|Year : 2021 | Volume
| Issue : 3 | Page : 270-274
Type 2 diabetes mellitus in Saudi Arabia: A review of the current situation
Muhammad Saad Tanveer, Muhammad Hassan Tanveer, Mamoona Javed
Parim Evidencia Ltd, London, UK
|Date of Submission||18-Oct-2020|
|Date of Decision||08-Mar-2021|
|Date of Acceptance||18-Feb-2021|
|Date of Web Publication||30-Sep-2021|
Mr. Muhammad Saad Tanveer
Parim Evidencia Ltd, 321–323 High Road, Romford, RM6 6AX London.
Source of Support: None, Conflict of Interest: None
Objectives: To review the effectiveness of current clinical interventions and integrated care program, and the cost-effectiveness of currently available pharmaceutical interventions in the management of Type 2 Diabetes Mellitus in Saudi Arabia. Data Sources and Methods: A systematic search of MEDLINE, EMBASE, ScienceDirect, CENTRAL, and Google Scholar was conducted to identify the relevant articles. A detailed inclusion–exclusion criterion was developed and implemented to screen the abstracts and full-texts. We extracted study data from eligible studies into a data extraction form and categorized into various themes to answer our research question. Study Selection and Themes: Seventeen studies categorized into three themes were included in this review. The evidence was compiled to report the effectiveness of current clinical interventions, integrated care program, and cost-effectiveness of pharmaceutical interventions. Conclusions: There is strong evidence of safety and efficacy of BIAsp 30 in T2DM patients. In addition, BIAsp 30 with or without OADs is more cost-effective compared with other pharmaceutical interventions. The integrated care program is more effective in reducing HbA1c in diabetic patients compared with usual care programs; however, the evidence is small and more studies are required. Recommendations: Most of the available studies are small cross-sectional studies. There is a dire need to conduct extensive and high-quality studies, with the sample size representative of Saudi T2DM populations, to generate larger data with high-quality evidence to provide more robust evidence in the future.
Keywords: Effectiveness, integrated care program, T2DM, type 2 diabetes mellitus
|How to cite this article:|
Tanveer MS, Tanveer MH, Javed M. Type 2 diabetes mellitus in Saudi Arabia: A review of the current situation. J Diabetol 2021;12:270-4
| Introduction|| |
Diabetes Mellitus (DM), a complex metabolic disorder, is related to different underlying causes for hyperglycemia. There are several types of diabetes; three main types include type 1, type 2 and gestational. Type 2 diabetes mellitus (T2DM) is the most common and constitutes 90% of all diabetes.
Diabetes is one of the fastest growing health challenges of this century, with the number of diabetic patients has more than tripled over the past two decades. The rising prevalence of DM is the result of a complex interaction among genetic, environmental, socioeconomic, and demographic factors. This continued surge in mainly due to the dramatic rise in T2DM, which is the seventh leading cause of mortality. The latest atlas by International Diabetes Federation (9th ed. 2019) reported that approximately 54.8 million adults (12.8%) aged 20–79 years had DM in the Middle East and North Africa Region (MENA) in 2019. Diabetic population in the MENA region is estimated to be double by 2045. Saudi Arabia is ranked 4th in the top five countries for the number of people with diabetes (20–79 years) among the MENA countries. IDF predicts that approximately one-quarter of Saudi adults will have diabetes by 2045.
Although T2DM is labeled a chronic progressive disease, it is reversible if diagnosed and treated promptly at early stages. Pharmacological interventions are available to control this ailment. However, self-management and lifestyle changes are critical in diabetic care and attaining T2DM control., This disease not only affects health-related quality of life but also is a substantial economic burden on healthcare. In addition to that, T2DM negatively affects patients’ quality of life, limits their social activities, and reduces their energy and vitality. Furthermore, inadequate glycemic control may lead to micro- and macrovascular complications. Therefore, it is essential to learn which pharmacological interventions are most effective and how to improve patients’ knowledge and skills to enable them to play their role in their journey back to a normal or near-normal life.
This review, therefore, is conducted to summarize the currently available literature, to get an overview of the current T2DM situation in Saudi Arabia.
