Impact of Ramadan on Achieving Joint National Committee (JNC) 7 Treatment Goals in CV Risk Patients

The proportion of patients enrolled in the study who achieve the JNC 7 (the seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure) treatment goals (blood pressure (BP) \<140/90 mmHg) in a primary-care setting at week 52. This variable was derived from the mean sitting blood pressure assessed by the investigators at week 52. To achieve JNC 7 treatment goals, the subject had to satisfy both blood pressure criteria - systolic blood pressure below 140 mm Hg and diastolic blood pressure below 90 mm Hg.

Time frame: Up to 52 weeks

Population: ITT dataset which included all patients, who received at least one dose of study medication.

Proportion of patients who achieved the JNC 7 treatment goals during the whole study duration (treated by internists and cardiologists as primary physician)

Time frame: Up to 52 weeks

Population: Per-protocol population

The proportion of patients enrolled in the study who achieve the JNC 7 (the seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure) treatment goals (blood pressure (BP) \<140/90 mmHg) in a primary-care setting after Ramadan. This variable was derived from the mean sitting blood pressure assessed by the investigators after Ramadan. To achieve JNC 7 treatment goals, the subject had to satisfy both blood pressure criteria - systolic blood pressure below 140 mm Hg and diastolic blood pressure below 90 mm Hg.

Time frame: 1 month

Population: Per-protocol (PP) population which included all eligible patients who did not experience any protocol violation and were treated with the study medication up to week 52 (study completers) according to the prescribing information.

Number of participants with adverse events in participants receiving Angiotensin II (Type 1) Receptor Blockers (ARBs) when given in combination with Calcium-Channel Blockers (CCBs) during the whole study duration.

Time frame: Up to 52 weeks

Population: All subjects who took a combination of ARB and CCB drugs.

Percentage of participants who experienced a major cardiovascular (CV) event

Time frame: Up to 52 weeks

Population: All subjects included in the study according to the study protocol i.e. patients who did not violate any inclusion or exclusion criteria

Compliance of patients during the whole study duration (treated by internists and cardiologists as primary physician). Subjects were asked how often they have not taken their medicine and were given five possible choices from none of the time to all of the time.

Time frame: Up to 52 weeks

Population: Per-protocol population including all patients with data at 52 weeks

Compliance of patients up to 10 days after Ramadan (treated by internists and cardiologists as primary physician). Subjects were asked how often they have not taken their medicine and were given five possible choices from none of the time to all of the time.

Time frame: 10 days after Ramadan

Population: Per-protocol population including all patients with data 10 days after Ramadan

Compliance of patients up to 10 days before ramadan (treated by internists and cardiologists as primary physician). Subjects were asked how often they have not taken their medicine and were given five possible choices from none of the time to all of the time.

Time frame: 10 days before Ramadan

Population: Per-protocol population including all patients with data 10 days before Ramadan

Change from baseline in diastolic blood pressure before and after the month of Ramadan

Time frame: Baseline, 10 days before Ramadan, 10 days after Ramadan and 52 weeks

Population: Per-protocol population

Change from baseline in systolic blood pressure before and after the month of Ramadan

Time frame: Baseline, 10 days before Ramadan, 10 days after Ramadan and 52 weeks

Population: Per-protocol population

The overall assessment of treatment by patients at 52 weeks. Assessed using a verbal rating scale with 5 categories: Outstanding, very satisfactory, satisfactory, marginal and not satisfactory.

Time frame: Up to 52 weeks

Population: Per-protocol population

The overall assessment of treatment by physicians at 52 weeks. Assessed using a verbal rating scale with 5 categories: Outstanding, very satisfactory, satisfactory, marginal and not satisfactory.

Time frame: Up to 52 weeks

Population: Per-protocol population

The proportion of patients enrolled in the study who achieve the JNC 7 (the seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure) treatment goals (blood pressure (BP) \<140/90 mmHg) in a primary-care setting at the end of the 1 year treatment duration. This variable was derived from the mean sitting blood pressure assessed by the investigators at the end of the 1 year treatment duration. To achieve JNC 7 treatment goals, the subject had to satisfy both blood pressure criteria - systolic blood pressure below 140 mm Hg and diastolic blood pressure below 90 mm Hg. At this timepoint, a diagnosis of diabetes mellitus and/or kidney disease was also taken into account. Subjects with either of the mentioned conditions had to have systolic blood pressure lower than 130 mm Hg and diastolic blood pressure below 80 mm Hg to satisfy JNC 7 treatment goals.

Time frame: Up to 52 weeks

Population: Per-protocol population