Introduction
Patients, materials and methods
Design and conduct of the study
Assessment of safety and tolerability
Statistical methods
Results
Demographics and medical history
Total number of participants (n; %) | 292; 100.0% |
Male participants (n; %) | 162; 55.5% |
Age (µ ± SD; min–max) | 73.6 ± 10.6; 24–96 years |
Weight (µ ± SD; min–max) | 79.9 ± 13.7; 49–125 kg |
Height (µ ± SD; min–max) | 169.2 ± 8.6; 147–190 cm |
Smoking behavior (n; %)
| |
Smoker | 41; 14.0% |
Former smoker | 55; 18.8% |
Non-smoker | 196; 67.1% |
Time since diagnosis (n; %)
| |
<1 year | 123; 42.1% |
1–4 years | 70; 24.0% |
4–7 years | 35; 12.0% |
≥7 years | 58; 19.9% |
Revascularization | 167; 57.2% |
Diabetes | 92; 31.5% |
Hypertension | 243; 83.2% |
Hyperlipidemia | 225; 77.1% |
Substance exposure
Dosage | Visit 1 n (%) | Visit 2 n (%) | Future use n (%) |
---|---|---|---|
375 mg | 254 (87.3) | 133 (49.1) | 132 (50.0) |
500 mg | 34 (11.7) | 99 (36.5) | 93 (35.2) |
750 mg | 3 (1.0) | 39 (14.4) | 39 (14.8) |
Total | 291 (100.0) | 271 (100.0) | 264 (100.0) |
Medication class | Number of prescriptions n (%) | Number of drugs |
---|---|---|
RAAS inhibitors | 200 (68.5) | 25 |
Ca antagonists | 52 (17.8) | 9 |
Beta blocker | 225 (77.1) | 20 |
Antihypertensive combination | 35 (12.0) | 19 |
Diuretics | 65 (22.3) | 17 |
Antianginal drugs | 336 (115.1) | 22 |
Antithrombotics | 141 (48.3) | 10 |
Other medications | 496 (169.9) | 134 |
Total | 1550 (530.8) | 256 |
Treatment outcome
Visit 1 | Visit 2 | |||||
---|---|---|---|---|---|---|
Heart rate (bpm) | Systolic blood pressure (mm Hg) | Diastolic blood pressure (mm Hg) | Heart rate (bpm) | Systolic blood pressure (mm Hg) | Diastolic blood pressure (mm Hg) | |
Min | 47 | 100 | 50 | 42 | 100 | 56 |
Max | 108 | 180 | 120 | 99 | 164 | 108 |
Median | 72 | 138 | 80 | 70 | 130 | 80 |
Mean | 72.5 | 137.3 | 80.8 | 69.5 | 130.7 | 78.7 |
SD | 11.6 | 16.1 | 10.3 | 9.5 | 12.4 | 8.0 |
N
| 290 | 292 | 292 | 286 | 285 | 285 |
Subgroups | ∆ AP attacks |
N
a
| ||
---|---|---|---|---|
Male vs. female | −4.5 vs. −4.4 | 161 | vs. | 125 |
Diagnosis <1 year vs. ≥1 year | −4.1 vs. −4.8 | 123 | vs. | 160 |
Meteorosensitivity present vs. absent | −4.9 vs. −4.1 | 115 | vs. | 174 |
Beta blocker and CCB vs. beta blocker or CCB | −3.9 vs. −4.5 | 46 | vs. | 196 |
CAD b, macrovascular vs. microvascular disease | −4.7 vs. −4.3 | 97 | vs. | 192 |
Atrial fibrillation c probable vs. improbable | −7.7 vs. −4.0 | 33 | vs. | 256 |
Type 2 diabetes mellitus, present vs. absent | −5.5 vs. −4.1 | 92 | vs. | 183 |
Safety
Patient | Original Description | SOCsb | Intensity | Relationship |
---|---|---|---|---|
1 | Occasional reflux gastritis | Gastrointestinal disorders | Mild | Possible |
2 | Nausea | Gastrointestinal disorders | Moderate | Probable |
2 | Vertigo | Ear and labyrinth disorders | Moderate | Probable |
3 | Liver function levels raised | Investigations | Mild | Possible |
3 | Renal function tests raised | Investigations | Mild | Possible |
Discussion
Limitations of the study
-
The study was not conducted in a controlled environment; no randomization was performed, no control or placebo group was present and the patients were exposed to a multitude of other therapeutic procedures. Therefore, the observed improvements are not necessarily related to the administration of ranolazine; however, concomitant cardiovascular therapies were constant in 84.1% of the patients. Thus, uncontrolled external factors seem to exhibit only limited influence.
-
292 participants represent 40.6% of the maximum number of 720 patients; however, this number was not determined by formal sample size estimation and is therefore irrelevant for the descriptive character of the results. The 292 patients are roughly equal to 0.1% of 250,000 patients in Austria suffering from stable AP [8].
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Subgroups were formed post hoc, recruitment did not aim at specific proportions for each subgroup; however, the results of the subgroup comparisons are in good accordance with the available literature.
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In the subgroup with patients with atrial fibrillation the diagnosis was not confirmed by an ECG.
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Participants were recruited at practices for primary care and by internal specialists, not at hospitals. Thus, extremely severe cases might have been underrepresented.
-
There was no standardized test to measure the improvement in exercise capacity.
Generalizability
Interpretation
Conclusion
-
Ranolazine uptitration as possible by the SmPC is not a frequent treatment option for Austrian patients; however, patients still exhibit improvement.
-
Patients exposed to ranolazine experience improved quality of life.
-
In patients with stable angina and concomitant type 2diabetes mellitus or potential atrial fibrillation a specific benefit of ranolazine may be expected.
-
Ranolazine is equally suitable for both genders.
-
Ranolazine is tolerable and carries a favorable safety profile with a low number of ADRs when used according to Austrian real-world standards