Displaying publications 1 - 20 of 302 in total

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  1. Eikelboom JW, Bosch J, Connolly SJ, Tyrwitt J, Fox KAA, Muehlhofer E, et al.
    Eur Heart J Cardiovasc Pharmacother, 2022 Dec 02;8(8):786-795.
    PMID: 35383832 DOI: 10.1093/ehjcvp/pvac023
    AIMS: To describe outcomes of patients with chronic coronary artery disease (CAD) and/or peripheral artery disease (PAD) enrolled in the Cardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS) randomized trial who were treated with the combination of rivaroxaban 2.5 mg twice daily and aspirin 100 mg once daily during long-term open-label extension (LTOLE).

    METHODS AND RESULTS: Of the 27 395 patients enrolled in COMPASS, 12 964 (mean age at baseline 67.2 years) from 455 sites in 32 countries were enrolled in LTOLE and treated with the combination of rivaroxaban and aspirin for a median of 374 additional days (range 1-1191 days). During LTOLE, the incident events per 100 patient years were as follows: for the primary outcome [cardiovascular death, stroke, or myocardial infarction (MI)] 2.35 [95% confidence interval (CI) 2.11-2.61], mortality 1.87 (1.65-2.10), stroke 0.62 (0.50-0.76), and MI 1.02 (0.86-1.19), with CIs that overlapped those seen during the randomized treatment phase with the combination of rivaroxaban and aspirin. The incidence rates for major and minor bleeding were 1.01 (0.86-1.19) and 2.49 (2.24-2.75), compared with 1.67 (1.48-1.87) and 5.11 (95% CI 4.77-5.47), respectively, during the randomized treatment phase with the combination.

    CONCLUSION: In patients with chronic CAD and/or PAD, extended combination treatment for a median of 1 year and a maximum of 3 years was associated with incidence rates for efficacy and bleeding that were similar to or lower than those seen during the randomized treatment phase, without any new safety signals.

    Matched MeSH terms: Drug Therapy, Combination
  2. Lim KY, Khoo CS, Rajah R, Tan HJ, Tajurudin FW
    Med J Malaysia, 2023 Sep;78(5):635-638.
    PMID: 37775491
    INTRODUCTION: Epilepsy is a neurological disease with high global prevalence. Almost one-third of epilepsy patients continue having seizures despite adequate treatment. Perampanel has been widely used in the Western countries as an adjunctive therapy for both generalized and focal seizures. Owing to its high cost, the use of perampanel is limited in our country.

    MATERIALS AND METHODS: We conducted a descriptive, retrospective study among epilepsy patients treated with perampanel. We aimed to assess the efficacy and safety of perampanel as an adjunctive in our hospital.

    RESULTS AND CONCLUSIONS: From our cohort of 25 patients, most of the patients were either on one or three anti-seizure medications (ASMs) prior to initiation of perampanel. Perampanel was added in 88% of them due to persistent seizures. Twenty-two (88%) patients experienced reduction in seizure frequency. 12% experienced mild side effects, which were leg cramps, hyponatremia and drowsiness. Only 1 patient stopped perampanel due to its side effects.

    CONCLUSION: Perampanel is a well-tolerated ASM that should be widely used as an adjunctive. More studies with regards to its efficacy and safety involving more centres are encouraged in Malaysia.

