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1.  Pharmacist intervention for glycaemic control in the community (the RxING study) 
BMJ Open  2013;3(9):e003154.
Objective
To determine the effect of a community pharmacist prescribing intervention on glycaemic control in patients with poorly controlled type 2 diabetes.
Design
Pragmatic, before–after design.
Setting
12 community pharmacies in Alberta, Canada.
Participants
Type 2 diabetes receiving oral hypoglycaemic medications and with glycated haemoglobin (HbA1c) of 7.5–11%.
Intervention
Pharmacists systematically identified potential candidates by inviting patients with type 2 diabetes to test their HbA1c using validated point-of-care technology. Pharmacists prescribed 10 units of insulin glargine at bedtime, adjusted by increments of 1 unit daily to achieve a morning fasting glucose of ≤5.5 mmol/L. The patients were followed up at 2, 4, 8, 14, 20 and 26 weeks.
Primary outcome
Change in HbA1c from baseline to week 26.
Secondary outcomes
Proportion of patients achieving target HbA1c, changes in oral hypoglycaemic agents, quality of life and patient satisfaction, persistence on insulin glargine, number of insulin dosage adjustments per patient and number of hypoglycaemic episodes.
Results
We screened 365 patients of whom 111 were eligible. Of those, 100 (90%) were enrolled in the study; all 11 patients who did not consent refused to use insulin. Average age was 64 years (SD 10.4), while average diabetes duration was 10.2 years (SD 7). HbA1c was reduced from 9.1% (SD 1) at baseline to 7.3% (SD 0.9); a change of 1.8% (95% CI 1.4 to 2, p<0.001). Fasting plasma glucose was reduced from 11 (SD 3.3) to 6.9 mmol/L (SD 1.8); a change of 4.1 mmol/L (95% CI of 3.3 to 5, p=0.007). Fifty-one per cent of the patients achieved the target HbA1c of ≤7% at the end of the study.
Conclusions
This is the first completed study of independent prescribing by pharmacists. Our results showed similar improvements in glycaemic control as previous physician-led studies. RxING provides further evidence for the benefit of pharmacist care in diabetes.
Trial registration
clinicaltrials.gov; Identifier: NCT01335763.
doi:10.1136/bmjopen-2013-003154
PMCID: PMC3787489  PMID: 24068762
Diabetes; HbA1c; Pharmacist; insulin glargine
2.  Metformin and Exercise in Type 2 Diabetes 
Diabetes Care  2011;34(7):1469-1474.
OBJECTIVE
To determine the effect of metformin on the acute metabolic response to submaximal exercise, the effect of exercise on plasma metformin concentrations, and the interaction between metformin and exercise on the subsequent response to a standardized meal.
RESEARCH DESIGN AND METHODS
Ten participants with type 2 diabetes were recruited for this randomized crossover study. Metformin or placebo was given for 28 days, followed by the alternate condition for 28 days. On the last 2 days of each condition, participants were assessed during a nonexercise and a subsequent exercise day. Exercise took place in the morning and involved a total of 35 min performed at three different submaximal intensities.
RESULTS
Metformin increased heart rate and plasma lactate during exercise (both P ≤ 0.01) but lowered respiratory exchange ratio (P = 0.03) without affecting total energy expenditure, which suggests increased fat oxidation. Metformin plasma concentrations were greater at several, but not all, time points on the exercise day compared with the nonexercise day. The glycemic response to a standardized meal was reduced by metformin, but the reduction was attenuated when exercise was added (metformin × exercise interaction, P = 0.05). Glucagon levels were highest in the combined exercise and metformin condition.
CONCLUSIONS
This study reveals several ways by which metformin and exercise therapies can affect each other. By increasing heart rate, metformin could lead to the prescription of lower exercise workloads. Furthermore, under the tested conditions, exercise interfered with the glucose-lowering effect of metformin.
doi:10.2337/dc10-2207
PMCID: PMC3120188  PMID: 21602430
3.  Enrolment in primary care networks: impact on outcomes and processes of care for patients with diabetes 
Background:
Primary care networks are a newer model of primary care that focuses on improved access to care and the use of multidisciplinary teams for patients with chronic disease. We sought to determine the association between enrolment in primary care networks and the care and outcomes of patients with diabetes.
Methods:
We used administrative health care data to study the care and outcomes of patients with incident and prevalent diabetes separately. For patients with prevalent diabetes, we compared those whose care was managed by physicians who were or were not in a primary care network using propensity score matching. For patients with incident diabetes, we studied a cohort before and after primary care networks were established. Each cohort was further divided based on whether or not patients were cared for by physicians enrolled in a network. Our primary outcome was admissions to hospital or visits to emergency departments for ambulatory care sensitive conditions specific to diabetes.
