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Related Experiment Videos

The didanosine Expanded Access Program: safety analysis

I M Pike1, C Nicaise

  • 1Bristol-Myers Oncology Division, Princeton, New Jersey 08543-4500.

Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America
|February 1, 1993
PubMed
Summary

Didanosine expanded access provided treatment for patients unable to join trials. Major risks include pancreatitis and neuropathy, but didanosine shows minimal myelosuppression compared to zidovudine.

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Area of Science:

  • Pharmacology
  • Clinical Medicine
  • Drug Safety

Background:

  • Didanosine (ddI) Expanded Access Program (EAP) provided access to patients ineligible for clinical trials.
  • Two protocols were established: Treatment Investigational New Drug (IND) for zidovudine-intolerant patients and an open-label protocol for those with deteriorating conditions on zidovudine.
  • The program aimed to gather safety and efficacy data on didanosine in a broader patient population.

Purpose of the Study:

  • To evaluate the safety and tolerability of didanosine in patients not enrolled in clinical trials.
  • To assess the adverse event profile of didanosine, focusing on pancreatitis, peripheral neuropathy, and diarrhea.
  • To compare the hematologic effects of didanosine with zidovudine.

Main Methods:

Related Experiment Videos

  • Analysis of safety data from the first 7,806 patients enrolled in the didanosine EAP.
  • Retrospective review of adverse events, including pancreatitis, peripheral neuropathy, and diarrhea.
  • Assessment of hematologic parameters in patients receiving didanosine, with comparison to baseline and zidovudine data.

    • Main Results:

    • The most frequent major adverse events were pancreatitis (5% of patients), peripheral neuropathy, and diarrhea.
    • Patients with a prior history of pancreatitis had a higher risk of developing it with didanosine.
    • Didanosine demonstrated minimal myelosuppression, with stable hematologic parameters, particularly in patients with normal baseline values, contrasting with zidovudine's effects.

    Conclusions:

    • Didanosine EAP provided critical access to treatment for patients with limited options.
    • While pancreatitis and neuropathy are significant risks, didanosine is generally well-tolerated and minimally myelosuppressive.
    • Patients previously treated with zidovudine tolerated didanosine well, suggesting potential for sequential therapy.