Differential side effects profile in mCRPC patients treated with abiraterone or enzalutamide: A meta-analysis of randomized controlled trials.

73 Background: Abiraterone and enzalutamide are currently approved for mCRPC patients. Both drugs have distinct mechanisms of action and may have different toxicity profile. There are limited data comparing the side effects of abiraterone and enzalutamide. We performed a meta-analysis of randomized controlled trials (RCT) to better characterize the risk of adverse events associated with both drugs. Methods: We performed a literature search on MEDLINE for studies reported from January 1966 to July 31, 2015. Abstracts presented at ASCO meetings from 2004 to 2015 were selected manually. Phase III RCT were included in analysis. We assessed the risk of adverse events reported in RCT by performing two meta-analysis: abiraterone-prednisone vs. placebo-prednisone (2,283 pts) and enzalutamide vs. placebo (2,914 pts). Summary of incidence, relative-risks (RR), and 95% confidence intervals (CI) were calculated using random-effects or fixed-effects models based on the heterogeneity of included studies. Results: Overall, enzalutamide was not associated with all-grade (RR 1.06 - 95% CI 0.67-1.65) or grade ≥3 (RR 0.81 - 95% CI 0.28-2.33) cardiovascular events, but was associated with increased risk of all-grade fatigue (RR 1.29 - 95% CI 1.15-1.44). On the other hand, abiraterone was associated with increased risk of all-grade (RR 1.28 - 95% CI 1.06-1.55) and grade ≥3 (RR 1.76 - 95% CI 1.12-2.75) cardiovascular events, but was not associated with all-grade (RR 0.85 - 95% CI 0.58-1.23) or grade ≥3 (RR 1.07 - 95% CI 0.97-1.19) fatigue. No evidence of publication bias was observed. Conclusions: In this meta-analysis, abiraterone was associated with an increased risk of cardiovascular events, while enzalutamide was associated with an increased risk of fatigue.

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Poly(ADP-Ribose) Polymerase Inhibitors (PARPi) for Patients With Advanced Breast Cancer: a Meta-analysis of Randomized Controlled Trials

10.21203/rs.3.rs-48500/v1 ◽

2020 ◽

Author(s):

YongCheng Su ◽

XiaoGang Zheng

Keyword(s):

Breast Cancer ◽

Randomized Controlled Trials ◽

Fixed Effects ◽

Meta Analysis ◽

Parp Inhibitors ◽

Cochrane Library ◽

Controlled Trials ◽

Randomized Controlled ◽

Increased Risk ◽

Grade 3

Abstract BACKGROUND: Poly(ADP–ribose) polymerase (PARP) inhibitors are new class of drugs that are currently being studied in several malignancies. However, datas about the efficacy and safety of the PARP inhibitors are limited. Therefore, we conducted a meta-analysis of randomized controlled trials (RCT) in patients with breast cancer.METHODS: Pubmed/Medline, Embase, Cochrane Library, and abstracts presented at the annual meeting of the American Society of Clinical Oncology (ASCO) were searched for articles published from 2000 to June 2018.Summary incidences and the RR, HR with 95% confidence intervals, were calculated by using a random-effects or fixed-effects model.RESULTS: The summary HR indicated PARPi was not associated with OS (HR=0.83, 95%CI 0.66–1.06, Z=1.49, P=0.14), while it could significantly improve PFS ande time to deterioration (TTD) of global health status/quality of life(GHS/QoL) as compared with traditional standard therapy, the HR was 0.60(95%CI 0.50-0.72; Z=5.52, P＜0.00001) and 0.4 (95%CI 0.29–0.54,z=5.80 ,p=0.000),respectively.The RR of grade 3 or more anemia ,fatigue and headache was 3.02 (95% CI, 0.69–13.17;p = 0.14,,I2=90%),0.77 (95%CI, 0.34–1.73;p=0.52,I2=7%) and 1.13 (95% CI,0.30–4.18;p=0.86,I2=0%),respectively.CONCLUSION: The findings of this meta-analysis showed that PARPi has no significant effect on OS, while it could significantly improve in PFS and TTD of GHS/QoL for patients with advanced or metastatic breast cancer.Furthermore,our findings also demonstrated that the PARPi treatment is connected with an increased risk of grade 3 or more anemia adverse events.