    Matched MeSH terms: Drug Therapy, Combination
  3. Tweed CD, Wills GH, Crook AM, Amukoye E, Balanag V, Ban AYL, et al.
    Int J Tuberc Lung Dis, 2021 Apr 01;25(4):305-314.
    PMID: 33762075 DOI: 10.5588/ijtld.20.0513
    BACKGROUND: Treatment for TB is lengthy and toxic, and new regimens are needed.METHODS: Participants with pulmonary drug-susceptible TB (DS-TB) were randomised to receive: 200 mg pretomanid (Pa, PMD) daily, 400 mg moxifloxacin (M) and 1500 mg pyrazinamide (Z) for 6 months (6Pa200MZ) or 4 months (4Pa200MZ); 100 mg pretomanid daily for 4 months in the same combination (4Pa100MZ); or standard DS-TB treatment for 6 months. The primary outcome was treatment failure or relapse at 12 months post-randomisation. The non-inferiority margin for between-group differences was 12.0%. Recruitment was paused following three deaths and not resumed.RESULTS: Respectively 4/47 (8.5%), 11/57 (19.3%), 14/52 (26.9%) and 1/53 (1.9%) DS-TB outcomes were unfavourable in patients on 6Pa200MZ, 4Pa200MZ, 4Pa100MZ and controls. There was a 6.6% (95% CI -2.2% to 15.4%) difference per protocol and 9.9% (95%CI -4.1% to 23.9%) modified intention-to-treat difference in unfavourable responses between the control and 6Pa200MZ arms. Grade 3+ adverse events affected 68/203 (33.5%) receiving experimental regimens, and 19/68 (27.9%) on control. Ten of 203 (4.9%) participants on experimental arms and 2/68 (2.9%) controls died.CONCLUSION: PaMZ regimens did not achieve non-inferiority in this under-powered trial. An ongoing evaluation of PMD remains a priority.
    Matched MeSH terms: Drug Therapy, Combination
  4. Gul N, Rehman IU, Shah Y, Ali AM, Ali Z, Shehzad O, et al.
    PLoS One, 2024;19(11):e0311435.
    PMID: 39570934 DOI: 10.1371/journal.pone.0311435
    INTRODUCTION: Type II Diabetes mellitus (T2DM) patients often do not achieve glycemic control with oral hypoglycemic agents (OHAs). There are two main approaches to address this challenge: transitioning to a triple OHA regimen, or adding Insulin to the existing dual OHA regimen.

    AIM: This study aimed to compare the efficacy of adding Insulin to dual OHAs (Sitagliptin + Metformin) against adding a third OHA to Sitagliptin + Metformin in achieving glycemic control among patients with uncontrolled T2DM.

    METHOD: A pre-post study was conducted between 21 September 2023 and 21 December 2023 at Services Hospital Peshawar, Pakistan. Patients with uncontrolled T2DM with >7% HbA1c were divided into group 1 (Sitagliptin + Metformin plus a third OHA), and group 2 (Sitagliptin + Metformin plus pre-mixed Insulin 70/30). Glycemic control based on HbA1c values, fasting and random blood sugar levels, lipid profile, and body weight were evaluated after 3 months of therapy. The pre- and post- effect was compared by using a paired t-test.

    RESULTS: The study included n = 80 patients with T2DM. Between groups 1 and 2, no significant difference was found in HbA1c values (9.1 vs. 9, with p = 0.724). However, BMI, cholesterol, and LDL significantly decreased in group 1 compared to group 2 (p<0.001 vs. p = 0.131, p = 0.023 vs. p = 0.896, and p = 0.003 vs. p = 0.395, respectively). Additionally, the incidence of hypoglycemic episodes was significantly lower in group 1 (7.5%) than in group 2 (47.5%, p = 0.004). No significant difference was observed between the triple OHA and dual OHA plus Insulin regimens in achieving glycemic control.

    CONCLUSION: The triple OHA regimen improved BMI, cholesterol, and LDL levels, and reduced hypoglycemic episodes more effectively than dual OHA plus Insulin, despite similar HbA1c outcomes, suggesting it may be preferable for uncontrolled T2DM.

    Matched MeSH terms: Drug Therapy, Combination*
  5. Naing C, Racloz V, Whittaker MA, Aung K, Reid SA, Mak JW, et al.
    PLoS One, 2013;8(12):e78819.
    PMID: 24312446 DOI: 10.1371/journal.pone.0078819
    BACKGROUND: This study aimed to synthesize available evidence on the efficacy of dihydroartemisinin-piperaquine (DHP) in treating uncomplicated Plasmodium vivax malaria in people living in endemic countries.

