-
The Cochrane Database of Systematic... May 2013This is an updated Cochrane review of the previous published version.Mitoxantrone (MX) has been shown to be moderately effective in reducing the clinical outcome... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
This is an updated Cochrane review of the previous published version.Mitoxantrone (MX) has been shown to be moderately effective in reducing the clinical outcome measures of disease activity in multiple sclerosis (MS) patients.
OBJECTIVES
The main objective was to assess the efficacy and safety of MX compared to a control group in relapsing-remitting (RRMS), progressive relapsing (PRMS) and secondary progressive (SPMS) MS participants.
SEARCH METHODS
We searched the Cochrane Multiple Sclerosis and Rare Diseases of the Central Nervous System Group Specialised Register (June 2012) and reference lists of articles. We also undertook handsearching and contacted trialists and pharmaceutical companies.
SELECTION CRITERIA
Randomised, double-blinded, controlled trials (RCTs) comparing the administration of MX versus placebo or MX plus steroids treatment versus placebo plus steroids treatment were included.
DATA COLLECTION AND ANALYSIS
The review authors independently selected articles for inclusion. They independently extracted clinical, safety and magnetic resonance imaging (MRI) data, resolving disagreements by discussion. Risk of bias was evaluated to assess the quality of the studies. Treatment effect was measured using odds ratios (OR) with 95% confidence intervals (CI) for the binary outcomes and mean differences (MD) with 95% CI for the continuous outcomes. If heterogeneity was absent, a fixed-effect model was used.
MAIN RESULTS
Three trials were selected and 221 participants were included in the analyses. MX reduced the progression of disability at two years follow-up (proportion of participants with six months confirmed progression of disability (OR 0.30, 95% CI 0.09 to 0.99 and MD -0.36, 95% CI- 0.70 to -0.02; P = 0.04)). Significant results were found regarding the reduction in annualised relapse rate (MD -0.85, 95% CI -1.47 to -0.23; P = 0.007), the proportion of patients free from relapses at one year (OR 7.13, 95% CI 2.06 to 24.61; P = 0.002) and two years (OR 2.82, 95% CI 1.54 to 5.19; P = 0.0008), and the number of patients with active MRI lesions at six months or one year only (OR 0.24, 95% CI 0.10 to 0.57; P = 0.001). Side effects reported in the trials (amenorrhoea, nausea and vomiting, alopecia and urinary tract infections) were more frequent in treated patients than in controls, while no major adverse events have been reported. These results should be considered with caution because of the heterogeneous characteristics of included trials in term of drug dosage, inclusion criteria and quality of included trials. Moreover, it was not possible to estimate the long-term efficacy and safety of MX.
AUTHORS' CONCLUSIONS
MX shows a significant but partial efficacy in reducing the risk of MS progression and the frequency of relapses in patients affected by worsening RRMS, PRMS and SPMS in the short-term follow-up (two years). No major neoplastic events or symptomatic cardiotoxicity related to MX have been reported; however studies with longer follow-up (not included in this review) have raised concerns about the risk of systolic disfunction (˜12%) and therapy-related acute leukaemias (0.8%), which are increasingly reported in the literature.MX should be limited to treating patients with worsening RRMS and SPMS and with evidence of persistent inflammatory activity after a careful assessment of the individual patients' risk and benefit profiles. Assessment should also consider the present availability of alternative therapies with less severe adverse events.
Topics: Disease Progression; Humans; Immunosuppressive Agents; Mitoxantrone; Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive; Multiple Sclerosis, Relapsing-Remitting; Randomized Controlled Trials as Topic
PubMed: 23728638
DOI: 10.1002/14651858.CD002127.pub3 -
Health Technology Assessment... 2012Follicular lymphoma (FL) is a non-Hodgkin's lymphoma which typically presents when the disease is at an advanced stage. The majority of patients receive first-line... (Review)
Review
BACKGROUND
Follicular lymphoma (FL) is a non-Hodgkin's lymphoma which typically presents when the disease is at an advanced stage. The majority of patients receive first-line therapy of rituximab in combination with chemotherapy, with two-thirds receiving cyclophosphamide, vincristine and prednisolone. The clinical and cost-effectiveness of other chemotherapies in combination with rituximab in first-line therapy is not known.
OBJECTIVE
To systematically evaluate and appraise the clinical effectiveness and cost-effectiveness of rituximab (MabThera(®), Roche Products) in combination with chemotherapy, compared with chemotherapy alone, for the first-line treatment of symptomatic stage III-IV FL.