Results:
Compared with patients whose prevalent diabetes is managed outside of primary care networks, patients in primary care networks had a lower rate of diabetes-specific ambulatory care sensitive conditions (adjusted incidence rate ratio 0.81, 95% confidence interval [CI] 0.75 to 0.87), were more likely to see an ophthalmologist or optometrist (risk ratio 1.19, 95% CI 1.17 to 1.21) and had better glycemic control (adjusted mean difference −0.067, 95% CI −0.081 to −0.052).
Interpretation:
Patients whose diabetes was managed in primary care networks received better care and had better clinical outcomes than patients whose condition was not managed in a network, although the differences were very small.
doi:10.1503/cmaj.110755
PMCID: PMC3273535  PMID: 22143232
4.  Effect of Adding Pharmacists to Primary Care Teams on Blood Pressure Control in Patients With Type 2 Diabetes 
Diabetes Care  2010;34(1):20-26.
OBJECTIVE
To evaluate the effect of adding pharmacists to primary care teams on the management of hypertension and other cardiovascular risk factors in patients with type 2 diabetes.
RESEARCH DESIGN AND METHODS
We conducted a randomized controlled trial with blinded ascertainment of outcomes within primary care clinics in Edmonton, Canada. Pharmacists performed medication assessments and limited history and physical examinations and provided guideline-concordant recommendations to optimize medication management. Follow-up contact was completed as necessary. Control patients received usual care. The primary outcome was a ≥10% decrease in systolic blood pressure at 1 year.
RESULTS
A total of 260 patients were enrolled, 57% were women, the mean age was 59 years, diabetes duration was 6 years, and blood pressure was 129/74 mmHg. Forty-eight of 131 (37%) intervention patients and 30 of 129 (23%) control patients achieved the primary outcome (odds ratio 1.9 [95% CI 1.1–3.3]; P = 0.02). Among 153 patients with inadequately controlled hypertension at baseline, intervention patients (n = 82) were significantly more likely than control patients (n = 71) to achieve the primary outcome (41 [50%] vs. 20 [28%]; 2.6 [1.3–5.0]; P = 0.007) and recommended blood pressure targets (44 [54%] vs. 21 [30%]; 2.8 [1.4–5.4]; P = 0.003). The 10-year risk of cardiovascular disease, based on changes to the UK Prospective Diabetes Study Risk Engine, were predicted to decrease by 3% for intervention patients and 1% for control patients (P = 0.005).
CONCLUSIONS
Significantly more patients with type 2 diabetes achieved better blood pressure control when pharmacists were added to primary care teams, which suggests that pharmacists can make important contributions to the primary care of these patients.
doi:10.2337/dc10-1294
PMCID: PMC3005466  PMID: 20929988
5.  Improving hypertension management through pharmacist prescribing; the rural alberta clinical trial in optimizing hypertension (Rural RxACTION): trial design and methods 
Background
Patients with hypertension continue to have less than optimal blood pressure control, with nearly one in five Canadian adults having hypertension. Pharmacist prescribing is gaining favor as a potential clinically efficacious and cost-effective means to improve both access and quality of care. With Alberta being the first province in Canada to have independent prescribing by pharmacists, it offers a unique opportunity to evaluate outcomes in patients who are prescribed antihypertensive therapy by pharmacists.
Methods
The study is a randomized controlled trial of enhanced pharmacist care, with the unit of randomization being the patient. Participants will be randomized to enhanced pharmacist care (patient identification, assessment, education, close follow-up, and prescribing/titration of antihypertensive medications) or usual care. Participants are patients in rural Alberta with undiagnosed/uncontrolled blood pressure, as defined by the Canadian Hypertension Education Program. The primary outcome is the change in systolic blood pressure between baseline and 24 weeks in the enhanced-care versus usual-care arms. There are also three substudies running in conjunction with the project examining different remuneration models, investigating patient knowledge, and assessing health-resource utilization amongst patients in each group.
Discussion
To date, one-third of the required sample size has been recruited. There are 15 communities and 17 pharmacists actively screening, recruiting, and following patients. This study will provide high-level evidence regarding pharmacist prescribing.
Trial Registration
Clinicaltrials.gov NCT00878566.
doi:10.1186/1748-5908-6-94
PMCID: PMC3199859  PMID: 21834970
6.  2010 Canadian Hypertension Education Program (CHEP) recommendations: The scientific summary – an update of the 2010 theme and the science behind new CHEP recommendations 
The present article is a summary of the theme, the key recommendations for management of hypertension and the supporting clinical evidence of the 2010 Canadian Hypertension Education Program (CHEP). In 2010, CHEP emphasizes the need for health care professionals to stay informed about hypertension through automated updates at www.htnupdate.ca. A new interactive Internet-based lecture series will be available in 2010 and a program to train community hypertension leaders will be expanded. Patients can also sign up to receive regular updates in a pilot program at www.myBPsite.ca. In 2010, the new recommendations include consideration for using automated office blood pressure monitors, new targets for dietary sodium for the prevention and treatment of hypertension that are aligned with the national adequate intake values, and recommendations for considering treatment of selected hypertensive patients at high risk with calcium channel blocker/angiotensin-converting enzyme inhibitor combinations and the use of angiotensin receptor blockers.
