Prednisone (Deltasone) for ITP | ChemoExperts.Platelet Disorder Support Association - for People with ITP

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Article history Submitted:. Connected Content. A related article has been published: High-dose dexamethasone vs prednisone for adult ITP. Cite Icon Cite. Medscape Continuing Medical Education online. Figure 1. View large Download PPT. Table 1 Patient demographics and baseline characteristics.

Median age, y range 43 44 View Large. Table 2 Comparison of outcomes between the 2 arms. Table 3 Duration of prednisone administration in the PDN arm. Median duration, wk range. Figure 2. Figure 3. Figure 4. Table 4 Adverse events during treatment. ALT 1 1. Conflict-of-interest disclosure: The authors declare no competing financial interests.

Search ADS. The American Society of Hematology evidence-based practice guideline for immune thrombocytopenia. International consensus report on the investigation and management of primary immune thrombocytopenia. Guidelines for the investigation and management of idiopathic thrombocytopenic purpura in adults, children and in pregnancy.

Response of resistant idiopathic thrombocytopenic purpura to pulsed high-dose dexamethasone therapy. Initial treatment of immune thrombocytopenic purpura with high-dose dexamethasone. Standardization of terminology, definitions and outcome criteria in immune thrombocytopenic purpura of adults and children: report from an international working group. Assessment of a therapeutic strategy for adults with severe autoimmune thrombocytopenic purpura based on a bleeding score rather than platelet count.

Mycophenolate mofetil MMF for the treatment of steroid-resistant idiopathic thrombocytopenic purpura. Dexamethasone plus rituximab yields higher sustained response rates than dexamethasone monotherapy in adults with primary immune thrombocytopenia. Intravenous immunoglobulin or high-dose methylprednisolone, with or without oral prednisone, for adults with untreated severe autoimmune thrombocytopenic purpura: a randomised, multicentre trial. Long-term effect of high-dose dexamethasone with or without low-dose dexamethasone maintenance in untreated immune thrombocytopenia.

Comparison between pulsed high-dose dexamethasone and daily corticosteroid therapy for adult primary immune thrombocytopenia: a retrospective study. Prednisone versus high-dose dexamethasone for untreated primary immune thrombocytopenia. Rituximab and dexamethasone vs dexamethasone monotherapy in newly diagnosed patients with primary immune thrombocytopenia. Low doses v conventional doses of corticoids in immune thrombocytopenic purpura ITP : results of a randomized clinical trial in children, adults.

Morbidity and mortality in adults with idiopathic thrombocytopenic purpura. Long-term observation of adults with chronic idiopathic thrombocytopenic purpura. Long-term follow-up of idiopathic thrombocytopenic purpura in patients.

Standardization of bleeding assessment in immune thrombocytopenia: report from the International Working Group. Newly diagnosed immune thrombocytopenia in children and adults: a comparative prospective observational registry of the Intercontinental Cooperative Immune Thrombocytopenia Study Group. Antiplatelet antibodies detected by the MAIPA assay in newly diagnosed immune thrombocytopenia are associated with chronic outcome and higher risk of bleeding.

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Always seek the advice of your physician or other qualified healthcare provider before starting any new treatment, discontinuing an existing treatment and to discuss any questions you may have regarding your unique medical condition. All rights reserved. The Platelet Disorder Support Association is a c 3 organization and donations are tax deductible to the fullest extent allowed by law.

Side Effects A partial list of the possible side effects includes: cataracts, gastrointestinal discomfort, osteoporosis, obesity, moon face, hypertension high blood pressure , diabetic metabolism blood sugar changes , sleep disturbances insomnia , psychiatric syndromes mood changes , delayed wound healing, atrophy muscle wasting, including the heart muscle , potassium loss, and changes in the skin.

Predicting Success While 50 to 90 percent of ITP patients see a rise in platelet counts with an initial high dose of corticosteroids, only 10 to 30 percent have a durable remission, and some of those may require further treatment. Corticosteroids: Related Web Sites Healthline. First, this option would likely be preferred by many patients simply on the basis of convenience.

