Wednesday, 24 September 2014

IMMUNOSUPRESSION --- A LIVER TRANSPLANTATION SUCCESS STORY.Part 1

IMMUNOSUPRESSION  --- A LIVER TRANSPLANTATION SUCCESS STORY.

DR. Thomas E Starzl did first liver transplantation in 1963. Since then Liver transplantation has evolved like anything. From initial one year survival rates of 20% now we have reached up to 5 year survivals of more than 90%.

It is a fascinating story about its evolution. What is the prime reason for this Success.
Yes, techniques have improved, Yes ICU care has improved but the prime reason for this Phenomenal Success is development in IMMUNOSUPRESSION DRUGS.

As we all know whenever some foreign subject enters our body, it tries to react against it. So, whenever other person’s liver enters our body. It reacts against the foreign liver also. To stop this we need to suppress body’s immunity and here comes precisely role of immunosuppressive drugs.

So, Let us go in past and start our journey from 1963 from where liver transplantation started and see how immunosuppression and liver transplantation success have travelled hand in hand.

Precyclosporine Era :

In 1967 in the following research paper Dr.Thomas Starzl reported his first extended survival (1 year) after liver transplantation. This was before an important immunosuppression drug cyclosporine was invented.



       Corticosteroids and azathioprine were used in combination as immunosupressants by Starzl et al. in his first 5 transplants.
       The majority of the Colorado (place were dr.starzl was doing liver transplantation) series from 1963 to 1976 received corticosteroids, azathioprine, and antilymphocyte globulin.
       Survival in the Early and Late Phases of the Colorado Experience (Follow-up to January 1979)
       Primary cause of death was rejection (reaction of body against liver)in 20% of cases
        
Time period
No of patients
One year survival
1963-1976
111
28%

As you can see one year  survival in 111 patient at that time was only 28%.



·      Cyclosporin Era:

At the end of 1970s and in the beginning of 1980s in the following research paper  Dr.R.Y.Calne first described use of cyclosporine in the kidney transplantation.


Dr.Starzl immediately used this drug in liver transplantation and published his results in 14 patients.


As you can see he showed that one year survival rate was almost 100% in patients for whom cyclosporine with steroid drug prednisolone was used.

In 1988 he published his experience with 1000 liver transplants in which cylosporin was used and showed 5 year survival of almost 70% in patients whom cyclosporine compared to around just 20% in patients using earlier immunosuppressant drugs like azathioprine.


Now something about cyclosporine:

       Can be administered intravenously, although it is usually given orally as a tablet or an oral suspension
       After oral administration, cyclosporine is variably absorbed in the jejunum and enters the lymphatic system.
       Peak blood levels are achieved in two to four hours.
       Cyclosporine levels should be monitored frequently in the peritransplant period (typically daily), with decreasing frequency as graft function stabilizes and rejection becomes less of a threat.
       Initial dosage 10 to 15 mg/kg/day divided into 2 doses. For any immunosuppressant its blood level has to be monitored so that it gives adequate immunosuppression while avoiding its toxic effects.
        
       Cyclosporin level in the blood goals:
       Week 1-2     250-350 ng (nanogram)/mL
       Weeks 3-4   200-300
       Weeks 5-24            150-250 ng/mL
       Weeks 25+  100-200 ng/mL
       Distant – can tolerate levels <100

Adverse effects:
       Hypertension
       Renal dysfunction
       Hirsutism
       Hyperkalemia
       Gingival hyperplasia
       Hypomagnesemia
       Neurologic toxicity


Tacrolimus: (latest and most widely used drug):

Its success results were first published in New England Journal of medicine in 1994






As you can see there was no difference in survival between tacrolimus and cyclosporin. So absolutely you will be tempted to question then why tacrolimus is a better drug for preventing rejection?? (Damage due to reaction of body against foreign liver)



But as you can see from the above graft proportion of patients who developed rejection were much less in tacrolimus group and also proportion of patents who require another drug for rejection was also much less in the tacrolimus group.

       Initial dose 0.1 to 0.15 mg/kg/day orally
       Blood level Goals (variable per patient/disease)
      Early Post-OLT – 10-15 ng/ml
      3-6 Months – 8-10
      >6 Months – 5-7 (variable)
       Tacrolimus dosing should be individualized.
       start with a low dose (0.5 to 1 mg every
       12 hours) on postoperative day one, and aim for a level of 7 to 10 ng/mL by the end of the first week.
       Often with the addition of an auxiliary agent like mycophenolate mofetil or a monoclonal antibody
Adverse effects:

       Posttransplant diabetes mellitus
       Nausea, vomiting, diarrhea
       Hyperkalemia
       Tremor
       Hypertension
       Hypomagnesemia
       Headache
       Renal dysfunction

Tripple Therapy ;

Now a days triple therapy is used for any liver transplantation, that is adding of mycophenolate to tacrolimus and steroid (prednisolone). Why it is effective??


Add caption





AS you can see from this research patient survival and graft survival was  higher when another drug mycophenolate was added to the tacrolimus and steroids.



Freedom from rejection is also much higher with triple drug therapy.

As you can see from each and every graft here that as we progressed from precyclosporinera to cyclosproin aera and to tacrolimus and to the present triple drug therapy how liver transplantation survival rates have improved and rejection rate have decreased.

Liver transplant success story is a truly success story of imuunosupressants.


Will post in another post about other drugs like sirolimus, monoclonal antibodies how to use various immunosuppressant in different situations.

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