PMCID: PMC2886553  PMID: 20485687
Clinical practice guidelines; High blood pressure; Hypertension; Knowledge translation
7.  The Canadian Heart Health Strategy and Action Plan: Cardiac rehabilitation as an exemplar of chronic disease management 
BACKGROUND:
In October 2006, federal funding was announced for the development of a national strategy to fight cardiovascular disease (CVD) in Canada. The comprehensive, independent, stakeholder-driven Canadian Heart Health Strategy and Action Plan (CHHS-AP) was delivered to the Minister of Health on February 24, 2009.
OBJECTIVES:
The mandate of CHHS-AP Theme Working Group (TWG) 6 was to identify the optimal chronic disease management model that incorporated timely access to rehabilitation services and end-of-life planning and care. The purpose of the present paper was to provide an overview of worldwide approaches to CVD and cardiac rehabilitation (CR) strategies and recommendations for CR care in Canada, within the context of the well-known Chronic Care Model (CCM). A separate paper will address end-of-life issues in CVD.
METHODS:
TWG 6 was composed of content representatives, primary care representatives and patients. Input in the area of Aboriginal and indigenous cardiovascular health was obtained through individual expert consultation. Information germane to the present paper was gathered from international literature and best practice guidelines. The CCM principles were discussed and agreed on by all. Prioritization of recommendations and overall messaging was discussed and decided on within the entire TWG. The full TWG report was presented to the CHHS-AP Steering Committee and was used to inform the recommendations of the CHHS-AP.
RESULTS:
Specific actionable recommendations for CR are made in accordance with the key principles of the CCM.
CONCLUSIONS:
The present CR blueprint, as part of the CHHS-AP, will be a first step toward reducing the health care burden of CVD in Canada.
PMCID: PMC2827223  PMID: 20101356
Canadian Heart Health Strategy and Action Plan; Cardiac rehabilitation; Chronic care model
9.  2009 Canadian Hypertension Education Program recommendations: The scientific summary – an annual update 
The present report highlights the key messages of the 2009 Canadian Hypertension Education Program (CHEP) recommendations for the management of hypertension and the supporting clinical evidence. In 2009, the CHEP emphasizes the need to improve the control of hypertension in people with diabetes. Intensive reduction in blood pressure (to less than 130/80 mmHg) in people with diabetes leads to significant reductions in mortality rates, disability rates and overall health care system costs, and may lead to improved quality of life. The CHEP recommendations continue to emphasize the important role of patient self-efficacy by promoting lifestyle changes to prevent and control hypertension, and encouraging home measurement of blood pressure. Unfortunately, most Canadians make only minor changes in lifestyle after a diagnosis of hypertension. Routine blood pressure measurement at all appropriate visits, and screening for and management of all cardiovascular risks are key to blood pressure management. Many young hypertensive Canadians with multiple cardiovascular risks are not treated with antihypertensive drugs. This is despite the evidence that individuals with multiple cardiovascular risks and hypertension should be strongly considered for antihypertensive drug therapy regardless of age. In 2009, the CHEP specifically recommends not to combine an angiotensin-converting enzyme inhibitor with an angiotensin receptor blocker in people with uncomplicated hypertension, diabetes (without micro- or macroalbuminuria), chronic kidney disease (without nephropathy [micro- or overt proteinuria]) or ischemic heart disease (without heart failure).
PMCID: PMC2707168  PMID: 19417857
Clinical practice guidelines; High blood pressure; Hypertension; Knowledge translation
10.  The 2009 Canadian Hypertension Education Program recommendations for the management of hypertension: Part 2 – therapy 
OBJECTIVE:
To update the evidence-based recommendations for the prevention and management of hypertension in adults for 2009.
OPTIONS AND OUTCOMES:
For lifestyle and pharmacological interventions, evidence from randomized controlled trials and systematic reviews of trials was preferentially reviewed. Changes in cardiovascular morbidity and mortality were the primary outcomes of interest. However, for lifestyle interventions, blood pressure lowering was accepted as a primary outcome given the lack of long-term morbidity and mortality data in this field. Progression of kidney dysfunction was also accepted as a clinically relevant primary outcome among patients with chronic kidney disease.
EVIDENCE:
A Cochrane collaboration librarian conducted an independent MEDLINE search from 2007 to August 2008 to update the 2008 recommendations. To identify additional published studies, reference lists were reviewed and experts were contacted. All relevant articles were reviewed and appraised independently by both content and methodological experts using prespecified levels of evidence.
