Es una recopilación de lo bueno de varias otras, pero es una de las más completas y "útiles" muy aplicable a latinoamérica... Solo mucho ojo, con las contraindicaciones para metformina ahí plasmadas. Sugiero utilizar también IFG estimado...
GUÍA DEL TRATAMIENTO DE LA DIABETES MELLITUS TIPO 2 - SAD 2010
sábado, 30 de julio de 2011
jueves, 28 de julio de 2011
viernes, 22 de julio de 2011
Se salvó la pioglitazona, de momento...
Press release
21/07/2011
European Medicines Agency recommends new contra-indications and warnings for pioglitazone to reduce small increased risk of bladder cancer
Benefit-risk balance remains positive in a limited population of type 2 diabetics
Finalising its review on antidiabetic pioglitazone-containing medicines and the occurrence of bladder cancer, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) confirmed that these medicines remain a valid treatment option for certain patients with type 2 diabetes but that there is a small increased risk of bladder cancer in patients taking these medicines. However, the CHMP also concluded that the small increased risk could be reduced by appropriate patient selection and exclusion, including a requirement for periodic review of the efficacy and safety of the individual patient’s treatment.
Prescribers are advised not to use these medicines in patients with current or a history of bladder cancer or in patients with uninvestigated macroscopic haematuria. Risk factors for bladder cancer should be assessed before initiating pioglitazone treatment. In light of age-related risks, the balance of benefits and risks should be considered carefully both before initiating and during treatment in the elderly. Prescribers should review the treatment of patients on pioglitazone after three to six months (and regularly afterwards) to ensure that only patients who are deriving sufficient benefit continue to take it.
The CHMP reviewed all available data on the occurrence of bladder cancer, including results of preclinical studies, clinical studies, epidemiological studies and spontaneous reports. The Committee also considered the advice from its Scientific Advisory Group (SAG) on Diabetes/Endocrinology.
The CHMP concluded that the evidence from different sources shows that there is a small increased risk of bladder cancer with pioglitazone. Recently available data from epidemiological studies (Kaiser Permanente Northern California cohort study, French CNAMTS cohort study, GPRD case control study) point to a small increased risk (relative risk ranging from 1.12 to 1.33) of bladder cancer in diabetic patients treated with pioglitazone, in particular in patients treated for the longest durations and with the highest cumulative doses.
Furthermore, in a meta-analysis of randomised controlled clinical studies, 19 out of 12,506 patients taking pioglitazone had bladder cancer (0.15%) compared with 7 out of 10,212 patients not taking pioglitazone (0.07%). A possible risk after short term treatment cannot be excluded.
In line with the recommendations of the SAG, the CHMP concluded that there are some patients who cannot be adequately treated by other treatments and who will benefit from treatment with pioglitazone. The CHMP agreed that it was not possible to further restrict the current indications of pioglitazone. Instead, prescribers are advised to carefully select patients and monitor response to treatment. In patients responding to treatment, the CHMP concluded that the benefits outweigh the risks.
The CHMP agreed that there is a need for further analysis of the types, evolution and severity of bladder cancer in patients treated with pioglitazone compared to diabetics not treated with pioglitazone. It remains unclear as to whether it is an early effect or a risk with prolonged use/high cumulative dose. Therefore, the CHMP has asked the marketing authorisation holder to conduct a pan-European epidemiological study focussing on more robust characterisation of the risk, in particular the risk period and risk with increasing age, to inform the evidence-base for risk minimisation measures.
Notes
- The European review of the centrally authorised pioglitazone-containing medicines Actos, Glustin, Competact, Glubrava and Tandemact and the occurrence of bladder cancer was conducted in the context of a formal review, initiated at the request of the European Commission under Article 20 of Regulation (EC) No 726/2004, on 16 March 2011.
- A European Commission Decision on this opinion will be issued in due course.
- Actos and Glustin were authorised in the EU in October 2000, Competact in July 2006, Tandemact in January 2007 and Glubrava in December 2007. The medicines are marketed by Takeda.
jueves, 21 de julio de 2011
FDA panel votes against dapagliflozin for DM2
An FDA advisory panel on Tuesday voted against recommending approval of Bristol-Myers Squibb and AstraZeneca’s dapagliflozin for adults with type 2 diabetes due to concerns about a potential risk of breast and bladder cancer. The FDA is expected to issue a final decision on approval of the drug by October 28.