For most patients, a four-day course of treatment with one possible iteration 10 days later will be much less burdensome than a two- to three-month course of therapy. This trial indicates that both interventions will cause a small number of patients to experience insomnia or mood disorder, but there is no evidence from this study that the frequency of these psychotropic effects would be significantly more common with HD-DXM.

Alternatively, adverse effects typically associated with longer steroid exposures weight gain, Cushingoid facies, and hyperglycemia can be expected more frequently with a prednisone taper. Finally, since more than half of adult patients will ultimately require some treatment other than corticosteroids, the HD-DXM strategy may offer the advantage of permitting the clinician to identify which patients will require additional therapy e. If the physician and the patient value these potential advantages, they can now proceed with HD-DXM knowing that it is at least as effective as a prednisone taper for both short- and long-term responses.

Sign In or Create an Account. Sign In. Search Dropdown Menu. Patients under the age of 65 years, or those with private insurance plans: If you have insurance and are looking for patient assistance or copay assistance for Prednisone, we have provided links that may help. Visit our Patient Assistance page and click the links to various patient assistance programs for help paying for Prednisone. Depending upon your income, they may be able to help cover the cost of:.

For Branded medications may be available for generic medications too , check with the manufacturer to determine if a co-pay card is offered and if it could reduce your monthly copay. Medicare and Medicaid patients Patients 65 years or older : The clinic providing treatment will likely pre-authorize medications and immune therapies such as Prednisone and are the best source to help you understand drug cost. What is Emotional Wellness? Emotional wellness is having a positive outlook balanced with a realistic understanding of current life events.

This requires both an awareness and acceptance of your emotions. It is with this knowledge that you can develop a plan to take the necessary actions to positively impact your life. Emotional wellness uses an ongoing process to continually reflect on the stressors of life in a constructive manner to move forward and create happiness. Because emotional wellness is deeply connected with physical, social, and spiritual wellness, pursuing it often becomes particularly difficult in times of major illness.

Despite this difficulty, working toward emotional wellness has been connected to improved treatment outcomes and a higher likelihood of achieving goals of therapy. Learn more about pursuing emotional wellness while receiving treatment with Prednisone.

High-dose dexamethasone vs prednisone for treatment of adult immune thrombocytopenia: a prospective multicenter randomized trial. Blood ;

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Treating low platelets with prednisone.Corticosteroids

Dexamethasone is given at the rate of 40 mg per day for four days, equivalent to about mg of prednisone a day. There is no taper. The series can be repeated periodically as needed. A partial list of the possible side effects includes: cataracts, gastrointestinal discomfort, osteoporosis, obesity, moon face, hypertension high blood pressure , diabetic metabolism blood sugar changes , sleep disturbances insomnia , psychiatric syndromes mood changes , delayed wound healing, atrophy muscle wasting, including the heart muscle , potassium loss, and changes in the skin.

Initial CR was the only definite positive indicator associated with an increased incidence of SR in the initial responders of both arms analyzed by the logistic regression model OR, 0. Moreover, none of the baseline parameters was significantly correlated with SR in either arm. Duration of PDN administration is shown in Table 3. We attempted to compare the incidence of SR without maintaining therapy between the 2 arms. Because a 3-month interval might be necessary to exclude the impact of the maintaining dose of PDN, the comparison was made between the HD-DXM arm and the 25 patients 15 achieving SR who were able to terminate PDN within 3 months of follow-up.

These numbers did not include patients who discontinued prednisone because of a loss of response. We further estimated the duration of response stratified by the quality of the initial response CR or R. Patients in the HD-DXM arm benefitted from consistently higher platelet levels subsequent to the achievement of initial response.

Kaplan-Meier estimates of the duration of response. Kaplan-Meier estimates of the cumulative loss of response stratified by initial response quality CR or R. Antiplatelet autoantibodies were detected in patients No deaths were recorded throughout the treatment or the follow-up periods. Both treatments were well tolerated in general.

Most of the adverse effects were mild to moderate graded 1 or 2 and usually resolved spontaneously after medication was completed. All adverse events had been previously described or reported. Of the 2 patients who discontinued treatment because of adverse effects in the PDN arm, 1 was a year-old woman who suffered from pneumonia and required intravenous antibiotics to control the infection; the other was a year-old woman with grade 3 hyperglycemia and no history of diabetes mellitus or impaired glucose tolerance.