    METHODOLOGY AND PRINCIPAL FINDINGS: This is a meta-analysis of randomized controlled trials (RCT). We searched relevant studies in electronic databases up to May 2013. RCTs comparing efficacy of (DHP) with other artemisinin-based combination therapy (ACT), non-ACT or placebo were selected. The primary endpoint was efficacy expressed as PCR-corrected parasitological failure. Efficacy was pooled by hazard ratio (HR) and 95% CI, if studies reported time-to-event outcomes by the Kaplan-Meier method or data available for calculation of HR Nine RCTs with 14 datasets were included in the quantitative analysis. Overall, most of the studies were of high quality. Only a few studies compared with the same antimalarial drugs and reported the outcomes of the same follow-up duration, which created some difficulties in pooling of outcome data. We found the superiority of DHP over chloroquine (CQ) (at day > 42-63, HR:2.33, 95% CI:1.86-2.93, I (2): 0%) or artemether-lumefentrine (AL) (at day 42, HR:2.07, 95% CI:1.38-3.09, I (2): 39%). On the basis of GRADE criteria, further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.

    DISCUSSION/CONCLUSION: Findings document that DHP is more efficacious than CQ and AL in treating uncomplicated P. vivax malaria. The better safety profile of DHP and the once-daily dosage improves adherence, and its fixed co-formulation ensures that both drugs (dihydroartemisinin and piperaquine) are taken together. However, DHP is not active against the hypnozoite stage of P. vivax. DHP has the potential to become an alternative antimalarial drug for the treatment uncomplicated P. vivax malaria. This should be substantiated by future RCTs with other ACTs. Additional work is required to establish how best to combine this treatment with appropriate antirelapse therapy (primaquine or other drugs under development).

    Matched MeSH terms: Drug Therapy, Combination/adverse effects; Drug Therapy, Combination/methods
  6. Destiani DP, Naja S, Dewi S, Rahmadi AR, Sulaiman SAS, Abdulah R
    Osteoporos Int, 2021 May;32(5):805-816.
    PMID: 33210179 DOI: 10.1007/s00198-020-05743-z
    Even though new drugs for the treatment of rheumatoid arthritis (RA) have been developed, methotrexate (MTX) remains a commonly used drug for RA management. In addition to monitoring disease activity during RA treatment, bone erosion should be closely assessed throughout long-term RA management. In this review article, we present a systematic review of MTX effectiveness in reducing the risk of bone erosion. We reviewed randomized controlled trial studies that involved MTX monotherapy or MTX in combination with placebo. Evaluation of the progression of bone erosion was examined by radiographic assessment such as total Sharp score (TSS) or van der Heijde score (SvdH or vdH TSS), joint space narrowing (JSN), erosion score (ERO), and proportion of radiographic nonprogressors. Several key factors were found to influence the response to MTX treatment, such as gene polymorphism. The exact mechanism of the prevention of bone erosion by MTX remains unclear, which warrants future investigations. The variability of RA disease activity in study subjects resulted in variations in the results reported by individual studies. Collective analysis suggests that MTX could slow down the progression of bone erosion based on a radiographic score of less than 0.5-1/year.
    Matched MeSH terms: Drug Therapy, Combination
  7. Martínez-Domínguez SJ, Nyssen OP, Lanas Á, Alfaro E, Jonaitis L, Mahmudov U, et al.
    Helicobacter, 2024;29(4):e13111.
    PMID: 39001621 DOI: 10.1111/hel.13111
    BACKGROUND: The influence of indications for Helicobacter pylori investigation on prescriptions and effectiveness is unknown. The aim of the study was to assess the impact of indications for H. pylori investigation on prescriptions, effectiveness, compliance, and tolerance.

    METHODS: International, prospective, non-interventional registry of the management of H. pylori infection by European gastroenterologists (Hp-EuReg). Treatment-näive patients registered from 2013 to 2023 at e-CRF AEG-REDCap were analyzed. The effectiveness was assessed by modified intention-to-treat analysis.