Objectives of this review include
To understand the current clinical practice
To explore the effectiveness of the integrated care programme
To review the cost-effectiveness of currently available pharmaceutical interventions
| Materials and Methods|| |
We systematically searched five databases; Medline, Embase, Science Direct, Cochrane Central Register of Controlled Trials (CENTRAL), and Google Scholar for this review. All five databases were searched from inception to June 2020 to retrieve the relevant literature. Our core search strategy was based on the keywords extracted from relevant articles, Medical Subject Headings (MeSH), and the controlled vocabulary used by each database. The search strategy used for Medline, Embase, and Cochrane is reported in the Supplementary Material and was constructed from search terms relating to type 2 diabetes mellitus to Saudi Arabia.
All published randomized and non-randomized clinical trials, including cluster and cross-over trials, were eligible for inclusion in this review. In addition to this, analytical observational studies including prospective and retrospective cohort studies, prospective and retrospective case–control studies, cross-sectional studies, controlled before-and-after studies, and systematic reviews were also eligible for inclusion. We, however, excluded letters to the editor, editorials, expert opinions, case studies, and case series. In addition to this, the search was narrowed by applying filters to limit the studies only to the English language and human. The search was designed to retrieve the studies conducted on the Saudi population. However, we also included the studies which encompassed any other population in addition to the Saudi population.
The studies were screened in abstract screening software “Rayyan QCRI.” Primary research studies relevant to T2DM in the Saudi population, reporting the clinical and cost-effectiveness or safety of relevant medical interventions, and integrated care programme were included in our research. The full texts of all included studies were screened using the same inclusion criteria as abstract screening but focused on identifying studies with relevant outcomes.
| Results|| |
Seventeen studies categorized into three themes were included in this review. The evidence was compiled to report the effectiveness of current clinical interventions, integrated care program, and cost-effectiveness of pharmaceutical interventions.
As T2DM is known to be a progressive disease, over time, the new hypoglycemic agents (OHAs) are added to a patient’s treatment regimen to achieve a normal blood sugar level. However, in patients whose blood sugar levels were not adequately controlled even with two OHAs regimens, a third OHA may be included in the care regimen. Alternatively, the physician and patient may decide to switch to insulin-based therapy. Alavudeen et al. conducted a qualitative prospective study to compare the effectiveness of biphasic insulin plus metformin and triple OHA. The authors found that HbA1c in insulin-based therapy group was significantly lower compared with triple OHA group (8.18 ± 1.32 vs. 8.79 ± 1.81, P = 0.0238). The results suggested that Biphasic insulin and metformin regimen is more appropriate in T2DM patients with secondary failure to OHA.
Glycemic control is crucial to prevent diabetes complications. Treatment regimens generally follow stepwise algorithms and guidelines. However, there is evidence of patients’ resistance to initiate insulin therapies, primarily because of patients’ perception of failure in lifestyle changes. In addition, many patients consider insulin as a last resort and want to delay it unless there was no alternative. However, it is essential to decide on a suitable and clinically effective treatment approach to benefit the patients. VISION, an observational study, enrolled 1192 adult T2DM patients from the MENA region to explore the patterns of insulin initiation and intensification. The study found that despite being on oral antidiabetic drugs, two-third patients had baseline HbA1c ≥9% (mean HbA1c = 9.9%), which indicates a significant delay in insulin therapy initiation. The authors found that through this 18-month study, the average HbA1c declined from 9.9% to 7.3%. Only 5.1% patients reported hypoglycemia during the first 6 months. The patients’ satisfaction with the treatment rose significantly; from 6.2% to 29.1% for complete satisfaction with the treatment and 13.7% to 44.5% for somewhat satisfaction with the treatment.
DISCOVER, an observational study, was conducted to assess variations in treatment patterns in T2DM patients. The study found that metformin (with or without sulfonylureas) is the first choice of physicians for T2DM patients. Metformin was followed by DPP4 inhibitors, in particular sitagliptin, as a second-line treatment; which was followed by the second and third generation of sulfonylureas. Patients’ vitamin B12 levels should be regularly checked when treated with metformin as the drug is known to reduce vitamin B12 uptake in the small intestine. Alharbi et al. conducted a retrospective observational study in T2DM adult patients treated with or without metformin to assess metformin-related vitamin B12 deficiency. The authors found that B12 deficiency prevalence was 9.4% in metformin-treated patients and 2.2% in non-metformin treated patients. However, deficiency occurred with metformin dose greater than 2000 mg/day (AOR: 21.67; 95% CI: 2.87–163.47) or for use over a period greater than 4 years (AOR: 6.35; 95% CI: 1.47–24.47).
