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BACKGROUND: Once a patent expires, generic analogue drugs are alternatives to brand name drugs. Because bioequivalence/biodistribution problems have been reported for many generic analogue drugs, we prospectively evaluated 31 patients to reveal the differences in the doses used and the efficacy and adverse events of two different intravenous esmolol formulations. METHODS: This was a prospective observational pilot study. Our aim was to reveal the possible differences in the required doses between two different formulations (brand name drug vs generic analogue drug) of intravenous esmolol in beats per minute, systolic blood pressure, diastolic blood pressure and mean arterial pressure in intra- and postoperative patients with supraventricular tachycardia and hypertension. The patients were categorised into two groups according to the medication they received (brand name drug or generic analogue drug). RESULTS: Esmolol was given to 31 patients (16 generic analogue drug and 15 brand name drug). Although there was a statistically significant difference in bolus (mg/kg) and continued (mg/kg/h) drug dose used (brand name drug/generic analogue drug, mean (standard deviation), 0.3 (0.1) vs 0.38 (0.1), p = 0.03 for bolus dose, and 0.22 (0.09) vs 0.29 (0.08) for continued dose at 10 min (p = 0.03), 0.19 (0.06) vs 0.24 (0.05) at 20 min (p = 0.01) and 0.14 (0.05) vs 0.18 (0.05) at 30 min (p = 0.02)), there were no time-related statistical significant differences in the reduction rates of the two drugs (p = 0.47). There were no time-related statistically significant differences between the two groups in systolic blood pressure, diastolic blood pressure, mean arterial pressure and beats per minute, nor in their adverse events. CONCLUSION: In this pilot study, smaller doses were given for controlling the patient's haemodynamics when a brand name drug was used. Because there were no significant time-related differences in the reduction rates of the two drugs nor in any haemodynamic differences between the two groups, optimal titration of the drug used could effectively control the patient's haemodynamics. The adverse events were also similar in both groups.

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Background: Beta-blockers have been shown to decrease mortality and morbidity in heart failure with reduced ejection fraction (HFrEF) patients. However, the side effects are also dose-related, leading to the underdosing. Cost constraint may be one of the limitations of appropriate beta-blocker use; this can be improved with generic drugs. However, the effects in real life practice have not been investigated. Methods and results: This study aimed to compare the efficacy and safety of generic and brand beta-blockers in HFrEF patients. We performed a retrospective cohort analysis in HFrEF patients who received either generic or brand beta-blocker in Chiang Mai Heart Failure Clinic. The primary endpoint was the proportion of patients who received at least 50% target dose of beta-blocker between generic and brand beta-blockers. Adverse events were secondary endpoints. 217 patients (119 and 98 patients received generic and brand beta-blocker, respectively) were enrolled. There were no differences between groups regarding age, gender, etiology of heart failure, New York Heart Association (NYHA) functional class, left ventricular ejection fraction (LVEF), rate of receiving angiotensin converting enzyme inhibitor (ACEI), angiotensin recepter blocker (ARB), or spironolactone. Patients receiving brand beta-blockers had lower resting heart rate at baseline (74.9 and 84.2 bpm, p = .001). Rate of achieved 50% target dose and target daily dose did not differ between groups (40.4 versus 44.5% and 48.0 versus 55.0%, p > .05, respectively). Rate of side effects was not different between groups (32.3 versus 29.5%, p > .05) and the most common side effect was hypotension. Conclusion: This study demonstrated that beta-blocker tolerability was comparable between brand and generic formulations. Generic or brand beta-blockers should be prescribed to HFrEF patients who have no contraindications.

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BACKGROUND: Generic medications are approved on the basis of bioequivalence with brand medications in healthy volunteers rather than the target population, there remains a substantial uncertainty regarding their clinical effectiveness and safety. The object of this paper is to compare the clinical equivalence of generic statin drugs in patients. METHODS: Literature published before September 2016, which is indexed in PubMed, EMBASE, RISS, comparing generic to brand products in statins. Outcomes included blood lipid level, proportion of days covered (adherence), hospitalization and mortality. RESULTS: 511 citations were screened, of which 11 studies met eligibility criteria (6 randomized clinical trials, 5 observational studies). Generic atorvastatin was clinical equivalent with brand drugs in blood lipid level (3 RCTs) and generic simvastatin was also clinical equivalent with brand drugs (2 RCTs). 2 of 3 studies reported no significant difference in proportion of days covered except 1 study which reported generic statin significantly enhance proportion of days covered (p0.05). 1 study reported that all cause of mortality was significantly low in generic drugs (p<0.0001). CONCLUSION: Published data on comparing clinical efficacy of generic and brand statins were insufficient in both quantity and quality. This systematic review suggests that additional studies on clinical equivalence and safety of generic medications in patients would be needed.

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Beta blockers are the initial treatment for rate control of supraventricular tachyarrhythmia in patients without a history of myocardial infarction or left ventricular dysfunction. In this article we report the recurrence of atrial fibrillation after switching to the generic formulation of atenolol.