Oral octreotide capsules for the treatment of acromegaly: comparison of 2 phase 3 trial results.

PURPOSE: Results are presented from 2 to 3 trials investigating oral octreotide capsules (OOC) as an alternative to injectable somatostatin receptor ligands (iSRLs) in the treatment of acromegaly. METHODS: CH-ACM-01 was an open-label trial (N = 155) and CHIASMA OPTIMAL was a double-blind placebo-controlled (DPC) trial (N = 56), both investigating OOC as maintenance therapy for patients with acromegaly who were biochemical responders receiving iSRLs. RESULTS: Baseline characteristics in both trials reflected those expected of patients with acromegaly responding to treatment and were similar between trials, despite differences in inclusion criteria. OOC demonstrated a consistent degree of biochemical response across trials, with 65% of patients in CH-ACM-01 maintaining response during the core period and 64% of patients in CHIASMA OPTIMAL at the end of the DPC. Mean insulin-like growth factor I (IGF-I) levels remained within inclusion criteria at the end of treatment in both trials. Of 110 patients entering the fixed-dose phase in CH-ACM-01, 80% maintained or improved acromegaly symptoms from baseline to the end of treatment. Over 85% of patients in both trials elected to continue into the extension phases. OOC were found to be well tolerated across both trials, and no dose-related adverse events were observed. CONCLUSIONS: OOC demonstrated remarkably consistent results for biochemical response, durability of response, and preference to continue with oral treatment across these 2 complementary landmark phase 3 trials, despite differences in the design of each. Trial registration NCT03252353 (August 2017), NCT01412424 (August 2011).

CO2 laser in oral graft-versus-host disease: a pilot study.

This paper is the first to report the benefits of CO2 laser treatment for pain control in severe oral chronic graft-versus-host disease (GVHD). A CO2 laser device was used during 17 treatment sessions in four patients. The CO2 laser was applied over the mucosal lesions using 1 W for 2-3 s/1 mm(2). This treatment resulted in a consistent and significant decrease in pain, measured using a standard visual analogue scale. These results suggest that the CO2 laser can be used for the alleviation of pain in oral chronic GVHD.

Dietary folate and the incidence and prevention of neural tube defects: a proposed triple intervention approach in Israel.

The efficacy of folic acid in the prevention of neural tube defects depends on whether it is administered to women during the period surrounding conception. Optimizing the compliance of women at this critical time is a public health challenge. We assess the need for formulation of public health policy in Israel aimed at enhancing folate intake by women, examine policy implementation strategies, and review policy options regarding the approaches to enhance folic acid intake.

Health knowledge, attitudes, and practice (KAP)--a basis for health promotion policy in Israel.

OBJECTIVE: To review how health promotion policy can be based on research data. DATA SOURCES: The Department of Health Promotion, Ministry of Health, Israel, in collaboration with Midgam Research and Consultation Company and the Israel Center for Disease Control have conducted ongoing research on health knowledge, attitudes, and practice in Israel as a basis for health policy. MAIN FINDINGS: Based on data from 1995 to 2000: 1. There is a positive trend in healthy dietary habits. 2. There is no decrease in smoking rates. 3. There is an increase in drinking rates of wine. 4. There is an increase in aerobic exercise. More Israelis declare they eat healthy foods, but currently this is only for 50% of the population. There is a need for health promotion efforts to further increase positive dietary habits. There is an immediate need for extensive health promotion efforts to decrease smoking rates in Israel. Also, there is a need for health promotion campaigns to decrease drinking in Israel. Although more people are participating in aerobic physical exercise, there is a need to further increase this number. CONCLUSION: Data on health knowledge, attitudes, and practice is an important source for health promotion policy. By trends seen in a national survey of health knowledge, attitudes, and practice conducted every two years, additional health promotion policy can be shaped.