Neither patient showed an elevation in platelet count by the time of exit. Although guidelines by the American Society of Hematology recommended longer courses of corticosteroids as first-line treatment, 2 it should be noted that this recommendation was based on a randomized, controlled trial RCT in which a short course of high-dose methylprednisolone followed by PDN acted more effectively than that followed by placebo.

In most studies, initial response was achieved in approximately two-thirds of patients. The incidence of overall response was higher in the HD-DXM arm, though the difference was not statistically significant by PP population. HD-DXM also more significantly reduced bleeding manifestations.

Both the average bleeding score and the number of patients presenting bleeding symptoms were lower in the HD-DXM arm. These 2 interventions led to comparable SR rates and duration of response by Kaplan-Meier analysis.

These findings suggest that HD-DXM could be a more effective choice at the early stage of treatment and could produce at least equivalent long-term outcomes to conventional PDN without the burden of long-term corticosteroid administration. No deaths occurred throughout our study. One reason was that, for safety, we excluded patients with life-threatening bleeding at enrollment. Most adverse effects were tolerable. Occurrence of adverse events was more frequent and long-lasting in the PDN arm, with 2 cases discontinuing therapy because of adverse effects.

The better tolerance of HD-DXM might be attributed to its limited duration because adverse events in this arm were usually transient and spontaneously resolved after the completion of medication.

In addition to platelet count, bleeding manifestations should also be considered as an essential parameter of disease severity in ITP. The IWG has published a standardization of bleeding assessment in ITP based on bleeding manifestations and severity 23 ; however, unfortunately, it was not yet available when our study was designed in Antiplatelet autoantibodies were detected in approximately half of the enrolled patients, comparable to a recent observational registry study.

In conclusion, results from this prospective, multicenter, randomized, controlled study suggest that 1 or 2 courses of HD-DXM provides a more effective and more rapid response as initial treatment of ITP, with at least comparable long-term prognosis and better tolerance when compared with conventional PDN.

The publication costs of this article were defrayed in part by page charge payment. Michael's Hospital, University of Toronto, for language editing of the manuscript. Contribution: Y.

All authors read and edited the manuscript. Sign In or Create an Account. Sign In. Search Dropdown Menu. Skip Nav Destination Content Menu. Close Key Points. Article Navigation. ITP is NOT a cancer, but it is commonly managed by hematologists blood doctors who often treat blood cancers as well. ITP is an uncommon condition and may be caused by auto-immune disorders, infections, certain medications, or pregnancy.

Although ITP may spontaneously resolve, for some patients lifelong therapy may be needed. The effectiveness of medications may depend upon the causes of ITP and the ability to remove these causes, or whether a splenectomy removal of the spleen has been performed, or is able to be performed.

In general, steroids such as prednisone and dexamethasone have the fastest "0 - 50" time. A 5-year bumper-to-bumper warranty helps us worry less about something breaking or going wrong with our vehicle after we buy it. The ability for a treatment to maintain the platelet count within the goal range is similar to setting the cruise control on a car. A Complete Blood Count CBC is a frequently ordered blood test that tells clinicians the status of your: 1 White blood cell count, 2 Hemoglobin, and 3 Platelet count at the time the test was taken.

Common uses: 1 White blood cell count WBC : is used to determine infection risk, or response to chemotherapy. Certain chemotherapy agents may harm our good infection-fighting cells.

Sometimes chemotherapy may need to be delayed to allow these cells to recover. Red blood cell transfusions, and sometimes iron can be given to restore the hemoglobin level, but anemia treatment should always aim at treating the underlying cause or condition. Certain medications that increase bleeding risk, such as: aspirin, certain chemotherapy agents, and blood thinners, may need to be stopped temporarily until the platelet count is within a safe range. It is commonly used to monitor liver and kidney function when beginning new medications such as chemotherapy.