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Risk of Infection with Ibrutinib in Patients with B-Cell Malignancies: A Meta-Analysis of Phase III Randomized Controlled Trials

Blood ◽

10.1182/blood-2018-99-113743 ◽

2018 ◽

Vol 132 (Supplement 1) ◽

pp. 2871-2871

Author(s):

Somedeb Ball ◽

Wasawat Vutthikraivit ◽

Avash Das ◽

Peggy J Edwards ◽

Fred Hardwicke ◽

...

Keyword(s):

B Cell ◽

Meta Analysis ◽

Final Analysis ◽

Phase Iii ◽

Controlled Trials ◽

Risk Of Infection ◽

B Cell Malignancies ◽

Randomized Controlled ◽

Increased Risk ◽

Grade 3

Abstract Introduction: Ibrutinib is an oral Bruton's tyrosine kinase (BTK) inhibitor which has transformed the management of several B-cell malignancies, particularly chronic lymphocytic leukemia (CLL). B-cell malignancies inherently confer increased risk of infections due to defects in innate and adaptive immunity. Recent studies have provided conflicting data regarding the risk of infection with ibrutinib therapy, with some reports suggesting an increased risk of infection owing to BTK inhibition while others suggesting decreased risk due to B-cell recovery and humoral reconstitution. We conducted a systematic review and meta-analysis of all phase III randomized controlled trials (RCT) to determine the relative risk of infection associated with the ibrutinib. Methods: We performed a systematic search of Embase, PubMed, Web of Science, Scopus, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, and Clinical Trials.gov with appropriate keywords through 07/10/18, to find all RCTs comparing ibrutinib with other agents or placebo in patients with B-cell malignancies and also reporting infection as a treatment-emergent adverse event. The search strategy, study selection, data extraction, and analysis were performed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta Analyses (PRISMA) guidelines. We pooled the point estimates using random effects model of the generic inverse-variance method described by Der Simonian and Laird. Statistical analyses were performed using the Stata/SE 15.1 (StataCorp LP, College Station, TX, USA). Results: A total of 6 phase III RCTs randomizing 1811 patients (pt; 935 on ibrutinib arms and 876 in the control arms) were included in the final analysis. Four trials were conducted in pts with CLL, one in pts with Waldenstrom macroglobulinemia and the other one in pts with mantle cell lymphoma. Characteristics of these trials are shown in Table 1. In 4 RCTs ibrutinib was compared with an active agent (i.e., ofatumumab, chlorambucil, temsirolimus, and rituximab) and in the other two trials, it was compared with placebo. Ibrutinib was administered as a 1st-line therapy in the RESONATE-2 trial and both as 1st line and in refractory disease in the iNNOVATE trial. The median duration of treatment across studies with ibrutinib was 17.7 months (range 9.4-38.7 months). Ibrutinib was associated with a statistically significant increased incidence of total infections (any grade) in pts with B-cell malignancies [pooled risk ratio (RR) = 1.34, 95% confidence interval (CI): 1.06-1.69, p=0.015, I2=73.2%, fig. 1A]. Pneumonia and upper respiratory tract infection (URTI) were two most commonly reported infection in pts across trials. The incidence of pneumonia (grade 3-5) and URTI (any grade) with ibrutinib was not significantly different from the same in the control arm (pooled RR = 1.30, 95% CI: 0.84-2.02, p=0.237, I2=0.0%, fig. 1B, and pooled RR =1.26, 95%CI: 0.94-1.70, p=0.122, I2=34.5%, fig. 1C respectively). In subgroup analysis of trials (n=4) in pts with CLL only, ibrutinib was associated with a trend towards increased incidence of total infection (any grade) in pts with CLL, but the result was not statistically significant (pooled RR =1.24, 95% CI: 0.99-1.54, p=0.061, I2=75.7%, fig. 2A). No statistically significant difference was noted in the incidence of pneumonia (grade 3-5) and URTI (any grade) in pts with CLL on ibrutinib, as compared to their counterparts in the control arms (pooled RR =1.19, 95%CI: 0.76-1.88, p=0.448, I2=0.0% fig. 2B, and pooled RR =1.16, 95%CI: 0.86-1.56, p=0.341, I2=25.4%, fig. 2C, respectively). No publication bias was observed across all the studies included in final analysis. Conclusion: In this meta-analysis, ibrutinib was associated with significantly increased risk of infection in pts with B-cell malignancies, whereas this risk was not significantly increased when the analysis was limited to patients with CLL. Future well-designed prospective trials with longer duration of follow up are needed to truly evaluate the association of ibrutinib and infections in pts with B-cell malignancies. Disclosures Short: Takeda Oncology: Consultancy. Maiti:Celgene Corporation: Other: Research funding to the institution.

