Bedtime Regimen Research Articles

Morning vs. bedtime levothyroxine administration: what is the ideal choice for children?

Background The present study compared the administration of levothyroxine (LT4) before breakfast and bedtime in school children diagnosed with hypothyroidism and analyzed the effects of timing on thyroid functioning and patient satisfaction. Methods A total of 163 children with acquired hypothyroidism (125 females and 38 males) between 8 and 18 years of age and taking LT4 for at least 3 months were enrolled in the study. The timing of administration of the drug of all subjects was shifted to bedtime. The levels of thyroid hormone and blood lipid, anthropometric measurements, Pediatric Quality of Life Inventory, Morisky Medication Adherence Scale and hypothyroidism symptoms scores were analyzed and compared at the beginning of the study and 3 months later after the shift in the timing of drug administration. Results There was no difference between the bedtime and morning regimens of LT4 with respect to thyroid hormone levels, quality of life, drug adherence and symptoms of hypothyroidism. At the end of the study, 45 of 70 new-onset treated subjects preferred the bedtime regimen. Also, drug adherence was found to be better in these patients. Conclusions We found no difference between the bedtime and morning regimens in both new-onset and long-standing treated patients. In naive patients, consideration of patient's preference for timing of drug administration may increase their adherence to medication. Therefore, we suggest that choice of drug administration timing should be based on the preference of patients.

Rationale on the decision-making process for opicapone's bedtime regimen in Parkinson's disease

Rationale on the decision-making process for opicapone's bedtime regimen in Parkinson's disease

Effectiveness of bedtime levothyroxine intake as compared to morning levothyroxine intake in children

Background: The study was conducted to assess the effectiveness of bedtime Levothyroxine administration as compared to morning Levothyroxine administration in thyroid profile, renal and lipid parameters, anthropometric and vital parameters in children attending endocrinology OPD at a tertiary care center in Southern India.Methods: It is an open label randomized control study. 154 children who were diagnosed to have hypothyroidism, on levothyroxine supplementation and in euthyroid state at the start of study were included. Children were randomly allocated into two groups. One group received levothyroxine in early morning (1hr before food) and another group received levothyroxine in bedtime (2hrs after food) up to 3 months. At baseline, 6 weeks and 12weeks, thyroid profile, renal and lipid parameters and vital parameters were measured during follow up. Anthropometric parameters were measured at baseline and 12 weeks.Results: In 6th week analysis, mean TSH level of morning group (2.35±0.38 mIU/L) and bedtime group (2.42±0.40 mIU/L) did not show any statistical difference (p=0.8). In 12th week analysis mean TSH level of morning group (2.18±0.34 mIU/L) and bedtime group (1.90±0.33 mIU/L) did not show any statistical difference (p=0.24). At 6th week analysis, mean free T4 level of bedtime group (1.45±0.08 ng/dl) is higher than morning group (1.33±0.2 ng/dl). This difference is statistically significant (p= 0.03). At 12 th week analysis, mean free T4 level of bedtime group (1.65±0.04 ng/dl) is higher than morning group (1.31±0.06 ng/dl). This difference is statistically significant (p<0.00001). A 12weeks, the difference in mean serum cholesterol of morning group (152.79±4.59 mg/dl) and bedtime group (143.58±3.059 mg/dl) is statistically significant (p=0.001). At 6 and12 weeks, other parameters like serum triglycerides, HDL cholesterol, renal parameters, anthropometry, vital parameters of morning group and bedtime group did not show any statistical significant difference.Conclusions: There is a significant improvement in free T4 level when levothyroxine was taken at bedtime. The efficacy of bedtime regimen of levothyroxine is quite comparable to the efficacy of morning regimen. There is considerable decrease in serum cholesterol level when levothyroxine was taken at bedtime. Bedtime regimen may result in good compliance in school going children. Parents should be allowed to choose either morning or bedtime regimen depending on their convenience.

Treatment-Time Regimen of Hypertension Medications Significantly Affects Ambulatory Blood Pressure and Clinical Characteristics of Patients With Resistant Hypertension

