BACKGROUND: ABT-288, a highly selective histamine-3 receptor antagonist, demonstrated efficacy across several preclinical cognitive domains, and safety in healthy subjects and elderly volunteers.

OBJECTIVE: Evaluate the efficacy and safety of ABT-288 in subjects with mild-to-moderate Alzheimer's dementia.

METHODS: The study used a randomized, double-blind, placebo- and active-controlled, parallel group design with pre-defined futility criteria to permit early study termination. A total of 242 subjects were randomized in an equal ratio to ABT-288 1 mg or 3 mg, donepezil 10 mg, or placebo once daily for 12 weeks. The primary efficacy endpoint was the change from baseline to final evaluation on the 13-item Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) total score.

RESULTS: The study was prematurely terminated because futility criteria were met. Point estimates on the ADAS-Cog scores for both ABT-288 dose groups were numerically inferior to placebo but no statistical differences were detected. Donepezil demonstrated statistically significant improvement. Adverse events were generally mild and self-limiting.

CONCLUSION: ABT-288 did not demonstrate efficacy in the symptomatic treatment of Alzheimer's dementia.

BACKGROUND: Novel and promising results in acne treatment with infrared lasers have been reported. The 1,550-nm erbium glass laser is one of the infrared lasers that may be useful in the treatment of acne.

OBJECTIVE: The aim of this study was to evaluate the efficacy of an erbium glass laser in treatment of active acne and to study the effect of this type of laser on sebaceous glands.

PATIENTS AND METHODS: Twenty-four patients with active acne lesions were treated using 1,550-nm (30-40 mJ) fractional erbium glass laser. Every patient received 4 sessions with a 2-week interval. Follow-up was done every 3 months for 1 year. The image analyzer computer system was used to measure the sebaceous gland size.

RESULTS: A significant reduction (p < .0001) in the mean count of lesions was observed after treatment and in the follow-up period. A significant reduction in the size of sebaceous glands was also evident after laser treatment.

CONCLUSION: Treatment of active acne with the 1,550-nm erbium glass laser is effective. Papules, pustules, and nodules all respond well to therapy. The sebaceous gland size decreased significantly, which accounts for the long remission period.

OBJECTIVE: To study the efficacy and safety of preoperative intravenous tranexamic acid to reduce blood loss during and after elective lower-segment cesarean delivery.

METHODS: A single-blind, randomized placebo-controlled study was undertaken of women undergoing elective lower-segment cesarean delivery of a full-term singleton pregnancy at a center in Cairo, Egypt, between November 2013 and November 2014. Patients were randomly assigned (1:1) using computer-generated random numbers to receive either 1g tranexamic acid or 5% glucose 15 minutes before surgery. Preoperative and postoperative complete blood count, hematocrit values, and maternal weight were used to calculate the estimated blood loss (EBL) during cesarean, which was the primary outcome. Analyses included women who received their assigned treatment, whose surgery was 90 minutes or less, and who completed follow-up.

RESULTS: Analyses included 100 women in each group. Mean EBL was significantly higher in the placebo group (700.3 ± 143.9 mL) than in the tranexamic acid group (459.4 ±7 5.4 mL; P<0.001). Only six women, all in the placebo group, experienced an EBL of more than 1000 mL. There were no reports of thromboembolic events up to 4 weeks postoperatively.

CONCLUSION: Preoperative administration of tranexamic acid safely reduces blood loss during elective lower-segment cesarean delivery. Australian New Zealand Clinical Trials Registry:ACTRN12615000312549.

OBJECTIVE: To investigate the efficacy of inspiratory muscle training (IMT) on respiratory functions, respiratory muscle strength, and asthma symptoms in asthmatic children.

METHODS: In a randomized placebo-controlled assessor-blinded study, 34 children with asthma were randomized to receive either the IMT at 40% of the maximal inspiratory pressure (IP) for 20 min/session, thrice/week, over 12 consecutive weeks (IMT group;  = 17) or placebo IMT at 5% of IP (placebo group;  = 17). Additionally, both groups received the conventional respiratory rehabilitation (CRR) program. Outcome measurements performed pre- and post-treatment, included respiratory functions [forced expiratory volume at the first second (FEV), forced vital capacity (FEV), and FEV/FVC], respiratory muscle strength [represented by IP and maximal expiratory pressure (EP), and asthma control test (ACT).