A total of 14 tests are run simultaneously and are shown below. Diffusion March 25, This Site. Google Scholar. The Hematologist 13 3. McMillan R. Chronic idiopathic thrombocytopenia purpura. Initial treatment of immune thrombocytopenic purpura with high-dose dexamethasone. The American Society of Hematology evidence-based practice guideline for immune thrombocytopenia. Competing Interests Dr.

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Treating low platelets with prednisone -

Moreover, adverse events caused by corticosteroids often outweigh the benefits because of the long-term administration.

Platelet counts should be confirmed on 2 separate occasions at least 7 days apart when defining CR or R. Secondary end points included bleeding scores, time to response, duration of response, and adverse events.

Bleeding scores were assessed at both baseline and evaluation of the initial response. Time to response was defined as the duration from initiation of treatment to achievement of CR or R. Initial responders underwent monthly follow-up visits for at least 1 year or until loss of R. Adverse events were evaluated according to Common Terminology Criteria for Adverse Events, version 3. Patients who experienced severe adverse effects would stop the allocated intervention and exit the study by determination of physicians.

Each patient underwent a safety follow-up for 1 month after medication was terminated. Calculation of sample size was based on 1 of the primary end points, the initial response, resulting from the lack of definite data for SR. We included all patients who received allocated intervention as intention-to-treat population in the description of baseline characteristics and the analysis of efficacy and safety.

To provide supplemental data, incidences of the 2 primary end points were described by per-protocol PP population, which excluded cases discontinuing the allocated intervention and cases lost to follow-up. Descriptive statistics were used to summarize baseline characteristics and safety data. We used a logistic regression model to evaluate the correlation between certain baseline parameters and initial or sustained response.

The Kaplan-Meier method and log-rank test were used to evaluate differences in duration of response between groups. Between January and May , patients were screened for eligibility and were ultimately enrolled, of whom 97 were randomly assigned to the HD-DXM arm and 98 to the PDN arm. Two cases in the HD-DXM arm and 1 in the PDN arm did not receive the allocated intervention due to consent withdrawal 1 vs 1 or amended diagnosis 1 vs 0.

Three cases in the HD-DXM arm and 7 in the PDN arm exited the study during treatment due to consent withdrawal 2 vs 1 , requirement of additional intervention 1 vs 4 or adverse events 0 vs 2. Baseline characteristics were comparable between the 2 arms Table 1. There were more females than males with no significant difference in age between genders.

One hundred and 55 patients Skin Visceral bleeding was observed in 26 patients These patients presented with significantly more severe bleeding manifestations, with a median bleeding score of 4. Bleeding score was graded by an ITP-specific bleeding scale by Khellaf et al. However, the difference was not significant if evaluated by PP population These data included ITP-modifying additional therapy administered to initial nonresponders and patients who failed to achieve sustained response.

There was also no significant difference in the incidence of SR evaluated by PP population Initial CR was the only definite positive indicator associated with an increased incidence of SR in the initial responders of both arms analyzed by the logistic regression model OR, 0. Moreover, none of the baseline parameters was significantly correlated with SR in either arm. Duration of PDN administration is shown in Table 3.

We attempted to compare the incidence of SR without maintaining therapy between the 2 arms. Because a 3-month interval might be necessary to exclude the impact of the maintaining dose of PDN, the comparison was made between the HD-DXM arm and the 25 patients 15 achieving SR who were able to terminate PDN within 3 months of follow-up.

Patients in the HD-DXM arm benefitted from consistently higher platelet levels subsequent to the achievement of initial response. Kaplan-Meier estimates of the duration of response. Kaplan-Meier estimates of the cumulative loss of response stratified by initial response quality CR or R. Antiplatelet autoantibodies were detected in patients No deaths were recorded throughout the treatment or the follow-up periods. Both treatments were well tolerated in general.

Most of the adverse effects were mild to moderate graded 1 or 2 and usually resolved spontaneously after medication was completed. All adverse events had been previously described or reported.

Of the 2 patients who discontinued treatment because of adverse effects in the PDN arm, 1 was a year-old woman who suffered from pneumonia and required intravenous antibiotics to control the infection; the other was a year-old woman with grade 3 hyperglycemia and no history of diabetes mellitus or impaired glucose tolerance. Neither patient showed an elevation in platelet count by the time of exit.

