Efficacy and safety of empagliflozin in type 2 diabetes mellitus Saudi patients as add-on to antidiabetic therapy: a prospective, open-label, observational study

The Saudi Food and Drug Authority (SFDA) approved sodium-glucose cotransporter-2 (SGLT2) inhibitors in 2018. The efficacy and safety of empagliflozin (EMPA) have been confirmed in the U.S., Europe, and Japan for patients with type 2 diabetes mellitus (T2DM); however, analogous evidence is lacking for Saudi T2DM patients. Therefore, the current study aimed to assess the efficacy and safety of EMPA in Saudi patients (n = 256) with T2DM. This is a 12-week prospective, open-label, observational study. Adult Saudi patients with T2DM who had not been treated with EMPA before enrolment were eligible. The exclusion criteria included T2DM patients less than 18 years of age, adults with type one diabetes, pregnant women, paediatric population. The results related to efficacy included a significant decrease in haemoglobin A1c (HbA1c) (adjusted mean difference −0.93% [95% confidence interval (CI) −0.32, −1.54]), significant improvements in fasting plasma glucose (FPG) (−2.28 mmol/L [95% CI −2.81, −1.75]), and a reduction in body weight (−0.874 kg [95% CI −4.36, −6.10]) following the administration of 25 mg of EMPA once daily as an add-on to ongoing antidiabetic therapy after 12 weeks. The primary safety endpoints were the change in the mean blood pressure (BP) values, which indicated significantly reduced systolic and diastolic BP (−3.85 mmHg [95% CI −6.81, −0.88] and −0.06 mmHg [95% CI −0.81, −0.88], respectively) and pulse rate (−1.18 [95% CI −0.79, −3.15]). In addition, kidney function was improved, with a significant reduction in the urine albumin/creatinine ratio (UACR) (−1.76 mg/g [95% CI −1.07, −34.25]) and a significant increase in the estimated glomerular filtration rate (eGFR) (3.54 mL/min/1.73 m2 [95% CI 2.78, 9.87]). Furthermore, EMPA reduced aminotransferases (ALT) in a pattern (reduction in ALT > AST). The adjusted mean difference in the change in ALT was −2.36 U/L [95% CI −1.031, −3.69], while it was −1.26 U/L [95% CI −0.3811, −2.357] for AST and −1.98 U/L [95% CI −0.44, −3.49] for GGT. Moreover, in the EMPA group, serum high-density lipoprotein (HDL) significantly increased (0.29 mmol/L [95% CI 0.74, 0.15]), whereas a nonsignificant increase was seen in low-density lipoprotein (LDL) (0.01 mmol/L [95% CI 0.19, 0.18]) along with a significant reduction in plasma triglyceride (TG) levels (−0.43 mmol/L [95% CI −0.31, −1.17]). Empagliflozin once daily is an efficacious and tolerable strategy for treating Saudi patients with insufficiently controlled T2DM as an add-on to ongoing antidiabetic therapy

Hepatocellular carcinoma first presenting as a tumor of the oral cavity

Hepatocellular carcinoma (HCC) is the sixth most common neoplasm worldwide; HCC metastasis is common affecting 50% of cases. However, metastasis to the oral cavity is extremely infrequent. We present a case of hepatocellular cancer first presenting as a mass lesion at the upper alveolus and review metastatic hepatocellular carcinoma to the oral cavity in 73-year-old male patient. Keywords: Oral cavity, Hepatocellular carcinom

The Impact of COVID-19 on Essential Medicines and Personal Protective Equipment Availability and Prices in Saudi Arabia

This was a questionnaire-based cross-sectional study that explored the impact of the COVID-19 pandemic on the availability of essential medicine and personal protective equipment (PPE) in Saudi Arabia. Purposive sampling technique was used to recruit individuals working in the supply chain departments in different healthcare sectors in Saudi Arabia. One hundred and three pharmaceutical and medical supply chain employees participated in the study. Most of the participants (58.3%) were aged ≥35 years, male (65%), and pharmacists (92.2%). The majority of participants had at least two years of experience in supply chain (77.6%), worked in public hospitals (95.15%), and were mostly working at healthcare institutions located in Riyadh province (59.2%). Approximately 51% of the participants reported shortages of 10 or more essential drugs. Tocilizumab, hydroxychloroquine, lopinavir/ritonavir, ribavirin, dexamethasone, enoxaparin, interferon beta-1b, cisatracurium besylate, prednisolone, hydrocortisone, methimazole, and methylprednisolone were reported to be in shortage by at least 8% of the participants. Almost 70% of the participants reported that the pandemic did not significantly impact the prices of prescription drugs in shortage (e.g., ≥25%). Moreover, about 70% of the participants reported direct purchasing or procurement of drugs in shortage. Surgical masks, face shields, medical gowns, and N95 respirators were reported to be in short supply by 33% or more of the participants. Approximately 53% of the participants reported the prices of PPE in shortage had seen an increase by at least 25% during the pandemic. Although the COVID-19 pandemic has caused a significant disruption in the global pharmaceutical supply chain, its impact was largely manageable in Saudi healthcare institutions. This can be attributable to multiple reasons such as the effective exchange programs between hospitals and the drastic increase in public healthcare spending to ameliorate the negative impact of the pandemic on the healthcare sector

Drug shortages in Saudi Arabia: Root causes and recommendations

Drug shortages are a multifaceted problem that has been recurring in Saudi Arabia over the past decade with its significant negative impact on patient care. However, there is a dearth of evidence about possible domestic reasons, if any, behind this recurring problem. Recently, the Pharmacy Education Unit at King Saud University College of Pharmacy has called for a meeting with multiple stakeholders from academia, pharmaceutical care, pharmaceutical industry, purchasing and planning, and regulatory bodies to unveil the root domestic causes of the drug shortages in the Kingdom. Four major topics were used to guide the discussion in this meeting, including: current situation of drug shortages in Saudi Arabia, major factors contributing to drug shortages, challenges and obstacles to improve drug supply, and stakeholders’ recommendations to manage drug shortages. The meeting was audio-recorded and transcribed into verbatim by five authors. The text was then reviewed and analyzed to identify different themes by the first and third authors. Multiple causes were identified and several recommendations were proposed. The main domestic causes of drug shortages that were explored in this study included poor medication supply chain management, lack of government regulation that mandates early notification of drug shortages, a government procurement policy that does not keep pace with the changes in the pharmaceutical market, low profit margins of some essential drugs, weak and ineffective law-violation penalties against pharmaceutical companies and licensed drug importers and distributors, and overdependence on drug imports. The participants have also proposed multiple recommendations to address drug shortages. Policy makers should consider these factors that contribute to drug shortages in Saudi Arabia as well as the recommendations when designing future initiatives and interventions to prevent drug shortages. Keywords: Shortage, Drugs, Patient safet