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Treatment of Advanced Gastro-Entero-Pancreatic Neuro-Endocrine Tumors: A Systematic Review and Network Meta-Analysis of Phase III Randomized Controlled Trials

Cancers ◽

10.3390/cancers13020358 ◽

2021 ◽

Vol 13 (2) ◽

pp. 358

Author(s):

Claudio Ricci ◽

Giuseppe Lamberti ◽

Carlo Ingaldi ◽

Cristina Mosconi ◽

Nico Pagano ◽

...

Keyword(s):

Systematic Review ◽

Randomized Controlled Trials ◽

Meta Analysis ◽

Progression Free Survival ◽

Phase Iii ◽

Neuroendocrine Neoplasms ◽

Controlled Trials ◽

Endocrine Tumors ◽

Randomized Controlled ◽

Grade 3

Several new therapies have been approved to treat advanced gastro-entero-pancreatic neuroendocrine neoplasms (GEP–NENs) in the last twenty years. In this systematic review and meta-analysis, we searched MEDLINE, ISI Web of Science, and Scopus phase III randomized controlled trials (RCTs) comparing two or more therapies for unresectable GEP–NENs. Network metanalysis was used to overcome the multiarm problem. For each arm, we described the surface under the cumulative ranking (SUCRA) curves. The primary endpoints were progression-free survival and grade 3–4 of toxicity. We included nine studies involving a total of 2362 patients and 5 intervention arms: SSA alone, two IFN-α plus SSA, two Everolimus alone, one Everolimus plus SSA, one Sunitinib alone, one 177Lu-Dotatate plus SSA, and one Bevacizumab plus SSA. 177Lu-Dotatate plus SSA had the highest probability (99.6%) of being associated with the longest PFS. This approach was followed by Sunitinib use (64.5%), IFN-α plus SSA one (53.0%), SSA alone (46.6%), Bevacizumab plus SSA one (45.0%), and Everolimus ± SSA one (33.6%). The placebo administration had the lowest probability of being associated with the longest PFS (7.6%). Placebo or Bevacizumab use had the highest probability of being the safest (73.7% and 76.7%), followed by SSA alone (65.0%), IFN-α plus SSA (52.4%), 177Lu-Dotatate plus SSA (49.4%), and Sunitinib alone (28.8%). The Everolimus-based approach had the lowest probability of being the safest (3.9%). The best approaches were SSA alone or combined with 177Lu-Dotatate.

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Benefits and Risks of Chloroquine and Hydroxychloroquine in The Treatment of Viral Diseases: A Meta-Analysis of Placebo Randomized Controlled Trials

10.1101/2020.04.13.20064295 ◽

2020 ◽

Cited By ~ 1

Author(s):

Jing Wang ◽

Li Yu ◽

Kefeng Li

Keyword(s):