    RESULTS: Overall, 53,636 treatment-naïve cases from 34 countries were included. Most frequent indications were: dyspepsia with normal endoscopy (49%), non-investigated dyspepsia (20%), duodenal ulcer (11%), gastric ulcer (7.7%), and gastroesophageal reflux disease (GERD) (2.6%). Therapy effectiveness varied by indication: duodenal ulcer (91%), gastric ulcer (90%), preneoplastic lesions (90%), dyspepsia with normal endoscopy (89%), GERD (88%), and non-investigated dyspepsia (87%). Bismuth-metronidazole-tetracycline and clarithromycin-amoxicillin-bismuth quadruple therapies achieved 90% effectiveness in all indications except GERD. Concomitant clarithromycin-amoxicillin-tinidazole/metronidazole reached 90% cure rates except in patients with non-investigated dyspepsia; whereas sequential clarithromycin-amoxicillin-tinidazole/metronidazole proved optimal (≥90%) in patients with gastric ulcer only. Adverse events were higher in patients treated for dyspepsia with normal endoscopy and duodenal ulcer compared with the remaining indications (23% and 28%, p 

    Matched MeSH terms: Drug Therapy, Combination
  8. Leong CF, Cheong SK, Fadilah SA
    Med J Malaysia, 1999 Dec;54(4):517-9.
    PMID: 11072473
    A 56-year-old Chinese lady with valvular heart disease and atrial fibrillation was referred to us from a private hospital for further management of autoimmune haemolytic anaemia. Physical examination and laboratory investigations did not support the diagnosis of haemolytic anaemia. However, direct antiglobulin test (DAT) was strongly positive with anti-IgG and negative with anti-C3d. There was also mild anaemia and reticulocytosis, which was attributable to persistent haematuria. The DAT became positive after commencing Unasyn and cessation was associated with decreasing reactivity of the positive DAT. We believe that the positive DAT in this patient was most likely due to the Unasyn therapy.
    Matched MeSH terms: Drug Therapy, Combination/adverse effects*
  9. Bukhsh A, Goh BH, Lee LH, Khan TM
    J Infect Public Health, 2017 02 10;10(5):692-693.
    PMID: 28209323 DOI: 10.1016/j.jiph.2016.09.012
    Matched MeSH terms: Drug Therapy, Combination/methods
  10. Prasetyo AA, Rachmawati B, Riwanto I
    Med J Malaysia, 2024 Aug;79(Suppl 4):63-67.
    PMID: 39215417
    INTRODUCTION: Cholestasis is bile flow disruption that leads to bile accumulation, which could lead to liver fibrosis. Ursodeoxycholic acid (UDCA) has a hepatoprotective effect. Glutathione (GSH) is an endogenous antioxidant that plays a role in maintaining the function and structure of liver cells. This study aimed to examine the effect of UDCA-GSH combination therapy in multiple doses on liver function in the Sprague-Dawley rats' liver fibrosis model.

    MATERIALS AND METHODS: This was a randomised post-testonly study. A total of 28 rats were assigned into four groups: Group 1 is control group (C), samples had bile duct ligation and UDCA monotherapy 20 mg; Group 2, bile duct ligation + UDCA 10 mg + glutathione 10 mg (P1); Group 3, bile duct ligation + UDCA 20 mg + glutathione 15 mg (P2); Group 4, bile duct ligation + UDCA 30 mg + glutathione 20 mg (P3). Serum AST, ALT, ALP activity, total, direct and indirect bilirubin were collected. Shapiro-Wilk test was used for the normality test. All groups' data were compared using Kruskall-Wallis and Mann-Whitney tests.

    RESULTS: There was a significant difference in the ALP level in all rats and between the C and P2 groups. ALP level of all groups decreased significantly compared to the control group. Combination therapy group showed lower bilirubin levels. ALT levels significantly differed between the C-P1, P1-P2, and P1-P3 groups.

    CONCLUSION: UDCA-GSH therapy improves liver function in BDL rats' models compared to UDCA monotherapy.