RESULTS: At a significance level adjusted to <.008, there were significant post-treatment differences between the IMT and placebo groups in FEV (=.003), FVC (=.001), FEV/FVC (=.004), IP (=.002), EP (=.004), and ACT (=.001) adjusted to the pretreatment values, in favor of the IMT group.

CONCLUSION: Incorporation of IMT in the CRR program for children with asthma can improve respiratory function, enhance respiratory muscle strength, and improve children's perception of asthma symptoms.

Seventy-one patients with T2 and T3 bladder cancer were randomized to receive either two courses of epirubicin 120 mg/m2 i.v. push every 21 days pro-operatively, and four additional courses post-operatively (group I = 34 patients), or radical surgery (group 11 = 37 patients). At a median follow-up of 24 months (range 22 months to 38 months) 25 patients from group I and 14 patients from group II are still alive and disease-free. The estimated two-year disease-tree survival percentages were 73.5 and 37.9%, respectively (P = 0.05). After initial chemotherapy, resected specimens were subjected to histopathologieal study of chemotherapeutic effects. Necrosis was detected in 95% of cases with squamous cell carcinoma and in 57.3% of cases with transitional cell carcinoma. We conclude that the benefit which was obtained by pre-operative and post-operative chemotherapy with epirubicin is promising and may represent a significant improvement in the treatment of patients with carcinoma of the bilharzial bladder.

BACKGROUND: The value of continuous-infusion chemotherapy (EPOCH) vs. the standard CHOP combination was evaluated in 78 patients with previously untreated aggressive non-Hodgkin's lymphoma in a randomized phase III clinical trial.

PATIENTS AND METHODS: The EPOCH regimen given to 38 patients consisted of the drugs etoposide (50 mg/m2), vincristine (0.4 mg/m2), and doxorubicin (10 mg/m2), all given in a continuous infusion on days 1-4. Cyclophosphamide (750 mg/m2) was administered on day 6 as i.v. bolus, while prednisone was given orally 60 mg/m2 on days 1-6. Courses were repeated every three weeks. CHOP was given to 40 patients as routinely prescribed.

RESULTS: Forty-eight patients were males and thirty were females. Their ages ranged from 19-75 years (median 45 years). Forty-three (55%) had grade 2 and thirty-five (45%) had grade 3 pathologic subtype. Nine patients (12%) presented with stage I, fourteen (18%) with stage II, forty (51%) with stage III, and fifteen (19%) with stage IV disease. The different clinico-pathologic characteristics, including international index categories, were comparable in the two groups. The number of courses given ranged between 3 and 9 (median 6) for both the EPOCH and CHOP regimens. Complete remission (CR) was achieved in 19 (50%), and 27 (67%) of the 38 and 40 patients for both the EPOCH and CHOP combinations, respectively. After a median observation time of 27 months, the four-year overall and failure-free survival rates were 42% and 30% for the EPOCH and 71% and 54% for the CHOP regimen (P = 0.006 and 0.1 for the overall and FFS rates, respectively). Toxicities were comparable and were mostly of grades 1 and 2, except for hair loss, hematologic toxicities, and infectious episodes which were more common in the EPOCH group. In the EPOCH group, overall survival rates were 55% vs. 22% (P < 0.04) at four years for the low-risk (2 prognostic factors) and high-risk (> 2 factors) groups, respectively.

CONCLUSIONS: Thus, it may be concluded that continuous-infusion (EPOCH) chemotherapy did not improve treatment outcome over that of the CHOP regimen for aggressive non-Hodgkin's lymphoma patients.

