High-Dose, Short-Duration, Early Valacyclovir Therapy for Episodic Treatment of Cold Sores: Results of Two Randomized, Placebo-Controlled, Multicenter Studies

ABSTRACT Oral valacyclovir is better absorbed than oral acyclovir, increasing acyclovir bioavailability three- to fivefold. This provides the opportunity to explore whether high systemic acyclovir concentrations are effective in the treatment of cold sores (herpes labialis). Two randomized, double-blind, placebo-controlled studies were conducted. Subjects were provided with 2 g of valacyclovir twice daily for 1 day (1-day treatment), 2 g of valacyclovir twice daily for 1 day and then 1 g of valacyclovir twice daily for 1 day (2-day treatment), or a matching placebo and instructed to initiate treatment upon the first symptoms of a cold sore. In study 1, the median duration of the episode (primary endpoint) was reduced by 1.0 day (P = 0.001) with 1-day treatment and 0.5 days (P = 0.009) with 2-day treatment compared to placebo. Similarly, the mean duration of the episode was statistically significantly reduced by 1.1 days with 1-day treatment and 0.7 days with 2-day treatment compared to placebo. The proportion of subjects in whom cold sore lesion development was prevented and/or blocked was increased by 6.4% (P = 0.096) with 1-day treatment and 8.5% (P = 0.061) with 2-day treatment compared to placebo. The time to lesion healing and time to cessation of pain and/or discomfort were statistically significantly reduced with valacyclovir compared to placebo. In study 2, results similar to those in study 1 were obtained. AEs were similar across treatment groups. These studies provide evidence supporting a simple, 1-day valacyclovir treatment regimen for cold sores that is safe and effective. The 1-day valacyclovir regimen offers patients a unique and convenient dosing alternative compared to available topical therapies.

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Efficacy and Safety of GHX02 in the Treatment of Acute Bronchitis and Acute Exacerbation of Chronic Bronchitis: A Phase Ⅱ, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial

Frontiers in Pharmacology ◽

10.3389/fphar.2021.761575 ◽

2022 ◽

Vol 12 ◽

Author(s):

Su Won Lee ◽

Yee Ran Lyu ◽

Si Yeon Kim ◽

Won Kyung Yang ◽

Seung Hyung Kim ◽

...

Keyword(s):

Placebo Group ◽

Standard Dose ◽

Acute Bronchitis ◽

Multicenter Trial ◽

High Dose ◽

Efficacy And Safety ◽

Double Blind ◽

Treatment Groups ◽

The Mean ◽

Mean Differences

Acute bronchitis and acute exacerbations of chronic bronchitis (AECB) have cough and sputum as the main symptoms with a high prevalence and substantial economic burden. Although the demand for bronchitis treatment increases due to causes, such as air pollution, the appropriateness of antibiotic prescriptions and the effects of current symptomatic treatments for bronchitis are unclear. GHX02, which is a combined formulation containing four herbs, and has been clinically used for bronchitis in South Korea. We conducted a phase II, randomized, double-blind, and placebo-controlled, multicenter trial to evaluate its efficacy and safety. Patients with acute bronchitis or AECB were recruited and randomized to receive high-dose GHX02 (1920 mg/day), standard-dose GHX02 (960 mg/day), or placebo for 7 days. The primary outcome measure was the change in Bronchitis Severity Score (BSS) from baseline to Day 7. The secondary outcomes were the frequency of coughing fits, Questionnaire of Clinical Symptoms of Cough and Sputum (QCSCS), Leicester Cough Questionnaire (LCQ), Integrative Medicine Outcome Scale (IMOS), and Integrative Medicine Patient Satisfaction Scale (IMPSS). A total of 117 patients were randomized to parallel groups (38 in the high-dose GHX02, 41 in the standard-dose GHX02 group, and 38 in the placebo group). The mean differences in BSS from baseline to Day 7 in the treatment groups (4.2 ± 2.0 and 4.5 ± 1.8 in the high-dose GHX02 and standard-dose GHX02 groups, respectively) were higher than the placebo group (3.8 ± 2.1), p = 0.028. The mean differences in the frequency of coughing fits from baseline to Day 7 and IMPSS were better in the GHX02 treatment group than in the placebo group (standard-dose GHX02 group vs placebo group, p = 0.036). The QCSCS, LCQ, IMOS, and GHX02 of the treatment groups also showed more improvement than the placebo group, but there were no statistically significant differences between the groups. There were no severe adverse effects during the trial. This study supports that GHX02 is effective and safe for patients with bronchitis and provides the basis for progression to a phase III study.Clinical Trial Registration: [https://cris.nih.go.kr] WHO International Clinical Trials Registry Platform, Clinical Research Information Service [KCT0003665].

