M E T H O D S
50 consecutive patients, who were recently diagnosed with Stage 1 hypertension, (defined as the average of seated systolic blood pressure (BP) >140 mmHg but 90 mmHg but 18 years. Patients with a prior use of any anti-hypertensive medication were not included. The study was approved by the institution review board at the centre where it was conducted. Once patients had signed the informed consent form, the screening phase began. A complete physical examination was performed, including a 12-lead electrocardiogram and standard laboratory tests. Blood pressure and heart rate were measured. Patients were asked to define the quality of their sleep and only those with adequate recordings who reported a normal sleep or a sleep similar to previous nights were included. Patients with any of the following features were excluded from participation: night-time workers, patients with valvular heart disease and chronic obstructive pulmonary disease (identified upon discretion of a chest physician, patients with a history of sleep apnea/hypopnea, patients with recent acute coronary syndrome (within the last two months), significant systemic disease, history of any psychiatric disease including primary insomnia, symptomatic cerebrovascular disease (including previous transient ischemic attack within 6 months), obstructive coronary artery disease, any atrioventricular conduction disturbance more than 1st degree block, history of any arrhythmia, history of congestive heart failure, hepatic failure, hypertension above study criteria as well as suspicion of secondary hypertension forms, with serum creatinine >1.4 mg/dL, patients with a history of diabetes mellitus (or fasting blood glucose >125 mg/dL), pregnant women, patients with hypohyperthyroidism, patients with a body mass index >25 kg/m2, and patients who wished to consume alcohol during the study period. Patients using medication for other reasons including beta blocking agents, which are known for their negative impact on sleep quality, diuretics, which disturb sleep quality because of increased urine output, major psychotropic agents, oral steroids, or daily nonsteroidal anti-inflammatory drugs, high-dose acetylsalicylic acid were not included into the study.
Eligible patients underwent Pittsburgh Sleep Quality Index (PSQI), which has an established role in evaluating the sleep disturbances,( 10) by a blinded author, and were randomized to receive their first dose before leaving the clinic. Each patient was provided with enough medication for 6 weeks, and was asked to return to the clinic on day 7 (first visit). Patients were instructed to take the assigned study drug once a day in the morning approximately 1 h before breakfast, but were told not to take the study drug or eat breakfast on the days of the subsequent clinic visits. Visits were scheduled for 1, 2, 4, and 6 weeks after the initiation of active drug administration. Blood pressure and heart rate were measured after 5 minutes of rest in sitting position. The median of three consecutive measurements made at 1-min intervals was selected. Measurements were performed in the same arm using a validated semi-automated sphygmomanometer with appropriate cuff size. Titration was performed at each of these visits upon discretion of the primary physician considering the blood pressure level at each control. If after 2 weeks BP was not normalized, amlodipin 5-10 mg was decided to be added to each arm. Adverse events were recorded. After median of 6 weeks, patients underwent repeat PSQI test by the same author, blinded to study drugs. Test-retest reliability and validity of PQSI, which included seven individual scores (S1: sleep quality, S2: sleep latency, S3: sleep duration, S4: sleep efficiency, S5: sleep disturbance, S6: use of sleep medication and S7: day time dysfunction), was shown previously.( 1 1 ) Higher scores designated worsening in terms of sleep parameters, the total score of >5 indicated poor sleepers.( 10)
STAT I ST I C AL A NALY S I S
Parametric data were expressed as mean±standard deviation, and categorical data as percentages. SPSS 10.0 was used to perform statistical procedures. Parametric data were compared by Mann Whitney U test, and categorical data via chi square test. Temporal change of data was evaluated by Wilcoxon signed rank test. Correlations were searched by Pearson’s correlation. A p value
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