Background: The value of continuous-infusion chemotherapy (EPOCH) vs. the standard CHOP combination was evaluated in 78 patients with previously untreated aggressive non-Hodgkin's lymphoma in a randomized phase III clinical trial. Patients and methods: The EPOCH regimen given to 38 patients consisted of the drugs etoposide (50 mg/m2), vincristine (0.4 mg/m2), and doxorubicin (10 mg/m2), all given in a continuous infusion on days 1-4. Cyclophosphamide (750 mg/m2) was administered on day 6 as i.v. bolus, while prednisone was given orally 60 mg/m2 on days 1-6. Courses were repeated every three weeks. CHOP was given to 40 patients as routinely prescribed. Results: Forty-eight patients were males and thirty were females. Their ages ranged from 19-75 years (median 45 years). Forty-three (55%) had grade 2 and thirty-five (45%) had grade 3 pathologic subtype. Nine patients (12%) presented with stage I, fourteen (18%) with stage II, forty (51%) with stage III, and fifteen (19%) with stage IV disease. The different clinico- pathologic characteristics, including international index categories, were comparable in the two groups. The number of courses given ranged between 3 and 9 (median 6) for both the EPOCH and CHOP regimens. Complete remission (CR) was achieved in 19 (50%), and 27 (67%) of the 38 and 40 patients for both the EPOCH and CHOP combinations, respectively. After a median observation time of 27 months, the four-year overall and failure-free survival rates were 42%, and 30% for the EPOCH and 71% and 54% for the CHOP regimen (P = 0.006 and 0.1 for the overall and FFS rates, respectively). Toxicities were comparable and were mostly of grades 1 and 2, except for hair loss, hematologic toxicities, and infectious episodes which were more common in the EPOCH group. In the EPOCH group, overall survival rates were 55% vs. 22% (P < 0.04) at four years for the low-risk (2 prognostic factors) and high-risk (> 2 factors) groups, respectively. Conclusions: Thus, it may be concluded that continuous-infusion (EPOCH) chemotherapy did not improve treatment outcome over that of the CHOP regimen for aggressive non-Hodgkin's lymphoma patients.

Background: The value of continuous-infusion chemotherapy (EPOCH) vs. the standard CHOP combination was evaluated in 78 patients with previously untreated aggressive non-Hodgkin's lymphoma in a randomized phase III clinical trial. Patients and methods: The EPOCH regimen given to 38 patients consisted of the drugs etoposide (50 mg/m2), vincristine (0.4 mg/m2), and doxorubicin (10 mg/m2), all given in a continuous infusion on days 1-4. Cyclophosphamide (750 mg/m2) was administered on day 6 as i.v. bolus, while prednisone was given orally 60 mg/m2 on days 1-6. Courses were repeated every three weeks. CHOP was given to 40 patients as routinely prescribed. Results: Forty-eight patients were males and thirty were females. Their ages ranged from 19-75 years (median 45 years). Forty-three (55%) had grade 2 and thirty-five (45%) had grade 3 pathologic subtype. Nine patients (12%) presented with stage I, fourteen (18%) with stage II, forty (51%) with stage III, and fifteen (19%) with stage IV disease. The different clinico- pathologic characteristics, including international index categories, were comparable in the two groups. The number of courses given ranged between 3 and 9 (median 6) for both the EPOCH and CHOP regimens. Complete remission (CR) was achieved in 19 (50%), and 27 (67%) of the 38 and 40 patients for both the EPOCH and CHOP combinations, respectively. After a median observation time of 27 months, the four-year overall and failure-free survival rates were 42%, and 30% for the EPOCH and 71% and 54% for the CHOP regimen (P = 0.006 and 0.1 for the overall and FFS rates, respectively). Toxicities were comparable and were mostly of grades 1 and 2, except for hair loss, hematologic toxicities, and infectious episodes which were more common in the EPOCH group. In the EPOCH group, overall survival rates were 55% vs. 22% (P < 0.04) at four years for the low-risk (2 prognostic factors) and high-risk (> 2 factors) groups, respectively. Conclusions: Thus, it may be concluded that continuous-infusion (EPOCH) chemotherapy did not improve treatment outcome over that of the CHOP regimen for aggressive non-Hodgkin's lymphoma patients.