Anakinra in hospitalized patients with severe COVID-19 pneumonia requiring oxygen therapy: Results of a prospective, open-label, interventional study.

OBJECTIVE: The aim of this study was to evaluate the efficacy of anakinra in patients who were admitted to hospital for severe COVID-19 pneumonia requiring oxygen therapy. METHODS: A prospective, open-label, interventional study in adults hospitalized with severe COVID-19 pneumonia was conducted. Patients in the interventional arm received subcutaneous anakinra (100 mg twice daily for 3 days, followed by 100 mg daily for 7 days) in addition to standard treatment. Main outcomes were the need for mechanical ventilation and in-hospital death. Secondary outcomes included successful weaning from supplemental oxygen and change in inflammatory biomarkers. Outcomes were compared with those of historical controls who had received standard treatment and supportive care. RESULTS: A total of 69 patients were included: 45 treated with anakinra and 24 historical controls. A need for mechanical ventilation occurred in 14 (31%) of the anakinra-treated group and 18 (75%) of the historical cohort (p < 0.001). In-hospital death occurred in 13 (29%) of the anakinra-treated group and 11 (46%) of the historical cohort (p = 0.082). Successful weaning from supplemental oxygen to ambient air was attained in 25 (63%) of the anakinra-treated group compared with 6 (27%) of the historical cohort (p = 0.008). Patients who received anakinra showed a significant reduction in inflammatory biomarkers. CONCLUSION: In patients with severe COVID-19 pneumonia and high oxygen requirement, anakinra could represent an effective treatment option and may confer clinical benefit. TRIAL REGISTRATION NUMBER: ISRCTN74727214.

Unique Characteristics of Prepubertal Onset Systemic Lupus Erythematosus.

OBJECTIVES: The aim of this study was to investigate the influence of age at disease onset on disease expression and outcomes of pediatric systemic lupus erythematosus SLE (pSLE). METHODS: A total of 103 patients with pSLE from Sultan Qaboos University Hospital, Oman, were retrospectively studied. Epidemiological, clinical phenotype, disease severity, serology, treatment, and outcome were compared among the three groups using univariate statistical tests. RESULTS: The mean disease duration of the cohort was 9.8 ± 4.7 years. The patients were divided into three groups: prepubertal onset (n=39) with mean age at diagnosis of 5.1 ± 2.0 years and pubertal disease onset (n=29) with mean age at diagnosis of 10.8 ± 1.0 years as well as postpubertal disease onset (n=35) group with mean age at diagnosis of 15.3 ± 1.6 years. The prepubertal pSLE cohort demonstrates unique characteristics with increased frequency of familial SLE (61%) of which 49% were from first-degree relatives. Similarly, this group had distinctive clinical features, which included increased renal disease in pubertal and postpubertal groups, respectively (51% vs 23% vs 20%; p=0.039). Prepubertal, similar to pubertal group, had a higher incidence of cutaneous manifestations than in the postpubertal group (74% vs 69% vs 46%; p=0.029). Laboratory features in prepubertal group were distinct with increased frequency of positive anti-cardiolipin antibodies (47%), anti-glycoprotein antibodies (42%), ANCA (62%), and low complement levels (97%) compared to pubertal and postpubertal group. The prepubertal group also has the lowest frequency of positive SSA antibodies (18%) and SSB antibodies (5.1%). The overall mean SLEDAI score in pSLE cohort was 15.6 ± 18.5. The mean SLEDAI scores among the groups showed no significance difference (p=0.110). The overall SLICC DI ≥1 was 36% with a mean damage score of 0.76 ± 1.38. No significant differences in damage index (SLICC DI ≥1) were noted among the groups. CONCLUSIONS: Distinct clinical features were identified in prepubertal onset pSLE population of Arab ethnicity. Given the high rate of consanguineous marriage and high frequency of familial SLE in this cohort, these manifestations could be explained by higher frequency of genetic factors that influence the disease pathogenesis.

Lifestyle Changes among ACS Survivors in Arabian Gulf Countries (Gulf COAST Registry).

BACKGROUND: We described lifestyle changes one year after acute coronary syndrome (ACS) among patients in Arabian Gulf countries. METHODOLOGY: Data of patients admitted to 29 hospitals in 4 countries with the diagnosis of ACS were analysed from Gulf citizens with ACS events (Gulf COAST) registry. A total of 3565 ACS patients recruited in the Gulf COAST registry had a one-year follow up available. There was a significant correlation between return to work and the age of patient (p < .001). At one-year post ACS, the majority were performing their usual activities (93%), but only 39% were exercising. Smoking cessation was successful in 60% of patients and most non-quitters tried or considered quitting (18 and 21% of the total population of smokers, respectively). Sexual activity was reported from 2290 male patients at one-year follow up. The majority reported performing sexual activity (66%) with no fear of sexual intercourse (57%). RESULTS AND CONCLUSION: At one year after an ACS, the majority of our patients returned to their work, sexual activity and other usual activity. Clearly, improvement is needed when it comes to smoking cessation and exercise.

