Rafael Venson

Meta‐analysis of the Efficacy and Safety of Adalimumab, Etanercept, and Infliximab for the Treatment of Rheumatoid Arthritis

Study Objective. To evaluate the efficacy and safety of using the anti‐tumor necrosis factor‐α (anti‐TNF‐α) drugs adalimumab, etanercept, and infliximab for the treatment of rheumatoid arthritis.

A Systematic Review and Meta-analysis of the Efficacy and Safety of Etanercept for Treating Rheumatoid Arthritis

The aim of this study was to evaluate the efficacy and safety of etanercept (ETA) for treating rheumatoid arthritis. A systematic review was performed to search for randomized clinical trials comparing subcutaneous doses of ETA at 25 mg twice a week or 50 mg weekly to a placebo group, with or without methotrexate. Studies of low quality (less than 3 points on Jadad’s scale) were excluded. The efficacy was assessed by using the criteria of the American College of Rheumatology (ACR). Safety data were evaluated based on serious adverse events, serious infections, malignancy and deaths. Withdrawals as a result of adverse events or lack of efficacy were also evaluated. Eight studies met the inclusion criteria, comprising 2385 patients. In the efficacy meta‐analysis, a greater number of ETA‐treated patients achieved the efficacy criteria within 6 months of treatment, where the relative risk (RR) was 2.94 [2.27, 3.81] for achieving ACR20, 5.28 [3.12, 8.92] for ACR50 and 4.83 [1.74, 13.47] for ACR70. After 1 year, the RR for achieving ACR20, ACR50 and ACR70 were 1.14 [1.07, 1.23], 1.36 [1.21, 1.53] and 1.56 [1.30, 1.88], respectively. This response rates were higher for ETA‐treated patients in comparison with control group patients. For safety, there were no statistically significant differences between treated patients and controls. This was also confirmed by withdrawals as a result of adverse events, which were not statistically different between the two groups. However, more patients withdrew from control groups because of a lack of efficacy as compared with ETA groups (RR = 0.48 [0.30, 0.78]).

Comparative efficacy of oral nucleoside or nucleotide analog monotherapy used in chronic hepatitis B: a mixed-treatment comparison meta-analysis.

To compare the efficacy of nucleoside or nucleotide analog monotherapy for the treatment of chronic hepatitis virus B (HBV) with adefovir dipivoxil, entecavir, lamivudine, telbivudine, and tenofovir disoproxil fumarate.

Effect of a Pharmaceutical Care Program on quality of life and satisfaction with pharmacy services in patients with type 2 diabetes mellitus

The aim is to evaluate the humanistic outcomes in type 2 diabetic patients by the adoption of pharmacotherapy follow-up in community pharmacies. Controlled, non-randomized, 12-months trial; n=161 patients distributed into control and intervention groups; 6 community pharmacies involved, all in the Curitiba city region, in the state of Parana were used. The health-related quality of life (HRQoL) and the satisfaction index were determined using both the DQOL assessment tool, which measures HRQoL, and the satisfaction evaluation tool (QSSF). Interventions on 119 negative therapeutic outcomes were done (2.3/patient [SD=1.6]); the most commonly found problems were related to ineffectiveness of pharmacotherapy (68.1%). The Intervention-Group showed a significant improvement in HRQoL compared with the Control Group (0.08 vs -0.01, respectively; p=0.036). Satisfaction and impact domains presented the most significant improvement (0.13 vs 0.00 [p=0.030] and 0.07 vs -0.04 [p=0.033], respectively). After adjusting for baseline variables, the difference in improvement scores between groups on the QSSF was attributed to the allocation of patients in the intervention group. Pharmacotherapy follow-up of type 2 diabetic patients in community pharmacies can improve the HRQoL and satisfaction of patients.