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Sumatriptan nasal spray for the acute treatment of migraine

Neurology ◽

10.1212/wnl.49.5.1225 ◽

1997 ◽

Vol 49 (5) ◽

pp. 1225-1230 ◽

Cited By ~ 79

Author(s):

R. Ryan ◽

A. Elkind ◽

C. C. Baker ◽

W. Mullican ◽

S. DeBussey ◽

...

Keyword(s):

Adverse Events ◽

Migraine Attack ◽

Nasal Spray ◽

Acute Treatment ◽

International Headache Society ◽

Migraine Treatment ◽

Multicenter Studies ◽

Double Blind ◽

Treatment Groups ◽

Migraine Medication

Background: Sumatriptan nasal spray may be particularly useful for patients whose nausea and vomiting preclude them from using oral migraine medication or for patients who prefer not to use an injectable migraine medication. The objective of this study was to evaluate in two clinical studies the efficacy and tolerability of the intranasal form of sumatriptan in the acute treatment of a single migraine attack. International Headache Society-diagnosed adult migraineurs in two randomized, double-blind, parallel-group, multicenter studies (n = 409 and 436) used sumatriptan nasal spray 20 mg, 10 mg, or placebo (2:1:1) for the acute treatment of a single migraine attack at home. Predose and at predetermined postdose intervals, patients recorded headache severity (none, mild, moderate, severe); time to meaningful relief; clinical disability (none, mildly impaired, severely impaired, bed rest required); presence/absence of nausea, photophobia, and phonophobia; and the occurrence of adverse events. Two hours postdose in the two studies, moderate or severe baseline pain was reduced to mild or none in 62 to 63% of patients treated with sumatriptan 20 mg, 43 to 54% of patients treated with sumatriptan 10 mg, and 29 to 35% of placebo-treated patients (p < 0.05 20 mg versus placebo for both studies and 10 mg versus placebo for study 1). Onset of relief relative to placebo began as early as 15 minutes postdose(sumatriptan 20 mg, study 2). Clinical disability at 2 hours postdose was reported as mildly impaired or normal in 72 to 74% of patients treated with sumatriptan 20 mg, 56 to 68% of patients treated with sumatriptan 10 mg, and 47 to 58% of placebo-treated patients (p < 0.05 20 mg versus placebo for both studies). Similar efficacy rates were observed for nausea, photophobia, and phonophobia. The most common adverse event in the active treatment groups was disturbance of taste (bad, bitter, or unpleasant taste). Aside from this event, the pattern and incidence of adverse events did not differ among treatment groups. From these results we determined that sumatriptan nasal spray is a rapidly effective, well-tolerated migraine treatment. The 20-mg dose was effective in treating the entire migraine symptom complex, and the 10-mg dose was less consistently effective.

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Paroxetine in the Treatment of Panic Disorder a Randomised, Double-Blind, Placebo-Controlled Study

The British Journal of Psychiatry ◽

10.1192/bjp.167.3.374 ◽

1995 ◽

Vol 167 (3) ◽

pp. 374-379 ◽

Cited By ~ 171

Author(s):

S. Oehrberg ◽

P. E. Christiansen ◽

K. Behnke ◽

A. L. Borup ◽

B. Severin ◽

...