DATA SOURCES
A systematic review of literature and an economic evaluation were carried out. Key databases [including MEDLINE In-Process & Other Non-Indexed Citations; Cumulative Index to Nursing and Allied Health Literature (CINAHL); EMBASE; The Cochrane Library, including the Cochrane Database of Systematic Reviews (CDSR), Cochrane Central Register of Controlled Trials (CENTRAL), Database of Abstracts of Reviews of Effects (DARE), NHS Economic Evaluation Database (NHS EED) and Health Technology Assessment (HTA) databases; Science Citation Index (SCI); and BIOSIS], plus research registers and conference proceedings, were searched for relevant studies from inception up to October 2010.
REVIEW METHODS
One reviewer assessed titles and abstracts of studies identified by the search strategy, obtained the full text of relevant papers and screened them against inclusion criteria. Data from included studies were extracted by one reviewer using a standardised data extraction form and checked by a second reviewer. The quality of included studies was assessed by one reviewer and checked by a second. A patient-level simulation model was developed to estimate the costs and quality-adjusted life-year (QALY) gains from the perspective of the UK NHS and Personal Social Services, with costs and benefits discounted at 3.5% annually.
RESULTS
Four randomised controlled trials comparing rituximab plus chemotherapy (R-chemotherapy) with chemotherapy alone in untreated, symptomatic patients with stage III-IV FL were identified. R-chemotherapy compared with chemotherapy alone increased the likelihood of a response to treatment in all four trials, with no additional toxicity of clinical relevance. Overall response rates were significantly improved in all four trials, with a difference between the R-chemotherapy and chemotherapy arms of between 5% and 24%, respectively. Complete response rates were also improved, with a difference between the R-chemotherapy and chemotherapy arms of between 2% and 25%, respectively. Exploratory meta-analyses were conducted; the level of statistical heterogeneity was very high and thus we believe the response rates from the individual trials to be a more robust estimator of the efficacy of the specific R-chemotherapy regimens. Over a follow-up period of 4-5 years, R-chemotherapy significantly increased the overall survival rate compared with chemotherapy alone in three trials, although data for two trials were compromised owing to the use of additional treatments. The incremental cost-effectiveness ratio (ICER) for the addition of rituximab to CVP (cyclophosphamide, vincristine and prednisolone), CHOP (cyclophosphamide, doxorubicin/adriamycin, vincristine and prednisolone) and MCP [mitoxantrone, chlorambucil (Leukeran(®), Aspen) and prednisolone] was £7720, £10,834 and £9316 per QALY gained, respectively, when it was assumed that first-line rituximab maintenance was not used. A scenario analysis is also presented, assuming that responders to R-chemotherapy in first-line induction receive maintenance with rituximab, increasing the ICER to £14,959, £21,687 and £20,493 per QALY gained, respectively.
LIMITATIONS
These relate to the sources of data used for the effectiveness in first and second line and the assumed utility values; there is uncertainty about the effect of salvage treatment on patients who had been previously treated with an anthracycline regimen. There is uncertainty whether or not rituximab is as effective in second-line treatment when patients have been previously treated with rituximab.
CONCLUSIONS
The results from four randomised trials comparing R-chemotherapy with chemotherapy alone showed an improvement in clinical effectiveness outcomes, with minimal clinically relevant additional adverse events or toxicity. The cost per QALY gained is estimated to be < £25,000 for all three comparisons under our base-case assumption and is considerably lower if first-line rituximab maintenance is not assumed. More data on patients pre-treated with rituximab and on the effect of first-line maintenance with rituximab is required for future work.
FUNDING
The National Institute for Health Research Health Technology Assessment programme.
Topics: Antibodies, Monoclonal, Murine-Derived; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Chlorambucil; Cost-Benefit Analysis; Cyclophosphamide; Doxorubicin; England; Female; Humans; Lymphoma, Follicular; Male; Middle Aged; Mitoxantrone; Models, Economic; Prednisolone; Prednisone; Randomized Controlled Trials as Topic; Rituximab; Vincristine; Wales
PubMed: 23021127
DOI: 10.3310/hta16370 -
Breastfeeding Medicine : the Official... Dec 2012Despite popular and historical use, there has been little modern research conducted to determine the safety and efficacy of herb use during breastfeeding. The purpose of... (Review)
Review
OBJECTIVES
Despite popular and historical use, there has been little modern research conducted to determine the safety and efficacy of herb use during breastfeeding. The purpose of this study was to systematically review the clinical literature on herbal medicine and lactation.
