Author Correction: Meta-analyses of sulodexide and other drugs in prevention and treatment of post-thrombotic syndrome.

Correction to: Eur Rev Med Pharmacol Sci 2022; 26 (24): 9372-9381. DOI: 10.26355/eurrev_202212_30688-PMID: 36591846-published online on December 21, 2022. After publication, the authors found a typo in the discussion section. The sentence to amend is the following one: ·       In meta-analyses of observational studies, we found a low incidence of PTS, with 9% of patients presenting PTS among patients receiving sulodexide and a 50% reduction in the risk of PTS in patients receiving rivaroxaban. The "9%" in the sentence below should be changed to "15%" (in order to align the Discussion section with the Results section and the Abstract. There are amendments to this paper. The Publisher apologizes for any inconvenience this may cause. https://www.europeanreview.org/article/30688.

Meta-analyses of sulodexide and other drugs in prevention and treatment of post-thrombotic syndrome.

OBJECTIVE: Post-thrombotic syndrome (PTS) is a common chronic complication of deep vein thrombosis. Elastic compression (ECS) is the common pillar for PTS prevention and treatment, while the pharmacological approach for PTS includes direct oral anticoagulants (DOACs) and venoactive drugs (VADs) for prevention and treatment, respectively. Sulodexide can be used both in long-term prevention and in the treatment of PTS. To better understand the efficacy of the main drugs used in the prevention (sulodexide or DOACs) and treatment of PTS (sulodexide or VADs), pairwise meta-analyses of observational studies and RCTs were conducted. MATERIALS AND METHODS: A literature search in MEDLINE, Embase, and Cochrane Library for observational studies and RCTs was performed. Incidence of PTS, reduction in PTS signs or symptoms and proportion of patients with complete venous ulcers healing were the primary outcomes for prevention and treatment of PTS, respectively. Fixed and Random effect model meta-analyses were performed. Heterogeneity and publication bias were assessed. R® software was used for the analysis. RESULTS: 893 articles were identified during the search. 8 observational studies (6 for DOACs and 2 for sulodexide) and 2 RCTs for sulodexide, out of the 11 studies included in the qualitative synthesis, were included for the prevention and treatment of PTS, respectively. Meta-analyses of observational studies showed an overall incidence of PTS of 15% (95% CI, 11-19) for sulodexide, and a 50% reduction of PTS signs and/or symptoms for rivaroxaban compared to warfarin (OR, 0.50; 95% CI, 0.38-0.65). The overall estimate of the two sulodexide RCTs showed a significant improvement in complete ulcer healing, with an OR of 2.32 (95% CI, 1.49-3.63). CONCLUSIONS: In prevention of PTS, sulodexide and rivaroxaban showed a low incidence and reduced risk of PTS respectively, while in PTS treatment, sulodexide was significantly effective in the complete ulcers healing. These results confirm the need to move from the traditional single-pillar approach with elastic compression stockings to a more effective multi-pillar approach, tailoring the treatment to each individual patient.

Biologics for psoriatic arthritis: network meta-analysis in review.

OBJECTIVE: A review of network meta-analysis to assess efficacy and safety of biologics for the treatment of psoriatic arthritis (PsA). MATERIALS AND METHODS: A systematic search was conducted on electronic databases to identify Bayesian meta-analysis reporting clinical parameters of efficacy, safety and cost-effectiveness of biologics that are approved for the treatment of PsA patients. RESULTS: We identified 19 studies and included them for review. There is insufficient statistical evidence to demonstrate clear differences in effectiveness between available biologic agents for PsA due to many differences in methods and clinical parameters reported in the studies. Old biologics are reported to be safe. CONCLUSIONS: New molecules approved for the treatment of PsA appear promising treatments but further comparative studies methodologically well-conducted are necessary. It is also necessary to follow strictly international recommendations to conduct NMA to better help physicians and decision-makers in making appropriate decisions.

Systematic literature review and Bayesian network meta-analysis of episodic cluster headache drugs.