Keyword(s):

Panic Disorder ◽

Cognitive Therapy ◽

Panic Attacks ◽

Controlled Study ◽

Positive Trend ◽

Double Blind ◽

Treatment Groups ◽

Efficacy Measures ◽

The Mean ◽

Primary Measure

BackgroundThis study compared the efficacy and tolerability of paroxetine with placebo in the treatment of panic disorder.MethodAfter three weeks of placebo, patients received 12 weeks of treatment with paroxetine (20, 40, or 60 mg) or placebo, and finally two weeks of placebo. Dosages were adjusted according to efficacy and tolerability. Standardised cognitive therapy was given to all patients. The primary measure of outcome was reduction in the number of panic attacks.ResultsAnalysis of the results showed statistically significant differences in favour of paroxetine between the two treatment groups in two out of the three primary measures of outcome, i.e. 50% reduction in total number of panic attacks and number of panic attacks reduced to one or zero over the study period. For the third measure of outcome, the mean change in the total number of attacks from baseline, there was a positive trend in favour of paroxetine. The results of the primary measures of outcome were strongly supported by the results of the secondary efficacy measures of outcome. In addition, paroxetine, at all doses, was very well tolerated.ConclusionParoxetine plus cognitive therapy was significantly more effective than placebo plus cognitive therapy in the treatment of panic disorder.

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A study using Sepia 200c given prophylactically postpartum to prevent anoestrus problems in the dairy cow

British Homeopathic Journal ◽

10.1016/s0007-0785(05)80226-1 ◽

1991 ◽

Vol 80 (03) ◽

pp. 149-156 ◽

Cited By ~ 9

Author(s):

A.V. Williamson ◽

W.J. Crawford ◽

B. Rennie ◽

W.L. Mackie

Keyword(s):

Reproductive Performance ◽

Day Treatment ◽

Control Group ◽

Double Blind ◽

Service Period ◽

Significant Difference ◽

Placebo Trial ◽

The Mean ◽

And Control ◽

Action List

AbstractThe results obtained from a study model using Sepia 200c in a herd of dairy cows led to an extended study. Overall reproductive performance was monitored monthly by a farm action list and the technique of palpation of the ovaries per rectum was used to determine pregnancy and cyclical status. A total of 101 cows were randomly treated with Sepia 200c on day 14 or 21 postpartum.Statistical analysis of the results was based on the differences between the untreated Control and Sepia-treated groups in periparturient disorders and pre- and post-service periods, and between the two Sepia-treated groups.In the pre-service period, a significant difference was found between the sepia-treated groups in the proportion of heifers calved, the number of assisted calvings and pre-service problems compared to Control. A difference of 9.9 total mean days to oestrus post-treatment was found between the Sepia-treated groups.During the post-service period, significant differences were found in the conception rate to first service, the percentage of cows in calf and total culled.A reduction (non significant) was found in the 21-day treatment group compared to control and 14-day treatment in the mean days calving to conception interval and the calving index. However, between the Sepia-treated groups a significant difference was found in total mean days calving to conception interval.The results of this study appear to demonstrate a difference in effect between the Sepia-treated groups and Control group. The study has been extended into a double blind placebo trial to find the effect of using a placebo and assess the use of Sepia given earlier postpartum on herd reproductive performance.

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Comparing the serum TAG response to high-dose supplementation of either DHA or EPA among individuals with increased cardiovascular risk: the ComparED study

British Journal Of Nutrition ◽

10.1017/s0007114519000552 ◽

2019 ◽

Vol 121 (11) ◽

pp. 1223-1234 ◽

Cited By ~ 7

Author(s):

Janie Allaire ◽

Cécile Vors ◽

William S. Harris ◽

Kristina Harris Jackson ◽

André Tchernof ◽

...