Clinical Trials ◽

Adverse Events ◽

Randomized Controlled Trials ◽

Meta Analysis ◽

Viral Diseases ◽

Controlled Trials ◽

Significant Heterogeneity ◽

Efficacy And Safety ◽

Randomized Controlled ◽

Increased Risk

AbstractBackground and ObjectiveRecently, in the scramble to find drugs to treat COVID-19, chloroquine (CQ) and its derivative hydroxychloroquine (HCQ) have rapidly gained the public’s attention. In this study, we conducted a meta-analysis of randomized clinical trials (RCTs) to evaluate the efficacy and safety of CQ and HCQ in the treatment of viral diseases.MethodsWe searched PubMed, EMBASE, Cochrane Central, Web of Science, Clinical Trials Registries, CNKI, Wanfang Data, CQVIP, and Preprint Servers through April 4, 2020, for randomized controlled trials (RCTs) that examined the efficacy and safety of CQ and HCQ against viral infection. We analyzed pooled data on the overall efficacy, the relative risks over the placebo, and the prevalence of adverse events. Trial sequential analysis (TSA) was also performed to evaluate the random errors in the meta-analysis. Potential moderators of drug-placebo efficacy differences were analyzed by meta-regression.ResultsThe analysis included 11 RCTs with 2613 adult patients. Both the plasma viral load (standard mean difference: 0.29, 95% CI: −1.19 - 1.76, P = 0.70) and the improvement of clinical symptoms (odds ratio: 2.36, 95% CI: 0.81 - 6.92, P = 0.11) were not different between the intervention and placebo arm. There was significant heterogeneity for the efficacy assessment, which was primarily explained by the mean patients’ age and the sample size. Compared to the placebo, CQ and HCQ had increased risk of mild adverse events (risk ratio: 1.51, 95% CI: 1.35 - 1.70, P < 0.05, TSA adjusted 95% CI: 1.31 - 2.19), which were statistically significant in nervous, integumentary, and gastrointestinal systems. The most common adverse events were observed in the nervous system, with the pooled prevalence of 31.4 % (95% CI: 10.5% - 56.7%).ConclusionsInsufficient data were available to support the antiviral efficacy of CQ and HCQ due to the high heterogeneity caused by patients’ age. Mild side effects are expected for the current antiviral dose regimens of CQ and HCQ. Treatment outcomes may be enhanced by better-selected patients based on age and well-controlled adverse events.This meta-analysis was registered on OSF (ID: https://osf.io/386aw)

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Obinutuzumab-Related Adverse Events: A Systematic Review and Meta-Analysis

Blood ◽

10.1182/blood-2019-128677 ◽

2019 ◽

Vol 134 (Supplement_1) ◽

pp. 5259-5259

Author(s):

Irina Amitai ◽

Anat Gafter-Gvili ◽

Pia Raanani ◽

Ronit Gurion

Keyword(s):

