Real-world safety experience with immune checkpoint inhibitors in Saudi Arabia.

Lay abstract Real-world safety experience with immune checkpoint inhibitors in Saudi Arabia: Immune Checkpoint Inhibitors (ICIs) are rapidly growing and changing cancer care. With introduction of ICIs the landscape for cancer treatment has changed significantly. ICIs are known to induce immune-related adverse effects. This research is intended to shed light on ICIs and describe our safety experience with these agents. This study is a retrospective cohort study aimed to determine the safety of ICIs and its related adverse events at a tertiary hospital in Saudi Arabia. The study was conducted in the oncology center at King Abdulaziz Medical City, Riyadh. We identified study participants by using electronic health care system (BestCare)® to involve patients who received ICIs treatment during the study period from January 2016 up to December 2018, to include a total of 53 patients. Most of our patients were on nivolumab (37 patients) followed by atezolizumab (10 patients), and pembrolizumab (6 patients). The average number of emergency room visits after receiving treatment was three visits per patient. Renal adverse events occurred following ICIs use in nine patients, and none of the reported cases experienced a grade ≥3 event. Moreover, 13 patients experienced a hepatic adverse event, of whom only 1 patient experienced a grade ≥3 event leading to treatment discontinuation. As for diarrhea, among all patients who received ICIs, 14 patients experienced diarrhea, and 5 of them had grade ≥3 events. Also, thyroxine abnormalities occurred in seven patients. While, Pneumonitis occurred in four patients following ICIs use. In addition, we noticed other adverse events with ICIs including (skin reaction, nausea, vomiting, thrombocytopenia, neutropenia, and neurological adverse events). Furthermore, 17 patients required steroids to manage ICIs adverse events. And, no patients in our study required additional management with other immunosuppressive agents.Immunotherapies are rapidly growing and changing cancer care. Immune Checkpoint Inhibitors (ICIs) have the ability to block inhibitory checkpoints and restore the functions of the immune system. ICIs are used for the treatment of several types of cancer, and nowadays, many studies are ongoing in order to get approvals for newer indications. ICIs are known to induce immune-related adverse effects. The safety of ICIs and the most common immune-related adverse events are not yet well recognized for our population since this class of medications is lately introduced in our region, where only limited studies in our population are available in the literature. This research is intended to shed light on ICIs and describe our safety experience with these agents. This study is a retrospective cohort study aimed to determine the safety of ICIs and its related adverse events at a tertiary hospital in Saudi Arabia. The study was conducted in the oncology center at King Abdulaziz Medical City, Riyadh. Study participants were identified by using the electronic health care system (BestCare)® to include patients who were treated with ICIs during the study period from January 2016 up to December 2018. A total of 53 patients were included. Most of our patients were on nivolumab (37 patients) followed by atezolizumab (10 patients), and pembrolizumab (6 patients). The average number of emergency room visits after receiving ICIs was three visits per patient. Renal adverse events occurred following ICIs use in nine patients, and none of the reported cases experienced a grade ≥3 event. Moreover, 13 patients experienced a hepatic adverse event, of whom only 1 patient experienced a grade ≥3 event leading to treatment discontinuation. As for diarrhea, among all patients who received ICIs, 14 patients experienced diarrhea, and 5 of them had grade ≥3 events. Also, thyroxine abnormalities occurred in seven patients. While, pneumonitis occurred in four patients following ICIs use. In addition, we noticed other adverse events with ICIs, including (skin reaction, nausea, vomiting, thrombocytopenia, neutropenia, and neurological adverse events). Furthermore, 17 patients required steroids to manage ICIs adverse events. And, no patients in our study required additional management with other immunosuppressive agents. Patients treated with immune checkpoint inhibitors could have a variety of adverse drug events that might lead to treatment discontinuation and increase overall emergency room visits. This study highlights the most common adverse drug events associated with ICIs use at a tertiary care center in Saudi Arabia.

Comparison of the application of treatment Panel III and American College of Cardiology/American heart Association guidelines for blood cholesterol treatment in Saudi Arabia.

