Ninguno de los 30 nuevos fármacos aprobados para diabetes en la última década mejora la diabetes

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Ninguno de los 30 nuevos fármacos aprobados para diabetes en la última década mejora la diabetes

Notapor Fisio » Mié, 21 Ene 2015, 06:50

Ninguno de los 30 nuevos fármacos aprobados para diabetes en la última década mejora la diabetes. Y algunos son dañinos. El resto los efectos secundarios a largo plazo una incógnita. E incluso los que llevan más tiempo como insulina o metformina no tienen gran evidencia científica en diabetes tipo 2.

http://www.medpagetoday.com/Cardiology/Diabetes/49227

In 1997, a group of experts convened by the American Diabetes Association changed the definition of type 2 diabetes, lowering the blood sugar threshold, and instantly as many as 1.9 million more Americans had the condition.

The same pattern played out in 2003, in an even bigger way, when the association changed the definition of a condition known as pre-diabetes and -- overnight -- 25 million more Americans were affected.

But from 2004 to 2013, none of the 30 new diabetes drugs that came on the market were proven to improve key outcomes, such as reducing heart attacks or strokes, blindness, or other complications of the disease



Imagen

La medicina transmite al paciente una falsa seguridad terapéutica, porque piensa que ya está siendo tratado por el fármaco, dejando de buscar una solución efectiva que solo puede ser su estilo de vida. Se fomentan pacientes pasivos y dependientes del criterio médico y farmacéutico, alejando a la gente de tomar las riendas de su salud con terapias más efectivas que las médicas y farmacéuticas para mejorar la sensibilidad insulínica, la glucosa, el tono caridovascular y la mortalidad por cualquier causa, fundamentalmente nutricion, deporte, relajacion (eje HPA y tono simpático) y aire libre (hay más infartos los días de mayor polución).
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Re: Ninguno de los 30 nuevos fármacos aprobados para diabetes en la última década mejora la diabetes

Notapor Fisio » Jue, 11 Jun 2015, 13:17

En Estados Unidos hicieron una bajada de umbral diagnóstico en glucosa como se comenta más arriba y valores más estrictos de glucosa en sangre. Resultado: urgencias por hipoglicemia 40% superiores a las urgencias por hiperglicemia. Más daño médico. Con el problema añadido de que las urgencias por hipoglicemia son más peligrosas, de hecho la mortalidad es enorme, 5% a 30 días y 20% a un año, al menos en aquel país.

Estudio

http://archinte.jamanetwork.com/article ... id=1871566

Diabetes Treatment Fails

Diet and exercise are proven to be much more effective at preventing pre-diabetes from becoming diabetes.

A major study published in 2002 found that the combination of diet and exercise reduced the odds of pre-diabetes becoming diabetes by 58% compared with 31% among those using the common diabetes drug metformin.



http://www.medpagetoday.com/Endocrinolo ... etes/47215

Not only was ultra-tight glucose control linked to excess deaths in the star-crossed ACCORD trial, but it was no more effective than standard therapy in reducing cardiovascular events among patients with type 2 diabetes,


http://www.medpagetoday.com/MeetingCoverage/ADA/9739


"Our patients are now more likely to experience adverse events related to overtreatment of diabetes mellitus. Striving for too low an HbA1c"

http://www.medscape.com/viewarticle/825483
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Re: Ninguno de los 30 nuevos fármacos aprobados para diabetes en la última década mejora la diabetes

Notapor Fisio » Jue, 11 Jun 2015, 13:34

Ejercicio + placebo el doble de efectivo que fármacos + consejos de hábitos de vida en prediabéticos y gente en riesgo de diabetes tipo 2

http://www.nejm.org/doi/full/10.1056/NEJMoa012512
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Re: Ninguno de los 30 nuevos fármacos aprobados para diabetes en la última década mejora la diabetes

Notapor Fisio » Vie, 12 Jun 2015, 00:30

Vamos con el tema insulinas. Las insulinas cada vez son mejores y más seguras? O más interesantes económicamente sumado a toda la incertidumbre de riesgos a largo plazo vs las anteriores conocidas?

Las primeras insulinas se aislaron del pancreas de cerdo y otros animales comenzando a usarse en 1922. En 1982 se aprobó la insulina humana sintetizada con tecnología recombinante mediante ADN humano en E Coli. Y en 1996 por último salieron los tratamientos más modernos, que son los análogos a la insulina. Veamos si son avances de la medicina como dicen, o si por el contrario suponen tener que dedicar más esfuerzo económico para lo mismo o peor...

