TY - JOUR
T1 - The long-term clinical benefit and effectiveness of switching to once-daily quetiapine extended release in patients with schizophrenia
AU - Chue, P.
AU - Malla, A.
AU - Bouchard, R. H.
AU - Lessard, S.
AU - Ganesan, S.
AU - Stip, E.
AU - Johnson, S.
AU - Chen, E.
AU - Ahn, Y. M.
AU - Kim, Y. S.
AU - Robinson, G.
AU - Schweikert, C.
AU - Gendron, A.
AU - Eriksson, H.
N1 - Funding Information:
We thank Robert Balshaw from Syreon Corporation for statistical assistance, and Christina Clark from MDH Consulting Inc. for editorial assistance; funded by Astra Zeneca Canada Inc. The SPECTRUM XR study group included the following investigators: Dinesh Arya; Gail Robinson (Australia); Pierre Chue; Hubert Colohan; Norman Costigan; Thomas Joseph Raedler; Soma Ganesan; Richard Williams; Redha Mahfoudi; Nizar Ladha; Javed Ali; Ranjith Chandrasena; Leonardo Cortese; Satpal Girgla; Magda Hanna; Rajendra Harricharan; Sunny Johnson; Anil Joseph; Arthur David Kantor; Serge Lessard; Rama Prayaga; Rustom Sethna; Amarendra Singh; Stephen Stokl; Roch-Hugo Bouchard; Guylene Cloutier; Theodore Kolivakis; Ashok Malla; Javad Moamai; Emmanuel Stip; Mohammad Hussain; Mysore Renuka-Prasad (Canada); Eric Chen; Fan Kwong Tsang; Edwin Lee (Hong Kong); Yong Min Ahn; Tae-Youn Jun; Yong Sik Kim; Chang Uk Lee; Kang-Seob Oh; Jung Seo Yi (Republic of Korea).
Funding Information:
This study (D1443L00025) was funded by AstraZeneca Canada Inc. P.C., A.G. and C.S. conceived and designed the study. P.C. was the international principal investigator (PI). With the exception of P.C. and the Astra Zeneca employees (A.G., C.S., H.E.) all the other authors were site PIs in their respective countries. P.C., A.G. and C.S. drafted the initial manuscript with editorial assistance from Christina Clark. P.C., A.G. and C.S. interpreted the results with statistical assistance from Robert Balshaw. All the authors contributed to interpretation of the results and drafting of the manuscript. All the authors reviewed and approved the final version of the manuscript.
PY - 2013/3
Y1 - 2013/3
N2 - Objective: To evaluate the long-term clinical benefit and effectiveness of switching to once-daily quetiapine extended release (XR) from an oral antipsychotic in patients with schizophrenia. Reasons for switching included insufficient efficacy, tolerability, and/or non-acceptability. The primary endpoint was the percentage of patients achieving an improvement in Clinical Global Impression-Clinical Benefit (CGI-CB) scale scores. Research design and methods: A 24-week, international, multicentre, open-label, prospective study (www.clinicaltrials.gov: NCT00640601). After a 7-14 day enrolment period (depending whether prior antipsychotic mono-or combination therapy), all patients received quetiapine XR 300 mg once daily (day 1), 600 mg/day (day 2), 600-800 mg/day (day 3) and 400-800 mg/day thereafter, with down-titration and discontinuation of prior antipsychotic by day 4. Results: A total of 62% of patients completed the study and 56.9% (LOCF, ITT) achieved a significant improvement in CGI-CB (95% CI [0.51, 0.63]; p = 0.02). Switches due to insufficient efficacy showed a significant improvement (60%, 95% CI [0.51, 0.68]; p = 0.02), compared to 54.4% ([0.44, 0.64]; p = 0.38) and 52.4% ([0.36, 0.68]; p = 0.76) of switches due to insufficient tolerability and non-acceptability respectively (both p = ns). Patients previously on olanzapine and quetiapine IR showed a significant improvement in CGI-CB (62.6% [p = 0.02] and 61.2% [p = 0.04], respectively). Somnolence (18.0%) and dizziness (14.6%) were the main adverse events. Anticholinergic use decreased from 7.1 to 2.7%. Overall mean weight gain was 0.4 kg; 12.9% of patients experienced a weight gain of ≥7% and 15% experienced a clinically relevant shift in triglycerides from baseline. Conclusions: A majority of patients switched from other antipsychotics to quetiapine XR experienced clinical benefit. This was supported by all other efficacy outcomes regardless of the reason for switching. Safety data confirmed quetiapine XR was safe and well tolerated. The open-label design and lack of a placebo group represent limitations.
AB - Objective: To evaluate the long-term clinical benefit and effectiveness of switching to once-daily quetiapine extended release (XR) from an oral antipsychotic in patients with schizophrenia. Reasons for switching included insufficient efficacy, tolerability, and/or non-acceptability. The primary endpoint was the percentage of patients achieving an improvement in Clinical Global Impression-Clinical Benefit (CGI-CB) scale scores. Research design and methods: A 24-week, international, multicentre, open-label, prospective study (www.clinicaltrials.gov: NCT00640601). After a 7-14 day enrolment period (depending whether prior antipsychotic mono-or combination therapy), all patients received quetiapine XR 300 mg once daily (day 1), 600 mg/day (day 2), 600-800 mg/day (day 3) and 400-800 mg/day thereafter, with down-titration and discontinuation of prior antipsychotic by day 4. Results: A total of 62% of patients completed the study and 56.9% (LOCF, ITT) achieved a significant improvement in CGI-CB (95% CI [0.51, 0.63]; p = 0.02). Switches due to insufficient efficacy showed a significant improvement (60%, 95% CI [0.51, 0.68]; p = 0.02), compared to 54.4% ([0.44, 0.64]; p = 0.38) and 52.4% ([0.36, 0.68]; p = 0.76) of switches due to insufficient tolerability and non-acceptability respectively (both p = ns). Patients previously on olanzapine and quetiapine IR showed a significant improvement in CGI-CB (62.6% [p = 0.02] and 61.2% [p = 0.04], respectively). Somnolence (18.0%) and dizziness (14.6%) were the main adverse events. Anticholinergic use decreased from 7.1 to 2.7%. Overall mean weight gain was 0.4 kg; 12.9% of patients experienced a weight gain of ≥7% and 15% experienced a clinically relevant shift in triglycerides from baseline. Conclusions: A majority of patients switched from other antipsychotics to quetiapine XR experienced clinical benefit. This was supported by all other efficacy outcomes regardless of the reason for switching. Safety data confirmed quetiapine XR was safe and well tolerated. The open-label design and lack of a placebo group represent limitations.
KW - Antipsychotics
KW - Clinical benefit
KW - Quetiapine extended release
KW - Schizophrenia
UR - http://www.scopus.com/inward/record.url?scp=84873631602&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84873631602&partnerID=8YFLogxK
U2 - 10.1185/03007995.2012.762903
DO - 10.1185/03007995.2012.762903
M3 - Article
C2 - 23281876
AN - SCOPUS:84873631602
SN - 0300-7995
VL - 29
SP - 227
EP - 239
JO - Current Medical Research and Opinion
JF - Current Medical Research and Opinion
IS - 3
ER -