Although guidelines by the American Society of Hematology recommended longer courses of corticosteroids as first-line treatment, 2 it should be noted that this recommendation was based on a randomized, controlled trial RCT in which a short course of high-dose methylprednisolone followed by PDN acted more effectively than that followed by placebo.

The design of this study was based on the standardized definitions and outcome criteria of the IWG. Numerous studies, mostly retrospective, had presented data on the standard dose of PDN or its equivalent for initial treatment of adult primary ITP. In most studies, initial response was achieved in approximately two-thirds of patients. The incidence of overall response was higher in the HD-DXM arm, though the difference was not statistically significant by PP population.

HD-DXM also more significantly reduced bleeding manifestations. Both the average bleeding score and the number of patients presenting bleeding symptoms were lower in the HD-DXM arm. These 2 interventions led to comparable SR rates and duration of response by Kaplan-Meier analysis.

We found that initial CR was a definite positive predictor of better long-term outcomes. However, patients in the HD-DXM arm generally benefitted from higher platelet level subsequent to achieving initial response. These findings suggest that HD-DXM could be a more effective choice at the early stage of treatment and could produce at least equivalent long-term outcomes to conventional PDN without the burden of long-term corticosteroid administration.

No deaths occurred throughout our study. One reason was that, for safety, we excluded patients with life-threatening bleeding at enrollment. Most adverse effects were tolerable. Occurrence of adverse events was more frequent and long-lasting in the PDN arm, with 2 cases discontinuing therapy because of adverse effects.

The better tolerance of HD-DXM might be attributed to its limited duration because adverse events in this arm were usually transient and spontaneously resolved after the completion of medication. In addition to platelet count, bleeding manifestations should also be considered as an essential parameter of disease severity in ITP. The IWG has published a standardization of bleeding assessment in ITP based on bleeding manifestations and severity 23 ; however, unfortunately, it was not yet available when our study was designed in Antiplatelet autoantibodies were detected in approximately half of the enrolled patients, comparable to a recent observational registry study.

HD-DXM also enables patients to avoid the burden of long-term corticosteroids. Furthermore, because it has been shown that repeated courses of medication may yield better long-term outcome, 8 future RCTs should be designed to compare the effect of repeated courses vs a limited course of HD-DXM. The publication costs of this article were defrayed in part by page charge payment. Michael's Hospital, University of Toronto, for language editing of the manuscript.

Contribution: Y. All authors read and edited the manuscript. Sign In or Create an Account. Sign In. Search Dropdown Menu. Skip Nav Destination Content Menu. Close Key Points. Article Navigation. CME article January 21, This Site. Google Scholar. Jing-xia Wang , Jing-xia Wang. En-qin Yang , En-qin Yang. Zheng-cheng Wang , Zheng-cheng Wang. Yu-qi Sang , Yu-qi Sang. Zuo-mu Bi , Zuo-mu Bi.

Cui-ai Ren , Cui-ai Ren. Fang Zhou , Fang Zhou. Guo-qiang Liu , Guo-qiang Liu. Jun Peng , Jun Peng. Ming Hou Ming Hou. Blood 3 : — Article history Submitted:. Connected Content. A related article has been published: High-dose dexamethasone vs prednisone for adult ITP. Cite Icon Cite. Medscape Continuing Medical Education online. Figure 1. A partial list of the possible side effects includes: cataracts, gastrointestinal discomfort, osteoporosis, obesity, moon face, hypertension high blood pressure , diabetic metabolism blood sugar changes , sleep disturbances insomnia , psychiatric syndromes mood changes , delayed wound healing, atrophy muscle wasting, including the heart muscle , potassium loss, and changes in the skin.

Side effects from corticosteroids can be difficult to manage and grow in severity if the treatment is continued for a long period of time. The side effects of withdrawing from prednisone can also cause problems. It is important to work closely with your physician as the drug is discontinued. While 50 to 90 percent of ITP patients see a rise in platelet counts with an initial high dose of corticosteroids, only 10 to 30 percent have a durable remission, and some of those may require further treatment.

Corticosteroid drugs—including prednisone, dexamethasone and deflazacort—are often the first-line treatment approach for ITP. Some research indicates that short courses of dexamethasone are preferable in treating newly diagnosed cases.