METHODS
The databases PubMed, CAB Abstracts, Cochrane Central Register of Controlled Trials, HealthSTAR, Cumulative Index to Nursing and Allied Health Literature, and Reprotox were systematically searched for human trials from 1970 until 2010. Reference lists from relevant articles were hand-searched.
RESULTS
Thirty-two studies met the inclusion criteria. Clinical studies were divided into three categories: survey studies (n=11), safety studies (n=8), and efficacy studies (n=13). Six studies were randomized controlled trials. The most common herbs studied were St. John's wort (Hypericum perforatum L.) (n=3), garlic (Allium sativum L.) extract (n=2), and senna (Cassia senna L.) (n=2). Studies were very heterogeneous with regard to study design, herbal intervention, and outcome measures. Overall, poor methodological quality predominated among the studies.
CONCLUSIONS
Our review concludes that further research is needed to assess the prevalence, efficacy, and safety of commonly used herbs during breastfeeding.
Topics: Beverages; Breast Feeding; Dietary Supplements; Female; Garlic; Humans; Hypericum; Infant; Infant, Newborn; Lactation; Phytotherapy; Plant Preparations; Safety; Senna Extract; Senna Plant
PubMed: 22686865
DOI: 10.1089/bfm.2011.0122 -
Zhonghua Xue Ye Xue Za Zhi = Zhonghua... Dec 2011
Review
Topics: Adolescent; Adult; Antineoplastic Combined Chemotherapy Protocols; Child; Cytarabine; Daunorubicin; Female; Humans; Leukemia, Myeloid, Acute; Male; Middle Aged; Mitoxantrone; Young Adult
PubMed: 22339965
DOI: No ID Found -
The Cochrane Database of Systematic... Jan 2011Constipation is common in palliative care; it can generate considerable suffering due to the unpleasant physical symptoms. In the first Cochrane Review on effectiveness... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Constipation is common in palliative care; it can generate considerable suffering due to the unpleasant physical symptoms. In the first Cochrane Review on effectiveness of laxatives for the management of constipation in palliative care patients, published in 2006, no conclusions could be drawn because of the limited number of evaluations. This article describes the first update of this review.
OBJECTIVES
To determine the effectiveness of laxatives or methylnaltrexone for the management of constipation in palliative care patients.
SEARCH STRATEGY
We searched databases including MEDLINE and CENTRAL (The Cochrane Library) in 2005 and in the update to August 2010.
SELECTION CRITERIA
Randomised controlled trials (RCTs) evaluating laxatives for constipation in palliative care patients. In the update we also included RCTs on subcutaneous methylnaltrexone; an opioid-receptor antagonist that is now licensed for the treatment of opioid-induced constipation in palliative care when response to usual laxative therapy is insufficient.
DATA COLLECTION AND ANALYSIS
Two authors assessed trial quality and extracted data. The appropriateness of combining data from the studies depended upon clinical and outcome measure homogeneity.
MAIN RESULTS
We included seven studies involving 616 participants; all under-reported methodological features. In four studies the laxatives lactulose, senna, co-danthramer, misrakasneham, and magnesium hydroxide with liquid paraffin were evaluated. In three methylnaltrexone.In studies comparing the different laxatives evidence was inconclusive. Evidence on subcutaneous methylnaltrexone was clearer; in combined analysis (287 participants) methylnaltrexone, in comparison with a placebo, significantly induced laxation at 4 hours (odds ratio 6.95; 95% confidence interval 3.83 to 12.61). In combined analyses there was no difference in the proportion experiencing side effects, although participants on methylnaltrexone suffered more flatulence and dizziness. No evidence of opioid withdrawal was found. In one study severe adverse events, commonly abdominal pain, were reported that were possibly related to methylnaltrexone. A serious adverse event considered to be related to the methylnaltrexone also occurred; this involved a participant having severe diarrhoea, subsequent dehydration and cardiovascular collapse.
AUTHORS' CONCLUSIONS
The 2010 update found evidence on laxatives for management of constipation remains limited due to insufficient RCTs. However, the conclusions of this update have changed since the original review publication in that it now includes evidence on methylnaltrexone. Here it found that subcutaneous methylnaltrexone is effective in inducing laxation in palliative care patients with opioid-induced constipation and where conventional laxatives have failed. However, the safety of this product is not fully evaluated. Large, rigorous, independent trials are needed.
