University of Miami-Humana Health Service Research Center, Miami, FL 33125, USA.
Postgrad Med. 2010 Mar;122(2):112-20. doi: 10.3810/pgm.2010.03.2128.
Gastrointestinal (GI) symptoms are common in patients with type 2 diabetes mellitus (T2DM). This study assesses the impact of 1) metformin on GI symptoms and health-related quality of life (HRQoL) and 2) metformin-associated GI symptoms on medication adherence in patients with type 2 diabetes newly beginning therapy.
Patients with T2DM aged>or=18 years starting metformin from January to June 2007 who filled their prescriptions for >or=3 months were identified from a health benefits company database. Via telephone, GI symptom impact was evaluated in a 360-patient sample using the validated Bowel Symptom Questionnaire and Medical Outcomes Study 36-Item Short-Form Health (SF-36) survey. Adherence was assessed using the medication possession ratio (MPR). Logistic regression adjusting for demographic and clinical covariates was used to assess the relationship between GI symptoms and MPR<80%.
The most and least common GI symptoms reported were diarrhea (62.1%) and retching (21.1%), respectively. Most GI symptoms were associated with lower physical and mental HRQoL (P<0.05). Most changes in specific HRQoL reached the minimum important difference of 3 points. Bloating, nausea, and abdominal pain were significantly associated with MPR<80%. Adjustment for demographic, clinical, and HRQoL factors made these relationships less evident.
Metformin-associated GI symptoms in patients with T2DM lead to lower physical and mental HRQoL, which may result in patient nonadherence or physician reluctance to optimally titrate the metformin dose.
胃肠道(GI)症状在 2 型糖尿病(T2DM)患者中很常见。本研究评估了以下两个方面的影响:1)二甲双胍对 GI 症状和健康相关生活质量(HRQoL)的影响;2)2 型糖尿病新开始治疗的患者中与二甲双胍相关的 GI 症状对药物依从性的影响。
从一家健康福利公司的数据库中确定了 2007 年 1 月至 6 月期间开始使用二甲双胍的年龄≥18 岁的 T2DM 患者,这些患者的处方已服用了≥3 个月。通过电话,使用经过验证的肠症状问卷和医疗结局研究 36 项简明健康调查(SF-36)对 360 名患者样本中的 GI 症状影响进行评估。通过药物占有比(MPR)评估依从性。使用逻辑回归调整人口统计学和临床协变量来评估 GI 症状与 MPR<80%之间的关系。
报告的最常见和最不常见的 GI 症状分别是腹泻(62.1%)和呕吐(21.1%)。大多数 GI 症状与较低的身体和心理 HRQoL 相关(P<0.05)。大多数特定 HRQoL 的变化达到了 3 分的最小重要差异。腹胀、恶心和腹痛与 MPR<80%显著相关。对人口统计学、临床和 HRQoL 因素进行调整后,这些关系变得不那么明显。
T2DM 患者中与二甲双胍相关的 GI 症状会导致较低的身体和心理 HRQoL,这可能导致患者不依从或医生不愿意最佳调整二甲双胍剂量。