Randomized Clinical Trials on the Efficacy and Safety of Tocilizumab in Subjects with Rheumatoid Arthritis: A Systematic Review.

BACKGROUND: The current therapy of Rheumatoid Arthritis (RA) is confronted with many challenges such as inadequate response, infection, and treatment failure. AIM AND OBJECTIVE: The main objective was to assess the efficacy and safety of tocilizumab (TCZ) in subjects with RA using the available evidence from published randomized controlled trials. METHODS: The current systematic review was performed on nine randomized controlled trials from 2002 to 2016 for TCZ in subjects with rheumatoid arthritis. The primary outcomes were the clinical improvement in American College Rheumatology 20% (ACR20) or Disease Activity Score remission (DAS28), in addition to other outcomes such as ACR50 and ACR70 in the intention-to-treat population. RESULTS: We have conducted a systematic review on nine randomized controlled trials, with 4129 [100%] enrolled, of which 3248 [78.7%] were on the intention-to-treat. 2147 (66.1%) were treated with TCZ and 1101 (33.9%) have had received placebo or methotrexate or other conventional Disease- Modifying Anti-rheumatic Drugs (cDMARD) or biologic Disease-Modifying Anti-rheumatic Drugs (bDMARDs). In subjects taking TCZ with or without concomitant methotrexate, compared to placebo, subjects treated with TCZ 4 or 8 mg/kg were substantially and statistically significantly more likely than placebo or methotrexate to achieve the ACR20 and/or DAS28. There were no statistically significant differences in serious adverse events such as serious infection; however, subjects on TCZ were more likely to have increased lipid profiles. CONCLUSION: TCZ mono-therapy or in combination with methotrexate is valuable in diminishing rheumatoid arthritis disease activity and improving disability. Treatment with TCZ was associated with a significant surge in cholesterol levels but no serious adverse effects. Randomized clinical trials with safety as the primary outcome are warranted to report these safety issues.

A Systematic Review of Randomized Clinical Trials on the Efficacy and Safety of Pitavastatin.

BACKGROUND: A subpopulation of statin users such as subjects with chronic kidney disease (CKD), Human Immune virus (HIV), acute coronary syndrome (ACS), revascularization, metabolic syndrome, and/or diabetes may particularly benefit from pitavastatin pharmacotherapy. AIM: The current systematic review aimed systematically to evaluate the effect of pitavastatin on primary cardiac events in subjects receiving pitavastatin in comparison to the other four statin members. METHODS: We conducted a systematic review on phases III and IV of randomized controlled trials (RCT-s, 11 trials) for subjects with primary cardiac events who received pitavastatin. Subjects diagnosed with any type of dyslipidemia (population 4804) and received pitavastatin (interventions) versus comparator (comparison) with the primary efficacy endpoint of minimization of LDL-C and non- HDL-C, had an increase in HDL-C and/or reduction in major adverse cardiac events (MACE, cardiovascular death, myocardial infarction (fatal/nonfatal), and stroke (fatal/nonfatal) and/or their composite (outcomes). The secondary safety endpoint was the development of any adverse effects. RESULTS: In the included trials (11), participants (4804) were randomized for pitavastatin or its comparators such as atorvastatin, pravastatin, rosuvastatin, simvastatin and followed up for 12 to 52 weeks. In terms of the primary outcome (reduction in LDL-C), pitavastatin 4 mg was superior to pravastatin 40 mg in three trials, while the 2 mg pitavastatin was comparable to atorvastatin 10 mg in four trials and simvastatin 20 and 40 mg in two 2 trials. However, rosuvastatin 2.5 mg was superior to pitavastatin 2 mg in two trials. Pitavastatin increased HDL-C and reduced non-HDL-C in eleven trials. Regarding the safety profile, pitavastatin has proved to be tolerated and safe. CONCLUSION: The FDA-approved indications for pitavastatin included primary dyslipidemia and mixed dyslipidemia as a supplementary therapy to dietary changes to lower total cholesterol, LDL-C, apolipoprotein B (Apo B), triglycerides (TG), and enhance HDL-C. Pitavastatin might be suitable for subjects with diabetes, ACS (reduced revascularization), metabolic syndrome, CKD, HIV, and subjects with low levels of HDL-C. We highly recommend rational individualization for the selection of statin.

Scoping Review of Six Retrospective Studies: Risk Factors Associated With the Case Fatality Rate of People Infected With Coronavirus (COVID-19).

Background: It would be rational to describe the pattern of the clinical characteristics of the survivors and the nonsurvivors during the critical intensive-infection era of coronavirus disease 2019 (COVID-19). The explicit objective of the current scoping review was to delineate the predictive risk factors associated with case fatality rate (CFR). Methods: Six retrospective studies of subjects infected with COVID-19 published between December 1, 2020, and March 30, 2020, describing nonsurvivors in Wuhan/Hubei, China, were identified. Results: There were 1769 subjects with a mean age of 52 years, and 65.9% were male. The highest comorbidity reported was cardiovascular diseases at 22.2% (393/1769). The overall number of cases admitted to the intensive care unit was 228 (12.9%). The reported overall CFR was 7.7% (136/1769), with the highest at 28.2% (54/191), and the lowest at 1.4% (15/1099). The mean duration of onset until death for nonsurvivors was 15.3 days. Conclusion: We have found that older age, male gender, the longer duration from onset till death (days), development of acute respiratory distress syndrome/shock, preexisting diabetes, and preexisting cardiovascular diseases were the major risk factors associated with high CFR.

Clinical pharmacists' review of surgical antimicrobial prophylaxis in a tertiary hospital in Abu Dhabi.

BACKGROUND: There is a lack of evidence to support standard of care and concordance with surgical antimicrobial prophylaxis (SAP) guidelines in our setting. There is an opportunity for clinical pharmacists to facilitate this process across all surgical disciplines. OBJECTIVE: To assess adherence of surgeons to SAP guidelines. METHOD: This was a retrospective study of 250 patients who underwent surgery during 2012 in Mafraq Hospital, Abu Dhabi. We evaluated prescribing of SAP, antimicrobial selection, first-dose timing, dose interval, treatment duration and adherence of surgeons to local hospital guidelines. RESULTS: We reviewed 250 patients (193 were male and 57 were female, mean age 36 ± 1.2 years); 54 % had elective operations and 46 % underwent emergency surgery. Adherence to hospital guidelines was 32.1 %. Antimicrobial selection, timing of the first dose, dosage interval and treatment duration were concordant with the hospital guidelines in 26, 31 and 40.3 % of cases, respectively. Main barriers to adherence to hospital guidelines were lack of awareness and education. CONCLUSIONS: The present study indicated poor adherence to the SAP guidelines. The timing of administration of SAP was not appropriate in two-thirds of the patients and more than half received more than three doses of SAP inappropriately. Continuing medical education should target antimicrobial prophylaxis (selection, timing and duration), clinical pharmacy antibiotic services and cyclic auditing.