Topics: Analgesics, Opioid; Anthraquinones; Cathartics; Constipation; Humans; Lactulose; Magnesium Hydroxide; Naltrexone; Palliative Care; Paraffin; Quaternary Ammonium Compounds; Randomized Controlled Trials as Topic; Senna Extract
PubMed: 21249653
DOI: 10.1002/14651858.CD003448.pub3 -
Journal of the American Academy of... Jun 2010Evidence-based recommendations for therapeutic decision making in childhood psoriasis are lacking. (Review)
Review
BACKGROUND
Evidence-based recommendations for therapeutic decision making in childhood psoriasis are lacking.
OBJECTIVES
We sought to systematically review all available literature concerning treatment efficacy and safety in childhood psoriasis and to propose a recommendation for topical and systemic treatment of childhood psoriasis.
METHODS
Databases searched were PubMed, EMBASE, and the Cochrane Controlled Clinical Trial Register. All studies reporting on efficacy and safety of all treatment options in childhood psoriasis were obtained and a level of evidence was determined.
RESULTS
Literature search revealed 2649 studies, of which 64 studies met the inclusion criteria. The majority of topical and systemic therapies given in childhood psoriasis are efficacious. Short-term side effects were usually mild; long-term side effects were not described.
LIMITATIONS
Most conclusions formulated are not based on randomized controlled trials.
CONCLUSIONS
A rough summary of the proposed algorithm is as follows: first, calcipotriene with/without topical corticosteroids, followed by dithranol. Methotrexate is considered to be the systemic treatment of choice.
Topics: Anthralin; Anti-Bacterial Agents; Calcineurin Inhibitors; Calcitriol; Child; Dermatologic Agents; Glucocorticoids; Humans; Methotrexate; Psoriasis
PubMed: 19900732
DOI: 10.1016/j.jaad.2009.06.048 -
Journal of Alternative and... Aug 2009Mood and anxiety disorders pose significant health burdens on the community. Kava and St. John's wort (SJW) are the most commonly used herbal medicines in the treatment... (Review)
Review
BACKGROUND
Mood and anxiety disorders pose significant health burdens on the community. Kava and St. John's wort (SJW) are the most commonly used herbal medicines in the treatment of anxiety and depressive disorders, respectively.
OBJECTIVES
The objective of this study was to conduct a comprehensive review of kava and SJW, to review any evidence of efficacy, mode of action, pharmacokinetics, safety and use in major depressive disorder, bipolar disorder, seasonal affective disorder (SAD), generalized anxiety disorder, social phobia (SP), panic disorder (PD), obsessive-compulsive disorder (OCD), and post-traumatic stress disorder (PTSD).
METHODS
A systematic review was conducted using the electronic databases MEDLINE, CINAHL, and The Cochrane Library during late 2008. The search criteria involved mood and anxiety disorder search terms in combination with kava, Piper methysticum, kavalactones, St. John's wort, Hypericum perforatum, hypericin, and hyperforin. Additional search criteria for safety, pharmacodynamics, and pharmacokinetics were employed. A subsequent forward search was conducted of the papers using Web of Science cited reference search.
RESULTS
Current evidence supports the use of SJW in treating mild-moderate depression, and for kava in treatment of generalized anxiety. In respect to the other disorders, only weak preliminary evidence exists for use of SJW in SAD. Currently there is no published human trial on use of kava in affective disorders, or in OCD, PTSD, PD, or SP. These disorders constitute potential applications that warrant exploration.
CONCLUSIONS
Current evidence for herbal medicines in the treatment of depression and anxiety only supports the use of Hypericum perforatum for depression, and Piper methysticum for generalized anxiety.