International Diabetes Federation

There is no overwhelming evidence to prefer one species of insulin over another.

Highly purified animal insulins are effective agents to treat diabetes.

Human insulin is at least as good as highly purified pork insulin.

Genetically modified insulin analogues may provide advantages in patients with problematic hypoglycaemia but they are expensive and there are no long term safety data.

Disappointingly, the immunogenicity of human insulin is similar to that of highly purified pork insulin, to which it is clinically equivalent.

In many parts of the world, beef insulin provides access to a low cost insulin. While their prices remain lower, highly purified pork and to a lesser extent beef insulins are entirely acceptable and there is no reason to convert.

Human insulin has the theoretical advantage that it can be synthesized in limitless quantities at relatively low cost



http://www.modernes-tierisches-insulin. ... tement.pdf


OMS

Conclusion: The evidence indicates that across Type 1 and 2 diabetes, for both rapid- and long-acting analogue insulins, there is no clear advantage over human insulins, with inconsistent statistically significant advantages and lack of clinically important benefits.
Analogue insulins have not consistently been demonstrated to be cost-effective, and uncertainty remains regarding the association between analogue insulins and increased cancer risk.


http://www.who.int/selection_medicines/ ... review.pdf


Cochrane


Short acting insulin analogues versus regular human insulin in patients with diabetes mellitus

Short acting insulin analogues (Lispro, Aspart, Glulisine) act more quickly than regular human insulin. It can be injected immediately before meals and leads to lower blood sugar levels after food intake. Our analysis showed that short acting insulin analogues were almost identically effective to regular human insulin in long term glycaemic control and were associated with similar episodes of low blood sugar (hypoglycaemia). No information on late complications such as problems with the eyes, kidneys or feet are existing. Until long term safety data are available we suggest a cautious response to the vigorous promotion of insulin analogues.

Our analysis suggests only a minor benefit of short acting insulin analogues in the majority of diabetic patients treated with insulin. Until long term efficacy and safety data are available we suggest a cautious response to the vigorous promotion of insulin analogues. For safety purposes, we need a long-term follow-up of large numbers of patients and well designed studies in pregnant women to determine the safety profile for both the mother and the unborn child.


http://www.cochrane.org/CD003287/ENDOC_ ... s-mellitus


Human insulin versus animal insulin in people with diabetes mellitus

Human insulin was introduced for the routine treatment of diabetes mellitus in the early 1980s without adequate comparison of efficacy to animal insulin preparations. First reports of altered hypoglycaemic awareness after transfer to human insulin made physicians and especially patients uncertain about potential adverse effects of human insulin.

Reviewers’ conclusions: A comparison of the effects of human and animal insulin as well as of the adverse reaction profile did not show clinically relevant differences. Many patient-oriented outcomes like health-related quality of life or diabetes complications and mortality were never investigated in high quality randomised clinical trials. The story of the introduction of human insulin might be repeated by contemporary launching campaigns to introduce pharmaceutical and technological innovations that are not backed up by sufficient proof of their advantages and safety.


http://www.ncbi.nlm.nih.gov/pubmed/12137720

Long acting insulin analogues versus NPH insulin (human isophane insulin) for type 2 diabetes mellitus

Our analysis suggests, if at all only a minor clinical benefit of treatment with long-acting insulin analogues for patients with diabetes mellitus type 2 treated with "basal" insulin regarding symptomatic nocturnal hypoglycaemic events. Until long-term efficacy and safety data are available, we suggest a cautious approach to therapy with insulin glargine or detemir


http://www.cochrane.org/CD005613/ENDOC_ ... s-mellitus

Intermediate acting versus long acting insulin for type 1 diabetes mellitus

Long acting insulin preparations seem to exert a beneficial effect on nocturnal glucose levels. Their effect on the overall diabetes control is clinically unremarkable. Their use as a basal insulin regimen for type 1 diabetes mellitus warrants further substantiation.


http://www.cochrane.org/CD006297/ENDOC_ ... s-mellitus



Diapedia

While there are definitely some circumstances in which the insulin analogues may offer a benefit, many patients will do very well with the cheaper conventional insulins. Thus, the decision to start insulin analogues in an individual patient should be taken only when the conventional insulins have been proven inadequate.