Panel members voted 9-6 against a question that asked if the efficacy and safety data submitted in support of the drug provided substantial evidence to support approval. Specifically, panelists expressed concern about the drug’s cancer, liver and kidney risks, especially among elderly patients. Panel members who voted in support of dapagliflozin said they were also concerned about the potential safety implications, but said that more information on those risks could only be discovered in large patient registries and post-marketing studies that could be established following approval of the compound.
miércoles, 20 de julio de 2011
Escuchas Manu Chao ???
En lo personal, Manu Chao me parece de lo mejor que hay... Por qué ??? Fácil, lee un poco sus raíces y sus ideales aplicados a su preciosa música...
http://es.wikipedia.org/wiki/Manu_Chao
http://es.wikipedia.org/wiki/Manu_Chao
domingo, 17 de julio de 2011
Consejo de tomar ocho vasos de agua al día es "tontería" - Waterlogged ?
Los ocho vasos de agua al día como algo necesario para la salud, es un mito. El agua de grifo es una buena bebida y debemos beber todo lo que deseamos o necesitemos cuando tenemos sed. Pero la idea de que hay una cantidad "perfecta" que debemos beber no está basada en evidencia"
Dra. Margaret McCartney
domingo, 10 de julio de 2011
Stress associated with decreased fertility in women
These US and UK investigators assessed the association between salivary stress biomarkers (cortisol and alpha-amylase) and female fecundity in a prospective cohort study. They included 274 women aged 18 to 40 years who were attempting pregnancy. Women were observed for six cycles or until pregnancy. Women collected basal saliva samples on day 6 of each cycle, and used fertility monitors to identify ovulation and pregnancy test kits for pregnancy detection. They measured salivary cortisol (mcg/dL) and alpha- amylase (U/mL) concentration, time-to-pregnancy, and the probability of pregnancy during the fertile window.
They found: "Alpha-amylase but not cortisol concentrations were negatively associated with fecundity in the first cycle (fecundity odds ratio = 0.85) after adjusting for the couples' ages, intercourse frequency, and alcohol consumption. Statistically significant reductions in the probability of conception across the fertile window during the first cycle attempting pregnancy were observed for women whose salivary concentrations of alpha- amylase were in the upper quartiles in comparison with women in the lower quartiles."
The authors concluded: "Stress significantly reduced the probability of conception each day during the fertile window, possibly exerting its effect through the sympathetic medullar pathway."
Fuente: For the full abstract, click here.
Fertil Steril 95(7):2184-2189, June 2011 © 2011 to the American Society of Reproductive Endocrinology
Stress reduces conception probabilities across the fertile window: evidence in support of relaxation. Germaine M. Buck Louis, Kirsten J. Lum, Rajeshwari Sundaram, et al. Correspondence to Dr. Louis: louisg@mail.nih.gov
They found: "Alpha-amylase but not cortisol concentrations were negatively associated with fecundity in the first cycle (fecundity odds ratio = 0.85) after adjusting for the couples' ages, intercourse frequency, and alcohol consumption. Statistically significant reductions in the probability of conception across the fertile window during the first cycle attempting pregnancy were observed for women whose salivary concentrations of alpha- amylase were in the upper quartiles in comparison with women in the lower quartiles."
The authors concluded: "Stress significantly reduced the probability of conception each day during the fertile window, possibly exerting its effect through the sympathetic medullar pathway."
Fuente: For the full abstract, click here.
Fertil Steril 95(7):2184-2189, June 2011 © 2011 to the American Society of Reproductive Endocrinology
Stress reduces conception probabilities across the fertile window: evidence in support of relaxation. Germaine M. Buck Louis, Kirsten J. Lum, Rajeshwari Sundaram, et al. Correspondence to Dr. Louis: louisg@mail.nih.gov
sábado, 9 de julio de 2011
QEPD el gran Facundo...
Guatemala vive endémicamente de luto, pero ésta tragedia nos hace sentir tan indignados a todos los que luchamos por el simple bien diario, no podemos más que pedir perdón al mundo con humildad, pero sepan que la mayoría de Guatemaltecos sufrimos esa violencia indiscrimada a diario... Que estés en un mejor lugar gran Facundo.
miércoles, 6 de julio de 2011
lunes, 4 de julio de 2011
FDA approves Johnson & Johnson, Bayer’s Xarelto for DVT
The FDA on Friday approved Johnson & Johnson and Bayer’s Xarelto (rivaroxaban) for the prevention of deep vein thrombosis (DVT) in patients undergoing knee or hip replacement surgery. Bayer noted that Xarelto is the only new oral anticoagulant approved in the US for venous thromboembolism prophylaxis for patients undergoing knee or hip replacement surgery.
