Effects of Telmisartan/Hydrochlorothiazide Treatment in Hypertensive Patients Under Real-life Setting (POTASSIUM)

Evaluation of the Real-life Efficacy and Safety of a Fixed-dose Telmisartan/Hydrochlorothiazide, Including Its Effect on Plasma Potassium and on Glucose and Lipid Metabolism Parameters in Patients With Essential Arterial Hypertension

One of the most common adverse effects resulting from the therapy with thiazides, thiazide-like diuretics and loop diuretics is increased potassium secretion. Disregulation of plasma potassium may be a life-threatening condition due to increased risk of arrythmias. Moreover, it has been postulated that decrease in plasma potassium level may negatively affect glucose metabolism resulting in the increased risk of new-onset type 2 diabetes.The main goal of this study is to assess the efficacy and safety of telmisartan/hydrochlorothiazide in a broad population of hypertensive patients, including the effects of the therapy on plasma potassium level and also on selected parameters of glucose and lipid metabolism.

Study Overview

• Status: Completed
• Conditions: Primary Hypertension
• Intervention / Treatment: Drug: Telmisartan/hydrochlorothiazide (Pritor Plus, BAY98-7103)

• Study Type: Observational
• Enrollment (Actual): 1586

Contacts and Locations

Study Locations

• Poland
  • Many Locations, Poland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Primary care clinic hypertensive patients not treated with telmisartan/hydrochlorothiazide for approx. 3 mths.

Description

Inclusion Criteria:

• primary hypertension
• age>18 years

Exclusion Criteria:

• Cholestatic disorders or severe hepatic/renal failure
• allergy to telmisartan or hydrochlorothiazide
• treatment-resistant hypokalemia or hypercalcemia
• pregnancy and lactation period

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1	Drug: Telmisartan/hydrochlorothiazide (Pritor Plus, BAY98-7103); Patients treated with telmisartan/hydrochlorothiazide tablets under the real-life setting. Dosing regimen customised to the needs of each participating patient according to the investigators assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in systolic (SBP) and diastolic (DBP) blood pressure between first and final visit	approx. 3 mths after telmisartan/hydrochlorothiazide treatment initiation

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in plasma potassium between initial and final visit	approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation
Change in fasting plasma glucose between initial and final visit	approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation
Change in glycated haemoglobin A1C between initial and final visit	approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation
Change in plasma high density lipoprotein between initial and (continued)	approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation
Change in plasma low density lipoprotein between initial and final visit	approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation
Change in plasma cholesterol between initial and final visit	approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation
Change in plasma triglycerides between initial and final visit	approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation
Adverse events collection	approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: May 26, 2011
• First Submitted That Met QC Criteria: July 11, 2011
• First Posted (Estimate): July 12, 2011

Study Record Updates

• Last Update Posted (Estimate): July 4, 2012
• Last Update Submitted That Met QC Criteria: July 3, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: Hypertension; Telmisartan; Potassium; Lipid metabolism; Glucose metabolism; Hydrochlorothiazide
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Essential Hypertension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Natriuretic Agents; Membrane Transport Modulators; Diuretics; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Sodium Chloride Symporter Inhibitors; Hydrochlorothiazide; Telmisartan; Telmisartan, hydrochlorothiazide drug combination
• Other Study ID Numbers: 15297 (OTHER: City of Hope Medical Center); KL1010PL (Other Identifier: Company Internal)