Bone mineral density in juvenile onset systemic lupus erythematosus.

OBJECTIVE: To compare bone mineral density in patients with juvenile-onset Systemic lupus erythematosus and healthy controls. PARTICIPANTS: Serial bone mineral density measurements in 27 patients with juvenile-onset systemic lupus were compared to 97 healthy age-matched controls. RESULTS: All patients with juvenile-onset had low bone mineral density scores at initial assessment that progressed over disease course. Low body mass index was independently associated with a decline in bone mineral density Z scores; disease activity, use of immunosuppressive agents and vitamin D levels were not risk factors. CONCLUSIONS: Patients with juvenile-onset systemic lupus erythematosus have low bone mineral density.

Incidence and pattern of thyroid dysfunction in patients on chronic amiodarone therapy: experience at a tertiary care centre in oman.

OBJECTIVE: To determine the incidence and pattern of thyroid dysfunction (TD) in patients on chronic amiodarone therapy. METHODS: A retrospective study which evaluated 59 patients who had received amiodarone therapy regularly for at least 12 months from a period of 3 years from October 2007 to October 2010. The patients were followed-up at the cardiac clinic at Sultan Qaboos University Hospital, Muscat, Oman. RESULTS: The mean age of the cohort was 63 ± 13 years ranging from 27 to 98 years. Fifty-one percent (n = 30) of the patients were female. There were 11 (19%) cases of thyroid dysfunction (TD). Seven (12%) patients were hypothyroid, 3 (5%) had hyperthyroidism and 1 (2%) patient had sub-clinical hypothyroidism; no cases of sub-clinical hyperthyroidism were noted. Female gender and presence of anti-thyroid peroxidase antibodies were significantly associated with amiodarone-induced hypothyroidism (p = 0.001) while age, amiodarone dose and duration of therapy were not correlated with the development of TD (all p-values > 0.05). CONCLUSION: Amiodarone-induced thyroid dysfunction is prevalent. Hypothyroidism was more frequent and seen more in female patients and those who had positive anti-thyroid peroxidase antibodies. Initial screening and periodic monitoring of thyroid function is mandatory for all patients on amiodarone therapy.

Comparative efficacy of irbesartan/ hydrochlorothiazide and valsartan/hydrochlorothiazide combination in lowering blood pressure: a retrospective observational study in Oman.

OBJECTIVE: To compare blood pressure (BP) control in patients receiving irbesartan/hydrochlorothiazide (HCTZ) and valsartan/HCTZ at a tertiary care university hospital in Oman. SUBJECTS AND METHODS: This was a retrospective observational study, where 232 patients' medical records were reviewed during a 3-month period, July to September 2010, at Sultan Qaboos University Hospital in Oman. BP readings of the previous 6 months were also retrieved from the electronic medical records. Analyses were conducted using univariate statistical techniques. RESULTS: The mean age of the cohort was 58 ± 11 years (range: 21-88). Sixty-nine (30%) patients were on the irbesartan/HCTZ combination (150/12.5 mg) and 163 (70%) were on the valsartan/HCTZ combination. The patients on the valsartan/HCTZ combination were divided into two subgroups: 117 (72%) received 160/12.5 mg and 46 (28%) 80/12.5 mg. Diabetic patients (43/69, 62%, vs. 61/163, 37%, p < 0.001) and those with diabetic nephropathy (8/69, 12%, vs. 7/163, 4%, p = 0.039) were prescribed more often irbesartan/HCTZ than valsartan/HCTZ. In comparison to the valsartan/HCTZ cohort, the irbesartan/HCTZ group was associated with significant reductions in both systolic BP (SBP; -9 vs. -2 mm Hg; p = 0.021) and diastolic BP (DBP; -5 vs. 0 mm Hg; p = 0.022). BP reductions were noted more in diabetics than nondiabetics with the irbesartan/HCTZ patients associated with significant reductions in both SBP (-12 vs. 5.1 mm Hg; p < 0.001) and DBP (-6.4 vs. 1.9 mm Hg; p = 0.001). CONCLUSIONS: The irbesartan/HCTZ combination was associated with significant reductions in both SBP and DBP when compared with the valsartan/HCTZ combination. Specifically, the reductions were noted more in diabetics than nondiabetics.

