The Pattern of Anti–hyperglycemic Medication use in Subjects Attending the Diabetes Center in Basrah, Iraq

Abstract

Background: Metformin remains the most widely used first–line drug and is the cornerstone of type 2 diabetes treatment. The aim of the study is to explore the prescribing trends for anti–hyperglycemic agents used among a cohort of diabetics before they registered in the Diabetes Center in Basrah for the first time.

Methods: This is a cross sectional study conducted for the period from January 2010 to December 2011.

Results: Results of 2,123 consecutive patients with type 2 diabetes, who participated, were analyzed. Oral anti–hyperglycemic therapy was given for 64.8 % of our patients with type 2 diabetes mellitus. The majority of prescriptions were self–prescriptions (44.1%). Most of the general practitioners prescribe glibenclamide alone (74.5%).Eighty point four percent didn’t receive metformin. General practitioners mainly prescribe for illiterate people (29.3%) while internists mainly prescribe for university graduates (34.3%). Twenty nine point seven percent received no drug therapy despite poor glycemic control.

Conclusion: Most of our patients with type 2 diabetes mellitus were already on oral antihyperglycemic therapy, but the majority didn’t receive the first line drug, metformin. The attitude of physicians in primary care about management of type 2 diabetes mellitus needs to be re–evaluated urgently.

Keywords: Metformin; Type 2 diabetes mellitus; Oral anti–hyperglycemic drugs; Prescription

Background

The use of guidelines in the management of diabetes has been promoted as one method of ensuring the translation of evidence based medicine into clinical practice, thus standardizing care across the spectrum. Yet various quantitative and qualitative studies show a wide variation of adherence to guidelines for various reasons [1,2]. Diabetes treatment guidelines recommend initiating treatment with anti–hyperglycemic medication either concomitantly with, or following a brief period of lifestyle intervention (3–6 months) [3].

Treatment with anti–hyperglycemic agents, as monotherapy, led to a 2–to 3–fold increase in the proportion of patients with an HbA1c < 7% relative to diet alone in patients with newly diagnosed type 2 diabetes [4]. Early initiation of anti–hyperglycemic medication is associated with reductions in microvascular events and long–term, legacy effects with reductions in myocardial infarction and death in patients with newly diagnosed type 2 diabetes [5].

At diagnosis, highly motivated patients with HbA1c already near target (e.g. <7.5% [<58 mmol⁄mol]) could be given the opportunity to engage in lifestyle change for period of 3—6 months before embarking on pharmacotherapy (usually metformin). Those with moderate hyperglycemia or in whom lifestyle changes are anticipated to be unsuccessful, should be promptly started on an anti–hyperglycemic agent (also usually metformin) at diagnosis, which can later be modified or possibly discontinued if lifestyle changes are successful [3,6–8].

Since publication of the results of the UK Prospective Diabetes Study (UKPDS 34) in 1998, metformin, a biguanide glucoselowering agent, has been recommended as the first–line treatment [9]. Metformin remains the most widely used first–line drug and is the cornerstone of type 2 diabetes treatment [10]. However, 55% to 70% of patients who initially achieve their glycemic targets with metformin therapy have a progressive deterioration of glucose control in 2 to 3 years [11,12]. Continuation of metformin once started on insulin reduced HbA1c, with less weight gain, and less insulin dose in comparison with insulin alone [13].

After lifestyle change and metformin failure, there are limited data to guide us. Sulfonylurea (least expensive) is second line but studies have demonstrated a secondary failure rate that may exceed other drugs, ascribed to an exacerbation of islet dysfunction [14,15]. Metformin could achieve a similar glycemic control to sulfonylurea, but metformin did not cause weight gain, hypoglycemia or increase insulin concentration. The UKPDS clearly demonstrated that sulfonylurea had no protective effect on progressive β–cell failure in newly–diagnosed type 2 diabetic patients over the 15–year study duration [17]. Moreover, sulfonylurea were shown not to have a significant protective effect against atherosclerotic cardiovascular complications, and some studies even gave the notion that sulfonylurea may accelerate the atherogenic process [18]. Iraq is facing epidemic of type 2 diabetes that doubled over short period of time to reach now ~20% [19]. The aim of the study is to explore the prescribing trends for anti–hyperglycemic agents used among a cohort of diabetics before they registered in the Al–Faiha Diabetes and Endocrine Center in Basrah (FDEMC) for the first time.