RECOMMENDATIONS:
For lifestyle modifications to prevent and treat hypertension, restrict dietary sodium to less than 2300 mg (100 mmol)/day (and 1500 mg to 2300 mg [65 mmol to 100 mmol]/day in hypertensive patients); perform 30 min to 60 min of aerobic exercise four to seven days per week; maintain a healthy body weight (body mass index 18.5 kg/m2 to 24.9 kg/m2) and waist circumference (smaller than 102 cm for men and smaller than 88 cm for women); limit alcohol consumption to no more than 14 units per week in men or nine units per week in women; follow a diet that is reduced in saturated fat and cholesterol, and that emphasizes fruits, vegetables and low-fat dairy products, dietary and soluble fibre, whole grains and protein from plant sources; and consider stress management in selected individuals with hypertension. For the pharmacological management of hypertension, treatment thresholds and targets should be predicated on by the patient’s global atherosclerotic risk, target organ damage and comorbid conditions. Blood pressure should be decreased to lower than 140/90 mmHg in all patients, and to lower than 130/80 mmHg in those with diabetes mellitus or chronic kidney disease. Most patients will require more than one agent to achieve these target blood pressures. Antihypertensive therapy should be considered in all adult patients regardless of age (caution should be exercised in elderly patients who are frail). For adults without compelling indications for other agents, initial therapy should include thiazide diuretics. Other agents appropriate for first-line therapy for diastolic and/or systolic hypertension include angiotensin-converting enzyme (ACE) inhibitors (in patients who are not black), long-acting calcium channel blockers (CCBs), angiotensin receptor antagonists (ARBs) or beta-blockers (in those younger than 60 years of age). A combination of two first-line agents may also be considered as the initial treatment of hypertension if the systolic blood pressure is 20 mmHg above the target or if the diastolic blood pressure is 10 mmHg above the target. The combination of ACE inhibitors and ARBs should not be used. Other agents appropriate for first-line therapy for isolated systolic hypertension include long-acting dihydropyridine CCBs or ARBs. In patients with angina, recent myocardial infarction or heart failure, beta-blockers and ACE inhibitors are recommended as first-line therapy; in patients with cerebrovascular disease, an ACE inhibitor/diuretic combination is preferred; in patients with proteinuric nondiabetic chronic kidney disease, ACE inhibitors or ARBs (if intolerant to ACE inhibitors) are recommended; and in patients with diabetes mellitus, ACE inhibitors or ARBs (or, in patients without albuminuria, thiazides or dihydropyridine CCBs) are appropriate first-line therapies. All hypertensive patients with dyslipidemia should be treated using the thresholds, targets and agents outlined in the Canadian Cardiovascular Society position statement (recommendations for the diagnosis and treatment of dyslipidemia and prevention of cardiovascular disease). Selected high-risk patients with hypertension who do not achieve thresholds for statin therapy according to the position paper should nonetheless receive statin therapy. Once blood pressure is controlled, acetylsalicylic acid therapy should be considered.
VALIDATION:
All recommendations were graded according to strength of the evidence and voted on by the 57 members of the Canadian Hypertension Education Program Evidence-Based Recommendations Task Force. All recommendations reported here achieved at least 95% consensus. These guidelines will continue to be updated annually.
PMCID: PMC2707169  PMID: 19417859
Antihypertensive drugs; Blood pressure; Guidelines; High blood pressure; Hypertension; Lifestyle interventions
11.  Resistant hypertension 
Resistant hypertension is most often due to insufficient medical therapy. With a patient history, physical examination and focused laboratory tests, sufficient information can be gathered to lead to further directed medical therapy, which most often includes a diuretic as part of the drug regimen. Patients may require four or more classes of antihypertensives, some at high doses to achieve control. The clinician must be prepared to use sufficient medications at sufficient doses to achieve blood pressure targets. Referral to a hypertension specialist is appropriate if blood pressure remains uncontrolled despite therapy with three antihypertensive medications.
PMCID: PMC2707174  PMID: 19417863
Hypertension; Resistant hypertension
12.  Enhancing hypertension awareness and management in the elderly: Lessons learned from the Airdrie Community Hypertension Awareness and Management Program (A-CHAMP) 
BACKGROUND:
High blood pressure (BP) is an established and modifiable cardiovascular risk factor; however, awareness and management of this primarily asymptomatic disease remains suboptimal.
OBJECTIVES:
The Airdrie Community Hypertension Awareness and Management Program (A-CHAMP) was a community-based BP program for seniors designed to improve public and health care provider awareness and management of hypertension.
METHODS:
Volunteer peer health educators (VPHEs) were recruited from the community and trained to manage BP screening sessions in local pharmacies. Airdrie (Alberta) residents 65 years of age and older were invited by their family physicians (FPs) to attend the A-CHAMP sessions. VPHEs identified participants’ cardiovascular risk factors, assessed BP with a validated automated device and implemented a management algorithm. Participants with BP higher than 159/99 mmHg were directed to their pharmacists and FPs. All participants with elevated BP at the initial A-CHAMP session were invited to return to a follow-up session four to six months later.