Drug utilization pattern in an Omani pediatric population.

OBJECTIVE: Evidence suggests that medication errors have a higher incidence in children and infants than in adults. At present, there is limited local data that investigates the drug prescription trends in pediatric populations. This study aims at understanding drug utilization patterns in pediatric patients at Sultan Qaboos University Hospital (SQUH), Oman. MATERIALS AND METHODS: A retrospective cross-sectional study was conducted in the outpatient pediatric clinics and inpatient pediatric wards at SQUH, a tertiary care hospital attached to the Sultan Qaboos University Medical College, Oman. RESULTS: The average number of drugs per prescription was 2.3 ± 1.5, and it was almost similar in all age groups and in both males and females. About 16% of the study group received antibiotics. Paracetamol was the most prescribed drug in the patients (13%). Respiratory system drugs were the most prescribed class of drugs (22%) and salbutamol was the most prescribed drug in this class. CONCLUSIONS: This study will help in assessing rational usage and cost control of various medications used in the pediatric setting.

Drug utilization patterns in the emergency department: A retrospective study.

OBJECTIVES: The aim of this study was to assess the prescribing trends and costs of drugs in the emergency department (ED) at Sultan Qaboos University Hospital (SQUH), a tertiary care hospital, in Muscat, the Sultanate of Oman. MATERIALS AND METHODS: This was a retrospective cross-sectional study of all patients (n = 300) who attended the ED at SQUH in May 2012. Analyses were performed using descriptive and univariate statistics. RESULTS: The average age of patients was 34 ± 19 years. The average number of drugs prescribed per patients was 3.2 ± 1.9 and the majority of the patients (n = 78; 26%) received two drugs. The most common route of drug administration was the oral route (n = 481; 51%) followed by parenterally (n = 357; 38%). Non-steroidal anti-inflammatory drugs (NSAIDs) were the most commonly prescribed class of drugs (38%) followed by the gastro-intestinal tract drugs (19%) and central nervous system drugs (13%). The average cost per prescription was 242 ± 632 US$. Morphine had the highest cost (1885 US$) followed by cefuroxime (1404 US$) and filgrastim (939 US$) over the 1-month period. There was a significant positive correlation between hospital cost and age (P < 0.001), duration of stay at the ED (P = 0.008) and emergency types (P < 0.001). CONCLUSION: NSAIDs were the most frequent class of drugs administered to patients. Highest number of drugs was prescribed for cardiovascular diseases followed by respiratory and gastrointestinal diseases. Anti-infective drugs cost was the highest among all other classes. The results of the present study are attempts to highlight the importance of strategies that have to be implemented to optimize medication use at the ED.

Epidemiology of respiratory virus infections among infants and young children admitted to hospital in Oman.

The aim of this prospective study was to determine the epidemiology of respiratory viruses responsible for seasonal epidemics of influenza-like illness in infants and young children in Oman. All children ≤5 years of age consecutively admitted to Sultan Qaboos University Hospital in Oman over a 1-year period between December 2007 and December 2008 with acute respiratory infections were included. A multiplex polymerase chain reaction (PCR) for viral detection was performed on nasopharyngeal aspirates. Analyses were conducted using univariate statistical methods. Of the 259 infants and young children, at least one respiratory virus was detected in 130 samples (50%). The most prevalent viruses were respiratory syncytial virus (RSV; 43%; n = 56), adenovirus (15%; n = 20), and parainfluenza virus (PIV) (11%; n = 14). Dual or multiple viral infections were found in 23 cases (18%). The three most prominent symptoms of the cohort were fever (78%; n = 201), tachypnoea (77%; n = 200), and runny nose (61%; n = 158). The majority had bronchiolitis (39%; n = 101) while 37% (n = 96) had pneumonia. RSV was more likely to affect those that were young (4 months vs. 7.5 months; P = 0.002) and had tachypnoea (93% vs. 69%; P = 0.004), lower respiratory tract infections (91% vs. 80%; P = 0.039), and bronchiolitis (57% vs. 38%; P = 0.024). The study indicated that respiratory viruses are highly prevalent in children ≤5 years presenting with acute respiratory infections in Oman, of which RSV is the most prominent.

Sub-optimal serum gentamicin concentrations in sickle cell disease patients utilizing the Hartford protocol.

