Discontinuation of chronic benzodiazepine use in primary care: a nonrandomized intervention.

BACKGROUND: Chronic benzodiazepine use is a challenge in primary care practice. Protocols to support safe discontinuation are still needed, especially in countries with high utilization rates. OBJECTIVES: To evaluate the feasibility, effectiveness, and safety of a benzodiazepine discontinuation protocol in primary care setting. METHODS: Nonrandomized, single-arm interventional study, at primary care units. Family physicians (FPs) recruited patients (18-85 years-old) with benzodiazepine dependence and chronic daily use ≥3 months. Patients with daily dosages ≥30 mg diazepam-equivalent, taking zolpidem, with a history of other substance abuse or major psychiatric disease were excluded. After the switch to diazepam, the dosage was gradually tapered according to a standardized protocol. Primary endpoint was the percentage of patients who stopped benzodiazepine at the intervention last visit. Dosage reduction, withdrawal symptoms, patients' and FPs' satisfaction with the protocol were evaluated. RESULTS: From 66 enrolled patients (74% female; 66.7% aged >64 years; median time of benzodiazepine use was 120 months), 2 withdrew due to medical reasons and 3 presented protocol deviations. Overall, 59.4% of participants successfully stopped benzodiazepine (60.7% when excluding protocol deviations). Men had higher probability of success (relative risk = 0.51, P = 0.001). A total of 31 patients reported at least 1 withdrawal symptom, most frequently insomnia and anxiety. Most of participating FP considered the clinical protocol useful and feasible in daily practice. Among patients completing the protocol, 77% were satisfied. For the patients who reduced dosage, 85% kept without benzodiazepines after 12 months. CONCLUSION: The discontinuation protocol with standardized dosage reduction was feasible at primary care and showed long-term effectiveness.

Physicians' beliefs and attitudes about Benzodiazepines: a cross-sectional study.

BACKGROUND: In 2015, Portugal was the OECD country with the highest reported consumption of BZD. Physician's perceptions and attitudes regarding BZD are main determinants of related prescription habits. This study aimed to characterize beliefs and attitudes of Portuguese physicians regarding the prescription, management challenges, benefits, risks and withdrawal effects of BZD. METHODS: A cross-sectional, observational study with online data collection through anonymous self-administered questionnaire. Physicians registered with the Portuguese Medical Association were invited to participate through direct e-mail message. Physicians were asked to give their opinion (using a 5-points Likert scale) regarding the prescription of BZD, their benefits and risks in the management of insomnia and anxiety, the possible adverse effects of chronic use and alternative non-pharmacologic approaches. Descriptive statistics were used and groups were compared through logistic regression. RESULTS: A total of 329 physicians participated in the study (56% family physicians). Mean age was 44.10 ± 15.2 years, with 19.03 ± 14.9 years of clinical experience. Fifty eight percent of participants were female. Physicians reported BZD's negative impact on cognitive function (89%), association with road traffic accidents (88%) and falls (79%). Also, 58% shared the belief that chronic use is justified if the patient feels better and without adverse events. Although 68% reported to feel capable of helping patients to reduce or stop BZD, 55% recognized difficulties in motivating them. Compared to other medical specialists (altogether), family physicians were significantly more aware about the adverse effects of BZD and considered that chronic use may not be justified. Conversely, more family physicians expressed concerns about their skills to motivate patients engaging in withdrawal programs and to support them during the process. CONCLUSION: Our results show that physicians' awareness about risks of BZD chronic use is adequate though their attitudes and self-perceived skills towards promoting BZD withdrawal can be improved. Interventions in primary care are needed to capacitate physicians to better motivate patients for BZD withdrawal.

[Guideline: type 2 diabetes mellitus therapy: metformin, a critical perspective]. / Norma terapêutica da diabetes mellitus tipo 2: metformina uma perspectiva crítica.

Clinical guidelines have the potential to increase health gains, but also to cause harm. In this opinion article we state some misgivings about the application of the Portuguese National Health Directorate's guideline type 2 diabetes therapy: metformin in primary care. We seek to highlight guideline wording that may allow for multiple interpretations (alternatives to monotherapy with metformin, hierarchy of drugs to be associated with metformin, and metformin contraindications). Furthermore, we argue that it seems that choosing a glycemic target of 6.5% in a normative document to be applied in the general population may have unforeseen consequences.

The European and American use of exploratory approaches for first-in-human studies.

Exploratory approaches for first-in-human clinical studies have evolved over the last few years and have stimulated the issuance of national regulatory guidances in some European countries as well as the United States. With the increasing implementation of these approaches and the recent preparation of a multiregional regulatory guidance (ICH M3 rev2), an exchange of experiences on the opportunities and challenges of exploratory clinical trials was desirable; thus, a workshop focusing on the use of this clinical approach was planned and conducted in Lisbon, Portugal, March 18-19, 2009 sponsored by the Portuguese Health Authority (INFARMED) and DIA. The structure of the workshop focused in three main areas. Regulatory representatives from Portugal, Belgium, Germany, the United Kingdom and the United States formally reviewed their experiences. This was followed by a discussion on issues from an ethics review perspective as well as an insight to the opportunities in the area of biologics. The industry perspective was presented by representatives from Merck, Pfizer, J&J, Novartis, Speedel, AstraZeneca, GSK, and Roche. Finally, through break out sessions, issues were identified to be addressed moving forward. It is the purpose of this paper to report on the outcome of this workshop.