Effectiveness and Tolerability of Tarka® in the Treatment of Hypertensive Patients With High Risk of Developing Diabetes Mellitus

Study Overview
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Brief Summary
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The aim of this post-marketing observational study (PMOS) is to provide data on the effectiveness and tolerability of Tarka in patients with a high risk of developing diabetes mellitus, as prescribed by the physicians in a community setting and in accordance with the terms of the local marketing authorization. The following specific questions will be addressed: Effectiveness of Tarka in lowering the blood pressure in hypertensive patients being at high risk of developing diabetes, not controlled on single-drug therapy. Tolerability of Tarka as assessed by withdrawal rates.

Detailed Description
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This is a non-interventional, observational, open-label, multicountry, multicenter post-marketing study in which Tarka is prescribed in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication. Patients with a high risk of developing diabetes mellitus treated by secondary care specialists (such as internal medicine specialists, nephrologists, endocrinologists, etc.), whose hypertension is not controlled on single-drug therapy will be included. The assignment of the patient to the treatment with Tarka is not decided in advance by this protocol but falls within current practice. The prescription of Tarka is clearly separated from the decision to include the patient in this study. No additional procedures (other than standard of care) shall be applied to the patients. Each patient will be treated at the physician's discretion. Dosing schedule should be in the accordance with the locally approved Summary of Product Characteristics (SmPC). Physicians will be provided with a study kit that includes a protocol, Tarka's locally approved SmPC, and case reports forms for each patient to be enrolled. The patient's demographic data, height, weight and waist circumference will be reported in the Inclusion visit. The previous antihypertensive therapy should be noted (generic name of the drug and total daily dose). All other drugs the patient currently receives for cardiovascular disease treatment should be recorded as well. The patient will then be followed via regular office visits as determined by the physician. As this study is observational in nature, patient follow-up is not interventional and is left to the judgment of each physician within the 6-month period, which defines the survey for each patient. For indicative purposes, follow-up of participant should enable 3 patient visits during this period. For these reasons, the most likely visits are defined as Inclusion visit at which treatment with Tarka is to be commenced, and then Follow-up visit Month 3  and Follow-up visit Month 6, although dates will depend only on the decision of the physician. As a result, failure to meet these suggested dates will not constitute a breach of the protocol.

Official Title
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Effectiveness and Tolerability of Tarka in the Treatment of Hypertensive Patients With High Risk of Developing Diabetes Mellitus, Not Controlled on Single-drug Therapy: A Multicountry, Multicenter, Post-marketing Observational Study in the Routine Clinical Use

Conditions
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Hypertension

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients of either gender (more than 18 years of age), with established diagnosis of essential hypertension (systolic blood pressure/ diastolic blood pressure greater than 140/90 mmHg) Patients not controlled on single-drug therapy and decision was made to introduce Tarka Patients with a high risk of developing diabetes mellitus (defined according British Medical Society guidelines) with at least one of the following symptoms: Positive family history of diabetes or Obesity defined by a Body Mass Index (BMI) greater than 30 kg/m^2 or a waist circumference greater than 102 cm (males) or greater than 88 cm (females) or Impaired fasting plasma glucose (FPG) levels of 6.1 to 7.0 mmol/l (100-126 mg/dl) Exclusion Criteria: Patients with known or established Type 2 diabetes mellitus The use of Tarka is contraindicated in the following patients: Hypersensitive to the active substances or to any of the inactive ingredients With cardiogenic shock With second and third degree atrioventricular block - except in patients with a functioning artificial pacemaker With sick sinus syndrome - except in patients with a functioning artificial pacemaker With atrial fibrillation/flutter and concomitant Wolff-Parkinson-White syndrome With existing history of angioedema associated with administration of an angiotensin-converting enzyme (ACE) inhibitor With severe renal or severe liver impairment In pregnant women (women of childbearing potential who are unwilling to use contraception should not be included) Lactating women

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Single Patient group with Hypertension<br>Single Patient group with Hypertension | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to Study End | Participants were to be followed for 6 months. Changes in systolic and diastolic blood pressure were assessed by comparing the blood pressure measurements obtained at the end of Tarka treatment (approximately 6 months) to baseline values. For this analysis of effectiveness the last available value was considered the analysis time point end of study. | Baseline to 6 months/study end | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving Target Blood Pressure (Less Than 140/90) at Study End and the Need for Other Antihypertensive Drugs, Clustered by Type(s) of Drugs Added to Tarka. | The percentages of participants achieving and not achieving the target blood pressure of less than 140/90 mmHg at the end of the study are presented. Percentages of participants taking Tarka only or taking Tarka plus another antihypertensive drug are summarized by type of drug: beta blockers, angiotensin-converting enzyme (ACE) inhibitors, calcium antagonists, diuretics, and angiotensin II (AT-II) receptor antagonists. Participants taking drugs that did not fit any of the above groups (Other), unknown drugs (Unknown), or more than one additional antihypertensive agent are also summarized. | 6 months | 
| Evaluation of Adverse Events (AEs) Leading to Discontinuation of Tarka and a Summary of All AEs Possibly or Probably Related to Tarka by Frequency and Severity | The number of AEs leading to Tarka discontinuation are summarized. AEs that were considered by the investigator to be possibly or probably related to Tarka are summarized by the severity of the AE (classified as mild, moderate, or severe). AEs considered possibly or probably related to Tarka that led to the discontinuation of Tarka are also presented by severity. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Effectiveness and tolerability of Tarka, Hypertensive patients, Diabetes mellitus, Observational study