    Matched MeSH terms: Drug Therapy, Combination*
  11. Loh SP
    Med J Malaysia, 1993 Jun;48(2):207-10.
    PMID: 8350797
    Eight patients underwent major gynaecological operations. Their post-operative analgesia was provided by epidural buprenorphine 0.15 mg and bupivacaine 0.5%. The efficacy and side-effects of this combination were assessed. All patients had satisfactory analgesia ranging in duration from 10 hours to greater than 36 hours after a single dose injection. No significant side-effect was noted.
    Matched MeSH terms: Drug Therapy, Combination
  12. Ahmed AZ, Satyam SM, Shetty P, D'Souza MR
    Scientifica (Cairo), 2021;2021:6694340.
    PMID: 33510932 DOI: 10.1155/2021/6694340
    Doxorubicin-induced cardiotoxicity is the leading cause of morbidity and mortality among cancer survivors. The present study was aimed to investigate the cardioprotective potential of methyl gallate; an active polyphenolic nutraceutical, against doxorubicin-induced cardiotoxicity in Wistar rats. Twenty-four female Wistar rats (150-200 g) were divided into four groups (n = 6) which consist of normal control (group I), doxorubicin control (group II), test-A (group III), and test-B (group IV). Group III and group IV animals were prophylactically treated with methyl gallate 150 mg/kg/day and 300 mg/kg/day orally, respectively, for seven days. Doxorubicin (25 mg/kg; single dose) was administered through an intraperitoneal route to group II, III, and IV animals on the seventh day to induce acute cardiotoxicity. On the 8th day, besides ECG analysis, serum CK, CK-MB, LDH, AST, MDA, and GSH were assayed. Following gross examination of isolated hearts, histopathological evaluation was performed by light microscopy. A significant (p 
    Matched MeSH terms: Drug Therapy, Combination
  13. Tang ASO, Wong QY, Yeo ST, Ting IPL, Lee JTH, Fam TL, et al.
    Am J Case Rep, 2021 May 26;22:e931655.
    PMID: 34038399 DOI: 10.12659/AJCR.931655
    BACKGROUND Leprosy is an infection caused by Mycobacterium leprae. An extensive literature search did not reveal many reports of melioidosis in association with leprosy. CASE REPORT A 22-year-old woman, who was diagnosed with multibacillary leprosy, developed dapsone-induced methemoglobinemia and hemolytic anemia, complicated by melioidosis. Methemoglobinemia was treated with methylene blue and vitamin C. Two weeks of ceftazidime was initiated to treat melioidosis, and the patient was discharged on amoxicillin/clavulanic acid and doxycycline as melioidosis eradication therapy. However, she developed drug-induced hypersensitivity. Trimethoprim/sulfamethoxazole, as an alternative treatment for melioidosis eradication, was commenced and was successfully completed for 12 weeks. During the fifth month of multidrug therapy, the patient developed type II lepra reaction with erythema nodosum leprosum reaction, which was treated with prednisolone. Leprosy treatment continued with clofazimine and ofloxacin, and complete resolution of skin lesions occurred after 12 months of therapy. CONCLUSIONS Our case highlighted the challenges posed in managing a patient with multibacillary leprosy with multiple complications. Clinicians should be aware that dapsone-induced methemoglobinemia and hemolysis might complicate the treatment of leprosy. Our case also highlighted the safety and efficacy of combining ofloxacin and clofazimine as a leprosy treatment regimen in addition to gradual steroid dose titration in the presence of type II lepra reaction.
    Matched MeSH terms: Drug Therapy, Combination
  14. Ng, B.K., Lim, P.S., Ng, Y.L., Kew, T.Y., Abdul Kadir, A.K., Hatta, M.
    MyJurnal
    Primary malignant melanoma of the vagina is rare but aggressive. Various treatment options include surgery and adjuvant therapy has been advocated but the outcome remained unpredictable. Standard treatment protocol is yet to be established. We report a case of 54-year-old, Para 4+1, with malignant melanoma of the vagina. She underwent wide local excision but the surgical margin was not clear of malignant cells, hence adjuvant radiotherapy was given. Combination chemotherapy was initiated subsequently as her disease disseminated. She succumbed later due to septicaemic shock. The treatment options for vaginal melanoma were reviewed.
    Matched MeSH terms: Drug Therapy, Combination
  15. Tew MP, Tan PC, Saaid R, Hong JGS, Omar SZ
    Int J Gynaecol Obstet, 2022 Mar;156(3):508-515.
    PMID: 33890319 DOI: 10.1002/ijgo.13718
    OBJECTIVE: To evaluate the impact of preemptive metformin on the level of glycosylated hemoglobin (HbA1c) at 36 weeks of pregnancy in women with gestational diabetes mellitus controlled by diet change (GDMA1).

