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BackgroundThe aim of the Hospital Medicine and Therapeutics Committees (HMTC) is to promote the rational use of drugs through therapeutic improvement in terms of effectiveness, safety and cost.PurposeTo analyse the degree of adaptation to a protocol established by the HMTC on the use of the PCSK9 inhibitors (Evolocumab and Alirocumab).Material and methodsA retrospective observational study including patients who received Evolocumab and Alirocumab since the approval of the protocol (December 2016) until August 2018. It was established to adjust the diagnosis to the four indications under the National Health System coverage, providing also clinical and analytical data of the patient (previous lipid-lowering treatment, intolerance of statins and previous levels of low-density lipoprotein cholesterol (LDL-C)). Furthermore, we proposed to re-evaluate the result 1 month after starting treatment and suspend it if LDL-C >70 mg/dl or had not reduced >40% regarding the baseline value. The variables collected were: sex, age, diagnosis, type of PCSK9 inhibitor, previous LDL-C levels, previous cardiovascular event (CVD) (yes/no), previous treatment (yes/no) and discontinuations (yes/no). Data were obtained from electronic prescription software (APD-Prisma) and medical records.ResultsTwenty-six patients were treated, mean (SD) age 55 (21) years and 58% men: 77% of them received Alirocumab. Median (SD) previous LDL-C levels were 155.6 mg/dL (47, 6): 77% had suffered some previous CVD. One hundred per cent had been previously treated with lipid-lowering drugs. Discontinuation occurred at some time in 15% of patients. The main diagnosis was (73%) established atherosclerotic cardiovascular disease with the maximum tolerated dose of a statin and LDL-C level greater than 100 mg/dL. In no case, there was a re-evaluation on the next month. Fifty per cent reached levels<70 mg/dl but at 3 months with a median (SD) of 72 mg/dl (62, 9).ConclusionThe degree of adaptation to our protocol was irregular. While the adjustment to indications was fairly good, the follow-up based on clinical and analytical data could be improved.References and/or acknowledgementsNo conflict of interest

Among the amazing turn of events in preventing and reducing the risk of cardiovascular diseases since the discovery of statins, thousand of physicians started to prescribe it as a regular life-long treatment, but regarding the expanding number of patients on statin therapy, a wide spectrum of side effects started to appear. Statin-associated myopathy considered as one of the most common side effects and could be subtle for a long time, we performed a review to provide a clinical summary of statin-associated myopathy and to discuss possible mechanisms of risk factors and management of statin-associated myopathy. 

BackgroundA clinical trial sponsored by our hospital wished to compare HMG-CoA reductase inhibitors versus placebo for children with genetic diseases. For this purpose, and because the dosage in unavailable, our laboratory is in charge of the galenic development of simvastatin capsules and its placebo. According to GMP, the stability of the simvastatin capsule is evaluated.PurposeDevelopment and validation of a stability indicating HPLC-UV method for simvastatin capsules.Material and methodsThe HPLC system is a Thermofisher P4000. The column is an inertsil-CN, 250×4.6 mm with 5 µm particle. The mobile phase is an isocratic elution made up of 0.1% acetic acid buffer/methanol (50:50 v/v) at 1 mL/min flow rate. λ is included between 200 and 400 nm. Maximal absorbance of simvastatin is 237 nm. Calibration standard curve is between 30 and 70 µg/mL. Niacin is used as the internal standard. Linearity, trueness, accuracy and limits of quantification were evaluated according to SFSTP recommendations. Impurities were searched from SCR impurities of simvastatin dust according to pharmacopoeia 8.0. The matrix effect was evaluated.ResultsLinearity for simvastatin was validated with r² >0.99 and SD <15%. Recoveries and bias were < 15% for each validation standard. High and low limits of detections were far from the calibration standard curves. There was no matrix effect with the excipients. All impurities were detected and separated with a resolution >1.5.ConclusionA simple and rapid stability indicating HPLC-UV method was developed and validated according to ICH and SFSTP international recommendations. It will be used to evaluate the stability of our simvastatin capsule. We already have 3 months of validated stability.No conflict of interest

[This corrects the article DOI: 10.1371/journal.pone.0166857.].