BackgroundSecondary hyperparathyroidism (SHPT) is a common complication in chronic kidney disease (CKD) patients. Cinacalcet could be a therapeutic option although its use is controversial in patients not receiving dialysis. Thus, the aim of this study is to assess the effectiveness and safety of cinacalcet in patients with CKD and SHPT without renal replacement treatment (RRT) and without renal transplantation (RT).MethodsA retrospective observational study was conducted. Patients were included if they had collected cinacalcet, under off-label use, during 2010 and 2011. Patients selected were followed from the beginning of cinacalcet therapy for one year of treatment.ResultsA total of 37 patients were included with CKD stage 3 (38%), 4 (51%) and 5 (11%). Baseline mean PTH value was 400.86 ± 168.60 mg/dl. At 12 months, a 67% of patients achieved at least a 30% reduction in their PTH value (p<0.001; CI 49.7–83.6), and the overall mean reduction of PTH values was 38% (p< 0.001; IC -49.1, -27.5). A 28% of the patients achieved KDOQI PTH goals (p = 0.003, CI 12%-50%). At 12 months, mean serum calcium values decreased by 6% and mean serum phosphorus values increased by 13%. A 19% of patients experienced hypocalcemia episodes while an increase of 24% in hyperphosphatemia episodes was observed. A 25% of patients finished cinacalcet before a year of treatment. Main withdrawal reasons were: gastrointestinal and other discomfort (8%), hypocalcaemia (8%), non-compliance (3%), interactions (3%) and excess of efficacy (3%).ConclusionsCinacalcet was effective in patients with CKD and SHPT not receiving dialysis. Electrolytic imbalances could be managed with administration of vitamin D and analogues or phosphate binders.

Background Secondary hyperparathyroidism (SHPT) is a common complication of chronic kidney disease (CKD). Cinacalcet use is controversial in non-dialysis patients. Methods This retrospective observational study recruited patients receiving cinacalcet (off-label use) in 2010 and 2011. Patients were followed for three years from the beginning of treatment using an intention-to-treat approach. Results Forty-one patients were studied: 14 CKD stage 3 (34.1%), 21 CKD stage 4 (51.2%), and 6 CKD stage 5 (14.6%). Median baseline parathyroid hormone (PTH) was 396 (101–1,300) pg/mL. Upon cinacalcet treatment (22 ± 12 months), PTH levels decreased by ≥ 30% in 73.2% of patients ( P < 0.001; 95% confidence interval [CI], 59–87%), with a mean time for response of 18.7 months (95% CI, 15.4–22.1). Sixteen patients were followed for 36 months and treated for 32 ± 9 months. Mean reduction in their PTH levels was 50.1% ( P < 0.001; 95% CI, 33.8–66.4%) at 36 months, with 62.5% of patients ( P < 0.001; 95% CI, 35.9–89.1%) presenting reductions of ≥ 30%. Serum calcium levels decreased from 9.95 ± 0.62 mg/dL to 9.21 ± 0.83 and 9.12 ± 0.78 mg/dL at 12 and 36 months, respectively ( P < 0.001). Serum phosphorus levels increased from 3.59 ± 0.43 to 3.82 ± 0.84 at 12 months ( P = 0.180), remaining so at 36 months ( P = 0.324). At 12 and 36 months, 2 (12.5%) patients experienced hypocalcemia. Meanwhile, 1 (6.3%) and 4 (25.0%) patients reported hyperphosphatemia at 12 and 36 months, respectively. Conclusion Cinacalcet remained effective for at least 36 months in non-dialysis patients with SHPT. Electrolytic disturbances were managed with concurrent use of vitamin D and its analogs or phosphate binders.

