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
http://www.modernes-tierisches-insulin. ... tement.pdf
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.who.int/selection_medicines/ ... review.pdf
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.cochrane.org/CD003287/ENDOC_ ... s-mellitus
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.
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.cochrane.org/CD005613/ENDOC_ ... s-mellitus
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/CD006297/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.diapedia.org/management/evid ... -analogues
Independent Diabetes Trust
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.
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.
Poca calidad y estudios basados en surrogates en su mayoría, no en hard endpoints como vidas salvadas.