WHAT IS KNOWN AND OBJECTIVES: Several studies have reported that use of the Hartford nomogram in different patients' population was associated with low serum gentamicin concentrations (SGC) at different intervals or midpoints. This study was intended to determine the prevalence and predictors of SGC in patients with sickle cell disease (SCD) as another population representing low SGC while utilizing the Hartford protocol. METHODS: This retrospective observational study was carried out in a University-teaching hospital in Oman. The study was conducted from January 2005 through May 2008 and included all adult patients with SCD admitted during that time. Four-hundred and seven SGC representing 248 SCD patients were evaluated. The serum gentamicin concentration was considered sub-optimal if it was <2µg/mL (baseline of Hartford nomogram). Analyses were performed using univariate and multivariate statistical techniques. RESULTS AND DISCUSSION: Eighty-three percent (n=339) of SGC were sub-optimal. Multivariate analysis using logistic regression revealed that sub-optimal SGC were associated with younger patients with higher creatinine clearance. Specifically, patients who were ≤23years old were twice more likely to have sub-optimal SGC compared with those who were >23years of age (95% CI: 1·14-3·45; P=0·015). Patients with creatinine clearance of ≥200mL/min were 5·20 times more likely to have sub-optimal SGC compared with those with creatinine clearance <200mL/min (95% CI: 1·81-14·49; P=0·002). Furthermore, the logistic model also demonstrated that higher serum urea was associated with low SGC, with each one unit increase in serum urea, patients were 17% less likely to have sub-optimal SGC (95% CI: 0·72-0·96; P=0·011). Additionally, patients who were on piperacillin±tazobactam therapy given concurrently with gentamicin were 53% less likely to have sub-optimal SGC (95% CI: 0·28-0·83; P=0·009). WHAT IS NEW AND CONCLUSION: A majority of patients with SCD had sub-optimal SGC. The pharmacokinetic profile of such patients is apparently too variable to fit the existing Hartford protocol. The Hartford nomogram should be modified to address this issue. Otherwise, clinicians should revert to multiple daily dosing.

Juvenile systemic lupus erythematosus in the Sultanate of Oman: clinical and immunological comparison between familial and non-familial cases.

Consanguineous marriage is quite prevalent in the Sultanate of Oman, with up to 45% of marriages being consanguineous. The aim of this study was to determine demographic, clinical and serological characteristics between familial and non-familial cases of juvenile systemic lupus erythematosus (SLE) in a highly consanguineous region such as Oman. Hospital medical records were retrospectively reviewed for 44 consecutive children with juvenile SLE seen at Sultan Qaboos University Hospital, 16 with familial SLE and 28 with non-familial SLE. All the children included in the study were Omani, diagnosed before 13 years of age, and fulfilled the 1982 revised ACR criteria. Analyses were performed using descriptive statistics. There were largely no significant differences in the clinical and serological manifestations between the two cohorts. However, the familial SLE group was associated with worse SLEDAI score at onset of diagnosis compared with the non-familial cohort (12 vs. 17; p = 0.003) suggesting a greater severity of disease in the familial group. Even though the rate of familial SLE is higher in Oman (36%) compared with the Western world (10-12%), it appears that familial and non-familial SLE cases are in fact similar disease entities in both the West and the Middle Eastern countries.

Drug utilization pattern of anti-epileptic drugs: a pharmacoepidemiologic study in Oman.

PURPOSE: To get an insight into the type and aetiology of epileptic seizures; to describe the drug utilization pattern of anti-epileptic drugs (AEDs) for the treatment of various forms of epileptic seizures in this tertiary referral centre in Oman; and to compare our drug utilization pattern with that from other countries. In addition, the tolerability of AEDs and the use of therapeutic drug monitoring (TDM) were evaluated. METHODS: In a 6-month study, all epileptic patients aged 14 and above who were prescribed an AED were considered for analysis. Demographic data, type and aetiology of epileptic seizures, AED data, tests performed and adverse drug reaction (ADR) data were collected. RESULTS: A total of 1039 prescriptions originated from 488 epileptic patients. The age ranged from 14 to 77 years (median, 24 years). Generalized tonic-clonic seizures (51%) of idiopathic/cryptogenic origin (83%) were the most common type and aetiology of epileptic seizures, respectively. An average of 1.34 AEDs per patient was prescribed with 78% of patients being on monotherapy. Sodium valproate (49%) was the most frequently prescribed AED, followed by carbamazepine (44%), phenytoin (12%) and lamotrigine (11%). Ten patients suffered an ADR and phenobarbital followed by carbamazepine were most commonly the subject of TDM. CONCLUSIONS: Unlike the results in most other studies, generalized seizures represented the majority of epileptic seizures. The selection of the AEDs corresponded well with their known efficacy profiles for specific epileptic seizure types. Monotherapy was the type of therapy most frequently used, and sodium valproate and carbamazepine were the most commonly used AEDs.