Parecoxib, propacetamol, and their combination for analgesia after total hip arthroplasty: a randomized non-inferiority trial.

BACKGROUND: This study assessed non-inferiority of parecoxib vs. combination parecoxib+propacetamol and compared the opioid-sparing effects of parecoxib, propacetamol, and parecoxib+propacetamol vs. placebo after total hip arthroplasty. METHODS: In this randomized, placebo-controlled, parallel-group, non-inferiority study, patients received one of four IV treatments after surgery: parecoxib 40 mg bid (n = 72); propacetamol 2 g qid (n = 71); parecoxib 40 mg bid plus propacetamol 2 g qid (n = 72); or placebo (n = 38) with supplemental IV patient-controlled analgesia (morphine). Patients and investigators were blinded to treatment. Pain intensity at rest and with movement was assessed regularly, together with functional recovery (modified Brief Pain Inventory-Short Form) and opioid-related side effects (Opioid-Related Symptom Distress Scale) questionnaires up to 48 h. RESULTS: After 24 h, cumulative morphine consumption was reduced by 59.8% (P < 0.001), 38.9% (P < 0.001), and 26.8% (P = 0.005) in the parecoxib+propacetamol, parecoxib, and propacetamol groups, respectively, compared with placebo. Parecoxib did not meet criteria for non-inferiority to parecoxib+propacetamol. Parecoxib+propacetamol and parecoxib significantly reduced least-squares mean pain intensity scores at rest and with movement compared with propacetamol (P < 0.05). One day after surgery, parecoxib+propacetamol significantly reduced opioid-related symptom distress and decreased pain interference with function compared with propacetamol or placebo. CONCLUSION: Parecoxib and parecoxib+propacetamol provided significant opioid-sparing efficacy compared with placebo; non-inferiority of parecoxib to parecoxib+propacetamol was not demonstrated. Opioid-sparing efficacy was accompanied by significant reductions in pain intensity on movement, improved functional outcome, and less opioid-related symptom distress. Study medications were well tolerated.

Identifying the target NSCLC patient for maintenance therapy: an analysis from a placebo-controlled, phase III trial of maintenance pemetrexed (H3E-MC-JMEN).

BACKGROUND: This was a post hoc analysis of patients with non-squamous histology from a phase III maintenance pemetrexed study in advanced non-small cell lung cancer (NSCLC). PATIENTS AND METHODS: The six symptom items' [average symptom burden index (ASBI)] mean at baseline was calculated using the lung cancer symptom scale (LCSS). Low and high symptom burden (LSB, ASBI < 25; HSB, ASBI ≥ 25) and performance status (PS: 0, 1) subgroups were analyzed for treatment effect on progression-free survival (PFS) and overall survival (OS) using the Cox proportional hazard models adjusted for demographic/clinical factors. RESULTS: Significantly longer PFS and OS for pemetrexed versus placebo occurred in LSB patients [PFS: median 5.1 versus 2.4 months, hazard ratio (HR) 0.49, P < 0.0001; OS: median 17.5 versus 11.0 months, HR 0.63, P = 0.0012] and PS 0 patients (PFS: median 5.5 versus 1.7 months, HR 0.36, P < 0.0001; OS: median 17.7 versus 10.3 months, HR 0.54, P = 0.0019). Significantly longer PFS, but not OS, occurred in HSB patients (median 3.7 versus 2.8 months, HR 0.50, P = 0.0033) and PS 1 patients (median 4.4 versus 2.8 months, HR 0.60, P = 0.0002). CONCLUSIONS: ASBI and PS are associated with survival for non-squamous NSCLC patients, suggesting that maintenance pemetrexed is useful for LSB or PS 0 patients following induction.

Delays in receipt of immunizations in low-birth-weight children: a nationally representative sample.

BACKGROUND: Studies of very low-birth-weight (VLBW) children discharged from neonatal intensive care units have shown delays in receipt of routine childhood immunizations. However, a recent study of VLBW children in 3 health maintenance organizations found no significant delays in immunizations. OBJECTIVE: To assess the risk of immunization delays for moderately low-birth-weight (MLBW; 1500 g-2499 g) and VLBW (<1500 g) children compared with normal-birth-weight children in a nationally representative birth sample. DESIGN: Logistic regression analysis using the 1988 National Maternal and Infant Health Survey and the 1991 Longitudinal Follow-up Survey. SETTING: Nationally representative sample of children born in 1988 in the United States. PARTICIPANTS: A total of 8285 children whose mothers completed both surveys. MAIN OUTCOME MEASURES: Age at receipt of each of the first 4 doses of diphtheria and tetanus toxoids and pertussis vaccine, the first 3 doses of polio vaccine, and the first dose of measles-mumps-rubella vaccine for MLBW and VLBW children, and normal-birth-weight children. We also examined whether children were up-to-date for all immunizations at ages 12, 24, and 36 months based on birth-weight groups. RESULTS: Very low-birth-weight children received their first 3 doses of diphtheria and tetanus toxoids and pertussis vaccine and their first 2 doses of polio vaccine significantly later than normal-birth-weight children (P <.001). Very low-birth-weight children were significantly less likely to be up to date for all immunizations at ages 12 months (odds ratio [OR] =.556; P =.001), 24 months (OR =.439; P <.001), and 36 months (OR =.446; P <.001) compared with normal-birth-weight children. CONCLUSION: Very low-birth-weight children are at risk for immunization delays compared with normal-birth-weight children.