RESULTS:
Thirty VPHEs were recruited and trained. All 15 FPs and all six pharmacies in Airdrie participated. VPHEs assessed 406 seniors (approximately 40% of Airdrie seniors) during the three-month program. One hundred forty-eight participants (36.5%) had elevated BP at their first session. Of these, 71% returned for the follow-up session four to six months later. The mean (± SD) systolic BP decreased by 16.9±17.2 mmHg (P<0.05, n=105) compared with their first visit, and 56% of participants (59 of 105) reached Canadian targets for BP.
CONCLUSIONS:
A-CHAMP raised awareness, and identified and managed seniors with hypertension. At follow-up, BP showed statistically and clinically significant and sustained improvement. Participating health care providers and VPHEs indicated that A-CHAMP was effective and feasible in improving awareness and control of hypertension.
PMCID: PMC2640333  PMID: 18612498
Blood pressure; Hypertension
13.  Hypertension as a chronic disease: What can be done at a regional level? 
Historically, management of chronic diseases such as hypertension has tended to be reactive, with patients being passive recipients of care. In recent years, the chronic care model has been developed and implemented in many jurisdictions to ensure optimal, proactive care of people with chronic conditions. The model and its principles address the infrastructure and support that is necessary to enable this high-quality care. The role of the patient, primary care team, system and community are all addressed in this model. Experience suggests that application of chronic disease management principles to hypertension can result in significant benefits to all concerned.
PMCID: PMC2643192  PMID: 18548145
Chronic disease management; Hypertension
14.  The 2008 Canadian Hypertension Education Program recommendations for the management of hypertension: Part 2 – therapy 
OBJECTIVE:
To update the evidence-based recommendations for the prevention and management of hypertension in adults.
OPTIONS AND OUTCOMES:
For lifestyle and pharmacological interventions, evidence was preferentially reviewed from randomized controlled trials and systematic reviews of trials. Changes in cardiovascular morbidity and mortality were the primary outcomes of interest. However, for lifestyle interventions, blood pressure lowering was accepted as a primary outcome given the lack of long-term morbidity and mortality data in this field. Progression of kidney dysfunction was also accepted as a clinically relevant primary outcome among patients with chronic kidney disease.
EVIDENCE:
A Cochrane collaboration librarian conducted an independent MEDLINE search from 2006 to August 2007 to update the 2007 recommendations. To identify additional published studies, reference lists were reviewed and experts were contacted. All relevant articles were reviewed and appraised independently by content and methodological experts using prespecified levels of evidence.
RECOMMENDATIONS:
For lifestyle modifications to prevent and treat hypertension, restrict dietary sodium intake to less than 100 mmol/day (and 65 mmol/day to 100 mmol/day in hypertensive patients); perform 30 min to 60 min of aerobic exercise four to seven days per week; maintain a healthy body weight (body mass index 18.5 kg/m2 to 24.9 kg/m2) and waist circumference (smaller than 102 cm for men and smaller than 88 cm for women); limit alcohol consumption to no more than 14 units per week in men or nine units per week in women; follow a diet that is reduced in saturated fat and cholesterol, and one that emphasizes fruits, vegetables and low-fat dairy products, dietary and soluble fibre, whole grains and protein from plant sources; and consider stress management in selected individuals with hypertension. For the pharmacological management of hypertension, treatment thresholds and targets should be predicated on by the patient’s global atherosclerotic risk, target organ damage and comorbid conditions. Blood pressure should be decreased to lower than 140/90 mmHg in all patients, and to lower than 130/80 mmHg in those with diabetes mellitus or chronic kidney disease. Most patients will require more than one agent to achieve these target blood pressures. For adults without compelling indications for other agents, initial therapy should include thiazide diuretics. Other agents appropriate for first-line therapy for diastolic and/or systolic hypertension include angiotensin-converting enzyme (ACE) inhibitors (in nonblack patients), long-acting calcium channel blockers (CCBs), angiotensin receptor antagonists (ARBs) or beta-blockers (in those younger than 60 years of age). A combination of two first-line agents may also be considered for initial treatment of hypertension if systolic blood pressure is 20 mmHg above target or if diastolic blood pressure is 10 mmHg above target. Other agents appropriate for first-line therapy for isolated systolic hypertension include long-acting dihydropyridine CCBs or ARBs. In patients with angina, recent myocardial infarction or heart failure, beta-blockers and ACE inhibitors are recommended as first-line therapy; in patients with cerebrovascular disease, an ACE inhibitor/diuretic combination is preferred; in patients with protein-uric nondiabetic chronic kidney disease, ACE inhibitors are recommended; and in patients with diabetes mellitus, ACE inhibitors or ARBs (or, in patients without albuminuria, thiazides or dihydropyridine CCBs) are appropriate first-line therapies. All hypertensive patients with dyslipidemia should be treated using the thresholds, targets and agents outlined in the Canadian Cardiovascular Society position statement (recommendations for the diagnosis and treatment of dyslipidemia and prevention of cardiovascular disease). Selected high-risk patients with hypertension but who do not achieve thresholds for statin therapy according to the position paper should nonetheless receive statin therapy. Once blood pressure is controlled, acetylsalicylic acid therapy should be considered.