Keyword(s):

Individual Variation ◽

Hdl Cholesterol ◽

High Dose ◽

Double Blind ◽

Men And Women ◽

Predictors Of Response ◽

Normal Mean ◽

Secondary Analyses ◽

The Mean ◽

Long Chain

AbstractStudies have shown that the reduction in serum TAG concentrations with long-chain n-3 fatty acid supplementation is highly variable among individuals. The objectives of the present study were to compare the proportions of individuals whose TAG concentrations lowered after high-dose DHA and EPA, and to identify the predictors of response to both modalities. In a double-blind, controlled, crossover study, 154 men and women were randomised to three supplemented phases of 10 weeks each: (1) 2·7 g/d of DHA, (2) 2·7 g/d of EPA and (3) 3 g/d of maize oil, separated by 9-week washouts. As secondary analyses, the mean intra-individual variation in TAG was calculated using the standard deviation from the mean of four off-treatment samples. The response remained within the intra-individual variation (±0·25 mmol/l) in 47 and 57 % of participants after DHA and EPA, respectively. Although there was a greater proportion of participants with a reduction >0·25 mmol/l after DHA than after EPA (45 υ. 32 %; P < 0·001), the mean TAG reduction was comparable between groups (–0·59 (sem 0·04) υ. –0·57 (sem 0·05) mmol/l). Participants with a reduction >0·25 mmol/l after both DHA and EPA had higher non-HDL-cholesterol, TAG and insulin concentrations compared with other responders at baseline (all P < 0·05). In conclusion, supplementation with 2·7 g/d DHA or EPA had no meaningful effect on TAG concentrations in a large proportion of individuals with normal mean TAG concentrations at baseline. Although DHA lowered TAG in a greater proportion of individuals compared with EPA, the magnitude of TAG lowering among them was similar.

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Antiemetic effect of oral versus intravenous metoclopramide in patients receiving cisplatin: a randomized, double-blind trial.

Journal of Clinical Oncology ◽

10.1200/jco.1986.4.1.98 ◽

1986 ◽

Vol 4 (1) ◽

pp. 98-103 ◽

Cited By ~ 18

Author(s):

L B Anthony ◽

M G Krozely ◽

N J Woodward ◽

J D Hainsworth ◽

K R Hande ◽

...

Keyword(s):

High Performance ◽

Serum Levels ◽

Autonomic Arousal ◽

High Dose ◽

Tumor Type ◽

Double Blind ◽

Antiemetic Effect ◽

Dose Oral ◽

The Mean ◽

To Receive

In a study of the antiemetic effectiveness of high-dose oral metoclopramide, 66 previously untreated patients receiving 60 mg/m2 cisplatin were entered into a double-blind randomized trial. Patients were stratified according to age and tumor type, then randomized to receive either oral or intravenous (IV) high-dose metoclopramide. Patients were evaluated for antiemetic protection, toxicity, affect (anxiety, hostility, and depression), and autonomic arousal (pulse rate and blood pressure) at three-hour intervals on the day of their chemotherapy. Metoclopramide serum levels were measured by high-performance liquid chromatography. Results indicated no significant differences between the oral and IV groups on any measurement of antiemetic protection, affect, or autonomic arousal. There were also no significant differences in side effects except for frequency of stools; patients who received oral metoclopramide had significantly more stools than patients who received IV metoclopramide. The mean (+/- SD) serum metoclopramide level at four hours achieved orally was 1,171 +/- 660 ng/mL; the mean (+/- SD) level achieved IV was 1,030 +/- 392 ng/mL (P = .498). We conclude that high-dose oral and IV regimens of metoclopramide as administered in this study have equivalent antiemetic efficacy in previously untreated patients receiving 60 mg/m2 cisplatin.

