RESUMO DAS CARACTERÍSTICAS DO MEDICAMENTO NOTA: ESTE RCM FOI O ANEXADO Á DECISÃO DA COMISSÃO, RELATIVA Á SUBMISSÃO PARA ARBITRAGEM; O TEXTO VÁLIDO NA ALTURA. O TEXTO NÃO É REVISTO OU ACTUALIZADO PELA EMEA E POR ISSO NÃO REPRESENTA NECESSARIAMENTE O TEXTO ACTUAL. 1. DENOMINAÇÃO MEDICAMENTO < Renitec e denominações associadas (ver Anexo I)>, <dosagem>,
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Maedica_art_18.inddMædica - a Journal of Clinical Medicine
Update in Diabetology
Cristian GUJA, MD, PhDa; Radu LICHIARDOPOL, MD, PhDa,b aThe National Institute of Diabetes, Nutrition and Metabolic Diseases „Prof. NC bThe University of Medicine and Pharmacy “Carol Davila”, Bucharest, Romania Several important developments in the does not decrease the frequency of cardiovas- diagnosis and treatment of diabetes cular events, at least not during the active pe-mellitus occurred during the last year. riod of the trial (2). The positive effect becomes First of all, continuing its initiative however evident after 10 years of follow-up from 2010, in January 2011, the Ame- (“metabolic memory” effect), highlighting the rican Association of Diabetes (ADA) included importance of a tight glycemic control at the in its annual clinical practice guideline the use diagnosis of T2DM (2). The practical conclu- of glycated haemoglobin (HbA1c) as a diagnos- sion is that therapeutic targets in T2DM should tic criterion for diabetes mellitus (1). Thus, be individualized to each patient. Thus, in old-HbA1c ≥6.5% is diagnostic for diabetes. er and more vulnerable patients, with concom-HbA1c between 5.7%-6.4% is considered to itant CVD and limited life expectancy, who de fine one of the categories of increased risk don’t tolerate hypoglycaemia the HbA1c target for diabetes (prediabetes): IFG and IGT, while a should be ~7.5%-8%. Contrariwise, in young- HbA1c < 5.7% is considered to be normal. In er patients without CVD, a HbA1c < 7% should order to be valid, the diagnostic test should be be targeted, even <6.5% if this can be achieved performed using a method that is standardized or traceable to the Diabetes Control and Com- plications Trial (DCCT) reference assay. The use views about diabetes and cancer. The key take- of HbA1cwas proposed also by the EASD (Eu- ho me message of the last 12 months is that ro pean Association for the Study of Diabetes) T2DM patients are at increased risk for cancer but it is up to the national diabetes associations and they should be periodically screened for to include it in their local clinical practice spe cific malignancies. On the positive side, guidelines.
met formin was reconfirmed to reduce the risk In respect to the current clinical practice, of cancer in T2DM and may also reduce morta- following the results of the major trials of car- li ty (3). This strengthens the position of metfor- diovascular prevention in type 2 diabetes (AC- min as the first step in the treatment of T2DM.
follow up analysis), it was established that in- drugs used for T2DM treatment. The last year tensive glycemic control leads to a decrease of brought the dawn of Thiazolidindiones. Thus, the microvascular diabetic complications but it Address for correspondence:Cristian Guja, MD, PhD, National Institute of Diabetes, Nutrition and Metabolic Diseases „Prof. NC Paulescu”, 5-7 Ion Movila Street, Buchareste-mail: [email protected] Maedica A Journal of Clinical Medicine, Volume 6 No.4 2011 341
a ban on drugs containing Rosiglitazone (Avan- The hopes for the launch of a new class of dia, Avandamet and Avaglim). In the same oral antidiabetic drugs – inhibitors of the sodi-time, the FDA restricted drastically its use in the um glucose cotransporter-2 (SGLT-2) in the USA – it cannot be prescribed as a first line proximal renal tubules were also set back. drug but only when other therapies failed. The Thus, in July 2011, the FDA voted against the main reason was the increasing evidence con- approval of dapagliflozin (Bristol-Myers Squibb firming the initial report of Niessen from 2007 and AstraZeneca), largely because of fears that regarding an increased risk of MI in patients us- the product may cause breast and bladder can- ing Rosiglitazone. In addition, the RECORD cer. Additional concern was related to the lack study (sponsored by GlaxoSmithKline) failed to of absence of hard pharmacokinetic data re- show any benefit of this drug in CVD preven- tion (4). Also during the last year, data was pub- To finish on a brighter side this up-to-date in lished (5) regarding the increased risk of blad- diabetology, two new drugs from the class of der cancer in T2DM patients treated with GLP-1 receptor agonists were approved for Pio glitazone (Actos). The risk is higher in those clinical practice last year. These are Liraglutide pa tients exposed to the highest cumulative do- (Victoza from Novo Nordisk) that was approved ses of Pioglitazone, especially the elderly. Follo- by the FDA for use in the USA (it was already wing these reports France and Germany suspe- used in Europe for a couple of years) and the n ded the use of Pioglitazone while the FDA re- once-weekly exenatide (Bydureon from Eli Lilly co mmended a labelling update for Pioglita zo- ne regarding this risk. A single European po si ti- on regarding this issue is still waited from EMEA.
– Standards of Medical Care in
3. McFarland MS, Cripps R – Diabetes
Diabetes — 2011. Diabetes Care 2011; 2. Teoh H, Home P, Leiter LA – Should
5. Stephenson J – Diabetes drug may be
4. Home PD, Pocock SJ, Beck-Nielsen H,
et al. – Rosiglitazone evaluated for
bladder cancer. JAMA 2011; 306:143.
Maedica A Journal of Clinical Medicine, Volume 6 No.4 2011
Assay for:Hoodia gordonii Fingerprint Analysis for Identity & Purity; Semi-Quantitative Analysis for Potency ->Hoodia gordonii: (lot #: 051128)High Performance Liquid Chromatography with Diode Array Detection DAD1 B, Sig=225,4 Ref=360,8 (36105H\005-0701.D)HPLC column : Onyx Monolithic C18 100 X 4.6mmMobile Phase A: WaterMobile Phase B: ACNTime %A %B0 min 80 205 min 20 805.01 min 0 1007