Type 2 diabetes mellitus (T2DM) is a complex metabolic disease characterized by several pathophysiological alterations, including insulin resistance and a progressive decrease in insulin secretion, which ultimately leads to increased blood glucose levels. blood. This multifactorial disease results from the interaction between genetic, epigenetic and lifestyle factors acting in a specific sociocultural environment.
Diabetes-related complications, such as microvascular and macrovascular alterations, resulting from uncontrolled glycemic levels, are responsible for increased morbidity and mortality and reduced quality of life. The burden of diabetes and diabetes-related complications results in a worrying increase in global healthcare spending.
Evidence from the literature suggests that despite tighter control of blood glucose and other cardiovascular risk factors, such as blood pressure and serum lipids, as well as the large number of therapies available, recommended targets are barely achieved. among patients with DM2. These unsatisfactory outcomes may be due to inappropriate intervention strategies on the part of the physician or patient-related issues such as noncompliance.
To achieve these objectives and improve therapeutic results, new models of care must be implemented, based on collaborative, proactive and integrated teamwork in which patients have an active role. The objective of this study is to review and investigate the effect of interventions carried out by clinical pharmacists in the management of T2DM, focusing only on randomized controlled trials conducted in hospitals or outpatient centers.
Methods
We searched PubMed and the Cochrane Central Register of Controlled Trials for randomized controlled trials evaluating the effectiveness of such interventions compared with usual care that took place in hospitals or outpatient settings.
Results
The database search yielded a total of 748 citations, of which 84 potentially met the inclusion criteria. After reading through, 39 studies met the inclusion criteria and were included in this systematic review.
Among the included studies, nine were conducted in North America, five in South America, three in Europe, one in Africa, and twenty-one in Asia. The settings in which the studies were conducted included hospitals, primary care health centers, and outpatient clinics. Globally, the included studies included a total of 6,411 participants. The duration of follow-up ranged from 45 days to 24 months.
The allocation sequence was concealed and outcome assessors were blinded in only a few studies (7.7% and 2.6%, respectively). In the majority of studies (97.5%), there was or could have been a risk of bias due to selective reporting of results. Only 13 studies (33.3%) reported outcome data completely and 19 studies (48.7%) were free of another source of bias.
> HbA1c and blood glucose
The mean HbA1c value decreased from baseline to follow-up in the intervention group in all studies. But this decrease reached statistical significance in only sixteen studies (47%). In these studies, the difference between the intervention group and the control group ranged from -0.05% to -2.1%. Regarding blood glucose, 22 studies reported this parameter as an outcome measure. Only six studies (27%) reported a statistically significant decrease in blood glucose (fasting or postprandial). Overall, the change difference between both groups ranged between -7.74 mg/dL and -76.32 mg/dL.
> Blood pressure
Twenty studies evaluated the change in systolic blood pressure (SBP) over the course of the study. The difference in change between the two groups ranged from +3.45 mmHg to -10.6 mmHg and was shown to be statistically significant in only seven studies (33.3%).
Regarding diastolic blood pressure (DBP), 15 studies reported data on this outcome. However, only three studies revealed a statistically significant difference in change from baseline to final follow-up between both groups. The difference between the two groups ranged from +1.32 mmHg to -9.1 mmHg.
> Lipid profile
Fifteen studies described total cholesterol as an outcome measure. However, only four studies (26.7%) were reported as statistically significant. The difference between both groups ranged between +10.06 mg/dL and -32.48 mg/dL. Regarding LDL cholesterol, 21 studies reported data on this outcome. For this parameter, the difference in change between both groups ranged between +2.1 mg/dl and -27 mg/dl, and was reported as statistically significant in only seven studies (33.3%).
Among the 15 studies that reported HDL cholesterol as an outcome measure, the difference in change between both groups was shown to be statistically significant in only one study (6.7%). The difference between the two groups ranged from -5.8 mg/dL to +11 mg/dL. Finally, 16 studies reported data on triglycerides and three studies (18.8%) observed statistical significance in the change between the two groups, which ranged from +21.26 mg/dL to -62.0 mg/dL.
> Body mass index
Sixteen studies described body mass index (BMI) as an outcome measure. Although eleven studies reported a greater reduction in this group compared to the control group, only one study (6.3%) revealed a statistically significant difference in change between both groups. The difference between the two groups ranged between +0.6 kg/m 2 and -1.94 kg/m 2 .
> 10-year risk of coronary heart disease
CHD risk was predicted among study participants in five studies. Compared with the control group, the difference was reported as statistically significant in only two studies (40%).
Because the methods used to assess this risk varied between studies, it is not possible to define a range for the difference in change between both groups in all studies. However, among studies that used the Framingham prediction method, this difference was -3.0% and -12.0%, respectively.
> Medication compliance and related quality of life
Medication adherence was assessed, using different methods, in 20 studies. In 12 studies, greater medication adherence was observed in the intervention group compared to the control group, but only four studies reported a statistically significant difference.
