Case Series: Sacubitril/Valsartan Role for Chemotherapy-Induced Cardiotoxicity: An in-Depth Investigation in Saudi Arabia.

Background: Chemotherapy-induced cardiotoxicity is a significant problem, ranking as the second most frequent cause of mortality in cancer patients. This adverse outcome encompasses many cardiovascular problems, such as heart failure. Sacubitril/valsartan has shown potential in the management of heart failure, however, its effectiveness in treating chemotherapy-induced heart failure has not been extensively explored. We performed a case series to investigate the safety and effectiveness of sacubitril/valsartan in treating chemotherapy-induced cardiomyopathy in Saudi Arabia. Methods: The case series was conducted at a single medical center in Makkah, Saudi Arabia. The data gathered included patient demographics, clinical features, laboratory results, echocardiographic findings, and medication information. The data underwent analysis using descriptive statistics. Results: Out of the total of eight patients who were part of the investigation, a notable majority of six individuals exhibited substantial enhancements in their ejection fraction (EF) after receiving sacubitril/valsartan medication. Conclusion: Our case series provides significant insights by revealing improvements in ejection fraction (EF) in six out of eight patients who had chemotherapy-induced cardiomyopathy after receiving sacubitril/valsartan treatment.

Comparative Assessment of Drug Lag for Approved Oncology Targeted Therapies Between Saudi Arabia, the United States, and the European Union.

INTRODUCTION: Pharmaceutical regulation on a global scale is a complex process, with regulatory bodies overseeing various aspects, including licensing, registration, manufacturing, marketing, and labeling. Among these, the USFDA plays a crucial role in upholding public health. The pharmaceutical industry contributes significantly to well-being by developing and distributing therapeutic agents. The journey of evaluating new pharmaceuticals involves meticulous examination through several phases, from safety and efficacy assessments to toxicity evaluation. Drug approval involves submitting New Drug Applications (NDAs) to regulatory agencies like the USFDA and EMA. However, disparities in durations contribute to the phenomenon known as "drug lag." This lag refers to delays in a pharmaceutical product's availability in one market compared to another. Addressing this issue is crucial, given its impact on patient access to treatments. METHOD: This study aims to analyze the extent of drug lag, focusing on newly approved oncology targeted therapies in Saudi Arabia, the United States, and the European Union. Data for cancer treatments authorized by the USFDA, EMA, and SFDA from January 1, 1997, to December 31, 2022, were collected from regulatory agency websites. The data sources included authorization letters, prescription information, and evaluation documents. We conducted a comparative assessment of drug lag for approved oncology targeted therapies between Saudi Arabia, the US, and the EU. RESULT: Our analysis identified 135 newly approved oncology-targeted drugs within the specified timeframe. Of these, 71 received approval in all three regions, while disparities were evident in others. The USFDA consistently had the highest number of approved drugs, with 98.5% of drugs initially approved there. In contrast, Saudi Arabia had the lowest number of approved drugs and a significantly longer median drug lag, indicating substantial delays in drug availability. CONCLUSION: This study highlights the significance of mitigating drug lag to enhance global healthcare outcomes and patient access to innovative therapies. Further research and collaborative efforts are essential to bridging these disparities and promoting equitable healthcare worldwide.

Risk of Lichen Sclerosus and Lichen Planus in Patients Receiving Immune Checkpoint Inhibitors.

INTRODUCTION: Immune checkpoint inhibitors (ICIs) are recommended for various types of cancer. On the other hand, these ICIs may cause immune-related adverse events (irAEs). Lichen sclerosus (LS) and lichen planus (LP) are two distinct phenotypes of irAEs that occur in a subset of patients treated with ICIs. These adverse effects have a detrimental effect on the patient's quality of life and treatment phases; however, the clinical evaluation and assessment of LS and LP remain uncertain. This study aims to assess and evaluate the risk of LS and LP associated with the use of ICIs via a systematic review of the literature and the USA FDA Adverse Events FAERS database. METHOD: The study searched electronic databases such as PubMed, Medline, Cochrane, and Google Scholar for case reports on immune-checkpoint-inhibitor-associated lichen sclerosus and lichen planus published in English between inception and 31 December 2021. The FDA's adverse event reporting system (FAERS) database was also analyzed. RESULTS: Thirty-eight case reports and two retrospective studies with a total of 101 patients, in addition to the FAERS data, were evaluated. More cases involved lichen planus (78.9%) than lichen sclerosis (21%). Nivolumab and pembrolizumab were most frequently reported with LS and LP, among other ICIs. Thirty-six out of thirty-eight patients with LS or LP experienced complete remission, while two patients experienced partial remission. Most of the cases had an excellent response to corticosteroids (92.1%), while the remainder had moderate (5.2%) and poor (2.6%) responses. Additionally, the reporting odds ratio (ROR) of the FAERS database indicated a favorable association for ICIs, the risk of LP, and LS. A stronger association was uniquely found between nivolumab and pembrolizumab. CONCLUSION: There have been published case reports for these adverse events. Healthcare providers should be aware of the possibility of lichen sclerosis and lichen planus developing in patients receiving ICIs which could necessitate hospitalization or discontinuation. Regulatory agencies are advised to monitor the risks as a potential safety signal.

