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Scope, draft for panel discussion, 05.01.2011 GUIDELINE TITLE: Management of adult patients with essential hypertension in primary care INITIATOR: Health Insurance Fund TARGET AUDIENCE: family physicians, primary care nurses PATIENT POPULATION COVERED: Adults (>18-years) with essential hypertension, including - patients with pre-existing cardiovascular disease and/or diabetes (type II or I) - elderly, defined as over 75 years - Screening and prevention of hypertension in adult population (should be covered by another national guideline (on cardiovascular prevention), reference to be included in the final guideline); Smoking cessation strategies (covered by another national guideline, but note that final guideline will have recommendation about advice to stop smoking); Exact diagnosis and management of secondary hypertension; Hypertension during pregnancy (covered by another national guideline, reference to be included in the final guideline); Diagnosis and management of children and adolescents with hypertension (need for a separate guideline to be assessed); Management of dyslipidaemia and weight problems (covered by another national guideline, reference to be included in the final guideline); Management of hypertensive crisis, hypertensive emergencies; Management of patients with hypertension and end stage renal disease. TOPICS NOT COVERED: - - - THE INTRODUCTION WILL INCLUDE: A short summary of diagnostic criteria for hypertension, e.g. from the prevention guideline, including number of blood pressure measurements needed and technique for blood pressure measurement. DRAFT QUESTIONS: Diagnosis 1. To confirm the diagnosis of hypertension: Should all adult patients with suspected hypertension be investigated with 1/7 Scope, draft for panel discussion, 05.01.2011 24 hour ambulatory blood pressure monitoring compared to standard blood pressure measures? (Critical outcomes: accuracy of 24 ambulatory blood pressure monitoring, positive predictive value, negative predictive value) 2. To investigate possible end organ damage: Should all patients with confirmed hypertension be investigated with Urinalysis Fasting plasma glucose measurement ECG S-crea GFR estimation Albuminuria measurement S-cholesterol measurement Lipid profiling Retinal examination (fundoscopy) Echocardiography (Critical outcomes: positive predictive value, negative predictive value, cost-effectiveness?) Non-pharmacological treatment 3. Should all patients with confirmed hypertension be offered dietary advice concerning salt restriction, compared with no salt restriction? (Critical outcomes - see the list developed by the panel attached (Panel – considering the relative safety and low cost, should we be satisfied with BP reduction here?)) 4. Should all patients with confirmed hypertension have exercise programs recommended, compared with no such recommendation? (Critical outcomes: see the list developed by the panel attached) Pharmacological treatment, first line therapy 5. Should all adult patients with confirmed hypertension be offered as initial therapy: Any combination treatment with ACEI plus thiazide OR ACEI plus BBL ACEI plus CCB ACEI plus ARB ARB plus thiazide ARB plus BBL 2/7 Scope, draft for panel discussion, 05.01.2011 ARB plus CCB ARB plus thiazide CCB + thiazide compared with any monotherapy (ACEI OR BBL OR CCB OR ARB OR THZ) (Critical outcomes: see the list developed by the panel attached) 6. Should all elderly (>75 years) adult patients with confirmed essential hypertension be offered as initial therapy monotherapy with ARB compared to any other class (ACEI OR BBL OR CCB OR THZ) ACEI compared to any other class (BBL OR CCB OR ARB OR THZ) CCB compared to any other class (ACEI OR BBL OR ARB OR THZ) BBL compared to any other class (ACEI OR CCB OR ARB OR THZ) THZ compared to any other class (ACEI OR BBL OR CCB OR ARB)? (Critical outcomes: see the list developed by the panel attached) 7. Should all elderly (>75 years) adult patients with confirmed hypertension be offered as initial therapy: Any combination treatment with ACEI plus thiazide OR ACEI plus BBL ACEI plus CCB ACEI plus ARB ARB plus thiazide ARB plus BBL ARB plus CCB ARB plus thiazide CCB + thiazide compared with any monotherapy (ACEI OR BBL OR CCB OR ARB OR THZ) (Critical outcomes: see the list developed by the panel attached, note that importance of adverse effects may need to be considered). 8. Should adult patients with newly diagnosed hypertension and co-morbidities (Panel to define, what should be covered: CHF, diabetes, CAD?) be offered as initial therapy: Any combination treatment with ACEI plus thiazide OR ACEI plus BBL ACEI plus CCB ACEI plus ARB ARB plus thiazide ARB plus BBL ARB plus CCB ARB plus thiazide 3/7 Scope, draft for panel discussion, 05.01.2011 CCB + thiazide compared with any monotherapy (ACEI OR BBL OR CCB OR ARB OR THZ) (Critical outcomes: see the list developed by the panel attached) 9. Should adult patients with newly diagnosed hypertension and co-morbidities (define CHF, diabetes, CAD?) be offered as initial therapy monotherapy with ARB compared to any other class (ACEI OR BBL OR CCB OR THZ) ACEI compared to any other class (BBL OR CCB OR ARB OR THZ) CCB compared to any other class (ACEI OR BBL OR ARB OR THZ) BBL compared to any other class (ACEI OR CCB OR ARB OR THZ) THZ compared to any other class (ACEI OR BBL OR CCB OR ARB)? (Critical outcomes: see the list developed by the panel attached) 10. Should adult patients with high initial blood pressure (Panel to define: SBP ≥ … or DBP ≥…) be offered as initial therapy: Any combination treatment with ACEI plus thiazide OR ACEI plus BBL ACEI plus CCB ACEI plus ARB ARB plus thiazide ARB plus BBL ARB plus CCB ARB plus thiazide CCB + thiazide compared with any monotherapy (ACEI OR BBL OR CCB OR ARB OR THZ) (Critical outcomes: see the list developed by the panel attached, note that importance of adverse effects may need to be considered) Pharmacological treatment, second line therapy 11. Should patients with hypertension, started on monotherapy, that have not responded to initial treatment, be offered Increased dose of same drug Compared to an alternative drug within the same class? (Critical outcomes: see the list developed by the panel attached, note that importance of adverse effects may need to be considered) 12. Should patients with hypertension, started on monotherapy, that have not responded to initial treatment, be offered Increased dose of same drug Compared to an alternative drug from another class? 4/7 Scope, draft for panel discussion, 05.01.2011 (Critical outcomes: see the list developed by the panel attached, note that importance of adverse effects may need to be considered) 13. Should patients with hypertension, started on monotherapy, that have not responded to initial treatment, be offered Increased dose of same drug Compared to any combination of drugs from different classes? (Critical outcomes: see the list developed by the panel attached, note that importance of adverse effects may need to be considered) 14. Should patients with hypertension, started on monotherapy, that have not responded to initial treatment, be offered An alternative drug from another class Compared to any combination of drugs from different classes? (Critical outcomes: see the list developed by the panel attached, note that importance of adverse effects may need to be considered) 15. Should patients with hypertension, started on combination treatment, that have not responded to initial treatment, be offered Increased dose of same drugs Compared to alternative drugs from the same classes? (Critical outcomes: see the list developed by the panel attached, note that importance of adverse effects may need to be considered) 16. Should patients with hypertension, started on combination treatment, that have not responded to initial treatment, be offered Increased dose of same drugs Compared to alternative drugs from different classes? (Critical outcomes: see the list developed by the panel attached, note that importance of adverse effects may need to be considered) 17. Should patients with hypertension, started on combination treatment, that have not responded to initial treatment, be offered Alternative dual combination treatment Compared to combination with a third class? (Critical outcomes: see the list developed by the panel attached, note that importance of adverse effects may need to be considered) 18. In patients on treatment for hypertension, what strategies should be offered to improve adherence? (Panel: will need to refine the list of strategies) Strategy 1 compared to doing nothing Strategy 2 compared to doing nothing Effective strategy 1 compared to Effective strategy 2 5/7 Scope, draft for panel discussion, 05.01.2011 Combining effective strategies compared to any single effective strategy HEALTHCARE SETTING: Which patients with hypertension must/can be treated in primary care level? What are the reasons to refer a patient to a specialist ? Are there patient sub-groups who should /must be treated by specialist? ECONOMIC EVALUATION: Cost-utility/cost-minimisation analyses to be carried out when making recommendations involving a choice between alternative interventions which may cause a budget impact of measurable size (Health Insurance Fund to refine). EVALUATION OF GUIDELINE IMPLEMENTATION: Expected increase in proportion of adults with hypertension treated by family physicians compared to cardiologists/other specialist; Decrease in amount of variations (diagnostics, treatment) in primary care hypertension treatment; Increase in number of consultations (non-pharmacological interventions) performed by family nurses; Better BP control rates; Exact indicators to be aligned in line with guideline recommendations. UPDATING THE GUIDELINE: After 5 years or when relevant evidence becomes available. 6/7 Scope, draft for panel discussion, 05.01.2011 OUTCOME RATINGS BY THE PANEL The rating scale is 1-3: not important 4-6: important 7-9: critically important for decision making. Mortality 8,7 CV Mortality 7,9 Stroke 7,89 Health related quality of life 7,7 Myocardial Infarction 7,5 Hypertensive emergencies 7 End stage renal disease 7 Development of new episode of cardiac failure 6,5 Vascular dementia 6,3 cost of therapy 6,2 Blood pressure control 5,8 Hospitalisation for cardiovascular reasons 5,8 Renal function, GFR 5,3 Withdrawals for adverse effects 5,2 Adverse effect - Sexual dysfunction 5,1 New onset of diabetes while on therapy 4,56 Hospitalisation for any reason 4,5 Progression to retinopathy 4,4 Adverse effect - Cough 4,3 Adverse effect - ankle oedema 3,5 7/7