    METHODS: A randomized, double-blind, placebo-controlled trial was performed in a university hospital. Women with GDMA1 were recruited at 16-30 weeks of pregnancy and randomized to oral metformin 500 mg twice daily or identical placebo tablets to delivery. Level of HbA1c was taken at recruitment and at 36 weeks of pregnancy. The primary outcome was the change in level of HbA1c at recruitment and 36 weeks of pregnancy.

    RESULTS: Data from 106 participants were analyzed. The level of HbA1c during pregnancy increased significantly with a mean increase of 0.20% ± 0.31% (P 

    Matched MeSH terms: Drug Therapy, Combination
  16. Fazal SA, Khan M, Nishi SE, Alam F, Zarin N, Bari MT, et al.
    Endocr Metab Immune Disord Drug Targets, 2018 Feb 13;18(2):98-109.
    PMID: 29141572 DOI: 10.2174/1871530317666171114122417
    BACKGROUND AND OBJECTIVE: Rheumatoid arthritis (RA) is a predominant inflammatory autoimmune disorder. The incidence and prevalence of RA is increasing with considerable morbidity and mortality worldwide. The pathophysiology of RA has become clearer due to many significant research outputs during the last two decades. Many inflammatory cytokines involved in RA pathophysiology and the presence of autoantibodies are being used as potential biomarkers via the use of effective diagnostic techniques for the early diagnosis of RA. Currently, several disease-modifying anti-rheumatic drugs are being prescribed targeting RA pathophysiology, which have shown significant contributions in improving the disease outcomes.

    DISCUSSION: Even though innovations in treatment strategies and monitoring are helping the patients to achieve early and sustained clinical and radiographic remission, the high cost of drugs and limited health care budgets are restricting the easy access of RA treatment. Both direct and indirect high cost of treatment are creating economic burden for the patients and affecting their quality of life.

