Background: Current tobacco treatment guidelines have established the efficacy of available interventions, but they do not provide detailed guidance for common implementation questions frequently faced in the clinic. An evidence-based guideline was created that addresses several pharmacotherapy-initiation questions that routinely confront treatment teams. Methods: Individuals with diverse expertise related to smoking cessation were empaneled to prioritize questions and outcomes important to clinicians. An evidence-synthesis team conducted systematic reviews, which informed recommendations to answer the questions. The GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) approach was used to rate the certainty in the estimated effects and the strength of recommendations. Results: The guideline panel formulated five strong recommendations and two conditional recommendations regarding pharmacotherapy choices. Strong recommendations include using varenicline rather than a nicotine patch, using varenicline rather than bupropion, using varenicline rather than a nicotine patch in adults with a comorbid psychiatric condition, initiating varenicline in adults even if they are unready to quit, and using controller therapy for an extended treatment duration greater than 12 weeks. Conditional recommendations include combining a nicotine patch with varenicline rather than using varenicline alone and using varenicline rather than electronic cigarettes. Conclusions: Seven recommendations are provided, which represent simple practice changes that are likely to increase the effectiveness of tobacco-dependence pharmacotherapy.
Background: Biological agents used for the treatment of psoriatic arthritis (PsA) and rheumatoid arthritis (RA) are associated with serious adverse effects (SAEs). Although several biologics have demonstrated good efficacy and tolerability in short-term trials, treatment guidelines recommend them as third line therapies due to a relative lack of long-term safety data. Objective: To determine the frequency and severity of adverse effects associated with the long-term use of biologics in the treatment of PsA and RA, and possible risk factors for such events in a real-life setting. Methods: We conducted a longitudinal study in PsA and RA patients only taking long-term biological agents from 2003 to 2011. Sources of information included dispensing pharmacy data and interviews with patients. Research staff conducted telephone interviews with patients inquiring about any apparent medication-related adverse drug reactions (ADRs) or SAEs. ADR/SAE’s data was based on pharmacy reports. We conducted a multivariate analysis to identify the factors associated with the risk of ADRs. Results: Of the 305 patients identified, we interviewed 268 patients. Most of these were taking adalimumab 127 (47.4%), 52 (19.4%) etanercept, 42 (15.7%) infliximab, 25 (9.3%) rituximab, 10 (3.7%) abatacept, 9 (3.4%) efalizumab, and 3 (1.1%) tocilizumab. Of the 268 patients, 116 (43.3%) experienced one or more adverse events related to biological agents with 1.6 events per patient, and of these 29 (25%) experienced one or more SAEs, with majority subjected to hospitalizations. The most frequently reported ADRs were administration site reactions as observed in 73 patients (27.2%), infections in 30 patients (11.2%), effects on nervous system in 22 patients (8.2%), and 15 (5.6%) patients withdrew due to ADRs. The use of rituximab was related with less risk of ADR [PR 0.42, 95% CI 0.18–0.96; p = 0.04] than other agents. No other predisposing factors were associated with risk of ADR. The monitoring of patients (medical consultation and laboratory test) was only completed by 48 patients (30.4%). Conclusion: These data showed the early biological experience in Brazil that were associated with ADRs, withdrawals due to ADRs and SAEs. The quantification of adverse effects (serious or nonserious) considering close monitoring and patients’ perceptions are increasingly important for future decision-making.
BackgroundThe use of psychotropic drugs by elderly people is widely spread around the world, given that prevalence of inappropriate medication is frequent. Strictly speaking, in Brazil, the vulnerable population of elderly people is more likely to use Potentially Inappropriate Psychotropic (PIP) due to the impact of social-economic characteristics, to the Brazilian Public Health System, and to the lack of patient monitoring. However, neither the use pattern nor the prevalence rate of PIP have been studied in Brazil so far. The objectives of this study were to determine the prevalence of PIP in elderly outpatients taking antidepressants, and to compare the performance of two different tools (Beers, STOPP).MethodsThis cross-sectional study involved all the aged outpatients (≥ 60 years of age) taking antidepressants attended by the public health system in a city of the State of São Paulo, Brazil. Data were obtained from a pharmacy database and medical records. All psychotropic drugs evaluated included: antidepressants, antipsychotics, anti-epileptics and benzodiazepines. STOPP and Beers criteria were applied to detect PIP.ResultsOne thousand one hundred forty prescriptions from 174 outpatients were subjected to two different screening tools. The average patient age was 67 (interquartile range 63–74) and the median number of drugs used was 3.0 (interquartile 2–4) per patient. The overall prevalence of PIP was 121 (69.5%). The levels of PIP observed according to tools were 39.6% (STOPP) and 29.9% (Beers).The long-term use of benzodiazepines was the most common PIP recognized, and the one which contributed more significantly to higher levels of PIP than other medications.ConclusionsThe prevalence of PIP was high among the elderly. STOPP criteria identified more PIP than Beers criteria. Knowledge of PIP prevalence should gear efforts to reduce the level of inappropriate prescriptions and may provide the need for developing national criteria.