Chloroquine (CQ) and hydroxychloroquine (HCQ) have recently become the focus of global attention as possible treatments for Coronavirus Disease 2019 (COVID-19). The current systematic review aims to assess their safety in short treatments (≤14 days), whether used alone or in combination with other drugs. Following the PRISMA and SWiM recommendations, a search was conducted using four health databases for all relevant English-, Chinese-, and Spanish-language studies from inception through 30 July 2021. Patients treated for any condition and with any comparator were included. The outcomes of interest were early drug adverse effects and their frequency. A total of 254 articles met the inclusion criteria, including case and case-control reports as well as cross-sectional, cohort, and randomised studies. The results were summarised either qualitatively in table or narrative form or, when possible (99 studies), quantitatively in terms of adverse event frequencies. Quality evaluation was conducted using the CARE, STROBE, and JADAD tools. This systematic review showed that safety depended on drug indication. In COVID-19 patients, cardiac adverse effects, such as corrected QT interval prolongation, were relatively frequent (0–27.3% and up to 33% if combined with azithromycin), though the risk of torsade de pointes was low. Compared to non-COVID-19 patients, COVID-19 patients experienced a higher frequency of cardiac adverse effects regardless of the regimen used. Dermatological adverse effects affected 0–10% of patients with autoimmune diseases and COVID-19. A broad spectrum of neuropsychiatric adverse effects affected patients treated with CQ for malaria with variable frequencies and some cases were reported in COVID-19 patients. Gastrointestinal adverse effects occurred regardless of drug indication affecting 0–50% of patients. In conclusion, CQ and HCQ are two safe drugs widely used in the treatment of malaria and autoimmune diseases. However, recent findings on their cardiac and neuropsychiatric adverse effects should be considered if these drugs were to be proposed as antivirals again.

Background The current complexity of pharmacotherapy in patients with orthopaedic infections increases the risk of drug-drug interactions (DDI). Purpose The aim of this study is to identify potential DDI (severe/moderate) and its clinical relevance in patients admitted to the infectious diseases unit (IDU) in a tertiary trauma hospital. Materials and methods Prospective observational study performed from January 2011 to April 2011 (100 days) in patients admitted to IDU for at least 7 days. The following variables were recorded for each patient from the database of the pharmacy: sex, age and pharmacology treatment during hospital stay. The laboratory product information and a Spanish DDI database (Medinteract NR) were used to determine potential DDI. Results The study included 35 patients (25 men and 10 women) with a mean of age of 53 years (range 20–82), an average hospital stay of 21.9 days (range 7–64) and 12.8 drugs per patient. The authors detected 151 potential DDI (21 severe, 130 moderate) in 33 of 35 patients (mean of potential DDI of 4.6 per patient). The most frequent of potentially hazardous associations were: paracetamol/dexketoprofen: 14 cases; rifampicin/paracetamol: 12 cases; dexketoprofen/enoxaparin: 8 cases; insulin/co-trimoxazole: 5 cases; daptomycin/simvastatin: 4 cases, being that one considered a potentially severe DDI. The authors observed one serious DDI with clinical relevance: thrombocytopaenia in a patient treated with leflunomide and metamizole, which was solved by stopping the treatment, and two cases of badly controlled pain in patients treated with rifampicin and paracetamol. Conclusions The incidence of potential DDI was very high, but only three of them had actual effects on the patient, being just one severe. This is probably due to the proactive role of the pharmacist when is carrying out the validation of the doctor's prescription using an electronic prescribing program. The integration of clinical pharmacist in IDU facilitates prevention and detection of DDI and its complications. It would be recommended to implement computer software for early detection of DDI to notify to the physician these potentially hazardous associations at the time of prescribing.

Purpose: Children are vulnerable to suffer negative outcomes due to medication (NOM), social media (SM) can be a non-interventional tool to gather safety data. The aim of this study is to assess paediatric Adverse Events (AE) or suspected Adverse Drug Reaction (ADR) detected in SM. Secondary objectives are the assessment of NOM, Drug Related Problems (DRP) and Medication Errors (ME). Methods: Observational, ambispective study assessing NOM in Public Parenting Forums (PPF) using data mining software. Entries that mentioned a medicine administered to children were analyzed and, if NOMs were detected, DRP, ME and AE were categorized. ME and ADR seriousness were assessed. ADR causality according Liverpool Causality Assessment (LCAT) and prevalence compared with those reported in Summary of Product Characteristics (SmPC) of each product. Results: Two forums (mumsnet.uk; socpetit.cat 2733 (81%)) were analyzed. Of 3375 entries, 635 contained a NOM and a DRP, 214 in English, 6 in Spanish and 217 in Catalan. 161 ADR were detected, including Serious AEs (SAEs), unknown, rare or very rare ADR. 29(16%) were not reported in SmPC. 95 ME were found, caused parents or caregivers (40; 42%) and healthcare professionals (HCP) (55; 58%). Severity ranged from no harm up to harm required intervention. Conclusion: ADR were found in PPF, including SAEs and ADR with low or unknown prevalence and suspect ADRs not included in the SmPC. ME that reached children were also found. As consequence, despite that the overall number of entries is not high, forums are a source of valuable pharmacovigilance information.