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Co-Administration of Iron and a Bioavailable Curcumin Supplement Increases Serum BDNF Levels in Healthy Adults

Antioxidants ◽

10.3390/antiox9080645 ◽

2020 ◽

Vol 9 (8) ◽

pp. 645 ◽

Cited By ~ 1

Author(s):

Helena Tiekou Lorinczova ◽

Owen Fitzsimons ◽

Leah Mursaleen ◽

Derek Renshaw ◽

Gulshanara Begum ◽

...

Keyword(s):

Iron Supplementation ◽

Energy Homeostasis ◽

Low Dose ◽

Controlled Study ◽

High Dose ◽

Double Blind ◽

Treatment Groups ◽

Novel Approach ◽

First Time ◽

Serum Bdnf

Brain-derived neurotrophic factor (BDNF) is key for the maintenance of normal neuronal function and energy homeostasis and has been suggested to improve cognitive function, including learning and memory. Iron and the antioxidant curcumin have been shown to influence BDNF homeostasis. This 6-week, double blind, randomized, placebo-controlled study examined the effects of oral iron supplementation at low (18 mg) and high (65 mg) ferrous (FS) iron dosages, compared to a combination of these iron doses with a bioavailable formulated form of curcumin (HydroCurcTM; 500 mg) on BDNF levels in a healthy adult cohort of 155 male (26.42 years ± 0.55) and female (25.82 years ± 0.54) participants. Participants were randomly allocated to five different treatment groups: both iron and curcumin placebo (FS0+Plac), low dose iron and curcumin placebo (FS18+Plac), low dose iron and curcumin (FS18+Curc), high dose iron and curcumin placebo (FS65+Plac) and high dose iron and curcumin (FS65+Curc). Results showed a significant increase in BDNF over time (26%) in the FS18+Curc group (p = 0.024), and at end-point between FS18+Curc and FS18+Plac groups (35%, p = 0.042), demonstrating for the first time that the combination with curcumin, rather than iron supplementation alone, results in increased serum BDNF. The addition of curcumin to iron supplementation may therefore provide a novel approach to further enhance the benefits associated with increased BDNF levels.

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Abstract P090: The Effect of Bupropion on Symptoms of Depression Among Patients Attempting to Quit Smoking Post-Myocardial Infarction: The ZESCA Trial

Circulation ◽

10.1161/circ.125.suppl_10.ap090 ◽

2012 ◽

Vol 125 (suppl_10) ◽

Author(s):

Kristian B Filion ◽

Sonia M Grandi ◽

Lawrence Joseph ◽

Jennifer O'Loughlin ◽

Gilles Paradis ◽

...

Keyword(s):

Myocardial Infarction ◽

Smoking Cessation ◽

Depressive Symptomatology ◽

Controlled Trial ◽

Double Blind ◽

Treatment Groups ◽

Symptoms Of Depression ◽

Quit Smoking ◽

The Mean

Background: Bupropion is a smoking cessation drug that can be prescribed immediately following a myocardial infarction (MI). Depression is prevalent during this period, and bupropion, which can also be prescribed as an anti-depressant, may improve symptoms of depression in this population. Methods: The ZESCA Trial is a randomized, double-blind, placebo-controlled trial that examined the efficacy of bupropion as a smoking cessation therapy in 392 hospitalized MI patients. Treatment duration was 9 weeks, and follow-up was 12 months. Depressive symptomatology was defined by a Beck Depression Inventory-II (BDI-II) score > 14. A total of 4 patients were missing baseline BDI-II scores and were excluded from this analysis. Differences in changes in depressive symptomatology from baseline were examined overall and in those with symptoms of depression at baseline. Results: The mean age was 53.9 years (standard deviation [SD] = 10.3), and 84% were male. A total of 20% of patients had depressive symptomatology at baseline. The median BDI-II score was 6.0 (inter-quartile range [IQR] = 2.0, 12.0) overall and 19.0 (16.0, 25.0) among those with depressive symptomatology at baseline. The mean BDI-II score was similar between treatment groups throughout the follow-up period (Figure). Similarly, there were no differences in BDI-II score between treatment groups at baseline or 9 weeks when restricted to those with depressive symptomatology at baseline. In this group, patients randomized to bupropion had a higher BDI-II score at 12 months (bupropion - placebo = 5.98, 95% confidence interval = 0.92, 11.04); the difference is likely due to differential participation at 12 months. At all follow-up visits, there were no differences in change in BDI-II score between treatment groups, both in the overall study population and in those with depressive symptomatology at baseline. Conclusions: Our results suggest that bupropion does not improve symptoms of depression in patients who are attempting to quit smoking post-MI.