ObjectiveThe aims of the study were to investigate the prevalence of long-term use of benzodiazepines in patients taking antidepressants and to identify the risk factors associated with the prolonged use of benzodiazepines.DesignCross-sectional study.SettingPublic health system in Brazil.ParticipantsOutpatients using antidepressants from January 2008 to December 2009 were included. The data were obtained from pharmacy databases and medical records. All individuals in the database were included in the study and were classified into two categories: (1) patients who had not used benzodiazepines combined with antidepressants or had combined the use of antidepressants with benzodiazepines for a short period (up to 4 weeks), and (2) those who used antidepressants plus benzodiazepines for a longer period (more than 4 weeks).Main outcome measureThe outcome measure is prolonged use of benzodiazepines (more than 4 weeks). We conducted a multivariate analysis to identify the factors associated with prolonged use of benzodiazepines.ResultsForty per cent of the 870 patients evaluated had prolonged use of benzodiazepines (more than 4 weeks). The risk factors associated with prolonged use were age above 35 years (prevalence ratio (PR): 2.18, 95% CI 1.55 to 3.06, P<0.001), female sex (PR: 1.47, 95% CI 1.07 to 2.02, P=0.019), diagnosis at least 3 years prior (PR: 2.1, 95% CI 1.6 to 2.8, P<0.001), use of selective serotonin reuptake inhibitor antidepressants (PR: 1.7, 95% CI 1.3 to 2.2, P<0.001) and having a prescription from a psychiatrist (PR: 6.5, 95% CI 3.2 to 13.2, P<0.001).ConclusionsProlonged use of benzodiazepines occurs more frequently in women, adults diagnosed several years earlier, users of selective serotonin reuptake inhibitor antidepressants and those who received a prescription from a psychiatrist. Education of clinicians, especially with regard to these populations, may decrease the overuse and misuse of benzodiazepines.
ObjectiveSome patients with dengue fever tend to develop thrombocytopenia during the course of infection and are thus vulnerable to haemorrhagic manifestations and other complications. However, the factors associated with the development of thrombocytopenia are unknown. We aimed to identify factors associated with an increased risk of thrombocytopenia and haematological changes in patients with confirmed dengue fever.DesignRetrospective cohort study.SettingBrazilian multicentre primary care databases.Participants387 patients had positive laboratory serological confirmation of dengue infection during 2014. The data were identified from two databases: Notification of Injury Information System (SINAN) and Municipal Laboratory.Main outcome measureThe presence of thrombocytopenia (platelet count <1 50×109/L). The associations of factors that predisposed patients to thrombocytopenia and haematological changes were analysed using logistic regression. ORs and 95% CIs were calculated.ResultsAmong 387 patients, 156 had both dengue and thrombocytopenia. The risk factors associated with thrombocytopenia included male sex (OR: 1.77, 95% CI: 1.16 to 2.71, p=0.007), age of 46–64 years (OR: 2.20, 95% CI: 1.15 to 4.21, p=0.009) or ≥65 years (OR: 3.02, 95% CI: 1.40 to 6.50, p=0.002), presence of leucopenia (OR: 6.85, 95% CI: 4.27 to 10.99, p<0.001) and high mean corpuscular haemoglobin (MCH) levels (OR: 2.00, 95% CI: 1.29 to 3.12, p=0.005).ConclusionOlder age, male sex, presence of leucopenia and high MCH levels were identified as risk factors associated with the development of thrombocytopenia in this population.
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