Adherence to Hormonal Therapy in Breast Cancer Patients in Saudi Arabia: A Single-Center Study.

Breast cancer is one of the most common types of cancer in women. Approximately three-quarters of all breast cancer patients have estrogen and/or progesterone receptor positivity. As a result, the majority of patients receive hormonal treatment for between five and 10 years. Long-term use of hormonal therapy reduces the recurrence rate and the risk of death. In Saudi patients, adherence to hormonal therapy is not adequately assessed. The primary objective of this study is to determine the clinical outcomes associated with hormonal therapy adherence in breast cancer patients. This is a retrospective cohort study of patients who received adjuvant hormonal therapy for hormone-receptor-positive breast cancer. Patients were included if they had received at least two prescription refills following their breast cancer diagnosis. The primary outcome measure was mortality and disease progression in relation to hormonal therapy adherence. Progression of disease is defined as local recurrence or radiographic evidence of metastatic disease. The secondary outcome measure was the study population's adherence to hormonal therapy. The proportion of days covered during hormonal therapy was used to assess adherence (PDC). PDC was calculated as the number of days in the prescription period divided by the total number of days in the prescription period. Patients are considered adherent if their PDC value is greater than 0.8. The mortality and disease progression curves were generated using the Kaplan-Meier method. The proportion of patients adhering to hormonal therapy was determined using descriptive analysis. The IRB granted approval. A total of 121 patients were included in the study from the 380 patients screened. Tamoxifen, letrozole, and anastrozole were administered to 58%, 27%, and 14% of patients, respectively. The median age was 53 years. Women who were postmenopausal constituted 52.3% of the study population. The majority of patients were in Stages II and I (56.2% and 16.53%, respectively). The majority of the tumors were Grade II (58.68 %). Adherence was not associated with disease progression (HR, 0.66; 95% CI, 0.25-1.72) or mortality (HR, 1.391; 95 percent CI, 0.33-5.82). Disease progression and mortality were not found to be significantly associated with hormonal therapy adherence in this study. A larger study is required to confirm the findings of our study.

Evaluate the Effectiveness of Outpatient Parenteral Antimicrobial Therapy (OPAT) Program in Saudi Arabia: A Retrospective Study.

(1) Background: Outpatient parenteral antibiotic therapy (OPAT) is a well-established and cost-effective measure that improves the efficient use of healthcare resources and increases bed availability. Only limited published data is available to illustrate OPAT implementation and outcomes in Saudi Arabia. The main objective of this study was to evaluate the effectiveness of OPAT in a tertiary center in Saudi Arabia. (2) Methods: In this retrospective study, clinical charts of enrolled patients were reviewed in a tertiary care center from the initial month of November 2017 to March 2020. All admitted patients with a central line and who enrolled in the OPAT of the hospital during this study period were included. The primary outcome was the 30-days readmission rate of OPAT patients. Secondary outcomes were factors associated with OPAT failure. Descriptive analysis of the data was used to express the results. (3) Results: We enrolled 90 patients; 54 (60%) were male; the mean age was 55.16 (±17.7) years old. The mean duration of the antimicrobial treatment was 21.9 (+24.6) days. All patients completed the intended course of therapy. Ertapenem was the most frequently used antimicrobial (43%), followed by vancomycin (11.2%). Urinary tract infections (UTIs) are some of the most common bacterial infections in 25 patients (26.9%), followed by osteomyelitis in 16 patients (17.2%). Extended-spectrum beta-lactamase E.coli was the highest common isolated microorganism (44.9%), followed by methicillin-resistant Staphylococcus aureus MRSA (16.9%). The readmission to the hospital during therapy was required for 12 patients (13.3%). Shifting from hospital care to OPAT care resulted in cost savings of 18 million SAR in the overall assessment period and avoided a total of 1984 patient days of hospitalization. (4) Conclusion: The findings have shown that OPAT therapy was effective with minimum hospital readmissions and therapy complications. OPAT programs can reduce healthcare costs and should be integrated into practice.