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Results of a Randomized, Open-Label, Phase IIIb Study of 2 Schedules of Decitabine in Higher-Risk Myelodysplastic Syndrome Patients

Blood ◽

10.1182/blood.v120.21.3846.3846 ◽

2012 ◽

Vol 120 (21) ◽

pp. 3846-3846

Author(s):

Depei Wu ◽

Xin Du ◽

Jie Jin ◽

Zhijian Xiao ◽

Zhixiang Shen ◽

...

Keyword(s):

Plasma Concentration ◽

Treatment Group ◽

Complete Remission ◽

Myelodysplastic Syndrome ◽

De Novo ◽

Day Treatment ◽

Treatment Schedule ◽

Open Label ◽

Treatment Groups ◽

The Mean

Abstract Abstract 3846 Aim: To evaluate the efficacy and safety of 3-day and 5-day treatment schedules of decitabine (nucleoside analogue) in Chinese patients with Myelodysplastic Syndrome (MDS). Methods: In this open-label, multi-center, phase 3b study, consenting men and women (n=132) above 18 years of age with de novo or secondary MDS fitting any of the recognized French-American-British classifications, with score on International Prognostic Scoring System (IPSS) ≥ 0.5 within 30 days before randomization, and having Eastern Cooperative Oncology Group performance (ECOG) status of 0–2, were enrolled. Patients were randomized (1:1) to either 3-day treatment schedule (15 mg/m2/day decitabine administered by continuous intravenous infusion within a 3-hour period, repeated every 8 hours for 3 consecutive days/cycle; cycles repeated every 6 weeks) or to 5-day treatment schedule (20 mg/m2 decitabine administered by a 1-hour infusion once-daily, on days 1 through 5/cycle; cycles repeated every 4 weeks), until minimum of 30 patients were included in the 3-day treatment group. All remaining patients were enrolled for the 5-day treatment. Patients were treated for ≥4 treatment cycles and for a maximum of 2 years, as long as the patient continued to benefit (absence of overt progression of disease or unacceptable toxicity). The primary efficacy endpoint was overall response rate (ORR) that included complete remission, bone marrow complete remission and partial remission, according to the International Working Group (IWG) 2006 response criteria. The secondary endpoints included hematological improvement, time to acute myeloid leukemia (AML) progression or death, and overall survival (OS). Safety and pharmacokinetics of decitabine were evaluated. Assuming a 10% dropout rate, with 132 enrolled patients, the study had 90% power at a 5% significance level to detect a >10% ORR. Results: Thirty-four patients were included in the 3-day treatment group and 98 patients were included in the 5-day treatment group. Overall, 78 (59.5%) patients prematurely discontinued the study (16 [12.2%] patients discontinued due to disease progression). The demographic and baseline characteristics were comparable between the 2 treatment groups. In the overall population, the median age was 53.9 years (range: 18.5 – 84.0), 59% were men, all had de novo MDS, the mean (SD) time since diagnosis of MDS was 4.2 (9.38) months, 41.4% patients were IPSS Intermediate-1 (0.5–1.0), 43% were IPSS Intermediate −2 (1.5–2.0) and 15.6% were IPSS high risk (≥2.5) and the majority (68.9% of patients) had ECOG score of 1. Median number of treatment cycles was 3 for each of the treatment groups. Based on the single sample proportion comparison with given value (10%), the significant ORR was achieved in the overall population (22.9%; 95% CI: 16.0, 31.1; p<0.001) as well as in the 3-day treatment group (26.5%; 95% CI: 12.9, 44.4) and 5-day treatment group (21.6%; 95% CI: 13.9, 31.2). The hematological improvement (CR+PR+HI) rate (% [95% CI]) for overall population, 3-day treatment group and 5-day treatment group was 39.7 (31.3, 48.6), 44.1 (27.2, 62.1) and 38.1 (28.5, 48.6) respectively. AML transformations or deaths occurred in 21 (16.0%) patients overall, and in 5 (14.7%) and 16 (16.5%) patients in the 3-day and 5-day treatment group respectively. For the overall population, the maximum estimated time to AML transformations or death was 27.8 months (3-day treatment: 17.9 months, 5-day treatment: 27.8 months). For the overall population, the 12-month OS was 80.6 % and 24-month OS was 60.7%. At steady state, the mean (SD) maximum plasma concentration and mean (SD) area under plasma concentration-time curve (AUC0-∞) was 54.44 (20.07) ng/mL and 118.93 (50.55) ng.hr/mL, respectively for the 3-day treatment group (n=7) and 222.35 (53.74) ng/mL and 180.43 (43.78) ng.hr/mL, respectively for the 5-day treatment group (n=17). Overall, at least one treatment-emergent adverse event (TEAE) occurred in 97 (74%) patients (32 [94.1%] patients in the 3-day treatment group and in 65 [67%] patients in the 5-day treatment group); TEAEs were related to study drug in 31 (91.2%) patients in the 3-day treatment group and 60 (61.9%) patients in the 5-day treatment group. Conclusion: Decitabine was found to be efficacious and safe for treatment of MDS. Results of this study were consistent with similar decitabine studies conducted previously. Disclosures: No relevant conflicts of interest to declare.