Patients with resistant hypertension (RH) are at greater risk for stroke, renal insufficiency, and cardiovascular disease (CVD) events than are those for whom blood pressure (BP) is responsive to and well controlled by therapeutic interventions. Although all chronotherapy trials have compared the effects on BP regulation of full daily doses of medications when ingested in the morning versus at bedtime, prescription of the same medications in divided doses twice daily (BID) is frequent. Here, we investigated the influence of hypertension treatment-time regimen on the circadian BP pattern, degree of BP control, and relevant clinical and laboratory medicine parameters of RH patients evaluated by 48-h ambulatory BP monitoring (ABPM). This cross-sectional study evaluated 2899 such patients (1701 men/1198 women), 64.2 ± 11.8 (mean ± SD) yrs of age, enrolled in the Hygia Project. Among the participants, 1084 were ingesting all hypertension medications upon awakening (upon-awakening regimen), 1436 patients were ingesting the full daily dose of ≥1 of them at bedtime (bedtime regimen), and 379 were ingesting split doses of ≥1 medications BID upon awakening and at bedtime (BID regimen). Patients of the bedtime regimen compared with the other two treatment-time regimens had lower likelihood of microalbuminuria and chronic kidney disease; significantly lower albumin/creatinine ratio, glucose, total cholesterol, and low-density lipoprotein (LDL) cholesterol; plus higher estimated glomerular filtration rate and high-density lipoprotein (HDL) cholesterol. The bedtime regimen was also significantly associated with lower asleep systolic (SBP) and diastolic (DBP) BP means than the upon-awakening and BID regimens. The sleep-time relative SBP and DBP decline was significantly attenuated by the upon-awakening and BID regimens (p < .001), resulting in significantly higher prevalence of non-dipping in these two treatment-time regimen groups (80.5% and 77.3%, respectively) than in the bedtime regimen (54.4%; p < .001 between groups). Additionally, the prevalence of the riser BP pattern, associated with highest CVD risk, was much greater, 31.0% and 29.8%, respectively, among patients of the upon-awakening and BID-treatment regimens, compared with the bedtime regimen (17.6%; p < .001 between groups). Patients of the bedtime regimen also showed significantly higher prevalence of properly controlled ambulatory BP (p < .001) as a result of a greater proportion of them showing complete control of asleep SBP and DBP means. Our findings demonstrate significantly lower asleep SBP and DBP means and attenuated prevalence of blunted nighttime BP decline, i.e., lower prevalence of CVD risk markers, in RH patients ingesting the full daily dose of ≥1 hypertension medications at bedtime than in those ingesting all of them upon awakening or ≥1 of them as split doses BID. In RH, ingesting the same medications BID neither improves ambulatory BP control nor reduces the prevalence of non-dipping, and cannot be considered chronotherapy. Collectively, findings of this study indicate that a bedtime hypertension medication regimen, in conjunction with proper patient evaluation by ABPM to corroborate the diagnosis of true RH and avoid treatment-induced nocturnal hypotension, should be the therapeutic scheme of choice for patients who, by conventional cuff methods (and in the absence of ABPM) and the morning-treatment regimen, have been mistakenly judged to be resistant to therapy. (Author correspondence: rhermida@uvigo.es)

Medikamentöse Therapie des Diabetes mellitus Typ 2

The sequelae and complications associated with type 2 diabetes mellitus can be reduced or inhibited by optimal therapy. Currently, a variety of medications are available for differentiated therapy, which should be used according to the German Diabetes Association Guidelines. Changes in lifestyle represent the basic therapeutic principle, and it is mandatory to continuously maintain these measures throughout life. If this is not adequately effective (HBA(1c) <6.5%), treatment with oral antidiabetic drugs (OAD) is necessary. Over time OAD monotherapy frequently fails, so that a combination of several oral antidiabetics is needed. The choice of oral antidiabetics is particularly dependent on the patient's body mass index and associated diseases. If combination therapy with OAD is not successful in achieving HbA1c values <6.5%, insulin therapy is required either in combination with OADs as a bedtime regimen or as intensive insulin therapy using both basal and short-term acting insulins.

Once-daily Insulin Glargine Administration in the Morning Compared to Bedtime in Combination with Morning Glimepiride in Patients with Type 2 Diabetes: An Assessment of Treatment Flexibility

To compare the incidence of nocturnal hypoglycemia and glycemic control following bedtime or morning insulin glargine (LANTUS; glargine) plus glimepiride. In this 24-week, multinational, open, randomized study, 624 patients with type 2 diabetes poorly controlled on oral therapy received morning or bedtime glargine plus morning glimepiride (2, 3 or 4 mg) titrated to a target fasting blood glucose level < or = 5.5 mmol/l. The incidence of nocturnal hypoglycemia was equivalent between the two groups, with morning glargine non-inferior to bedtime (13.0 VS. 14.9 % of patients; between-treatment difference -1.9 %; one-sided 95 % confidence interval -100 %; 2.84 %). At endpoint, similar improvements in glycemic control were observed with morning compared to bedtime glargine: HbA1c: -1.65 +/- 1.21 VS. -1.57 +/- 1.16 %; p = 0.42; fasting blood glucose: -4.25 +/- 2.82 VS. -4.48 +/- 2.75 mmol/l; p = 0.08. The endpoint mean daily glargine dose was comparable (34.7 +/- 17.4 VS. 32.4 +/- 17.0 IU; p = 0.15), and there was no significant between-treatment difference in the change in body weight (2.1 VS. 1.8 kg; p = 0.39). Once-daily glargine can be administered in a flexible morning or bedtime regimen (plus morning glimepiride) to achieve good glycemic control without any difference in hypoglycemia.

Best-Buy Regimen of Ursodeoxycholic Acid for Patients with Gallstones

Bedtime administration has been advocated as a strategy for reducing minimum effective dose, side effects, and costs of chenodeoxycholic acid treatment of cholesterol gallstones, but little information is available for ursodeoxycholic acid (UDCA). We prospectively determined the minimum effective dose of bedtime UDCA in 44 patients with radiolucent gallstones treated with a range of UDCA doses (4.6-17.0 mg/kg/day). The average minimum effective dose for reducing the cholesterol saturation index (SI) of gallbladder bile to a value of 0.8 was 8.4 mg/kg/day for bedtime UDCA. The greater potency of the bedtime regimen was confirmed in seven individual patients by comparison with a mealtime regimen. Cholesterol SI was reduced from 1.25 during placebo to 0.73 during 7 mg/kg/day for bedtime UDCA and to 0.81 during 10 mg/kg/day for mealtime UDCA. The effect of the bedtime regimen was not enhanced by a repeated-release tablet formulation of UDCA by comparison with UDCA in 15 patients. We conclude that the bile acid dose is reduced during bedtime UDCA administration by comparison with mealtime UDCA in individual patients and that the best-buy regimen is 8.4 mg/kg/day UDCA given at bedtime for patients with gallstones as a group. With this dose, gallstone dissolution can be supported by unsaturated gallbladder bile at minimum risk of dose-related side effects and at minimum treatment costs.