Topics: Anthracenes; Anti-Anxiety Agents; Antidepressive Agents; Anxiety; Bridged Bicyclo Compounds; Humans; Hypericum; Kava; Mood Disorders; Perylene; Phloroglucinol; Phytotherapy; Plant Extracts; Terpenes
PubMed: 19614563
DOI: 10.1089/acm.2009.0066 -
British Journal of Cancer Aug 2006A systematic review was performed to evaluate the clinical effectiveness of docetaxel in combination with prednisolone (docetaxel is licensed in the UK for use in... (Comparative Study)
Comparative Study Review
A systematic review was performed to evaluate the clinical effectiveness of docetaxel in combination with prednisolone (docetaxel is licensed in the UK for use in combination with prednisone or prednisolone for the treatment of patients with metastatic hormone-refractory prostate cancer. Prednisone is not used in the UK, but it is reasonable to use docetaxel plus prednisone data in this review of docetaxel plus prednisolone) for the treatment of metastatic hormone-refractory prostate cancer. A scoping search identified a trial of docetaxel plus prednisone vs mitoxantrone plus prednisone, but did not identify any trials comparing docetaxel plus prednisolone/prednisone with any other treatments. Therefore, we considered additional indirect evidence that would enable a comparison of docetaxel plus prednisolone/prednisone with other chemotherapy regimens and active supportive care. Systematic searching (upto April 2005) identified seven randomised controlled trials. One large well-conducted trial assessed docetaxel plus prednisone vs mitoxantrone plus prednisone; this showed statistically significant improvements with 3-weekly docetaxel in terms of overall survival, quality of life, pain response and PSA decline. Two other chemotherapy regimens that included docetaxel with estramustine also showed improved outcomes in comparison with mitoxantrone plus prednisone. Three trials that compared mitoxantrone plus corticosteroids with corticosteroids alone were identified and their results for overall survival combined, which showed very little difference between the two groups. The addition of clodronate to mitoxantrone plus prednisone showed no significant differences in comparison with mitoxantrone plus prednisone alone. The evidence suggests that chemotherapy regimens containing 3-weekly docetaxel are superior to mitoxantrone or corticosteroids alone.
Topics: Antineoplastic Agents, Hormonal; Antineoplastic Combined Chemotherapy Protocols; Docetaxel; Drug Resistance, Neoplasm; Humans; Male; Mitoxantrone; Neoplasm Metastasis; Prednisolone; Prostatic Neoplasms; Randomized Controlled Trials as Topic; Survival Analysis; Taxoids; Treatment Outcome
PubMed: 16880788
DOI: 10.1038/sj.bjc.6603287 -
The Cochrane Database of Systematic... Jan 2006Osteoarthritis (OA) is one of the most prevalent musculoskeletal diseases. Diacerein acts differently from traditional non-steroidal anti-inflammatory drugs (NSAIDs)... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Osteoarthritis (OA) is one of the most prevalent musculoskeletal diseases. Diacerein acts differently from traditional non-steroidal anti-inflammatory drugs (NSAIDs) which inhibit prostaglandin synthesis, leading to adverse gastrointestinal effects. It has been proposed that diacerein acts as a slow-acting, symptom-modifying and perhaps disease-structure modifying drug for OA.
OBJECTIVES
To assess the effectiveness and safety of diacerein for treatment of OA in adults with peripheral or axial osteoarthritis according the American College of Rheumatology and/or EULAR diagnostic criteria.
SEARCH STRATEGY
We searched MEDLINE (1966-2004), EMBASE (1980-2004), Cochrane Central Register of Controlled Trials (CENTRAL), The Cochrane Library, Issue 3, 2004, and LILACS(1982-2004) and hand searched reference lists of published articles. Pharmaceutical companies and authors of published articles were contacted. There was no language restriction.
SELECTION CRITERIA
Randomized controlled trials (RCT) or quasi-RCTs of placebo-controlled and comparative studies of diacerein in adults with primary or secondary OA fulfilling the American College of Rheumatology (ACR) criteria were eligible for inclusion. The main criteria for exclusion was evidence of secondary disease.
DATA COLLECTION AND ANALYSIS
Data abstraction and quality assessment was performed independently by three investigators according to predetermined criteria and the results were compared to determine the degree of agreement. Quality evaluation was done using Cochrane Handbook Criteria, Jadad and Schultz scores. Continuous outcome measures were pooled using weighted mean differences (WMD). Dichotomous outcome measures were pooled using random effects model and results were expressed as relative risks (RR).