Methods

Study design

This is a cross sectional study conducted for the period from January 2010 to December 2011. Data was collected on patients from FDEMC in Basrah (this is the secondary referring diabetic center in Basrah, Southern Iraq). The enrolled patients were from primary care referred to secondary care center. The finding indicates the state of care in whole Basrah, because this center receives patients from all primary care of Basrah and probably from whole Iraq.

Once patients registered in the center for the first time a full historyis taken with proper clinical examination. Baseline investigations with glycated hemoglobin are taken, as is lipid profile with plasma glucose and urine for protein. All the treatment is going to be re–evaluated and changed according to guidelines.

Inclusion criteria: patients aged over 18 with type 2 diabetes, defined in accordance with WHO criteria that had disease duration for at least one year before registration in the center.

The objective of the study was explained to the participants and their verbal consent was acquired before conducting the interview.

The objective of the study was explained to the participants and their verbal consent was acquired before conducting the interview. Verbal consent taken from each patient separately in front of the authors of the study at FDEMC. Simply, the verbal consent was taken from the patients by explaining to them the benefit of prescription pattern of oral anti–hyperglycemia drugs and the need for uniform prescription all over Iraq. The patients told that they are going to be enrolled in this study aiming to know the drugs used in the past period before attain the center to correct the inappropriate drugs in the future in the primary care setting. The ethical committee of Basrah Directorate of Health agrees on the study. No written consent was obtained because its cross sectional verbal communication study .The patients asked what treatment gives in the past period. No new treatment given.

Through a structured face– to– face interview socio–demographic data (age, sex, marital and educational status) were taken from each patient with information on smoking, duration of diabetes, medication used to treat diabetes currently, and who prescribed the drugs. Those on herbal remedies produced locally or imported from outside are considered in the category of no drugs as self prescription. Self prescription of prescription medications is feasible in Iraq from any pharmacy without medical advice is feasible all over the country.

Hypertension was defined as either resting systolic or diastolic blood pressure ≥130 or ≥80 mmHg respectively, recorded at two different clinical visits or the prescription of anti–hypertensive medication. Body Mass Index (BMI) was calculated as weight (in kilograms) divided by squared height (in meters squared).

Glycated hemoglobin was measured using cation exchange column chromatography methods on an automated HPLC instrument (Bio–Rad D–10, Bio–Rad Laboratories, Hercules, California, USA).

Exclusion criteria

Pregnant women, those with type 1 diabetes mellitus, those on insulin, those with no HbA1c, less than 1 year of diabetes, patients with serum creatinine above 1.4 mg⁄dl or those with heart failure were excluded.

Statistical analysis

Continuous variables are presented as means and Standard Deviations (SD), categorical data as frequencies and percentages. Data collected were analyzed by chi– square test as appropriate.

Results

Of 14135 registered patients with diabetes in this center, results of 2,123 consecutive patients with type 2 diabetes who participated were analyzed.

Clinical characteristics of the study population are summarized in Table 1. Mean age was 51.7±11.7 year with 81.7% of them above age of 40 years. Women were slightly more than men (54.0%) and 34.6% were illiterate and only 23.55% of the study sample were employed. 88.2% of women were house makers and 85.6% of all were married. More than half of the patients (53.8%) had diabetes duration 1–3 years. Family history of diabetes in first degree relatives was present in 60.8%. Mean BMI was 28.0±5.8 kg/m². Hypertension was present in 22.3% and 16.8% were current cigarette smokers with mean glycated hemoglobin 9.2±2.1 percent.