Systematic Review ◽

Adverse Events ◽

Randomized Controlled Trials ◽

Lymphoproliferative Disorder ◽

Meta Analysis ◽

Lymphoproliferative Disorders ◽

Controlled Trials ◽

Toxicity Profile ◽

Randomized Controlled ◽

Grade 3

Background: Rituximab, the first FDA-approved anti-CD20 monoclonal antibody has dramatically improved outcomes for patients with CD20 positive lymphoproliferative disorders for 2 decades. Obinutuzumab was developed to potentiate activity and overcome resistance to rituximab. Clinical data suggest obinutuzumab is superior to rituximab in specific lymphoproliferative disorder, at the potential cost of increased toxicity, especially infections. In order to better define the toxicity profile of obinutuzumab as opposed to rituximab, we conducted a systematic review and meta‐analysis of all randomized controlled trials comparing obinutuzumab with rituximab, either alone or combined with chemotherapy for any CD20 positive lymphoproliferative disorder, in order to assess safety. Methods: A comprehensive search was conducted until June 2019. Two reviewers appraised the quality of trials and extracted data. The Primary outcome was grade 3 to 4 infections; secondary outcomes included any adverse events, serious adverse events, and other grade 3 to 4 hematologic toxicity. Relative risks (RRs) with 95% confidence intervals (CIs) were estimated and pooled. A fixed‐effect model was used to pool data unless there was significant heterogeneity, in which case a random‐effects model was used. Results: Our search yielded 4 randomized controlled trials conducted between the years 2009 and 2014, including 3429 patients. Median age of patients in the trials was 58 to 62 years. The trials included patients with follicular lymphoma (FL) (2 trials), chronic lymphocytic leukemia, (1 trial), and diffuse large B cell lymphoma (1 trial). All trials compared between obinutuzumab and rituximab therapy: in 3 trials the antibody was combined with chemotherapy and in 1 trial it was given alone. In 2 trials, which included FL patients, the antibody was given also as maintenance therapy for up to 2 years. There was a statistically marginally increased rate of grade 3-4 infections (RR 1.17 [95% CI, 1.0‐1.36]) and febrile neutropenia (RR 1.23 [95% CI, 1.0‐1.5]) and a statistically significant increased rate of grade 3-4 adverse events (RR 1.15 [95% CI, 1.09‐1.2]) in the obinutuzumab arm vs rituximab. Also, the obinutuzumab arm showed increased risk of grade 3-4 thrombocytopenia (RR 2.8 [95% CI, 1.92‐4.06]), infusion related reactions (RR 2.8 [95% CI, 2.16‐3.64]) and cardiac events (RR 1.65 [95% CI, 1.11‐2.46]). There was no significant difference in grade 3-4 anemia and neutropenia rates, nor in the mortality rate at 36 months (RR 0.93 [95% CI, 0.78‐1.11]). Conclusions: Our systematic review and meta-analysis demonstrates that obinutuzumab has a more severe toxicity profile as compared to rituximab. As better clinical outcomes were reported with obinutuzumab in several CD20 positive lymphoproliferative disorders, but with more toxicity, clinicians are faced with a challenge upon deciding which therapy to choose for their patients. Disclosures Gurion: Roche: Consultancy.

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Immunomodulatory drug and dexamethasone-containing triple versus doublet combination treatments for relapsed or refractory multiple myeloma: a meta-analysis of phase III randomized controlled trials

10.21203/rs.3.rs-55347/v1 ◽

2020 ◽

Author(s):

Minjie Gao ◽

Xiao Yan ◽

Fei Li ◽

Kaihong Xu ◽

Qitian Mu ◽

...

Keyword(s):

Multiple Myeloma ◽

Randomized Controlled Trials ◽

Meta Analysis ◽

Phase Iii ◽

Controlled Trials ◽

Efficacy And Safety ◽

Refractory Multiple Myeloma ◽

Randomized Controlled ◽

Immunomodulatory Drug ◽

Grade 3

Abstract Background Triplet therapy has become the standard of care for relapsed or refractory multiple myeloma (RRMM) over the past few years. Prior to that, doublet therapy including dexamethasone and an immunomodulatory were standard. Several systematic studies have been conducted and many combinations with variable triplet therapies but have not always used the former standard therapy as a benchmark. The objective of this meta-analysis was to evaluate the efficacy and safety of triplet combinations that included dexamethasone and an immunomodulatory drug versus a doublet combination of just dexamethasone and an immunomodulatory for the treatment of RRMM. Methods A comprehensive literature search (PubMed, EMBASE, Cochrane Library) for phase III randomized controlled trials for efficacy and safety of triplet versus doublet combinations that specifically included dexamethasone and an immunomodulatory drug for treatment of RRMM. Efficacy (ORR, PFS, OS) and adverse events (≥ grade 3) were assessed using traditional statistical measures for aggregate data. Results Of 235 potential reports, 6 met the inclusion criteria (N = 115–792 participants). The methodological quality was ≥ 4 Jadad score for each. Triplet treatment had higher ORR (HR = 0.74, 95%CI: 0.65–0.84, P ≤ 0.001), PFS (HR = 0.63, 95%CI: 0.52–0.75, P ≤ 0.001), and OS (HR = 0.74, 95%CI: 0.65–0.84, P ≤ 0.001). The incidence of ≥ grade 3 diarrhea and fatigue were significantly higher in the triplet combination group. There was a trend toward increased incidence of ≥ grade 3 neutropenia, thrombocytopenia, thromboembolism, and peripheral neuropathy in the triplet therapy group. Notably, triplet therapy had a significantly lower rate of anemia compared to doublet therapy. Conclusions This study reinforces current guidelines and recommendations for triplet combinations containing dexamethasone and an immunomodulatory drug.