VALIDATION:
All recommendations were graded according to strength of the evidence and voted on by the 57 members of the Canadian Hypertension Education Program Evidence-Based Recommendations Task Force. All recommendations reported here achieved at least 95% consensus. These guidelines will continue to be updated annually.
PMCID: PMC2643190  PMID: 18548143
Antihypertensive drugs; Blood pressure; Guidelines; High blood pressure; Hypertension; Lifestyle interventions
15.  DreamTel; Diabetes risk evaluation and management tele-monitoring study protocol 
Background
The rising prevalence of type 2 diabetes underlines the importance of secondary strategies for the prevention of target organ damage. While access to diabetes education centers and diabetes intensification management has been shown to improve blood glucose control, these services are not available to all that require them, particularly in rural and northern areas. The provision of these services through the Home Care team is an advance that can overcome these barriers. Transfer of blood glucose data electronically from the home to the health care provider may improve diabetes management.
Methods and design
The study population will consist of patients with type 2 diabetes with uncontrolled A1c levels living on reserve in the Battlefords region of Saskatchewan, Canada. This pilot study will take place over three phases. In the first phase over three months the impact of the introduction of the Bluetooth enabled glucose monitor will be assessed. In the second phase over three months, the development of guidelines based treatment algorithms for diabetes intensification will be completed. In the third phase lasting 18 months, study subjects will have diabetes intensification according to the algorithms developed.
Discussion
The first phase will determine if the use of the Bluetooth enabled blood glucose devices which can transmit results electronically will lead to changes in A1c levels. It will also determine the feasibility of recruiting subjects to use this technology. The rest of the Diabetes Risk Evaluation and Management Tele-monitoring (DreamTel) study will determine if the delivery of a diabetes intensification management program by the Home Care team supported by the Bluetooth enabled glucose meters leads to improvements in diabetes management.
Trial Registration
Protocol NCT00325624
doi:10.1186/1472-6823-9-13
PMCID: PMC2689225  PMID: 19426530
16.  Metformin treatment in diabetes and heart failure: when academic equipoise meets clinical reality 
Trials  2009;10:12.
Objective
Metformin has had a 'black box' contraindication in diabetic patients with heart failure (HF), but many believe it to be the treatment of choice in this setting. Therefore, we attempted to conduct a pilot study to evaluate the feasibility of undertaking a large randomized controlled trial with clinical endpoints.
Study Design
The pilot study was a randomized double blinded placebo controlled trial. Patients with HF and type 2 diabetes were screened in hospitals and HF clinics in Edmonton, Alberta, Canada (population ~1 million). Major exclusion criteria included the current use of insulin or high dose metformin, decreased renal function, or a glycosylated hemoglobin <7%. Patients were to be randomized to 1500 mg of metformin daily or matching placebo and followed for 6 months for a variety of functional outcomes, as well as clinical events.
Results
Fifty-eight patients were screened over a six month period and all were excluded. Because of futility with respect to enrollment, the pilot study was abandoned. The mean age of screened patients was 77 (SD 9) years and 57% were male. The main reasons for exclusion were: use of insulin therapy (n = 23; 40%), glycosylated hemoglobin <7% (n = 17; 29%) and current use of high dose metformin (n = 12; 21%). Overall, contraindicated metformin therapy was the most commonly prescribed oral antihyperglycemic agent (n = 27; 51%). On average, patients were receiving 1,706 mg (SD 488 mg) of metformin daily and 12 (44%) used only metformin.
Conclusion
Despite uncertainty in the scientific literature, there does not appear to be clinical uncertainty with regards to the safety or effectiveness of metformin in HF making a definitive randomized trial virtually impossible.
Trial registration
ClinicalTrials.gov Identifier: NCT00325910
doi:10.1186/1745-6215-10-12
PMCID: PMC2644685  PMID: 19203392
19.  The 2007 Canadian Hypertension Education Program recommendations for the management of hypertension: Part 2 – therapy 
OBJECTIVE:
To provide updated, evidence-based recommendations for the prevention and management of hypertension in adults.
OPTIONS AND OUTCOMES:
For lifestyle and pharmacological interventions, evidence was reviewed from randomized controlled trials and systematic reviews of trials. Changes in cardiovascular morbidity and mortality were the primary outcomes of interest. However, for lifestyle interventions, blood pressure lowering was accepted as a primary outcome given the lack of long-term morbidity and mortality data in this field. For treatment of patients with kidney disease, the progression of kidney dysfunction was also accepted as a clinically relevant primary outcome.
