	187	Risk Ratio (M‐H, Random, 95% CI)	0.88 [0.71, 1.08]
2.2 no clinically important change	1	187	Risk Ratio (M‐H, Random, 95% CI)	0.81 [0.59, 1.10]
3 Mental state: 1a. General ‐ no clinically important change (<50% PANSS total score reduction) Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

3.1 Short term	1	187	Risk Ratio (M‐H, Random, 95% CI)	0.88 [0.71, 1.08]
4 Mental state: 1b. General ‐ average symptom score (PANSS total, high=poor) Show forest plot	2		Mean Difference (IV, Random, 95% CI)	Subtotals only

4.1 Short term	2	493	Mean Difference (IV, Random, 95% CI)	1.98 [‐8.24, 12.20]
5 Mental state: 2. Specific ‐ average positive and negative symptom scores ‐ short term (PANSS subscore, high=poor) Show forest plot	1		Mean Difference (IV, Random, 95% CI)	Subtotals only

5.1 positive symptoms	1	172	Mean Difference (IV, Random, 95% CI)	‐0.80 [‐2.95, 1.35]
5.2 negative symptoms	1	172	Mean Difference (IV, Random, 95% CI)	‐1.30 [‐3.13, 0.53]
6 Functioning: Average score ‐ short term (GAF, high=poor) Show forest plot	1		Mean Difference (IV, Random, 95% CI)	Subtotals only

7 Adverse effects: 1a. General ‐ at least one adverse effect Show forest plot	2	508	Risk Ratio (M‐H, Random, 95% CI)	1.03 [0.95, 1.11]

8 Adverse effect/event: 1b. General ‐death Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

8.1 suicide	1	187	Risk Ratio (M‐H, Random, 95% CI)	0.30 [0.01, 7.34]
9 Adverse effects: 2. Specific ‐ A. Cardiac ‐ i. QTc prolongation Show forest plot	2	508	Risk Ratio (M‐H, Random, 95% CI)	4.86 [1.94, 12.18]

10 Adverse effects: 2. Specific ‐ A. Cardiac ‐ ii. QTc change from baseline (ms, high=poor)) Show forest plot	2	495	Mean Difference (IV, Random, 95% CI)	18.60 [14.83, 22.37]

11 Adverse effects: 2. Specific ‐ B. Central nervous system ‐ i. Sedation Show forest plot	2	508	Risk Ratio (M‐H, Random, 95% CI)	0.87 [0.52, 1.44]

12 Adverse effects: 2. Specific ‐ B. Central nervous system ‐ ii. Specific extrapyramidal movements ‐ binary outcomes Show forest plot	2		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

12.1 akathisia	1	321	Risk Ratio (M‐H, Random, 95% CI)	0.45 [0.20, 0.98]
12.2 extrapyramidal symptoms	1	187	Risk Ratio (M‐H, Random, 95% CI)	0.65 [0.38, 1.11]
12.3 parkinsonism	1	321	Risk Ratio (M‐H, Random, 95% CI)	0.24 [0.09, 0.69]
12.4 tremor	1	187	Risk Ratio (M‐H, Random, 95% CI)	1.51 [0.37, 6.15]
13 Adverse effects: 2. Specific ‐ B. Central nervous system ‐ ii. Specific extrapyramidal movements ‐ average scores Show forest plot	2		Mean Difference (IV, Random, 95% CI)	Subtotals only

13.1 abnormal involuntary movements (AIMS, high=poor)	2	477	Mean Difference (IV, Random, 95% CI)	‐0.31 [‐0.86, 0.25]
13.2 akathisia (Barnes Akathisia Scale, high=poor)	2	500	Mean Difference (IV, Random, 95% CI)	‐0.22 [‐0.41, ‐0.03]
13.3 extrapyramidal symptoms (Simpson‐Angus Scale, high=poor)	2	500	Mean Difference (IV, Random, 95% CI)	‐0.46 [‐1.24, 0.32]
14 Adverse effects: 2. Specific ‐ C. Metabolic ‐ i. Cholesterol change from baseline (mg/dl, increase=poor) Show forest plot	1	176	Mean Difference (IV, Random, 95% CI)	‐4.90 [‐13.53, 3.73]

15 Adverse effects: 2. Specific ‐ C. Metabolic ‐ ii. Glucose change from baseline (mg/dl, iincrease=poor) Show forest plot	1	176	Mean Difference (IV, Random, 95% CI)	0.00 [‐9.85, 5.85]

16 Adverse effects: 2. Specific ‐ C. Metabolic ‐ iii. Weight ‐ significant gain Show forest plot	1	187	Risk Ratio (M‐H, Random, 95% CI)	1.30 [0.70, 2.41]

17 Adverse effects: 2. Specific ‐ C. Metabolic ‐ iii. Weight ‐ change from baseline (kg) Show forest plot	2	328	Mean Difference (IV, Random, 95% CI)	0.99 [0.12, 1.86]

18 Adverse effects: 2. Specific ‐ D. Sexual dysfunction Show forest plot	2	437	Risk Ratio (M‐H, Random, 95% CI)	2.90 [1.32, 6.35]

18.1 not‐specific ‐ sexual dysfunction	1	187	Risk Ratio (M‐H, Random, 95% CI)	4.54 [1.02, 20.16]
18.2 specific ‐ abnormal ejaculation	1	250	Risk Ratio (M‐H, Random, 95% CI)	2.44 [0.97, 6.14]

Comparison 1. SERTINDOLE versus RISPERIDONE

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