    CONCLUSION: The aim of this review is to describe the updated concept of RA pathophysiology and highlight current diagnostic tools used for the early detection as well as prognosis - targeting several biomarkers of RA. Additionally, we explored the updated treatment options with side effects besides discussing the global economic burden.
    Matched MeSH terms: Drug Therapy, Combination/adverse effects; Drug Therapy, Combination/economics; Drug Therapy, Combination/trends
  17. Krishnan K, Law ZK, Minhas JS, Bath PM, Robinson TG, Sprigg N, et al.
    Clin Med (Lond), 2022 Sep;22(5):449-454.
    PMID: 36507812 DOI: 10.7861/clinmed.2021-0597
    Acute stroke is the leading cause of disability in the UK and a leading cause of mortality worldwide. The majority of patients with ischaemic stroke present with minor deficits or transient ischaemic attack (TIA), and are often first seen by patient-facing clinicians. Urgent evaluation and treatment are important as many patients are at high risk of major vascular events and death within hours to days after the index event. This narrative review summarises the evidence on four antiplatelet treatments for non-cardioembolic stroke prevention: aspirin, clopidogrel, dipyridamole and ticagrelor. Each of these drugs has a unique mechanism and has been tested as a single agent or in combination. Aspirin, when given early is beneficial and short-term treatment with aspirin and clopidogrel has been shown to be more effective in high-risk TIA / minor stroke. This review concludes by highlighting gaps in evidence, including scope for future trials that could potentially change clinical practice.
    Matched MeSH terms: Drug Therapy, Combination
  18. Papot E, Jacoby S, Arlinda D, Avihingsanon A, Azwa I, Borok M, et al.
    HIV Res Clin Pract, 2022 Jul 19;23(1):37-46.
    PMID: 35938597
    A rapidly changing landscape of antiretrovirals and their procurement at scale has permitted the evaluation of new optimised second-line antiretroviral therapy (ART) in low- and middle-income countries. D2EFT is an open-label randomised controlled non-inferiority phase IIIB/IV trial in people living with HIV-1 (PWH) whose first-line non-nucleoside reverse transcriptase inhibitor (NNRTI)-based ART is failing. At inception, it compared a standard of care of boosted darunavir with two nucleos(t)ide reverse transcriptase inhibitors (NRTIs) to the novel NRTI-sparing regimen of boosted darunavir with dolutegravir. Implemented in 2017, participating sites were across Africa, Asia and Latin America. Around the time of implementation, the World Health Organization updated its treatment guidelines and recommended scaling up tenofovir disoproxil fumarate-lamivudine-dolutegravir (TLD). This situation pushed D2EFT investigators to consider the impact of the roll-out of TLD on the D2EFT research question. The protocol team agreed it was important to study TLD in second-line when an NNRTI regimen was failing, and focused on options to expedite the work by studying the question within the existing trial and network. All key issues (statistical, programmatic and financial) were reviewed to assess the benefits and risks of adding a third arm to the ongoing study, as opposed to developing a new randomised clinical trial with the same control arm and within the same network. The development of a new trial was deemed to be longer than adding a third arm, and to create a challenging situation with two competing clinical trials at the same sites which would slow down recruitment and impair both trials. On the other hand, adding a third arm would be demanding in terms of operationalisation, increased sample size and statistical biases to control. The optimal strategy was deemed to be the addition of a third arm, arriving retrospectively at a simplified multi-arm multi-stage clinical trial design to achieve statistical validity. The D2EFT study maintains additional value in a quickly evolving second-line ART strategy allowed by the progress in global access to ART.
    Matched MeSH terms: Drug Therapy, Combination
  19. Tan BE, Wong PY, Baibhav B, Thakkar S, Azhar AZ, Rao M, et al.
    Curr Probl Cardiol, 2023 Aug;48(8):101174.
    PMID: 35341798 DOI: 10.1016/j.cpcardiol.2022.101174
    Current guidelines recommend 6-12 months of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) followed by aspirin monotherapy indefinitely. We aimed to assess the efficacy and safety of clopidogrel vs aspirin in the post-PCI population after completing DAPT. We systematically searched 5 electronic databases to identify studies comparing clopidogrel with aspirin following completion of DAPT after PCI. We pooled outcomes for major adverse cardiac events (MACE), cardiac death, all-cause death, major bleeding, myocardial infarction (MI), and stroke. We included 5 studies with 13,850 patients, of whom 5601 (40.4%) received clopidogrel. Mean follow-up was 12-36 months. All patients received drug-eluting stents. Duration of DAPT before antiplatelet monotherapy was 1-18 months. Clopidogrel was associated with reductions in MACE (Risk ratio [RR] 0.77, 95% confidence interval [CI] 0.65-0.91), any stroke (RR 0.51; 95% confidence interval [CI] 0.35-0.76), ischemic stroke (RR 0.55; 95% CI 0.32-0.94), and hemorrhagic stroke (RR 0.24; 95% CI 0.09-0.68) when compared with aspirin. Cardiac death (RR 0.87; 95% CI 0.53-1.41), all-cause death (RR 1.06; 95% CI 0.81-1.39), major bleeding (RR 0.74; 95% CI 0.43-1.29), MI (RR 1.01; 95% CI 0.64-1.60), repeat revascularization (RR 0.88; 95% CI 0.71-1.09), target vessel revascularization (RR 0.76; 95% CI 0.52-1.13), and stent thrombosis (RR 0.96; 95% CI 0.35-2.59) were not significantly different among groups. Compared with aspirin, clopidogrel was associated with reductions in MACE and stroke (ischemic and hemorrhagic) following DAPT completion after PCI. There were no significant differences in mortality, major bleeding, MI, and repeat revascularization between groups.
    Matched MeSH terms: Drug Therapy, Combination
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