EULAR recommendations for cardiovascular disease risk management in patients with rheumatoid arthritis and other forms of inflammatory joint disorders: 2015/2016 update.

Patients with rheumatoid arthritis (RA) and other inflammatory joint disorders (IJD) have increased cardiovascular disease (CVD) risk compared with the general population. In 2009, the European League Against Rheumatism (EULAR) taskforce recommended screening, identification of CVD risk factors and CVD risk management largely based on expert opinion. In view of substantial new evidence, an update was conducted with the aim of producing CVD risk management recommendations for patients with IJD that now incorporates an increasing evidence base. A multidisciplinary steering committee (representing 13 European countries) comprised 26 members including patient representatives, rheumatologists, cardiologists, internists, epidemiologists, a health professional and fellows. Systematic literature searches were performed and evidence was categorised according to standard guidelines. The evidence was discussed and summarised by the experts in the course of a consensus finding and voting process. Three overarching principles were defined. First, there is a higher risk for CVD in patients with RA, and this may also apply to ankylosing spondylitis and psoriatic arthritis. Second, the rheumatologist is responsible for CVD risk management in patients with IJD. Third, the use of non-steroidal anti-inflammatory drugs and corticosteroids should be in accordance with treatment-specific recommendations from EULAR and Assessment of Spondyloarthritis International Society. Ten recommendations were defined, of which one is new and six were changed compared with the 2009 recommendations. Each designated an appropriate evidence support level. The present update extends on the evidence that CVD risk in the whole spectrum of IJD is increased. This underscores the need for CVD risk management in these patients. These recommendations are defined to provide assistance in CVD risk management in IJD, based on expert opinion and scientific evidence.

Purity determination and evaluation of new drug substances.

As a negative concept, purity is the absence of impurities and, hence, is not measurable directly. There are two major approaches to the determination of the purity of a chemical compound. The first is the absolute approach, based on thermodynamic methods; the total amount of impurities can be determined without detailed knowledge of these impurities. The second is the chromatographic approach, which gives information about the detection and determination of impurities as far as their nature and chemical behaviour are known. Impurities may be derived from different origins. Synthesis precursors, intermediates and side-reaction products are intrinsic impurities. In addition decomposition products, unwanted isomers and polymorphs may appear as impurities. The evaluation of impurity levels is the basis for specifications of drug substances. A total proportion of impurities of less than 1% seems to be a reasonable goal. Identification of impurities present in proportions estimated to be 0.1 % and above is also required. Finally, the setting of specification limits depends on a combination of factors based on knowledge of the chemistry and pharmacology of the components and the economics of the process.

Physico-chemical and analytical studies on suprofen.

Physico-chemical and analytical studies on alpha-methyl-4-(2-thienylcarbonyl)benzeneacetic acid (R 25 061, suprofen) are reported. The usual description data, purity tests and quantitative analysis methods are given. Spectral (UV, IR, NMR, MS) and chromatographic (TLC) properties are described. Stability tests for the drug substance are added also.