Regarding quality of life, despite the different tools used, only one of the twelve studies measuring this outcome reported a statistically significant difference between the two groups.
> Economic results
Six studies performed an economic analysis (only a few are mentioned below). Adibe et al. performed a cost-utility analysis of the pharmaceutical care intervention implemented in their study. The total cost per patient per year was USD 326 for the control group and USD 394 for the intervention group (p=0.1009). Furthermore, the quality-adjusted life year (QALY) per patient per year was 0.64 for the control group and 0.76 for the intervention group (p < 0.0001). Therefore, the authors found that the intervention was highly cost-effective.
Chan et al. estimated the cost-effectiveness of the pharmaceutical care program based on the expected projected cost savings due to reduced risk of CHD. The estimated potential cost savings was USD 5,086.3 per patient.
Simpson et al. also performed a cost-effectiveness analysis. This analysis was based on the costs of: pharmacist intervention, prescription drugs, health services provided by specialist physicians and other health professionals, emergency department visits, and hospitalizations.
The authors found that the total cost per patient per year was US$151.88 lower in the intervention group compared to the control group, and that the intervention group had a 0.26% reduction in the annualized risk of cardiovascular event compared to the control group. The probability that the intervention was cost-effective compared to usual care reached 95%.
Siaw et al. They also performed an economic evaluation by calculating the direct medical costs of outpatients, taking into account office visits, laboratory tests and procedures, and medications. The mean cost of direct diabetes-related outpatient care was $516.77 in the intervention group and $607.78 in the control group, resulting in a mean cost savings of $91.01. per patient.
Discussion
This systematic review stands out from previous systematic reviews because in addition to demonstrating the positive contribution of clinical pharmacists in the metabolic control of patients with T2DM, it also includes the economic and humanistic outcomes of pharmacist interventions.
Taking into account that the role of the pharmacist continues to be undervalued in the context of clinical interventions, specifically aimed at patients, unlike what happens with other health professionals with this work, it is also intended to emphasize that pharmacists are highly trained professionals and able to integrate multidisciplinary teams to improve patient education strategies, medication review, and case management with routine follow-up.
Pharmacists’ interventions frequently included medication management, educational interventions, and referrals to other health professionals. The diversity of interventions observed may be related to the difference in roles and integration of pharmacists within health systems in different countries, particularly with regard to prescribing authority and autonomy to make medication changes.
Evidence from the studies included in this review indicates that clinical pharmacists contribute positively to the management of patients with T2DM. For example, these types of interventions could be even more effective if they were part of routine patient follow-up.
In fact, almost all studies reported an improvement in HbA1c, blood glucose, blood pressure, lipid profile, and BMI in the intervention group. These findings are consistent with those of other systematic reviews on this topic.
The fact that pharmacists’ interventions resulted in a reduction in HbA1c and blood glucose is of great importance, since an improvement in glycemic control is related to a decreased risk of diabetes-related microvascular complications, that is, a reduced risk of stroke by 12%, a reduced risk of myocardial infarction by 14% and a reduced risk of heart failure by 16%.
Regarding blood pressure, lipid profile and BMI, the findings add to the evidence described in other studies. For example, in their review evaluating the effects of pharmaceutical care among outpatients with cardiovascular risk factors for diabetes, Santschi et al. reported that pharmaceutical interventions were associated with significant reductions in SBP and DBP, total cholesterol, LDL cholesterol, and BMI compared with usual care, but the same was not observed for HDL cholesterol.
There are few studies evaluating the risk of coronary heart disease after pharmacist interventions; however, these interventions have been associated with an improvement in the risk of coronary heart disease. Since the tools/formulas used to calculate this risk include some of the clinical outcomes mentioned above, such as HbA1c, SBP, and cholesterol, the decreased risk of CHD may be partly attributed to an improvement in these parameters.
Pharmacists’ interventions also had a positive impact on medication adherence in the majority of studies that included this outcome. Existing findings demonstrate that pharmacists have the potential to improve medication adherence among patients with T2DM, which in turn may translate into a beneficial effect on clinical outcomes, as observed in some studies.
The fact that pharmaceutical interventions did not result in a significant increase in quality of life in most studies could be explained by the lack of sensitivity of existing tools to detect subtle changes in this outcome.
Although pharmaceutical interventions have been shown to be cost-effective, the evidence is limited by the small number of studies that conducted an economic analysis. However, to inform and influence the decision of policy makers regarding the widespread inclusion of clinical pharmacists in the care of patients with T2DM, economic analyzes are essential due to current resource limitations in healthcare systems. .
This review has some limitations. First, although randomized controlled trials have the strongest study design, the included studies had some methodological weaknesses, as assessed by the Cochrane risk of bias tool.
Second, because pharmacists’ interventions were somewhat heterogeneous, it is difficult to identify the most effective intervention. In this work, the authors observed that educational and medication management interventions carried out by pharmacists could be a good approach for the management of type 2 diabetes mellitus.
Conclusions
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