Changing the treatment regimen is essential if the existing regimen fails to generate outcomes as expected or is resulting in severe adverse effects. An observational study conducted to compare the conversion of human insulin (HI) to biphasic insulin aspart 30 (BAIsp 30) increased life expectancy by 0.62 years (11.77 ± 0.20 vs. 11.15 ± 0.19 years), quality-adjusted life expectancy by 0.96 and quality-adjusted life years (QALYs) (7.03 ± 0.12 vs. 6.07 ± 0.11 QALYs). In addition to that, this treatment conversion reduced direct medical cost by cutting the costs of hypoglycemia and renal complications.
There is strong evidence of safety and efficacy of BIAsp 30 in T2DM patients. A 6-month prospective observational study conducted to assess the clinical effectiveness of BIAsp 30 with or without OADs found a significant reduction in mean HbA1c (−1.33 and −1.81%), fasting plasma glucose (−3.02 and −3.74mmol/L) and postprandial plasma glucose (−4.76 and −5.82 mmol/L) (P < 0.001) at 3 and 6 months when compared with baseline.
With the modern advancements in healthcare, patient satisfaction with the treatment regimen has gained more emphasis. This is now considered a component of clinical effectiveness. A 12-week prospective study examining patients satisfaction with liraglutide found that liraglutide addition to the existing treatment not only improved patient’s treatment satisfaction but also improved glycemic control. Hypoglycemia is commonly reported in T2DM Muslim patients who fast during Ramadan, mainly because of the use of anti-hyperglycemic medications. A prospective observational study was conducted in the Middle East to compare the effectiveness of vildagliptin and sulfonylurea on hypoglycemic events. The study reported that treatment with vildagliptin significantly reduced the occurrence of hypoglycemic events when compared with sulfonylurea (3.7% vildagliptin vs. 25.5% SU; P < 0.001).
Integrated care, a multidisciplinary approach involving a senior family physician, clinical pharmacy specialist, diabetic educator, health educator, dietician, and social worker have proven successful in T2DM management in Saudi Arabia. An open label controlled interventional study was conducted to evaluate the effect of an integrated care approach on glycemic control. The patients were randomly assigned to an integrated care (intervention) group or standard care (control) group. The study reported statistically significant reduction in HbA1c (−27.1%; 95% CI=−28.9%, −25.3%; P < 0.05) in the intervention group when compared with the control group.
Another interventional study conducted to explore the effectiveness of integrated care programme in the management of T2DM reported significant reductions in HbA1c levels in the intervention group when compared with the usual care control group (post-intervention relative reduction = −27.08%; P < 0.05). Jizan integrated lifestyle education (JILSE) programme was reported to reduce HbA1c by 16.87% in the intervention group when compared with the control group. The programme significantly improved diabetic knowledge level and was widely accepted by Saudi diabetic patients.
Al Asmary et al. conducted a study in Riyadh, Saudi Arabia to evaluate the impact of a multidisciplinary care program for patients with uncontrolled T2DM. The authors conducted a before-and-after study among patients with uncontrolled T2DM and/or comorbidities at a primary care center to assess the effectiveness of intensified and patient-specific multidisciplinary care. The authors found that HbA1c, FBG, triglycerides, and total cholesterol were significantly reduced in the post-intervention stage (reductions of 18.5%, 21.0%, 16.0%, and 10.5%, respectively). The reduction in HbA1c was highest among patients with uncontrolled diabetes without comorbidity (25.7%), moderate among patients with cardiovascular disease and/or dyslipidemia (12.6%), and minimal among those with renal problems (0.3%, P < 0.05). The authors concluded that integrated care was associated with a 20% improvement in glycemic control and up to a 16% reduction in serum lipids among T2DM patients.
Growing diabetic population and limited resources exert an excessive strain on healthcare. Therefore, it is essential to use clinically and cost-effective medical technologies to ensure the availability of evidence-based technologies to improve the health of patients.
A study conducted to compare the cost-effectiveness of Metformin extended-release (XR) to Metformin immediate release (IR) found that Metformin XR was not only more cost-effective when compared with Metformin IR (drug costs with metformin XR: 234,420 SAR vs. metformin IR: 236,826 SAR), but also increases patient’s quality-adjusted life years (QALYs).