OBJECTIVE: The drugs used in Europe to treat episodic cluster headache (eCH) are mainly verapamil and lithium carbonate, even though topiramate and pizotifen can be used. Galcanezumab, a humanized monoclonal antibody was approved by FDA recently for prophylaxis treatment of eCH. In order to evaluate the efficacy of galcanezumab compared to the drugs used for the preventive treatment of eCH, a systematic literature review (SLR) and network meta-analysis (NMA) of only randomized controlled trials (RCTs) was performed. MATERIALS AND METHODS: A literature search in MEDLINE, Embase and Cochrane Library including RCTs and observational studies was conducted. The primary outcomes for the NMA included the main change from baseline in reducing ECH attacks while the percentage of responders was used to pairwise comparisons of the observational studies. The NMA was conducted using a fixed-effect model and a random-effects model with deviance information criterion (DIC) reported for both models. The surface under the cumulative ranking (SUCRA) was shown only for the model with the lower DIC. RESULTS: Three RCTs and six observational studies were included in the SLR. The Bayesian NMA was performed on the two RCTs included in the SLR, specifically galcanezumab and verapamil studies. SUCRA indicated that galcanezumab had the highest probability of being the most effective treatment (probability = 66.33%) compared to verapamil (probability = 31.58%) and placebo (probability = 2.09%). Galcanezumab was also the treatment with the highest overall probability to be the second most effective (probability = 88.79%). CONCLUSIONS: The results suggest that galcanezumab is more effective compared to verapamil as a prophylaxis treatment for reducing eCH attacks in adults. Further, head-to-head RCTs of galcanezumab vs. treatments using in clinical practice are needed to better assess its comparative efficacy and benefit-risk profile.

Differences in biologics for treating ankylosing spondylitis: the contribution of network meta-analysis.

OBJECTIVE: Ankylosing Spondylitis (AS) is a chronic form of arthritis of unknown origin affecting the spine. In this study, we aimed to identify clinical and safety profiles of adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, and secukinumab that are biologic agents (biologics) mainly used for the treatment of AS, and to understand differences between them. MATERIALS AND METHODS: An extensive literature research was performed in MEDLINE and EMBASE in order to identify all network meta-analysis (NMA) and/or mixed treatment comparison (MTC) papers. NMA and/or MTC, with a ranking of the effectiveness of biologics in AS, were included in the analysis, and the adhesion to ISPOR guidelines was investigated. RESULTS: 60 studies were identified; after applying exclusion criteria methods, 7 studies underwent further analysis. Infliximab was the drug that exhibited the highest probability for achieving clinical efficacy by ASAS20 at 12 and 24 weeks. Considering only subcutaneous biologics, Golimumab achieved the highest probability for achieving the ASAS20 response at 12 weeks. CONCLUSIONS: Results from NMA on the use of biologics in AS indicates infliximab emerged as the drug with the highest probability of obtaining ASAS20 response both at 12 and 24 weeks of treatment.

A review of network meta-analysis comparing biologics in the treatment of rheumatoid arthritis.

OBJECTIVE: Even though in recent years significant improvements have been made in the management of patients with rheumatoid arthritis due to the introduction of biologic agents, it is still difficult to identify the most effective and safest available treatment. The choice and comparison between biological agents are a challenge, for only limited head-to-head clinical studies are available. The aim of this manuscript is to review the published network meta-analysis (NMA) to gain a better understanding of efficacy and safety of biological agents and small molecules in the management of RA patients. MATERIALS AND METHODS: We used MEDLINE and EMBASE to identify network meta-analyses from 2008 to June 2019 comparing efficacy and safety of licensed biological agents and tsDMARDS at the approved dosages using predefined text words related to the topic. The following scenarios have been investigated: patients not responding to csDMARD (cDMARDs - IR); csDMARD naïve patients; patients not responding to biologics (bDMARDs - IR); patients in biological monotherapy. RESULTS: On the basis of the data present in the literature, we are able to hypothesize some trends of response in terms of efficacy in different subsets of patients, for example patients in monotherapy, bDMARds unresponsive patients, and Methotrexate-naive patients. The differences of the results presented in many works are due to the different inclusion criteria used in the studies, the type of biologics agent used in each study (according to the available molecules in the different years of publication), as well as differences in the methodology of NMA and in the presentation of the data. CONCLUSIONS: We suggest that the next NMA follows the indications suggested by the Professional Society for Health Economics and Outcomes Research (ISPOR) so that the results are comparable and comprehensible.