Both prednisone and dexamethasone are types of corticosteroids, drugs based on a naturally occurring hormone produced by the adrenal glands involved in the control of inflammation, stress response, metabolism, behavior, electrolyte balance and more.

Prednisone and other corticosteroids disrupt the communication between the pituitary and adrenals, which can lead to adrenal insufficiency. It is very important that the corticosteroid dose be tapered gradually, especially after high dose or long-term use, giving the adrenals a chance to resume their natural hormone production.

Dexamethasone, in combination with rituximab, has produced better results in newly diagnosed patients than dexamethasone alone.

The usual starting dose of the corticosteroids prednisone or prednisolone for ITP patients is. For example, pounds would equal a dose of 60 mg. Dexamethasone is given at the rate of 40 mg per day for four days, equivalent to about mg of prednisone a day. There is no taper. The series can be repeated periodically as needed.

A partial list of the possible side effects includes: cataracts, gastrointestinal discomfort, osteoporosis, obesity, moon face, hypertension high blood pressurediabetic metabolism blood sugar changessleep disturbances insomniapsychiatric syndromes mood changesdelayed wound healing, atrophy muscle wasting, including the heart musclepotassium loss, and changes in the skin. Side effects from corticosteroids can be difficult to manage and grow in severity if the treatment is continued for a long period of time.

The side effects of withdrawing from prednisone can also cause problems. It is important to work closely with your physician as the drug is discontinued. While 50 to 90 percent of ITP patients see a rise in platelet counts with an initial high dose of corticosteroids, only 10 to 30 percent have a durable remission, and some of those may require further treatment.

Buy your copy at the Platelet Store. About PDSA. Stay Informed. The Platelet Disorder Support Association does not provide medical advice or endorse any medication, vitamins or herbs. The information contained herein is not intended nor implied to be a substitute for professional medical advice and is provided for educational purposes only. Always seek the advice of your physician or other qualified healthcare provider before starting any new treatment, discontinuing an existing treatment and to discuss any questions you may have regarding your unique medical condition.

All rights reserved. The Platelet Disorder Support Association is a c 3 organization and donations are tax deductible to the fullest extent allowed by law. Side Effects A partial list of the possible side effects includes: cataracts, gastrointestinal discomfort, osteoporosis, obesity, moon face, hypertension high blood pressurediabetic metabolism blood sugar changessleep disturbances insomniapsychiatric syndromes mood changesdelayed wound healing, atrophy muscle wasting, including the heart musclepotassium loss, and changes in the skin.

Predicting Success While 50 to 90 percent of ITP patients see a rise in platelet counts with an initial high dose of corticosteroids, only 10 to 30 percent have a durable remission, and some of those may require further treatment. Corticosteroids: Related Web Sites Healthline. Donate make a one-time donation start your monthly gift today donate in honor of someone donate in memory of someone donate to the research program donate to the pdsa college scholarship program why your donation matters other ways to donate.

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localhost › prednisone-itp. Adults, Prednisone mg/kg per day with taper ; Dexamethasone 40 mg/d × 4 days for cycles. Corticosteroids ("steroids") — Steroids prevent bleeding by decreasing the production of antibodies against platelets. If effective, the platelet count will. Prednisone is also commonly taken with the goal of achieving a long-term remission from ITP. localhost › prednisone-itp. These 2 interventions led to comparable SR rates and duration of response by Kaplan-Meier analysis. The taper schedule was determined by physicians but was supposed to be within 4 to 6 weeks. Antiplatelet autoantibodies were detected in patients Ming Hou Ming Hou. We are now a c3 non-profit organization, so your donations are tax-deductible. Table 1 Patient demographics and baseline characteristics. High-dose dexamethasone vs prednisone for treatment of adult immune thrombocytopenia: a prospective multicenter randomized trial.

Blood ; 3 : — This study compared the efficacy and safety of high-dose dexamethasone HD-DXM and conventional prednisone PDN on the largest cohort to date as first-line strategies for newly diagnosed adult primary immune thrombocytopenia ITP. Sustained response was achieved by Initial complete response was a positive indicator of sustained response, whereas presence of antiplatelet autoantibodies was a negative indicator.