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Randomized Controlled Trials of Remdesivir in Hospitalized COVID-19 Patients: A Systematic Review and Meta-Analysis

10.1101/2020.08.21.20179200 ◽

2020 ◽

Cited By ~ 1

Author(s):

Azza Sarfraz ◽

Zouina Sarfraz ◽

Marcos Sanchez-Gonzalez ◽

Jack Michel ◽

George Michel ◽

...

Keyword(s):

Placebo Group ◽

Adverse Events ◽

Randomized Controlled Trials ◽

Meta Analysis ◽

Antiviral Treatment ◽

Intervention Group ◽

Phase Iii ◽

Nucleoside Triphosphate ◽

Controlled Trials ◽

Randomized Controlled

Background: The first cases of the coronavirus disease 2019 (COVID-19) were reported in Wuhan, China. No antiviral treatment options are currently available with proven clinical efficacy. However, preliminary findings from phase III trials suggest that remdesivir is an effective and safe treatment option for COVID-19 patients with both moderate and severe disease. Objective: The aim of the present meta-analysis was to investigate whether remdesivir was effective for treating COVID-19 including reduced in-hospital adverse events, oxygen support, and mortality rates. Methods: According to PRISMA reporting guidelines, a review was conducted from January 1 2020 until 25 August 2020 with MeSH terms including COVID-19, COVID, coronavirus, SARS-CoV-2, remdesivir, adenosine nucleoside triphosphate analog, Veklury using MEDLINE, Scopus, and CINAHL Plus. A modified Delphi process was utilized to include the studies and ensure that the objectives were addressed. Using dichotomous data for select values, the unadjusted odds ratios (ORs) were calculated applying Mantel Haenszel (M-H) random-effects method in Review Manager 5.4. Results: Randomized controlled trials pooled in 3013 participants with 46.3% (n=1,395) in the remdesivir group and 53.7% (n=1,618) in the placebo group. The placebo group had a higher risk of mortality as compared to the intervention group with significant odds ratio (OR=0.61) (95% confidence interval of 0.45-0.82; P=0.001). There was minimal heterogeneity among the studies (I2=0%). Conclusions Our findings suggest that remdesivir extends clinical benefits by reducing mortality, adverse events and oxygen support in moderate to severely ill COVID-19 patients. Concerted efforts and further randomized placebo-controlled trials are warranted to examine the potency of anti-viral drugs and immune-pathological host responses contributing to severity of COVID-19.

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Anti-Angiogenesis Maintenance Therapy in Newly Diagnosed and Relapsed Ovarian Cancer: A Meta-analysis of Phase III Randomized Controlled Trials

Frontiers in Pharmacology ◽

10.3389/fphar.2021.726278 ◽

2021 ◽

Vol 12 ◽

Author(s):

Yizi Wang ◽

Shitai Zhang ◽

Zixuan Song ◽

Ling Ouyang ◽

Yan Li

Keyword(s):