The approval was based on late-stage data that showed Xarelto was more effective in both a head-to-head comparison with sanofi-aventis' Lovenox (enoxaparin) and when compared to enoxaparin followed by placebo. In the trials, Xarelto demonstrated a similar safety profile to enoxaparin, including lower rates of major bleeding.
The companies in January submitted regulatory filings in Europe and the US seeking approval of Xarelto for the prevention of stroke in patients with atrial fibrillation. Johnson & Johnson’s head of cardiovascular research Martin Fitchet noted that US regulators will probably announce a decision on the drug in this indication by the end of 2011, with a similar timeline expected for a decision in the EU. Bayer, which markets the drug in Europe and will lend sales support in the US, has forecast that Xarelto will generate more than 2 billion euros ($2.9 billion) in annual sales if it is approved for use in AF.
Citigroup analyst Matthew Dodds noted that Johnson & Johnson has been “waiting for a blockbuster” in the cardiovascular drug market and Xarelto “is widely viewed as that product.” He predicted that the drug may generate as much as $1.6 billion in annual sales, of which $1.2 billion would be in the atrial fibrillation indication.
Xarelto is the second oral anticoagulant approved by the FDA within the last nine months. In October, US regulators approved Boehringer Ingelheim’s Pradaxa (dabigatran) for the prevention of stroke in patients with AF. In addition, Pfizer and Bristol-Myers Squibb recently reported positive results from late-stage clinical trials of its Eliquis (apixaban) in AF and the companies are expected to file for regulatory approval of the drug by the end of this year.
viernes, 1 de julio de 2011
No pasa un mes sin escuchar otra bondad justificada para la maravillosa metformina...
The 10-Year Cost-Effectiveness of Lifestyle Intervention or Metformin for the Primary Prevention of Type 2 Diabetes Mellitus: An Intent-to-Treat Analysis of Diabetes Prevention
Study presented at the American Diabetes Association's 71st Scientific Sessions, held from June 24 to 28 in San Diego
Study presented at the American Diabetes Association's 71st Scientific Sessions, held from June 24 to 28 in San Diego
Tuesday, June 28,
Abstract No: 0136-LBOR
Abstract Type: Late Breaking Oral
Author(s): WILLIAM H. HERMAN, SHARON L. EDELSTEIN, ROBERT E. RATNER, MARIA G. MONTEZ, RONALD T. ACKERMANN, TREVOR J. ORCHARD, MARY A. FOULKES, PING ZHANG, CHRISTOPHER D. SAUDEK, MORTON B. BROWN, THE DIABETES PREVENTION PROGRAM RESEARCH GROUP
Location(s):
Rockville, MD, Washington, DC, San Antonio, TX, Indianapolis, IN, Pittsburgh, PA, Atlanta, GA, Baltimore, MD, Ann Arbor, MI
Abstract Body:
The Diabetes Prevention Program (DPP) randomized overweight adults with impaired glucose tolerance (IGT) and an elevated fasting glucose to intensive lifestyle (ILS), metformin (MET), or placebo (PBO) for an average of 3 years. The DPP Outcomes Study (DPPOS) followed participants for an additional 7 years during which time ILS and MET participants were encouraged to continue those interventions and all participants were offered a modified lifestyle intervention. A recent analysis demonstrated that the beneficial effects of ILS and MET on the incidence of type 2 diabetes persisted for at least 10 years after randomization. During both DPP and DPPOS, data on resource utilization, cost, and quality-of-life were collected prospectively. Economic analyses were performed from a health system perspective that considered direct medical costs. During DPPOS, the direct medical costs of ILS and MET were substantially lower than during DPP, and the costs of PBO were higher than during DPP. Over 10 years, the cumulative, undiscounted, per capita direct medical costs of the interventions were greater for ILS and MET than for PBO ($4,826 ILS vs. $2,489 MET vs. $953 PBO). The direct medical costs of care outside the DPP/DPPOS increased over time for all groups, but were highest for PBO. The cumulative undiscounted, per capita, direct medical costs of non-intervention-related medical care were greater for PBO ($31,299) than MET ($26,351) or ILS ($24,759). Over 10 years, the undiscounted per capita total direct medical costs were lower for both ILS ($29,585) and MET ($27,840) compared to PBO ($32,252). Quality-of-life was better for ILS compared to MET or PBO and the undiscounted quality-adjusted life-years accrued over 10 years were greater for ILS (6.81) than MET (6.69) or PBO (6.67 QALYs). Over 10 years, from a payer perspective, ILS and MET were less expensive and more effective than PBO. Both health policy and social policy should support the funding of intensive lifestyle and metformin for diabetes prevention in high-risk adults.
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