HD-DXM was generally tolerated better. This study is registered at www. Physicians should claim only the credit commensurate with the extent of their participation in the activity. All other clinicians completing this activity will be issued a certificate of participation. For CME questions, see page Compare the efficacy of high-dose dexamethasone vs conventional prednisone as a first-line strategy for newly diagnosed adult idiopathic thrombocytopenia, based on a prospective, multicenter, randomized trial.

Compare the safety of high-dose dexamethasone vs conventional prednisone as a first-line strategy for newly diagnosed adult idiopathic thrombocytopenia. Describe other advantages of high-dose dexamethasone and predictors of response to this drug as a first-line strategy for newly diagnosed adult idiopathic thrombocytopenia.

Immune thrombocytopenia ITP is an autoimmune thrombocytopenic syndrome characterized by decreased platelet count and an increased risk of bleeding. Conventionally, the pathogenesis of ITP has been described as autoantibody-mediated platelet overdestruction.

Recent studies indicated more complex mechanisms including cytotoxic T-lymphocyte—induced platelet lysis, impaired megakaryocyte maturation, and insufficient platelet production. Immune abnormalities of T-lymphocyte subsets play essential roles in the cellular and molecular mechanisms of ITP. Patients failing first-line treatment should be managed with splenectomy or second-line agents eg, thrombopoietic-stimulating agents, rituximab. Moreover, adverse events caused by corticosteroids often outweigh the benefits because of the long-term administration.

However, it must be recognized that neither of these studies included PDN as a control; therefore, a randomized comparison is still needed to clarify which of the 2 corticosteroid regimens is superior.

As consensus of definitions and outcome criteria in ITP have been achieved, 9 it is important to reassess the efficacy of ITP medications using the standardized criteria. The study was conducted in collaboration among 9 separate investigation sites in China. Data were collected from each participating site and sent to the principal investigation site at Qilu Hospital, Shandong University, for analysis. The study protocol was approved by the ethics committee on medical research of each participating site.

All patients provided written informed consent in accordance with the Declaration of Helsinki before enrollment. Patients eligible for enrollment were aged 18 years or older of both genders and were diagnosed with primary ITP according to the International Working Group IWG guidelines. However, for safety considerations, patients with life-threatening bleeding eg, massive hemorrhage with severe anemia, central nervous system bleeding were not permitted to enroll.

Any previous ITP-specific therapy was considered an exclusion criterion. Patients who had received corticosteroids or immunosuppression therapy for non-ITP diseases within 3 months before enrollment were excluded.

Other exclusion criteria included malignancy, connective tissue diseases, seropositive detection of HIV, hepatitis B virus or hepatitis C virus, pregnancy or lactation, active infection, hypertension, diabetes, cardiovascular diseases, liver and kidney function impairment, psychosis, and osteoporosis. Randomization was conducted centrally at Qilu Hospital, Shandong University, using precoded concealed envelopes generated by permuted-block randomization with a block size of 4.

No blinding of physicians or patients was used. Bleeding symptoms were graded by a standardized ITP-specific bleeding scale based on the site and severity of bleeding.

A modification was made to exclude age from the original scale so that only bleeding symptoms were described. Because platelet counts should be confirmed on 2 separate occasions at least 7 days apart when defining response, 9 the additional course of medication was also administered to patients who transiently fulfilled criteria of response but did not show response at the time of confirmation.

In responders, the medication was tapered gradually to a maintenance dose of less than 15 mg daily or complete termination. The taper schedule was determined by physicians but was supposed to be within 4 to 6 weeks. If complete response CR was achieved, the taper could begin as early as the third week. PDN was rapidly tapered to termination in nonresponders after 4 weeks.

In both arms, nonresponders exited the study and other treatments were considered. Platelet transfusion and hemostatic agents were permitted to prevent severe bleeding and were recorded.

Requirements for any additional ITP-modifying intervention were considered as treatment failure. The primary end points were initial response and SR. Platelet counts should be confirmed on 2 separate occasions at least 7 days apart when defining CR or R. Secondary end points included bleeding scores, time to response, duration of response, and adverse events. Bleeding scores were assessed at both baseline and evaluation of the initial response.