Ovarian Cancer ◽

Adverse Events ◽

Maintenance Therapy ◽

Randomized Controlled Trials ◽

Meta Analysis ◽

Phase Iii ◽

Controlled Trials ◽

Newly Diagnosed ◽

Randomized Controlled ◽

Fatal Adverse Events

Aim: Anti-angiogenesis agents have been added as maintenance therapy in ovarian cancer over the past decade. The aim of this meta-analysis was to analyze the efficacy of anti-angiogenesis therapy in newly diagnosed and relapsed ovarian cancer.Methods: PubMed, Embase, and Cochrane databases were searched for all phase III randomized controlled trials (RCTs) that assessed the efficacy and toxicity of anti-angiogenesis agents in ovarian cancer. Overall survival (OS) and progression-free survival (PFS) were used to evaluate the effectiveness of anti-angiogenesis therapy in ovarian cancer.Results: A total of 6097 patients with newly diagnosed ovarian cancer from 5 phase III RCTs and 2943 patients with relapsed ovarian cancer from 6 phase III RCTs were included in this meta-analysis. The pooled results showed that anti-angiogenesis maintenance therapy significantly improved PFS (hazard ratio [HR], 0.84; 95% confidence interval [CI], 0.76–0.93; p = 0.001), but not OS (HR, 0.98; 95% CI, 0.91–1.05; p = 0.49) compared with placebo in patients with newly diagnosed ovarian cancer. In patients with relapsed ovarian cancer, the pooled results showed a significant improvement on OS (HR, 0.89; 95% CI, 0.82–0.98; p = 0.02) and PFS (HR, 0.61; 95% CI, 0.52–0.72; p < 0.001). The pooled results also showed that the anti-angiogenesis agents were associated with an increase in the occurrence of severe hypertension, neutropenia, diarrhea, thrombocytopenia, headache, and bleeding in ovarian cancer. However, infrequent fatal adverse events occurred in the anti-angiogenesis groups.Conclusions: Study results suggest that anti-angiogenesis agents were an effective therapy for newly diagnosed and relapsed ovarian cancer, especially for relapsed ovarian cancer. Anti-angiogenesis agents may be associated with some severe but not fatal adverse events.Systematic Review Registration:https://www.crd.york.ac.uk/prospero/, identifier CRD42021283647

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Effects of Teriparatide versus Salmon Calcitonin Therapy for the Treat-ment of Osteoporosis in Asia: A Meta-analysis of Randomized Controlled Trials

Endocrine Metabolic & Immune Disorders - Drug Targets ◽

10.2174/1871530320999200817114817 ◽

2020 ◽

Vol 20 ◽

Author(s):

Changjun Chen ◽

Mohammed Alqwbani ◽

Jie Chen ◽

Ruitong Yang ◽

Songgang Wang ◽

...

Keyword(s):

Femoral Neck ◽

Adverse Events ◽

Randomized Controlled Trials ◽

Salmon Calcitonin ◽

Bone Markers ◽

Meta Analysis ◽

Controlled Trials ◽

Randomized Controlled ◽

Asian Patients ◽

Teriparatide Treatment

Objective: The objective of this meta-analysis was to compare the efficacy and safety of teriparatide versus salmon calcitonin for the treatment of osteoporosis in Asian patients and to investigate whether the results of global studies could be applicable to Asian patients. Methods: PubMed, OVID, Cochrane Central Register of Controlled Trials (CENTRAL) and EMBASE up to December 2018 were searched. Eligible randomized controlled trials (RCTs) that compared teriparatide versus salmon calcitonin in Asian osteoporosis popula-tion were included. Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were used for data synthe-sis, and Cochrane Collaboration software Review Manager 5.3 was used to analyze the pooled data. Results: Three RCTs involving 529 patients were included (mean age 68.7 yr; 93.4% females; mean follow-up 6 months); outcome measures included bone mineral density (BMD) of the femoral neck, total hip and lumbar spine; bone markers and adverse events. We found that the period of 6-months of teriparatide treatment was helpful for the improvement of the BMD of lumbar vertebra, however, the improvement of BMD was not significant in femoral neck and total hip join. There was a positive correlation between bone-specific alka-line phosphatase (BSAP) and osteocalcin (OCN) and the response of Asian patients to subcutaneous injection of 20 micrograms per day of teriparatide. And the proportion of the occurrence of adverse effect was more obvious in teriparatide group compared with salmon calciton-in, but there was no significant difference. Conclusion: Results suggested that the use of teriparatide could improve the lumbar BMD by short-term (six months) application in Asian osteoporosis patients, which is beneficial to the patients who cannot tolerate adverse events of long-term treatment. The BSAP and OCN bone markers could be useful to monitor the responses of Asian osteoporosis patients to teriparatide treatment. Finally, both of teriparatide and salmon calcitonin were well tolerated by Asian patients.

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