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罗格列酮能否与吡格列酮竞争?系统评价和批判性评价。

Will lobeglitazone rival pioglitazone? A systematic review and critical appraisal.

机构信息

Calcutta Medical Research Institute & CK Birla Hospital, Kolkata-27, India.

G.D Hospital & Diabetes Institute, Kolkata-13, India.

出版信息

Diabetes Metab Syndr. 2023 Apr;17(4):102747. doi: 10.1016/j.dsx.2023.102747. Epub 2023 Mar 21.

Abstract

BACKGROUND AND AIMS

Lobeglitazone (LGZ), a newly researched thiazolidinedione (TZD) thought to have lesser side effects compared with pioglitazone (PGZ), has been recently approved for the treatment of type 2 diabetes (T2D) in India. We aim to conduct an updated systematic review of LGZ to critically appraise its efficacy and safety in the context of PGZ.

METHODS

A systematic literature search was carried out in the electronic database of PubMed until Jan 15, 2023, using specific keywords and MeSH terms. All studies which evaluated LGZ in people with T2D were retrieved and data were synthesized with regard to its efficacy and safety. A comparative critical appraisal was additionally made in the context of PGZ in T2D.

RESULTS

Four randomized controlled, one prospective observational, and two real-world studies have evaluated the safety and efficacy of LGZ against placebo or active comparators either as monotherapy or in combination therapy. HbA1c reduction with LGZ 0.5 mg was superior to the placebo but similar to PGZ 15 mg and sitagliptin (SITA) 100 mg. Weight gain with LGZ was significantly higher compared to placebo and SITA but similar to PGZ. Edema was more frequently observed with LGZ compared to placebo, PGZ, and SITA.

CONCLUSION

No substantial evidence is yet available that suggests LGZ could be a better alternative to PGZ both in the context of glycemic or extra-glycemic effects. At least in the short-term, adverse events of LGZ are indifferent from PGZ. More data is additionally needed to claim any advantage of LGZ over PGZ.

摘要

背景与目的

洛格列酮(LGZ)是一种新研发的噻唑烷二酮类药物(TZD),与吡格列酮(PGZ)相比,其副作用较小,最近已在印度获准用于治疗 2 型糖尿病(T2D)。我们旨在对 LGZ 进行更新的系统评价,以批判性地评估其在 PGZ 背景下的疗效和安全性。

方法

我们在电子数据库 PubMed 中进行了系统文献检索,截至 2023 年 1 月 15 日,使用特定的关键词和 MeSH 术语。检索了所有评估 LGZ 用于 T2D 患者的研究,并就其疗效和安全性进行了数据综合。此外,还在 T2D 背景下对 PGZ 进行了比较性批判性评价。

结果

四项随机对照研究、一项前瞻性观察研究和两项真实世界研究评估了 LGZ 作为单药治疗或联合治疗与安慰剂或阳性对照药物(包括 PGZ 15mg 和西他列汀 100mg)相比的安全性和疗效。LGZ 0.5mg 组的糖化血红蛋白(HbA1c)降低效果优于安慰剂组,但与 PGZ 15mg 和西他列汀 100mg 组相似。LGZ 组的体重增加明显高于安慰剂组和西他列汀组,但与 PGZ 组相似。与安慰剂、PGZ 和西他列汀相比,LGZ 组更常观察到水肿。

结论

目前尚无充分证据表明,在血糖或血糖以外的效果方面,LGZ 可作为 PGZ 的更好替代药物。至少在短期内,LGZ 的不良反应与 PGZ 无差异。需要更多的数据来声称 LGZ 相对于 PGZ 具有任何优势。

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