PMID- 20199482 OWN - NLM STAT- MEDLINE DCOM- 20100603 LR - 20220316 IS - 1751-7893 (Electronic) IS - 1751-7885 (Linking) VI - 4 IP - 1 DP - 2010 Feb TI - Paliperidone extended-release tablets in patients with recently diagnosed schizophrenia. PG - 64-78 LID - 10.1111/j.1751-7893.2010.00165.x [doi] AB - AIM: Effective early and persistent antipsychotic treatment in recently diagnosed schizophrenia may positively impact long-term outcomes. Paliperidone extended-release (ER) was assessed in this population. METHODS: Post hoc analysis of pooled data from three 6-week, double-blind (DB), placebo-controlled, and three 1-year open-label (OL) studies of paliperidone ER in schizophrenia patients. Data stratified by time since diagnosis (< or =3 vs. >3 years). RESULTS: At DB (n = 1193) and OL baselines (n = 744), 259 (21.9%) and 188 (25.3%) patients were diagnosed < or =3 years. At DB end point, both populations improved with paliperidone ER versus placebo on Positive and Negative Syndrome Scale (PANSS) total, Clinical Global Impressions-Severity and Personal and Social Performance (PSP) scale scores (all P < 0.05). At OL end point, there were significant improvements from DB baseline in both populations on these scales (P < 0.0001), with greater improvement in the < or =3-year population on PANSS total (P < 0.001) and PSP (P < 0.001) scores. During DB treatment, only the < or =3-year population reported adverse events (AEs) in > or =5% (placebo-adjusted rate) of subjects receiving paliperidone ER: akathisia, extrapyramidal disorder not otherwise specified and somnolence. During OL treatment, akathisia and somnolence occurred more frequently (> or =5%) in the < or =3- versus >3-year population. OL study completion rates were 51.1% in < or =3-year, and 48.2% in >3-year subjects. CONCLUSIONS: Paliperidone ER significantly improved symptoms and functioning in schizophrenia patients, regardless of time since diagnosis. Recently diagnosed patients who continued treatment exhibited greater symptom reduction and functional benefit over the long term. Results also suggest that these patients may be more susceptible to certain AEs. FAU - Canuso, Carla M AU - Canuso CM AD - Ortho-McNeil Janssen Scientific Affairs, LLC, Titusville New Jersey, USA. ccanuso@its.jnj.com FAU - Bossie, Cynthia A AU - Bossie CA FAU - Amatniek, Joan AU - Amatniek J FAU - Turkoz, Ibrahim AU - Turkoz I FAU - Pandina, Gahan AU - Pandina G FAU - Cornblatt, Barbara AU - Cornblatt B LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't PL - Australia TA - Early Interv Psychiatry JT - Early intervention in psychiatry JID - 101320027 RN - 0 (Antipsychotic Agents) RN - 0 (Delayed-Action Preparations) RN - 0 (Isoxazoles) RN - 0 (Pyrimidines) RN - R8P8USM8FR (Paliperidone Palmitate) SB - IM MH - Adult MH - Akathisia, Drug-Induced/complications MH - Antipsychotic Agents/*administration & dosage/adverse effects MH - Delayed-Action Preparations/administration & dosage/adverse effects MH - Dose-Response Relationship, Drug MH - Female MH - Humans MH - Isoxazoles/*administration & dosage/adverse effects MH - Male MH - Paliperidone Palmitate MH - Psychiatric Status Rating Scales MH - Pyrimidines/*administration & dosage/adverse effects MH - Randomized Controlled Trials as Topic MH - Schizophrenia/complications/diagnosis/*drug therapy MH - Schizophrenic Psychology MH - Severity of Illness Index MH - Time Factors EDAT- 2010/03/05 06:00 MHDA- 2010/06/04 06:00 CRDT- 2010/03/05 06:00 PHST- 2010/03/05 06:00 [entrez] PHST- 2010/03/05 06:00 [pubmed] PHST- 2010/06/04 06:00 [medline] AID - EIP165 [pii] AID - 10.1111/j.1751-7893.2010.00165.x [doi] PST - ppublish SO - Early Interv Psychiatry. 2010 Feb;4(1):64-78. doi: 10.1111/j.1751-7893.2010.00165.x.