Time to response was defined as the duration from initiation of treatment to achievement of CR or R. Initial responders underwent monthly follow-up visits for at least 1 year or until loss of R. Adverse events were evaluated according to Common Terminology Criteria for Adverse Events, version 3.

Patients who experienced severe adverse effects would stop the allocated intervention and exit the study by determination of physicians. Each patient underwent a safety follow-up for 1 month after medication was terminated.

Calculation of sample size was based on 1 of the primary end points, the initial response, resulting from the lack of definite data for SR. We included all patients who received allocated intervention as intention-to-treat population in the description of baseline characteristics and the analysis of efficacy and safety. To provide supplemental data, incidences of the 2 primary end points were described by per-protocol PP population, which excluded cases discontinuing the allocated intervention and cases lost to follow-up.

Descriptive statistics were used to summarize baseline characteristics and safety data. We used a logistic regression model to evaluate the correlation between certain baseline parameters and initial or sustained response.

Two cases in the HD-DXM arm and 1 in the PDN arm did not receive the allocated intervention due to consent withdrawal 1 vs 1 or amended diagnosis 1 vs 0. Three cases in the HD-DXM arm and 7 in the PDN arm exited the study during treatment due to consent withdrawal 2 vs 1 , requirement of additional intervention 1 vs 4 or adverse events 0 vs 2. Baseline characteristics were comparable between the 2 arms Table 1. There were more females than males with no significant difference in age between genders.

One hundred and 55 patients Skin Visceral bleeding was observed in 26 patients These patients presented with significantly more severe bleeding manifestations, with a median bleeding score of 4.

Bleeding score was graded by an ITP-specific bleeding scale by Khellaf et al. However, the difference was not significant if evaluated by PP population These data included ITP-modifying additional therapy administered to initial nonresponders and patients who failed to achieve sustained response.

We evaluated potential prognostic parameters under the logistic regression model. Gender, age, and baseline platelet count had no significant correlation with response to either corticosteroid regimen. There was also no significant difference in the incidence of SR evaluated by PP population Initial CR was the only definite positive indicator associated with an increased incidence of SR in the initial responders of both arms analyzed by the logistic regression model OR, 0.

Moreover, none of the baseline parameters was significantly correlated with SR in either arm. Duration of PDN administration is shown in Table 3. We attempted to compare the incidence of SR without maintaining therapy between the 2 arms.

Because a 3-month interval might be necessary to exclude the impact of the maintaining dose of PDN, the comparison was made between the HD-DXM arm and the 25 patients 15 achieving SR who were able to terminate PDN within 3 months of follow-up. These numbers did not include patients who discontinued prednisone because of a loss of response. We further estimated the duration of response stratified by the quality of the initial response CR or R. Patients in the HD-DXM arm benefitted from consistently higher platelet levels subsequent to the achievement of initial response.

All adverse events had been previously described or reported. Of the 2 patients who discontinued treatment because of adverse effects in the PDN arm, 1 was a year-old woman who suffered from pneumonia and required intravenous antibiotics to control the infection; the other was a year-old woman with grade 3 hyperglycemia and no history of diabetes mellitus or impaired glucose tolerance.

Numerous studies, mostly retrospective, had presented data on the standard dose of PDN or its equivalent for initial treatment of adult primary ITP. In most studies, initial response was achieved in approximately two-thirds of patients. The incidence of overall response was higher in the HD-DXM arm, though the difference was not statistically significant by PP population. HD-DXM also more significantly reduced bleeding manifestations.

Both the average bleeding score and the number of patients presenting bleeding symptoms were lower in the HD-DXM arm.

These 2 interventions led to comparable SR rates and duration of response by Kaplan-Meier analysis. We found that initial CR was a definite positive predictor of better long-term outcomes. However, patients in the HD-DXM arm generally benefitted from higher platelet level subsequent to achieving initial response. These findings suggest that HD-DXM could be a more effective choice at the early stage of treatment and could produce at least equivalent long-term outcomes to conventional PDN without the burden of long-term corticosteroid administration.

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