Insulin analogues versus human insulin in type 1 diabetes: direct and indirect meta-analyses of efficacy and safety

All patients with Diabetes Mellitus (DM) receive insulin therapy. In this study, we evaluated the efficacy, safety and tolerability of human insulin and insulin analogues. We performed a systematic review of the literature and a meta-analysis according to the Cochrane Collaboration methodology. In the absence of clinical studies comparing insulins, we performed a mixed treatment comparison to establish the differences between the active treatments. We included studies published from 1995 to 2010. HbA1c results, episodes of hypoglycemia and nocturnal hypoglycemia data were extracted and analyzed. Thirty-five randomized clinical trials were selected after examining the abstract and a full text review. These studies included 4,206 patients who received long-acting insulin analogues and 5,733 patients who received short-acting insulin analogues. Pooled data regarding efficacy indicated no significant differences in HbA1c values between glargine or detemir (once daily) and NPH insulin. However, a twice-daily dose of detemir produced differences in HbA1c values that favored detemir (-0.14% [95% CI: -0.21 to -0.08]; p<0.0001; I2=0%). Direct and indirect comparisons are consistent and show that there were no significant differences between human insulin and insulin analogues in efficacy or safety. Our results indicate that long- and short-acting insulin analogues offer few clinical advantages over conventional human insulin.

Perfil dos usuários de anticitocinas disponibilizadas pelo Sistema Único de Saúde no estado do Paraná para o tratamento da artrite reumatoide

INTRODUCTION: The Brazilian Unified Health Care System (SUS) offers treatment for patients with RA through federal funding (Ministry of Health) and state co-financing. The Clinical Protocol and Therapeutic Guidelines for the treatment of rheumatoid arthritis describe the therapeutic regimen for the disease, including the anticytokines adalimumab, etanercept or infliximab. OBJECTIVES: The aim of this study was to evaluate the profile of registered users of those anticytokines, biologics registered in the Information System of the Pharmaceutical Assistance Specialized Division, managed by the Parana State Drug Center. METHODS: A cross-sectional study regarding data from March 2010 was conducted. Based on dispensation data, information regarding the following variables were collected: age; gender; regional health care centers; International Classification of Diseases (ICD); and drug dispensed. In addition, the monthly cost with anticytokines for the SUS was calculated. RESULTS: In the state of Parana, 923 patients on anticytokines were identified, 40%, 44% and 16% of whom receiving adalimumab, etanercept and infliximab, respectively. This generated a monthly cost of R

Economic evaluation of treatments for chronic hepatitis B

3,403,195.59. Regarding the ICD, the distribution of patients was as follows: 55% had ICD M05.8; 27%, ICD M06.0; 9%, ICD M6.8; 8%, ICD M5.0; and 1% had other ICDs related to the disease. The regional health care centers of the state of Parana with the largest number of patients on anticytokines were in the following municipalities: Ponta Grossa; Cornelio Procopio; Londrina; Cianorte; Maringa; Irati; and Campo Mourao. CONCLUSION: This study assessed the distribution and profile of users of anticytokines for the rheumatoid arthritis treatment covered by the SUS in the state of Parana, in March 2010.

Avaliação econômica das anticitocinas adalimumabe, etanercepte e infliximabe no tratamento da artrite reumatoide no Estado do Paraná

The aim of this study was to conduct a cost-utility study of adefovir, entecavir, interferon alpha, pegylated interferon alpha, lamivudine and tenofovir for chronic hepatitis B in the context of Brazilian Public Health Care System. A systematic review was carried out for efficacy and safety. Another review was performed to collect utility data and transition probabilities between health states. A Markov model was developed in a time horizon of 40 years with annual cycles for three groups of: HBeAg positive, HBeAg negative, and all patients. These strategies were compared to a fourth group that received no treatment. Discount rates of 5% were applied and sensitivity analyses were performed. Tenofovir offered the best cost-utility ratio for the three evaluated models: U

Efficacy, safety and tolerability of using abatacept for the treatment of rheumatoid arthritis

397, U

An analysis of quality of systematic reviews on pharmacist health interventions

385 and U