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Aspirin, Dipyridamole and Platelet Survival in Patients with Diabetes Mellitus

Clinical Science ◽

10.1042/cs0630205 ◽

1982 ◽

Vol 63 (2) ◽

pp. 205-209 ◽

Cited By ~ 6

Author(s):

Hilary Tindall ◽

R. Colin Paton ◽

George P. McNicol

Keyword(s):

Diabetic Patients ◽

High Dose ◽

Double Blind ◽

Regeneration Time ◽

Dose Aspirin ◽

Platelet Survival ◽

Group I ◽

The Mean ◽

Group Ii ◽

High Dose Aspirin

1. Platelet survival in 27 insulin-dependent diabetic patients with severe retinopathy was studied in a double-blind cross-over trial using placebo, aspirin (990 mg/day) and a combination of dipyridamole (225 mg/day) with aspirin at two dosage levels (330 mg and 990 mg/day). 2. Twenty patients (group I) had 51Cr-labelled-platelet survival after treatment with placebo and the high-dose-aspirin/dipyridamole combination. The remaining seven patients (group II) had platelet-regeneration times measured after each of the four treatment periods. 3. Treatment of group I patients with the high-dose-aspirin/dipyridamole combination resulted in significant (P < 0·001) prolongation of platelet survival from 7·3 ± 0·2 (mean ± sem) days to 8·4 ± 0·1 days. 4. In group II patients, when compared with the mean placebo result of 7·2 ± 0·2 days, the mean aspirin-labelled-platelet-regeneration time was significantly (P < 0·01) longer only after high-dose-aspirin/dipyridamole (9·8 ± 0·5 days) but not after low-dose-aspirin/dipyridamole (8·3 ± 0·5 days) or aspirin alone (7·3 ± 0·3 days). 5. These results suggest that it may be premature to consider reducing the dose of aspirin in aspirin/dipyridamole combinations below 1 g/day when used as antithrombotic therapy.

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