EVIDENCE:
A Cochrane collaboration librarian conducted an independent MEDLINE search from 2005 to August 2006 to update the 2006 Canadian Hypertension Education Program recommendations. In addition, reference lists were scanned and experts were contacted to identify additional published studies. All relevant articles were reviewed and appraised independently by both content and methodological experts using prespecified levels of evidence.
RECOMMENDATIONS:
Dietary lifestyle modifications for prevention of hypertension, in addition to a well-balanced diet, include a dietary sodium intake of less than 100 mmol/day. In hypertensive patients, the dietary sodium intake should be limited to 65 mmol/day to 100 mmol/day. Other lifestyle modifications for both normotensive and hypertensive patients include: performing 30 min to 60 min of aerobic exercise four to seven days per week; maintaining a healthy body weight (body mass index of 18.5 kg/m2 to 24.9 kg/m2) and waist circumference (less than 102 cm in men and less than 88 cm in women); limiting alcohol consumption to no more than 14 units per week in men or nine units per week in women; following a diet reduced in saturated fat and cholesterol, and one that emphasizes fruits, vegetables and low-fat dairy products, dietary and soluble fibre, whole grains and protein from plant sources; and considering stress management in selected individuals with hypertension.
For the pharmacological management of hypertension, treatment thresholds and targets should take into account each individual’s global atherosclerotic risk, target organ damage and any comorbid conditions: blood pressure should be lowered to lower than 140/90 mmHg in all patients and lower than 130/80 mmHg in those with diabetes mellitus or chronic kidney disease. Most patients require more than one agent to achieve these blood pressure targets. In adults without compelling indications for other agents, initial therapy should include thiazide diuretics; other agents appropriate for first-line therapy for diastolic and/or systolic hypertension include angiotensin-converting enzyme (ACE) inhibitors (except in black patients), long-acting calcium channel blockers (CCBs), angiotensin receptor blockers (ARBs) or beta-blockers (in those younger than 60 years of age). First-line therapy for isolated systolic hypertension includes long-acting dihydropyridine CCBs or ARBs. Certain comorbid conditions provide compelling indications for first-line use of other agents: in patients with angina, recent myocardial infarction, or heart failure, beta-blockers and ACE inhibitors are recommended as first-line therapy; in patients with cerebrovascular disease, an ACE inhibitor plus diuretic combination is preferred; in patients with nondiabetic chronic kidney disease, ACE inhibitors are recommended; and in patients with diabetes mellitus, ACE inhibitors or ARBs (or, in patients without albuminuria, thiazides or dihydropyridine CCBs) are appropriate first-line therapies. All hypertensive patients with dyslipidemia should be treated using the thresholds, targets and agents outlined in the Canadian Cardiovascular Society position statement (recommendations for the diagnosis and treatment of dyslipidemia and prevention of cardiovascular disease). Selected high-risk patients with hypertension who do not achieve thresholds for statin therapy according to the position paper should nonetheless receive statin therapy. Once blood pressure is controlled, acetylsalicylic acid therapy should be considered.
VALIDATION:
All recommendations were graded according to strength of the evidence and voted on by the 57 members of the Canadian Hypertension Education Program Evidence-Based Recommendations Task Force. All recommendations reported here achieved at least 95% consensus. These guidelines will continue to be updated annually.
PMCID: PMC2650757  PMID: 17534460
Antihypertensive drugs; Blood pressure; Guidelines; High blood pressure; Hypertension; Lifestyle interventions
20.  More medications, fewer pills: Combination medications for the treatment of hypertension 
Achieving blood pressure targets in hypertension can be challenging. Often, patients require multiple medications to reach these targets. The Canadian Hypertension Education Program has updated its past recommendations to reflect current knowledge regarding effective antihypertensive combinations. Evidence for the use of specific drug combinations in achieving blood pressure targets has been reviewed, and the inventory of effective drug combinations has been expanded. From a clinical perspective, fixed-dose antihypertensive combinations offer certain advantages in terms of efficacy, adherence, cost, convenience, patient-perceived ‘wellness’ and side effects. Consequently, in the future, fixed-dose combination formulations are likely to become increasingly used in the treatment of cardiovascular disease.
PMCID: PMC2650762  PMID: 17534465
Compliance; Drugs; Hypertension
21.  Overweight, physical activity and high blood pressure in children: a review of the literature 
Obesity is a growing problem in developed countries and is likely a major cause of the increased prevalence of high blood pressure in children. The aim of this review is to provide clinicians and clinical scientists with an overview of the current state of the literature describing the negative influence of obesity on blood pressure and it’s determinants in children. In short, we discuss the array of vascular abnormalities seen in overweight children and adolescents, including endothelial dysfunction, arterial stiffening and insulin resistance. We also discuss the potential role of an increased activation of the sympathetic nervous system in the development of high blood pressure and vascular dysfunction associated with obesity. As there is little consensus regarding the methods to prevent or treat high blood pressure in children, we also provide a summary of the evidence supporting relationship between physical activity and blood pressure in children and adolescents. After reviewing a number of physical activity intervention studies performed in children, it appears as though 40 minutes of moderate to vigorous aerobic-based physical activity 3–5 days/week is required to improve vascular function and reduce blood pressure in obese children. Future studies should focus on describing the influence of physical activity on blood pressure control in overweight children.