BACKGROUND: One of the major risk factors for cardiovascular diseases is hyperlipidemia. The primary aim of this study was to estimate the proportion of individuals between 40-75 years old that would be eligible for statin therapy based on ACC/AHA guideline as compared to ATP-III guideline in a population of patients in Saudi Arabia. We also intended to extrapolate the results to the entire Saudi population, and estimate the cost implications of the ACC/AHA treatment guideline. METHODS: This study was a retrospective, observational study involving adult patients aged between 40-75 years old. The study was conducted at the primary health care clinics at King Abdul-Aziz Medical/Riyadh. The eligibility for statins use was assessed and compared for each patient based on both the recent 2013 ACC-AHA guideline and the 2002 ATP-III guideline. The cost implication of applying the ACC/AHA treatment guideline was estimated based on the average cost for 40 mg Atorvastatin in the Saudi Market. RESULTS: A total of 1005 patients were included in the study. Using the ATP-III guideline, there were 139 male (43.7%) and 279 female (40.6%) eligible to receive statin therapy. Based on the 2013 ACC/AHA guideline, treatment is recommended in 315 males (99.1%) and 564 females (82.1%). On the other hand, high-intensity statin was recommended in 302 male (95%) and 400 female (58.2%). Only 74 (10.5%) patients were prescribed high-intensity statin of the 702 eligible patients. Extrapolating the results to the entire Saudi population, 2.369 million additional patients would be eligible for statin therapy when applying the ACC/AHA guideline. Applying the new guideline would result in a cost increase of at least 4.318 billion SR per year. CONCLUSIONS: The eligibility for statin therapy was much higher when applying the ACC/AHA guideline as compared to ATP-III guideline. Applying the recent ACC/AHA dyslipidemia guideline increased the number of patients eligible for statin therapy to approximately two folds. This would be associated with a substantial increase in cost and possibly side effects. The concerns surrounding the ACC/AHA guideline should be addressed at the national level.

Acute Kidney Injury in Pediatric Treated with Vancomycin and Piperacillin-Tazobactam in Tertiary Care Hospital.

BACKGROUND: Vancomycin and piperacillin-tazobactam (PTZ) are commonly used as empirical therapy for patients with health care associated infections. Vancomycin has been recognized as a nephrotoxic agent and in a few cases in the literature PTZ has been associated with interstitial nephritis nevertheless; the combination of these agents has routinely been used for many years. However, there have been some observational studies that showed high rates of acute kidney injury (AKI) in patients receiving vancomycin and PTZ concomitant treatment compared to patients receiving vancomycin alone. The incidence of AKI in adult patients receiving vancomycin and PTZ concomitant treatment was reported in these studies to be relatively high. Similar studies in pediatric patients are lacking. METHOD: We conducted a single center retrospective chart review of 248 pediatric patients receiving one of the following treatments: vancomycin alone 36 patients, vancomycin/PTZ 62 patients, vancomycin/ceftazidime 99 patients, and vancomycin/ceftriaxone 51 patients. RESULT: Our results showed a low incidence of AKI in patients on vancomycin/PTZ concomitant treatment where overall incidence was only (4.8%) three cases and only one of them (2.0%) in a patient receiving the vancomycin/ceftriaxone concomitant treatment. No cases of AKI present in patients receiving vancomycin with ceftazidime or vancomycin alone. There were no statistically significant differences between the four treatment groups in terms of AKI incidence, vancomycin trough, and use of nephrotoxins. CONCLUSION: Overall, the incidence of AKI was low in our study sample with no statistically significant increased risk when PTZ was used in combination with vancomycin in a pediatric population. However, further investigation with an equal larger sample size is needed to confirm our findings.

Sickness presenteeism among health care providers in an academic tertiary care center in Riyadh.

The term sickness presenteeism (SP) has been described as the act of going to work despite having a state of health that may be regarded as poor enough to justify sick leave. SP has been observed to be prevalent among three-quarters of health care providers (HCPs). Working while sick not only puts patients at risk but also decreases productivity and increases the probability of medical errors. Moreover, SP has been identified as a risk factor for many negative health outcomes among the HCPs themselves, such as depression, burnout, and serious cardiac events. The aim of this study was to identify the reasons for and prevalence of SP and perceptions of the impact of this practice on patient safety among HCPs. A cross-sectional study was conducted, including 279 purposively selected healthcare professionals (doctors, nurses, dentists, pharmacists and other health care professionals) working at the Ministry of National Guard Health Affairs-King Abdulaziz Medical City (MNGHA-KAMC). While nearly all of the participants (91%) believed that working while sick exposed patients to risk, the rate of SP during the past year was reported as 74%, and one fourth of respondents reported working while sick 3-4 times during the past year. More than half of the participants were not aware of the existence of a departmental policy regarding sick leave. The most common reasons reported for working while sick were not wanting to burden co-workers (71%), feelings of duty toward patients (67%), and avoiding an increased future workload caused by absence (59%). A lack of awareness regarding the existing rules and polices related to sick leave was reported by more than half of the participants. Several predisposing and enabling factors were reported as determinants influencing SP, e.g., observation of the practice of SP by peers and feelings of sympathy towards coworkers, including not wanting to overburden them, were reported to be determinants informing the decision of whether to work while sick.