MAIN RESULTS
Collectively, the seven identified studies including 2069 participants demonstrated a small, consistent, beneficial effect of diacerein in the treatment of OA. When compared to placebo, pain on a visual analog scale (0-100 mm) was evaluated in 1228 participants and showed a statistically significant difference in favour of diacerein WMD -5.16 (95%CI -9.75, -0.57) with an absolute change of 5 points on the scale; but the heterogeneity analysis result was important (P=0.04). When analysed separately by hip OA and knee OA, no difference was detected. According to the Lequesne Impairment Index for function, 1006 participants evaluated did not have improvement in the whole group or in the subgroup analysis with homogeneity in all results (P>0.10). For hip OA, three studies showed a WMD -0.21 (95%CI -0.82, 0.40). For knee OA, two studies showed WMD -0.95 (95%CI -2.64, 0.74). The summary WMD was -0.29 (95%CI -0.87, 0.28). Two long-term studies, one evaluating hip OA and another evaluating knee OA, analysed structural progression with radiographic measurements of joint space. In hip OA, there was statistical significant slowing of progression in contrast with knee OA that did not demonstrate this reduction. However, the overall effect was very different between studies (P=0.04 for hip OA and P= 0.85 for knee OA). The most frequent adverse event was diarrhea. 459 participants among 1083 participants that received diacerein (42%) were affected. 18% in the treatment group compared with 13% in the placebo group withdrew due to adverse events.
AUTHORS' CONCLUSIONS
There is 'gold' level evidence that diacerein has a small, consistent benefit in improvement in pain. Further research is necessary to confirm the short and long-term effectiveness and toxicity of diacerein therapy in OA.
Topics: Anthraquinones; Anti-Inflammatory Agents, Non-Steroidal; Humans; Osteoarthritis; Randomized Controlled Trials as Topic
PubMed: 16437519
DOI: 10.1002/14651858.CD005117.pub2 -
The Cochrane Database of Systematic... Oct 2005Mitoxantrone (MX) has been shown to be moderately effective in reducing the clinical outcome measures of disease activity in multiple sclerosis (MS) patients. (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Mitoxantrone (MX) has been shown to be moderately effective in reducing the clinical outcome measures of disease activity in multiple sclerosis (MS) patients.
OBJECTIVES
The objective was to assess the efficacy and safety of MX in relapsing-remitting MS (RRMS), progressive relapsing MS (PRMS) and secondary progressive MS (SPMS).
SEARCH STRATEGY
We searched the Cochrane MS Group Trials Register (searched April 2005), the Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 4, 2004), MEDLINE (Pub Med) (January 1966 to April 2005), EMBASE (January 1974 to April 2005), and reference lists of articles. We also undertook hand searching and contacting trialists and pharmaceutical companies.
SELECTION CRITERIA
The trials were selected if double-blinded, placebo-controlled, randomised, irrespective of eventual additive therapy (such as steroids).
DATA COLLECTION AND ANALYSIS
Three reviewers independently selected articles for inclusion, assessed trials' quality and extracted data.
MAIN RESULTS
Four trials involving 270 participants were included. MX was found to reduce the progression of disability at 2 years follow-up (proportion of participants with 6-months confirmed progression of disability: Odds Ratios (OR) 0.3, p = 0.05). Similar figures were found regarding the reduction in annualised relapse rate and the proportion of patients free from relapses at 1 and 2 years, as well as the number of patients with active MRI lesions at 6 months/ 1 year only. Side effects reported in the trials were more frequent in treated patients than in controls. Caution must be exercised in drawing conclusions from such data because of the heterogeneous quality and characteristics of the included trials, which are different in terms of treatment schedule and type of enrolled patients. More than half of the included patients came from a single study. Moreover, from the included trials, it was not possible to estimate the long-term efficacy and safety of MX, which may raise concerns about the risk of cardiotoxicity and therapy-related leukemias, which is increasingly reported in the literature.
AUTHORS' CONCLUSIONS
MX is moderately effective in reducing the disease progression and the frequency of relapses in patients affected by RR, PR and SP MS in the short-term follow-up (2 years), even if the results are based on trials heterogeneous in terms of drug dosage and inclusion criteria. No major neoplastic or symptomatic cardiotoxicity related to MX have been reported from the trials. However, longer follow-up studies are highly warranted to better explore the efficacy and safety of the drug, mainly as regards the long-term risk of therapy-related leukemias and cardiotoxicity. As a conclusion, MX has a partial efficacy, but, due to its unclear long-term safety profile, it should be used to treat patients with worsening RR and SP MS with evidence of worsening disability.
Topics: Humans; Immunosuppressive Agents; Mitoxantrone; Multiple Sclerosis; Randomized Controlled Trials as Topic
PubMed: 16235298
DOI: 10.1002/14651858.CD002127.pub2