In a Cochrane review of studies comparing insulin detemir to insulin glargine, no relevant differences between the two could be established

Insulin glargine: despite its huge popularity, the objective benefits of glargine compared to NPH insulin are limited

Combining short- and long-acting insulin analogues: ss with most insulin trials, however, these studies were not double-blind so some study effects due to increased attention in the newer regimen cannot be excluded.

The overall benefits of insulin analogues have been somewhat disappointing and are limited to slight differences in hypoglycaemia rates.


http://www.diapedia.org/management/evid ... -analogues



Independent Diabetes Trust

Exercise your choice
Already 40% of people with diabetes have had their insulin changed to insulin analogues, an unnecessarily change according to the evidence and the newly diagnosed are automatically being treated with analogues. On what basis analogues are being so widely prescribed? From the above evidence of lack of superiority, it can only be on assumptions of benefit not evidence of benefit. This could be as a result of heavy marketing of the analogues as ‘designer’ or ‘modern’ insulins, both of which imply superiority or benefit. It is also worth noting that insulin analogues are the only insulins still in patent and therefore they can be sold at a higher price and greater profit for industry.

Insulin analogues are significantly more expensive than ‘human’ and animal insulins and although the cost does not directly affect individual people in the UK, it does affect the overall NHS costs. Cost is less important than health risks, but Professor Edwin Gale questions whether people with diabetes are getting the best deal. He asks what choice people in the UK would make between treating 150-200 patients with long-acting analogues [rather than human insulin] or for the same cost, employing a full time specialist nurse to improve the education of people with diabetes so that they are better able to self-manage their diabetes.


http://iddt.org/about/gm-vs-animal-insulin


Poca calidad y estudios basados en surrogates en su mayoría, no en hard endpoints como vidas salvadas.
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Re: Ninguno de los 30 nuevos fármacos aprobados para diabetes en la última década mejora la diabetes

Notapor Fisio » Lun, 15 Jun 2015, 14:31

Metformina e insulina en diabetes tipo II: donde está la evidencia?

viewtopic.php?f=18&t=2482

viewtopic.php?f=18&t=2250&p=6270


Insulina en diabeticos tipo II puede producir diabetes tipo I en un subgrupo de pacientes

Insulin administration may trigger type 1 diabetes in Japanese type 2 diabetes patients with type 1 diabetes high-risk HLA class II and the insulin gene VNTR genotype.
Nishida W1, Nagata M, Imagawa A, Hanafusa T, Ohashi J, Takahashi K, Suehiro T, Yamada Y, Chujo D, Kawasaki E, Kawamura R, Onuma H, Osawa H, Makino H.
Author information
Abstract
CONTEXT:

Insulin administration causes various types of immune responses to insulin. We previously reported three cases of type 1 diabetes mellitus (T1DM) triggered by insulin administration in Japanese type 2 diabetes mellitus patients.
OBJECTIVE:

The objective of this study was to collect information and characterize insulin-triggered T1DM immunologically and genetically.
METHODS:

Data for six patients (four men and two women) with insulin-triggered T1DM aged 59.5 ± 12.8 years were collected. Serum or urinary C-peptides, islet-related autoantibodies, insulin antibody, human leukocyte antigen, or the insulin gene variable number of tandem repeat genotype were analyzed. Th1- or Th2-associated responses were evaluated using an Enzyme-Linked ImmunoSpot assay.
RESULTS:

None of the subjects had received insulin therapy or had an autoantibody to the 65-kDa isoform of glutamic acid decarboxylase before insulin administration. After insulin administration blood glucose control deteriorated acutely without any apparent cause, whereas C-peptide levels rapidly decreased to insulin-deficient levels. The mean duration of insulin administration to the development of T1DM was 7.7 ± 6.1 months. Islet-related autoantibodies became positive, whereas insulin allergy or a high titer of insulin antibody was observed in several cases. All had T1DM high-risk human leukocyte antigen class II (IDDM1) and the insulin gene variable number of tandem repeats genotype (IDDM2). GAD-reactive and insulin peptide-reactive Th1 cells, but not Th2 cells, were identified in two of four cases.
CONCLUSIONS:

The findings suggest that insulin administration may have triggered TIDM in patients with type 2 diabetes mellitus. IDDM1 and IDDM 2 as well as autoreactive T cells may contribute to the development of T1DM. Developing insulin-triggered T1DM if a patient's blood glucose control acutely deteriorates after insulin administration should be carefully considered.


http://www.ncbi.nlm.nih.gov/pubmed/24971665
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Re: Ninguno de los 30 nuevos fármacos aprobados para diabetes en la última década mejora la diabetes

Notapor Fisio » Lun, 15 Jun 2015, 14:36

El mercado de insulina doblándose en una década. Por los pacientes of course

Insulin Market Expected to Reach USD 32.24 Billion Globally in 2019

According to a new market report published by Transparency Market Research Global and China Insulin Market (Rapid-Acting, Short-Acting, Intermediate-Acting, Long-Acting, Premixed, Modern and Human Insulin) - Industry Analysis, Size, Share, Growth, Trends and Forecast (Value and Volume), 2013 - 2019, the global insulin market was valued at USD 19.99 billion in 2012 and is expected to grow at a CAGR of 6.1% from 2013 to 2019 to reach USD 32.24 billion in 2019.


http://www.transparencymarketresearch.c ... market.htm


Lamentablemente, las sociedades científicas españolas no hacen sino seguir el modelo de negocio de sus hermanas mayores norteamericanas y, en la actualidad, el complejo médico-industrial español se ha convertido en el grupo de poder que domina la agenda pública en relación con todos los asuntos relevantes relacionados con la salud, no solo científicos sino también políticos.


La industria de la diabetes y la casta médica

http://www.nogracias.eu/2015/01/10/el-s ... -diabetes/
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Re: Ninguno de los 30 nuevos fármacos aprobados para diabetes en la última década mejora la diabetes

Notapor Fisio » Vie, 26 Jun 2015, 16:04

Restricción de carbohidratos en diabetes. Endocrinos y dietistas siguen con las 5 + resopón a base de carbohidratos refinados. Y se sigue medicalizando en lugar de hacer políticas integradoras.

Dietary carbohydrate restriction as the first approach in diabetes management: Critical review and evidence base

The inability of current recommendations to control the epidemic of diabetes, the specific failure of the prevailing low-fat diets to improve obesity, cardiovascular risk, or general health and the persistent reports of some serious side effects of commonly prescribed diabetic medications, in combination with the continued success of low-carbohydrate diets in the treatment of diabetes and metabolic syndrome without significant side effects, point to the need for a reappraisal of dietary guidelines. The benefits of carbohydrate restriction in diabetes are immediate and well documented. Concerns about the efficacy and safety are long term and conjectural rather than data driven. Dietary carbohydrate restriction reliably reduces high blood glucose, does not require weight loss (although is still best for weight loss), and leads to the reduction or elimination of medication. It has never shown side effects comparable with those seen in many drugs. Here we present 12 points of evidence supporting the use of low-carbohydrate diets as the first approach to treating type 2 diabetes and as the most effective adjunct to pharmacology in type 1. They represent the best-documented, least controversial results. The insistence on long-term randomized controlled trials as the only kind of data that will be accepted is without precedent in science. The seriousness of diabetes requires that we evaluate all of the evidence that is available. The 12 points are sufficiently compelling that we feel that the burden of proof rests with those who are opposed.


http://www.sciencedirect.com/science/ar ... 0714003323


Point 1. Hyperglycemia is the most salient feature of diabetes.
Dietary carbohydrate restriction has the greatest effect on
decreasing blood glucose levels



Point 2. During the epidemics of obesity and type 2 diabetes,
caloric increases have been due almost entirely to increased
carbohydrates



Point 7. Dietary total and saturated fat do not correlate with risk
for cardiovascular disease
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Notapor africafern » Lun, 21 Sep 2015, 16:29

Gran apunte
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Re: Ninguno de los 30 nuevos fármacos aprobados para diabetes en la última década mejora la diabetes

Notapor Fisio » Sab, 26 Sep 2015, 08:57

Dieta y ejercicio superior a fármacos en personas en riesgo de diabetes

http://www.reuters.com/article/2015/09/ ... AA20150925
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Re: Ninguno de los 30 nuevos fármacos aprobados para diabetes en la última década mejora la diabetes

Notapor Fisio » Vie, 13 Oct 2017, 16:47

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