Gupta et al. conducted a cost-effectiveness analysis to assess the economic impact of switching from insulin glargine (IGlar), neutral protamine Hagedorn (NPH) insulin (all ± oral glucose-lowering drugs [OGLDs]), or biphasic human insulin 30 (BHI) to biphasic insulin aspart 30 (BIAsp 30). The authors reported that switching to BIAsp 30 significantly reduced the cost and improved the life expectancy.
Shafie et al. used The IMS CORE Diabetes Model to assess the cost-effectiveness of BIAsp 30 and oral antidiabetic drugs in 1-year and 30-year time horizons. The authors found that BIAsp 30 was highly cost-effective with ICERs of -0.03 GDPc/QALY. In addition to that, BIAsp 30 was expected to increase life expectancy by more than 1 year.
Home et al. conducted cost-effectiveness analyses of BIAsp 30 ± OADs and BHI 30 ± OADs using real-world observational data. One-year and 30-year incremental cost-effective ratios (ICERs) for Saudi Arabia were SAR 12,913 and SAR 837, respectively, indicating cost-effectiveness of switching to BIAsp 30 ± OADs from BHI 30 ± OADs.
Home et al. conducted cost-effectiveness analyses of switching NPH insulin ± oral glucose-lowering drugs (OGLDs) to insulin detemir ± OGLDs using real-world observational data. One-year and 30-year incremental cost-effective ratios (ICERs) for Saudi Arabia were SAR 27,221 and SAR 6,349, respectively, indicating cost-effectiveness of switching from NPH ± OGLDs to detemir ± OGLDs at both time horizons [Table 1].
| Discussion|| |
Clinical interventions for T2DM vary from patient to patient. Metformin is generally used as the first line of therapy; however, patients were offered a second or third line of therapy if they do not respond to initial treatments.
Standard care T2DM patients typically receive their care in either primary care or secondary care only. However, the integrated care is developed with the joint involvement of primary, secondary, and tertiary sectors. This model not only prevents or delays the onset of T2DM but also improves the delivery of diabetes care to people with T2DM across all four levels of care, i.e., specialist inpatient, specialist ambulatory care, specialist support to Primary Care, and chronic disease prevention and management in Primary Care, all supported by patient self-management. Moreover, integrated care saves the lives, eyes, and limbs of people with diabetes, and ensures care is in line with the quality, access and cost objectives of the National Clinical Programme for Diabetes.
Integrated care model has the potential to improve outcomes for T2DM patients. Two studies, a 6-month pilot randomized controlled trial (n = 56) and a cross-sectional study (n = 92) of patients attending the two services, conducted to evaluate the integrated care model for T2DM patients in Melbourne, Australia. Significant HbA1c improvements were observed over time. Moreover, participants from the integrated care setting perceived the quality of diabetes care to be higher than did participants from the hospital clinics. One key strength of the integrated care model is higher patient satisfaction with the quality of diabetes care received.
As the fundamental goal of healthcare is to improve health in general, integrated care facilitates the access of speciality care to underserved populations, improving the quality and safety of healthcare for these patients with uncontrolled T2DM. Other advantages, such as cost savings, in the longer term, could also be attained by avoiding costly diabetes complications in underserved populations.
Although this review found BIAsp 30 with or without OADs more cost-effective compared with other pharmaceutical interventions, the evidence is very limited and may change when compared with other interventions.
Limitations of the studies included in the review
We found many studies discussing T2DM from one perspective or the other. However, most of them are small cross-sectional studies (small sample size) focusing on specific areas/regions of the country, which means the results are not generalizable to the wider population. The issue is also highlighted by Robert and Al-Dawish. In addition to that, many of these studies have reported subjective results and did not provide any evidence of statistical significance. Most of the studies failed to control for confounding variables and effect modification, which causes doubts about these results’ credibility.
| Conclusions|| |
There is strong evidence of safety and efficacy of BIAsp 30 in T2DM patients. In addition, BIAsp 30 with or without OADs is more cost-effective compared with other pharmaceutical interventions. However, the integrated care program is proved to be more effective in reducing HbA1c in diabetic patients than the usual care program.
Extensive and high-quality studies, with the sample size representative of Saudi T2DM populations, are required to generate larger data with high-quality evidence to provide more robust evidence in the future.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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