PMCID: PMC1994042  PMID: 17583184
arterial compliance; insulin sensitivity; aerobic exercise; sympathetic nervous system
22.  Innovations in primary care: Implications for hypertension detection and treatment 
The majority of hypertension detection and management in Canada is provided by family physicians. Although various organizations have called attention to the poor rates of hypertension detection and control on a worldwide basis, the tools and infrastructure that allow for better hypertension management have generally been lacking in primary care. Recent advances in the fields of primary care and chronic disease management have led to the development of frameworks wherein chronic diseases such as hypertension can be more effectively managed. Such paradigms integrate the primary care physician, the specialist, technologies, and a wide variety of health system and community resources to provide optimal care to the patient with hypertension. The present review highlights many of the advances in primary health care delivery in Canada that apply to hypertension.
PMCID: PMC2560870  PMID: 16755317
Chronic disease management; Hypertension; Primary care
23.  The 2006 Canadian Hypertension Education Program recommendations for the management of hypertension: Part II – Therapy 
OBJECTIVE
To provide updated, evidence-based recommendations for the management of hypertension in adults.
OPTIONS AND OUTCOMES
For lifestyle and pharmacological interventions, evidence from randomized, controlled trials and systematic reviews of trials was preferentially reviewed. Changes in cardiovascular morbidity and mortality were the primary outcomes of interest. For lifestyle interventions, blood pressure (BP) lowering was accepted as a primary outcome given the lack of long-term morbidity/mortality data in this field. For treatment of patients with kidney disease, the development of proteinuria or worsening of kidney function was also accepted as a clinically relevant primary outcome.
EVIDENCE
MEDLINE searches were conducted from November 2004 to October 2005 to update the 2005 recommendations. In addition, reference lists were scanned and experts were contacted to identify additional published studies. All relevant articles were reviewed and appraised independently by content and methodological experts using prespecified levels of evidence.
RECOMMENDATIONS
Lifestyle modifications to prevent and/or treat hypertension include the following: perform 30 min to 60 min of aerobic exercise four to seven days per week; maintain a healthy body weight (body mass index of 18.5 kg/m2 to 24.9 kg/m2) and waist circumference (less than 102 cm for men and less than 88 cm for women); limit alcohol consumption to no more than 14 standard drinks per week in men or nine standard drinks per week in women; follow a diet that is reduced in saturated fat and cholesterol and that emphasizes fruits, vegetables and low-fat dairy products; restrict salt intake; and consider stress management in selected individuals. Treatment thresholds and targets should take into account each individual’s global atherosclerotic risk, target organ damage and comorbid conditions. BP should be lowered to less than 140/90 mmHg in all patients, and to less than 130/80 mmHg in those with diabetes mellitus or chronic kidney disease (regardless of the degree of proteinuria). Most adults with hypertension require more than one agent to achieve these target BPs. For adults without compelling indications for other agents, initial therapy should include thiazide diuretics. Other agents appropriate for first-line therapy for diastolic hypertension with or without systolic hypertension include beta-blockers (in those younger than 60 years), angiotensin-converting enzyme (ACE) inhibitors (in nonblack patients), long-acting calcium channel blockers or angiotensin receptor antagonists. Other agents for first-line therapy for isolated systolic hypertension include long-acting dihydropyridine calcium channel blockers or angiotensin receptor antagonists. Certain comorbid conditions provide compelling indications for first-line use of other agents: in patients with angina, recent myocardial infarction or heart failure, beta-blockers and ACE inhibitors are recommended as first-line therapy; in patients with diabetes mellitus, ACE inhibitors or angiotensin receptor antagonists (or in patients without albuminuria, thiazides or dihydropyridine calcium channel blockers) are appropriate first-line therapies; and in patients with nondiabetic chronic kidney disease, ACE inhibitors are recommended. All hypertensive patients should have their fasting lipids screened, and those with dyslipidemia should be treated using the thresholds, targets and agents recommended by the Canadian Hypertension Education Program Working Group on the management of dyslipidemia and the prevention of cardiovascular disease. Selected patients with hypertension, but without dyslipidemia, should also receive statin therapy and/or acetylsalicylic acid therapy.
VALIDATION
All recommendations were graded according to strength of the evidence and voted on by the 45 members of the Canadian Hypertension Education Program Evidence-Based Recommendations Task Force. All recommendations reported here achieved at least 95% consensus. These guidelines will continue to be updated annually.
PMCID: PMC2560865  PMID: 16755313
Blood pressure; Drugs; Guidelines; High blood pressure; Hypertension; Lifestyle interventions

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